AVANOS MEDICAL, INC. - Quarter Report: 2022 September (Form 10-Q)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2022

☐ 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 001-36440

AVANOS MEDICAL, INC.

(Exact name of registrant as specified in its charter)

Delaware

46-4987888

(State or other jurisdiction of incorporation)

(I.R.S. Employer Identification No.)

5405 Windward Parkway

Suite 100 South

Alpharetta,

Georgia

30004

(Address of principal executive offices)

(Zip code)

Registrant’s telephone number, including area code: (844) 428-2667

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


Title of each class	Trading Symbol	Name of exchange on which registered
Common Stock - $0.01 Par Value	AVNS	New York Stock Exchange

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

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting 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

☒

Accelerated filer

☐

Non-accelerated filer

☐

Emerging growth company

☐

Smaller reporting company

☐

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

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐ No ☒

As of October 26, 2022, there were 46,497,608 shares of the registrant’s common stock outstanding.

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PART I – FINANCIAL INFORMATION

Item 1. Financial Statements			4

Unaudited Condensed Consolidated Income Statements for the Three and Nine Months Ended Septe mber 30, 2022 and 2021			4

Unaudited Condensed Consolidated Statements of Comprehensive Income for the Three and Nine Months Ended September 30, 2022 and 2021			5

Unaudited Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021			6

Unaudited Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2022 and 2021			7

Unaudited Condensed Consolidated Cash Flow Statements for the Nine Months Ended September 30, 2022 and 2021			8

Notes to the Unaudited Condensed Consolidated Financial Statements			9

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations			25

Item 3. Quantitative and Qualitative Disclosures About Market Risk			30

Item 4. Controls and Procedures			31

PART II – OTHER INFORMATION			32

Item 1. Legal Proceedings			32
Item 1A. Risk Factors			32
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			33
Item 3. Defaults Upon Senior Securities			33
Item 4. Mine Safety Disclosures			33
Item 5. Other Information			33
Item 6. Exhibits			33
Signatures			35

Information Concerning Forward-Looking Statements

This Quarterly Report on Form 10-Q (this “Form 10-Q”) contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are included throughout this Form 10-Q, including in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Forward-looking statements include all statements that do not relate solely to historical or current facts, and can generally be identified by the use of words such as “may,” “believe,” “will,” “expect,” “intend,” “predict,” “potential,” “project,” “estimate,” “anticipate,” “plan,” or “continue” and similar expressions. The matters discussed in these forward-looking statements are based on the current plans and expectations of our management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied in the forward-looking statements. These factors include, but are not limited to:

•general economic conditions, particularly in the United States;

•fluctuations in global equity and fixed-income markets;

•risks related to the ongoing COVID-19 pandemic;

•the competitive environment;

•the loss of current customers or the inability to obtain new customers;

•litigation and enforcement actions;

•disruption in the supply of raw materials or the distribution of finished goods;

•price fluctuations in key commodities;

•fluctuations in currency exchange rates;

•changes in governmental regulations that are applicable to our business;

•our ability to realize the intended benefits of acquisition or merger transactions;

•changes in asset valuations, including write-downs of assets such as inventory, accounts receivable or other assets for impairment or other reasons; and

•any other matters described in Item 1A - “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 (the “Form 10-K”) and Part II, Item 1A - “Risk Factors” in this Form 10-Q.

You are cautioned not to unduly rely on such forward-looking statements when evaluating the information in this Form 10-Q. Where, in any forward-looking statement, an expectation or belief as to future results or events is expressed, such expectation or belief is based on the current plans and expectations of our management and expressed in good faith, and is believed to have a reasonable basis. There can be no assurance that any such expectation or belief will be achieved or accomplished.

Any forward-looking statement made in this Form 10-Q speaks only as of the date of this report. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable securities laws.


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PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

AVANOS MEDICAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED INCOME STATEMENTS

(in millions, except per share amounts)

(Unaudited)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Net Sales	$	202.1	$	184.1	$	602.5	$	551.2
Cost of products sold	92.0		93.9		269.4		284.3
Gross Profit	110.1		90.2		333.1		266.9
Research and development	7.3		8.4		23.1		24.7
Selling and general expenses	82.1		75.0		259.3		225.1
Other expense, net	2.0		3.4		2.9		33.7
Operating Income (Loss)	18.7		3.4		47.8		(16.6)
Interest income	0.3		0.2		0.5		0.2
Interest expense	(3.0)		(0.9)		(7.0)		(2.6)
Income (Loss) Before Income Taxes	16.0		2.7		41.3		(19.0)
Income tax (provision) benefit	(0.3)		(38.0)		(7.7)		13.8
Net Income (Loss)	$	15.7	$	(35.3)	$	33.6	$	(5.2)

Earnings (Loss) Per Share
Basic	$	0.34	$	(0.73)	$	0.71	$	(0.11)
Diluted	$	0.33	$	(0.73)	$	0.71	$	(0.11)

* Certain amounts have been adjusted to reflect a change in accounting principle as described in Note 1 to our Condensed Consolidated Financial Statements.

The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.


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AVANOS MEDICAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(in millions)

(Unaudited)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Net Income (Loss)	$	15.7	$	(35.3)	$	33.6	$	(5.2)
Other Comprehensive Income (Loss), Net of Tax
Unrealized currency translation adjustments	(5.1)		(3.7)		(9.1)		(5.6)
Defined benefit plans	—		0.1		—		0.1

Total Other Comprehensive Income (Loss), Net of Tax	(5.1)		(3.6)		(9.1)		(5.5)
Comprehensive Income (Loss)	$	10.6	$	(38.9)	$	24.5	$	(10.7)

* Certain amounts have been adjusted to reflect a change in accounting principle as described in Note 1 to our Condensed Consolidated Financial Statements.

The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.


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AVANOS MEDICAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in millions, except share data)

(Unaudited)


	September 30, 2022		December 31, 2021
ASSETS
Current Assets
Cash and cash equivalents	$	117.0	$	118.5
Accounts receivable, net of allowances	146.2		131.2
Inventories	193.6		159.3
Prepaid and other current assets	13.2		18.6
Total Current Assets	470.0		427.6
Property, Plant and Equipment, net	163.4		168.1
Operating Lease Right-of-Use Assets	32.5		38.6
Goodwill	823.6		801.6
Other Intangible Assets, net	258.7		141.2
Deferred Tax Assets	10.9		10.0
Other Assets	16.1		16.5
TOTAL ASSETS	$	1,775.2	$	1,603.6

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Current portion of long-term debt	$	6.2	$	—
Current portion of operating lease liabilities	13.4		14.7
Trade accounts payable	62.7		56.4
Accrued expenses	80.0		68.1
Total Current Liabilities	162.3		139.2
Long-Term Debt	247.8		130.0
Operating Lease Liabilities	36.8		42.8
Deferred Tax Liabilities	37.0		11.9
Other Long-Term Liabilities	27.8		9.1
Total Liabilities	511.7		333.0

Commitments and Contingencies

Stockholders’ Equity
Preferred stock - $0.01 par value - authorized 20,000,000 shares, none issued	—		—
Common stock - $0.01 par value - authorized 300,000,000 shares, 46,495,519 outstanding as of September 30, 2022 and 48,206,156 outstanding as of December 31, 2021	0.5		0.5
Additional paid-in capital	1,642.3		1,628.8
Accumulated deficit	(270.0)		(303.6)
Treasury stock	(66.4)		(21.3)
Accumulated other comprehensive loss	(42.9)		(33.8)
Total Stockholders’ Equity	1,263.5		1,270.6
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	1,775.2	$	1,603.6

* Certain amounts have been adjusted to reflect a change in accounting principle as described in Note 1 to our Condensed Consolidated Financial Statements.

The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.


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AVANOS MEDICAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY

(in millions)

(Unaudited)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Common Stock	$	0.5	$	0.5	$	0.5	$	0.5
Additional Paid-in Capital, beginning of period	1,637.4		1,621.3		1,628.8		1,609.4
Exercise or redemption of share-based awards	0.8		0.9		1.6		6.1
Stock-based compensation expense	4.1		3.5		11.9		10.2
Additional Paid-in Capital, end of period	1,642.3		1,625.7		1,642.3		1,625.7
Accumulated Deficit, beginning of period	(285.7)		(279.8)		(303.6)		(309.9)
Net income (loss)	15.7		(35.3)		33.6		(5.2)
Accumulated Deficit, end of period	(270.0)		(315.1)		(270.0)		(315.1)
Treasury Stock, beginning of period	(55.4)		(10.3)		(21.3)		(9.8)
Purchases of treasury stock	(11.0)		(0.1)		(45.1)		(0.6)
Treasury Stock, end of period	(66.4)		(10.4)		(66.4)		(10.4)
Accumulated Other Comprehensive Loss, beginning of period	(37.8)		(30.0)		(33.8)		(28.1)
Other comprehensive loss, net of tax	(5.1)		(3.6)		(9.1)		(5.5)
Accumulated Other Comprehensive Loss, end of period	(42.9)		(33.6)		(42.9)		(33.6)
Total Stockholders’ Equity, end of period	$	1,263.5	$	1,267.1	$	1,263.5	$	1,267.1

* Certain amounts have been adjusted to reflect a change in accounting principle as described in Note 1 to our Condensed Consolidated Financial Statements.

The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.


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AVANOS MEDICAL, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED CASH FLOW STATEMENTS

(in millions)

(Unaudited)


	Nine Months Ended September 30,
	2022		2021
Operating Activities
Net income (loss)	$	33.6	$	(5.2)
Depreciation and amortization	34.3		28.8
Stock-based compensation expense	11.9		10.2
Net loss on asset dispositions and impairments	—		4.9
Changes in operating assets and liabilities, net of acquisition:
Accounts receivable	(6.0)		(10.5)
Income tax receivable	—		47.7
Inventories	(35.8)		9.9
Prepaid expenses and other assets	3.5		1.1
Accounts payable	34.1		(11.9)
Accrued expenses	(18.5)		(24.5)
Deferred income taxes and other	0.1		(15.3)
Cash Provided by Operating Activities	57.2		35.2
Investing Activities
Capital expenditures	(14.4)		(16.3)
Acquisition of assets and investments in businesses	(116.1)		—
Cash Used in Investing Activities	(130.5)		(16.3)
Financing Activities
Proceeds from issuance of secured debt	250.0		—
Secured debt repayments	(125.0)		—
Revolving credit facility proceeds	150.0		20.0
Revolving credit facility repayments	(150.0)		(55.0)
Purchases of treasury stock	(45.1)		(0.6)
Payments of debt issuance costs	(2.9)		—
Proceeds from the exercise of stock options	1.6		6.1

Cash Provided by (Used in) Financing Activities	78.6		(29.5)
Effect of Exchange Rate Changes on Cash and Cash Equivalents	(6.8)		(3.1)
Decrease in Cash and Cash Equivalents	(1.5)		(13.7)
Cash and Cash Equivalents - Beginning of Period	118.5		111.5
Cash and Cash Equivalents - End of Period	$	117.0	$	97.8

* Certain amounts have been adjusted to reflect a change in accounting principle as described in Note 1 to our Condensed Consolidated Financial Statements.

The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.


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AVANOS MEDICAL, INC. AND SUBSIDIARIES

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Note 1. Accounting Policies

Background and Basis of Presentation

Avanos Medical, Inc. is a medical technology company focused on delivering clinically superior breakthrough medical device solutions to improve patients’ quality of life. Headquartered in Alpharetta, Georgia, Avanos is committed to addressing some of today’s most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. We develop, manufacture and market clinically superior solutions in more than 90 countries. References herein to “Avanos,” “Company,” “we,” “our” and “us” refer to Avanos Medical, Inc. and its consolidated subsidiaries.

Interim Financial Statements

We prepared the accompanying unaudited condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and the instructions to the Quarterly Report on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements, and the condensed consolidated financial statements in this Form 10-Q should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2021. Our unaudited interim condensed consolidated financial statements contain all necessary material adjustments, which are of a normal and recurring nature, to fairly state our financial condition, results of operations and cash flows for the periods presented.

Use of Estimates

Preparation of our condensed consolidated financial statements in accordance with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of net sales and expenses during the reporting periods. Estimates are used in accounting for, among other things, distributor rebate accruals, future cash flows associated with impairment testing for goodwill and long-lived assets, loss contingencies, and deferred tax assets and potential income tax assessments. Our estimates are subject to uncertainties associated with supply chain disruptions, which have caused volatility and adverse effects in global markets. Actual results could differ from these estimates, and the effect of any change could be material to our financial statements. Changes in these estimates are recorded when known.

Annual Goodwill Impairment Test

We test goodwill for impairment annually or more frequently whenever events or circumstances more likely than not indicate that the fair value of the reporting unit may be below its carrying value. We operate as a single reportable operating segment with one reporting unit. The fair value of our reporting unit was estimated using a combination of income (discounted cash flow analysis) and market approaches. The income approach is dependent upon several assumptions regarding future periods such as sales growth and a terminal growth rate. A weighted average cost of capital (“WACC”) was used to discount future estimated cash flows to their present values. The WACC was based on externally observable data considering market participants’ cost of equity and debt, optimal capital structure and risk factors specific to us. The market approach estimates the value of our company using a market capitalization methodology.

We completed our annual goodwill impairment test as of July 1, 2022, and determined that the fair value of our reporting unit exceeds the net carrying amount. There can be no assurance that the assumptions and estimates made for purposes of the annual goodwill impairment test will prove to be accurate. Volatility in the equity and debt markets, or increases in interest rates, could result in a higher discount rate. Changes in sales volumes, selling prices and costs of goods sold, and increases in interest rates could cause changes in our forecasted cash flows. Unfavorable changes in any of the factors described above could result in a goodwill impairment charge in the future.

Recently Adopted Accounting Pronouncements

Effective January 1, 2022, we adopted Accounting Standards Update (“ASU”) No. 2021-04, Issuers Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. This ASU is intended to clarify accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity-classified after modification or exchange. The accounting is determined based on whether the transaction was done to issue equity, issue or modify debt or for other reasons. Adoption of this ASU did not have a material effect on our financial position, results of operations or cash flows.


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Recently Issued Accounting Pronouncements

In October 2021, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2021-08, Business Combinations: Accounting for Contract Assets and Contract Liabilities from Contracts with Customers. This ASU pertains to acquired revenue contracts with customers in a business combination and addresses diversity in practice and inconsistency related to recognition of an acquired contract liability and payment terms and their effect on subsequent revenue recognized by the acquirer. This ASU is to be applied prospectively for years beginning after December 15, 2022. Adoption of this ASU is not expected to have a material effect on our financial position, results of operations or cash flows.

Change in Accounting Principle

During the third quarter of 2022, we elected to change our method of accounting for U.S. inventory from the Last-In, First-Out (“LIFO”) method to the First-In, First-Out (“FIFO”) method. We believe the FIFO method of accounting for inventory is preferable because it provides for an inventory balance that more closely reflects the inventory’s current cost, improves efficiency and enhances comparability with our peers. The effects of the change in accounting method from LIFO to FIFO have been retrospectively applied to all periods presented in all sections of this Form 10-Q, including Management's Discussion and Analysis.

As a result of the accounting change, accumulated deficit as of January 1, 2021 improved from $315.5 million, as reported under the LIFO method to $309.9 million using the FIFO method. Accumulated deficit as of January 1, 2022 improved from $310.3 million, as reported under the LIFO method to $303.6 million using the FIFO method.

The following financial statement line items within the accompanying condensed consolidated financial statements and unaudited interim 2022 and 2021 quarterly condensed consolidated financial statements were adjusted as follows:


Condensed Consolidated Income Statements
(in millions, except per share amounts)
(Unaudited)
	Three Months Ended						Three Months Ended
	September 30, 2022						September 30, 2021
	As Calculated (LIFO)		As Reported (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Cost of products sold	$	92.3	$	92.0	$	(0.3)	$	93.7	$	93.9	$	0.2
Income (loss) before income taxes	15.7		16.0		0.3		2.9		2.7		(0.2)
Income tax (provision) benefit	(0.3)		(0.3)		—		(38.0)		(38.0)		—
Net income (loss)	15.4		15.7		0.3		(35.1)		(35.3)		(0.2)
Earnings (loss) per share:
Basic	$	0.33	$	0.34	$	0.01	$	(0.73)	$	(0.73)	$	—
Diluted	$	0.33	$	0.33	$	—	$	(0.73)	$	(0.73)	$	—

	Nine Months Ended						Nine Months Ended
	September 30, 2022						September 30, 2021
	As Calculated (LIFO)		As Reported (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Cost of products sold	$	270.6	$	269.4	$	(1.2)	$	283.8	$	284.3	$	0.5
Income (loss) before income taxes	40.1		41.3		1.2		(18.5)		(19.0)		(0.5)
Income tax (provision) benefit	(7.5)		(7.7)		(0.2)		13.7		13.8		0.1
Net income (loss)	32.6		33.6		1.0		(4.8)		(5.2)		(0.4)
Earnings (loss) per share:
Basic	$	0.69	$	0.71	$	0.02	$	(0.10)	$	(0.11)	$	(0.01)
Diluted	$	0.69	$	0.71	$	0.02	$	(0.10)	$	(0.11)	$	(0.01)


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Condensed Consolidated Income Statements (cont’d)
(in millions, except per share amounts)
(Unaudited)
	Three Months Ended						Three Months Ended
	June 30, 2022						June 30, 2021
	As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Cost of products sold	$	88.1	$	86.6	$	(1.5)	$	100.7	$	100.0	$	(0.7)
Income (loss) before income taxes	16.5		18.0		1.5		(8.2)		(7.5)		0.7
Income tax (provision) benefit	(5.1)		(5.5)		(0.4)		46.1		46.0		(0.1)
Net income (loss)	11.4		12.5		1.1		37.9		38.5		0.6
Earnings (loss) per share:
Basic	$	0.24	$	0.27	$	0.03	$	0.79	$	0.80	$	0.01
Diluted	$	0.24	$	0.26	$	0.02	$	0.78	$	0.79	$	0.01

	Six Months Ended						Six Months Ended
	June 30, 2022						June 30, 2021
	As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Cost of products sold	$	178.3	$	177.4	$	(0.9)	$	190.1	$	190.4	$	0.3
Income (loss) before income taxes	24.4		25.3		0.9		(21.4)		(21.7)		(0.3)
Income tax (provision) benefit	(7.2)		(7.4)		(0.2)		51.7		51.8		0.1
Net income (loss)	17.2		17.9		0.7		30.3		30.1		(0.2)
Earnings (loss) per share:
Basic	$	0.36	$	0.38	$	0.02	$	0.63	$	0.63	$	—
Diluted	$	0.36	$	0.37	$	0.01	$	0.62	$	0.62	$	—

	Three Months Ended						Three Months Ended
	March 31, 2022						March 31, 2021
	As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Cost of products sold	$	90.2	$	90.8	$	0.6	$	89.4	$	90.4	$	1.0
Income (loss) before income taxes	7.9		7.3		(0.6)		(13.2)		(14.2)		(1.0)
Income tax (provision) benefit	(2.1)		(1.9)		0.2		5.6		5.8		0.2
Net income (loss)	5.8		5.4		(0.4)		(7.6)		(8.4)		(0.8)
Earnings (loss) per share:
Basic	$	0.12	$	0.11	$	(0.01)	$	(0.16)	$	(0.17)	$	(0.01)
Diluted	$	0.12	$	0.11	$	(0.01)	$	(0.16)	$	(0.17)	$	(0.01)


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Condensed Consolidated Statements of Comprehensive Income
(in millions)
(Unaudited)
	Three Months Ended						Three Months Ended
	September 30, 2022						September 30, 2021
	As Calculated (LIFO)		As Reported (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Net income (loss)	$	15.4	15.7		$	0.3	$	(35.1)	$	(35.3)	$	(0.2)
Comprehensive income (loss)	10.3		10.6		0.3		(38.7)		(38.9)		(0.2)

	Nine Months Ended						Nine Months Ended
	September 30, 2022						September 30, 2021
	As Calculated (LIFO)		As Reported (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Net income (loss)	$	32.6	$	33.6	$	1.0	$	(4.8)	$	(5.2)	$	(0.4)
Comprehensive income (loss)	23.5		24.5		1.0		(10.3)		(10.7)		(0.4)

	Three Months Ended						Three Months Ended
	June 30, 2022						June 30, 2021
	As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Net income (loss)	$	11.4	$	12.5	$	1.1	$	37.9	$	38.5	$	0.6
Comprehensive income (loss)	5.7		6.8		1.1		40.2		40.8		0.6

	Six Months Ended						Six Months Ended
	June 30, 2022						June 30, 2021
	As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Net income (loss)	$	17.2	$	17.9	$	0.7	$	30.3	$	30.1	$	(0.2)
Comprehensive income (loss)	13.2		13.9		0.7		28.4		28.2		(0.2)

	Three Months Ended						Three Months Ended
	March 31, 2022						March 31, 2021
	As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Net income (loss)	$	5.8	$	5.4	$	(0.4)	$	(7.6)	$	(8.4)	$	(0.8)
Comprehensive income (loss)	7.5		7.1		(0.4)		(11.8)		(12.6)		(0.8)


Condensed Consolidated Balance Sheets
(in millions)
(Unaudited)
	As of September 30, 2022						As of December 31, 2021
	As Calculated (LIFO)		As Reported (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Inventories	$	183.4	$	193.6	$	10.2	$	150.3	$	159.3	$	9.0
Accrued expenses(a)	77.5		80.0		2.5		68.1		68.1		—
Deferred tax liabilities	37.0		37.0		—		9.6		11.9		2.3
Accumulated deficit, end of period	(277.7)		(270.0)		7.7		(310.3)		(303.6)		6.7


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Condensed Consolidated Statements of Stockholders’ Equity
(in millions)
(Unaudited)
	Three Months Ended						Three Months Ended
	September 30, 2022						September 30, 2021
	As Calculated (LIFO)		As Reported (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Accumulated deficit, beginning of period	$	(293.1)	$	(285.7)	$	7.4	$	(285.2)	$	(279.8)	$	5.4
Net income (loss)	15.4		15.7		0.3		(35.1)		(35.3)		(0.2)
Total stockholders' equity	1,255.8		1,263.5		7.7		1,261.9		1,267.1		5.2

	Nine Months Ended						Nine Months Ended
	September 30, 2022						September 30, 2021
	As Calculated (LIFO)		As Reported (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Accumulated deficit, beginning of period	$	(310.3)	$	(303.6)	$	6.7	$	(315.5)	$	(309.9)	$	5.6
Net income (loss)	32.6		33.6		1.0		(4.8)		(5.2)		(0.4)
Total stockholders' equity	1,255.8		1,263.5		7.7		1,261.9		1,267.1		5.2

	Three Months Ended						Three Months Ended
	June 30, 2022						June 30, 2021
	As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Accumulated deficit, beginning of period	$	(304.5)	$	(298.2)	$	6.3	$	(323.1)	$	(318.3)	$	4.8
Net income (loss)	11.4		12.5		1.1		37.9		38.5		0.6
Total stockholders' equity	1,251.6		1,259.0		7.4		1,296.3		1,301.7		5.4

	Six Months Ended						Six Months Ended
	June 30, 2022						June 30, 2021
	As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Accumulated deficit, beginning of period	$	(310.3)	$	(303.6)	$	6.7	$	(315.5)	$	(309.9)	$	5.6
Net income (loss)	17.2		17.9		0.7		30.3		30.1		(0.2)
Total stockholders' equity	1,251.6		1,259.0		7.4		1,296.3		1,301.7		5.4

	Three Months Ended						Three Months Ended
	March 31, 2022						March 31, 2021
	As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Accumulated deficit, beginning of period	$	(310.3)	$	(303.6)	$	6.7	$	(315.5)	$	(309.9)	$	5.6
Net income (loss)	5.8		5.4		(0.4)		(7.6)		(8.4)		(0.8)
Total stockholders' equity	1,256.5		1,262.8		6.3		1,252.6		1,257.4		4.8


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Condensed Consolidated Cash Flow Statements
(in millions)
(Unaudited)
	Nine Months Ended						Nine Months Ended
	September 30, 2022						September 30, 2021
	As Calculated (LIFO)		As Reported (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Net income (loss)	$	32.6	$	33.6	$	1.0	$	(4.8)	$	(5.2)	$	(0.4)
Inventories	(34.6)		(35.8)		(1.2)		9.4		9.9		0.5
Accrued expenses(a)	(18.7)		(18.5)		0.2		(24.4)		(24.5)		(0.1)

	Six Months Ended						Six Months Ended
	June 30, 2022						June 30, 2021
	As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Net income (loss)	$	17.2	$	17.9	$	0.7	$	30.3	$	30.1	$	(0.2)
Inventories	(17.1)		(18.0)		(0.9)		8.7		9.0		0.3
Accrued expenses(a)	(28.7)		(28.5)		0.2		(5.6)		(5.7)		(0.1)

	Three Months Ended						Three Months Ended
	March 31, 2022						March 31, 2021
	As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change		As Reported (LIFO)		As Adjusted (FIFO)		Effect of Change
Net income (loss)	$	5.8	$	5.4	$	(0.4)	$	(7.6)	$	(8.4)	$	(0.8)
Inventories	(4.5)		(3.9)		0.6		2.8		3.8		1.0
Accrued expenses(a)	(28.6)		(28.8)		(0.2)		(2.0)		(2.2)		(0.2)

__________________________________________________

(a)We have elected to apply FASB Interpretation 18 (FIN 18) to the income tax effects arising from the change in accounting principle for interim reporting periods. As a result, we have presented the tax effects from the change in accounting principle in Accrued income taxes payable within Accrued expenses on the Condensed Consolidated Balance Sheets for the interim reporting periods disclosed in the tables above. For annual reporting periods, tax effects from the change in accounting principle are reflected in Deferred tax liabilities on the Condensed Consolidated Balance Sheets.


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Note 2. Business Acquisition

On January 20, 2022, we acquired all of the equity voting interests and completed the acquisition of OrthogenRx, Inc. (“OrthogenRx”), which is focused on the development and commercialization of treatments for knee pain caused by osteoarthritis. We expect the acquisition of OrthogenRx will enhance our chronic pain portfolio. The initial purchase price was $130 million at closing less working capital adjustments, with up to an additional $30 million payable in contingent cash consideration based on OrthogenRx’s growth in net sales during 2022 and 2023. The purchase price was funded by available cash on hand and the proceeds of borrowings, including an incremental $125.0 million tranche of term loans. The accompanying condensed consolidated income statement for the three and nine months ended September 30, 2022 includes $20.4 million and $56.9 million of net sales, respectively, from OrthogenRx since the closing of the acquisition. In the three and nine months ended September 30, 2022, we incurred $0.2 million and $1.6 million of costs, respectively, in connection with the OrthogenRx acquisition, which are included in “Selling and general expenses.”

We accounted for the OrthogenRx acquisition under the acquisition method of accounting for business combinations. Accordingly, the purchase price paid was allocated to the underlying net assets in proportion to their respective fair values. The fair value of the net assets acquired are based on estimates and assumptions relating to certain intangible assets acquired, liabilities assumed, income taxes and loss contingencies, which are subject to change during the measurement period (up to one year from the acquisition date). The deferred tax liability is subject to change as the estimated liability may be adjusted in conjunction with our year-end tax provision calculation. Any excess of the purchase price over the estimated fair values was recorded as goodwill. Fair values of assets acquired and liabilities assumed were determined using discounted cash flow analyses, and the fair value of the contingent cash consideration was estimated using a Monte Carlo simulation. The purchase price allocation, net of cash acquired, is shown in the table below (in millions):


Accounts receivable, net	$	13.7
Inventory	2.8
Other current assets	0.4
Accounts payable	(5.4)
Other current liabilities	(13.0)
Contingent consideration	(9.2)
Other non-current assets (liabilities)	(9.5)
Deferred tax liability	(23.7)
Identifiable intangible assets	135.6
Goodwill	24.4
Total	$	116.1

Goodwill arising from the OrthogenRx acquisition is not fully tax deductible. The identifiable intangible assets relating to the OrthogenRx acquisition include the following (in millions, except years):


	Identifiable Intangible Asset Amount		Weighted Average Useful Lives (Years)
Trademarks	$	1.3	10
Other	134.3		14
Total	$	135.6

Other intangible assets are primarily related to the OrthogenRx products that we currently market and distribute, combined into one composite intangible asset that includes customer relationships and exclusive distribution rights.


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The following unaudited pro forma financial information is presented in the table below for the three and nine months ended September 30, 2022 and 2021 as if the acquisition had occurred on January 1, 2021 (in millions, except per share amounts):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022 (Unaudited)		2021 (Unaudited)		2022 (Unaudited)		2021 (Unaudited)
Net sales	$	202.1	$	204.3	$	604.8	$	605.5

Net income	$	15.9	$	(28.2)	$	36.7	$	9.8

Earnings (Loss) Per Share:
Basic	$	0.34	$	(0.58)	$	0.78	$	0.20
Diluted	$	0.34	$	(0.58)	$	0.77	$	0.20

The pro forma financial information has been adjusted to include the effects of the acquisition, including acquisition-related costs, amortization of acquired intangibles and related tax effects. The pro-forma financial information is not necessarily indicative of the results of operations that would have been achieved.

Note 3. Supplemental Balance Sheet Information

Accounts Receivable

Accounts receivable consist of the following (in millions):


	September 30, 2022		December 31, 2021
Accounts receivable	$	140.0	$	122.0
Income tax receivable	12.2		13.0
Allowances and doubtful accounts:
Doubtful accounts	(5.7)		(3.6)
Sales discounts	(0.3)		(0.2)
Accounts receivable, net	$	146.2	$	131.2

Losses on receivables are estimated based on known troubled accounts and historical experience. Receivables are considered impaired and written off when it is probable that payments due will not be collected. Our provision for doubtful accounts was a net expense of $0.4 million and $1.0 million for the three and nine months ended September 30, 2022, respectively, compared to a net benefit of $0.1 million and $0.5 million for the three and nine months ended September 30, 2021, respectively.

Inventories

Inventories at the lower of cost (determined on the FIFO method) or net realizable value consists of the following (in millions):


	September 30, 2022		December 31, 2021
Raw materials	$	55.3	$	47.7
Work in process	34.1		33.2
Finished goods	96.7		71.6
Supplies and other	7.5		6.8
Total Inventory	$	193.6	$	159.3

As of September 30, 2022, our inventory reserve balance was $5.0 million consisting of $2.2 million for Halyard-branded inventory and $2.8 million for inventory obsolescence.


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Property, Plant and Equipment

Property, plant and equipment consists of the following (in millions):


	September 30, 2022		December 31, 2021
Land	$	1.1	$	1.1
Buildings and leasehold improvements	47.0		48.0
Machinery and equipment	230.1		223.2
Construction in progress	34.4		32.0
	312.6		304.3
Less accumulated depreciation	(149.2)		(136.2)
Total	$	163.4	$	168.1

Depreciation expense was $5.5 million and $16.3 million for the three and nine months ended September 30, 2022, respectively, compared to $5.4 million and $16.3 million for the three and nine months ended September 30, 2021, respectively.

Goodwill and Intangible Assets

The changes in the carrying amount of goodwill are as follows (in millions):


	Goodwill
Balance, December 31, 2021	$	801.6
Goodwill acquired (a)	24.4
Currency translation adjustment	(2.4)
Balance, September 30, 2022	$	823.6

____________________________________________

(a)We acquired $24.4 million of goodwill in conjunction with the acquisition of OrthogenRx described in Note 2, “Business Acquisition.” Goodwill was allocated to our existing medical devices reporting segment.

Intangible assets subject to amortization consist of the following (in millions):


	September 30, 2022						December 31, 2021
	Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount		Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount
Trademarks	$	92.5	$	(66.2)	$	26.3	$	90.9	$	(64.0)	$	26.9
Patents and acquired technologies	278.8		(192.1)		86.7		271.7		(177.7)		94.0
Other	187.4		(41.7)		145.7		61.2		(40.9)		20.3
Total	$	558.7	$	(300.0)	$	258.7	$	423.8	$	(282.6)	$	141.2

In the first quarter of 2022, we acquired $135.6 million of identified intangibles in conjunction with our acquisition of OrthogenRx, as described in Note 2, “Business Acquisition.” Amortization expense for intangible assets is included in “Costs of products sold” and “Selling and general expenses” and was $6.1 million and $18.0 million for the three and nine months ended September 30, 2022, respectively, compared to $4.2 million and $12.5 million for the three and nine months ended September 30, 2021, respectively.


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Amortization expense for the remainder of 2022 and the following four years and thereafter is estimated as follows (in millions):


	Amount
Remainder of 2022	$	12.4
2023	29.9
2024	29.9
2025	29.3
2026	22.7
Thereafter	134.5
Total	$	258.7

Accrued Expenses

Accrued expenses consist of the following (in millions):


	September 30, 2022		December 31, 2021
Accrued rebates and customer incentives	$	23.6	$	24.5
Accrued salaries and wages	33.4		29.3
Accrued taxes and other	9.5		3.0
Other	13.5		11.3
Total	$	80.0	$	68.1

Other Long-Term Liabilities

Other long-term liabilities consist of the following (in millions):


	September 30, 2022		December 31, 2021

Accrued compensation and benefits	$	4.3	$	4.4
Other (a)	23.5		4.7
Total	$	27.8	$	9.1

__________________________________________________

(a)For the September 30, 2022 period presented, amounts primarily relate to contingent consideration and indemnification liability associated with the OrthogenRx acquisition as described in Note 2, “Business Acquisition.”

Note 4. Fair Value Information

The following fair value information is based on a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The three levels in the hierarchy used to measure fair value are:

Level 1: Unadjusted quoted prices in active markets accessible at the reporting date for identical assets and liabilities.

Level 2: Quoted prices for similar assets or liabilities in active markets. Quoted prices for identical or similar assets and liabilities in markets that are not considered active or financial instruments for which all significant inputs are observable, either directly or indirectly.

Level 3: Prices or valuations that require inputs that are significant to the valuation and are unobservable.


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A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The following table includes the fair value of our financial instruments for which disclosure of fair value is required (in millions):


		September 30, 2022				December 31, 2021
	Fair Value Hierarchy Level	Carrying Amount		Estimated Fair Value		Carrying Amount		Estimated Fair Value
Assets
Cash and cash equivalents	1	$	117.0	$	117.0	$	118.5	$	118.5
Liabilities
Revolving Credit Facility	2	$	130.0	$	130.0	$	130.0	$	130.0
Term Loan Facility	2	124.0		124.0		—		—
Contingent consideration related to acquisition	3	9.2		9.2		—		—

Cash equivalents are recorded at cost, which approximates fair value due to their short-term nature. The fair value of amounts borrowed under our Revolving Credit Facility and Term Loan Facility approximates carrying value because borrowings are subject to a variable rate as described in Note 5, “Debt.” The fair value amount of the contingent consideration was determined using a Monte Carlo simulation using assumptions regarding net sales volatility, discount rate and others. See further discussion of the acquisition of OrthogenRx in Note 2, “Business Acquisition.”

Note 5. Debt

As of September 30, 2022 and December 31, 2021, our respective debt balances were as follows (in millions):


	Weighted-Average Interest Rate		Maturity	September 30, 2022		December 31, 2021 (a)
Revolving Credit Facility	4.18	%	2027	$	130.0	$	130.0
Term Loan Facility	4.18	%	2027	125.0		—
				255.0		130.0
Unamortized debt issuance costs				(1.0)		—
Current portion of long-term debt				(6.2)		—
Total Long-Term Debt, net				$	247.8	$	130.0

____________________________________________

(a)Borrowings for this period presented were under the Amended and Restated Credit Agreement dated as of October 30, 2018.

On June 24, 2022, we entered into a credit agreement (the “Credit Agreement”) with certain lenders which established credit facilities in an aggregate principal amount of $500.0 million, consisting of a five-year senior secured term loan of $125.0 million (the “Term Loan Facility”) and a five-year senior secured revolving credit facility allowing borrowings of up to $375.0 million, with a letter of credit subfacility in an amount of $75.0 million (the “Revolving Credit Facility”). All obligations under the Credit Agreement and certain hedging agreements and cash management arrangements thereunder are: (i) guaranteed by each of the Company’s direct and indirect, existing and future, material wholly owned domestic subsidiaries (“Guarantors”) and (ii) secured by a first priority lien on substantially all the assets of the Company and the Guarantors. The Credit Agreement contains an accordion feature that allows us to incur incremental term loans under the Term Loan Facility or under new term loan facilities or to increase the amount of the commitments under the Revolving Credit Facility, including through the establishment of one or more tranches under the Revolving Credit Facility. The Credit Agreement will mature on June 24, 2027.

Borrowings under the Term Loan Facility and Revolving Credit Facility bear interest at our option at either: (i) an adjusted term secured overnight financing rate (“SOFR”), plus a margin ranging between 1.50% to 2.00% per annum, depending on our consolidated total leverage ratio; (ii) an adjusted daily simple SOFR rate, plus a margin ranging between 1.50% to 2.00% per annum, depending on our consolidated total leverage ratio; or (iii) a base rate (calculated as the greatest of (a) the prime rate, (b) the NYFRB rate (being the greater of the federal funds effective rate or the overnight bank funding rate) plus 0.50%, and (c) the one month adjusted term SOFR rate plus 1.00%), plus a margin ranging between 0.50% to 1.00% per annum, depending on our consolidated total leverage ratio. The unused portion of the Revolving Credit Facility will be subject to a commitment fee ranging between 0.20% to 0.25% per annum, depending on our consolidated total leverage ratio. Unamortized debt discount


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and issuance costs are being amortized to interest expense over the life of the Term Loan Facility using the interest method, resulting in an effective interest rate of 4.4% as of September 30, 2022.

The Credit Agreement requires compliance with certain customary operational and financial covenants. As of September 30, 2022, we were in compliance with these covenants. In addition, the Credit Agreement contains certain other customary limitations on our ability to, among other things: incur additional indebtedness; pay dividends on or repurchase or redeem our capital stock; make loans, investments and acquisitions; sell, transfer or otherwise dispose of assets; guarantee other obligations; create or grant liens; and enter into certain types of transactions with affiliates. Notwithstanding such limitations, the Credit Agreement allows us to pay dividends, repurchase stock and make investments up to an “Available Amount,” as defined in the Credit Agreement, provided no event of default has occurred and certain financial ratios have been achieved on a pro forma basis. We are permitted to prepay all or a portion of the Term Loan Facility and the Revolving Credit Facility at any time without premium or penalty. As of September 30, 2022, we had $130.0 million of borrowings under the Revolving Credit Facility.

In connection with entering into the Credit Agreement, we terminated the Amended and Restated Credit Agreement dated as of October 30, 2018 by and among the Company, the lenders thereunder and Citibank N.A., as administrative agent (as amended and supplemented, the “Prior Credit Agreement”). The Prior Credit Agreement established a $250.0 million senior secured revolving credit facility, with a letter of credit sub-facility of $25.0 million. The Prior Credit Agreement was scheduled to mature on October 30, 2023. As a result of terminating the Prior Credit Agreement, for the nine months ended September 30, 2022, we incurred a debt extinguishment loss of $1.1 million, which is included in “Interest expense” in the accompanying consolidated income statement.

Debt Payments

The Credit Agreement requires quarterly principal installment payments on the Term Loan Facility of 10 percent of the total principal borrowed for the first eight quarters following funding and then quarterly installment payments of 20 percent of the total principal borrowed, at which time the remaining unpaid principal amount of the Term Loan Facility is due and payable by the Company upon the maturity date of June 24, 2027. The current portion of the Term Loan Facility is $6.2 million. Interest is payable quarterly. We have the right to voluntarily prepay the Term Loan Facility in accordance with the terms of the Credit Agreement. Interest is payable at the same rates set forth above for the Revolving Credit Facility

As of September 30, 2022, the aggregate amounts of long-term debt that will mature during each of the next four years and thereafter are as follows (in millions):


	Amount
Remainder of 2022	$	1.6
2023	6.2
2024	7.0
2025	9.4
2026	10.2
Thereafter	220.6
Total	$	255.0


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Note 6. Accumulated Other Comprehensive Income

The changes in the components of Accumulated Other Comprehensive Income (“AOCI”), net of tax, are as follows (in millions):


	Unrealized Currency Translation		Accumulated Other Comprehensive Loss
Balance, December 31, 2021	$	(33.8)	$	(33.8)
Other comprehensive income (loss)	(9.1)		(9.1)
Balance, September 30, 2022	$	(42.9)	$	(42.9)

The net changes in the components of AOCI, including the tax effect, are as follows (in millions):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Unrealized currency translation	$	(5.1)	$	(3.7)	$	(9.1)	$	(5.6)
Defined benefit pension plans	—		0.1		—		0.1

Defined benefit pension plans, net of tax	—		0.1		—		0.1



Change in AOCI	$	(5.1)	$	(3.6)	$	(9.1)	$	(5.5)

Note 7. Stock-Based Compensation

Stock-based compensation expense is included in “Cost of products sold,” “Research and development,” and “Sales and general expenses.” Stock-based compensation expense for the three and nine months ended September 30, 2022 and 2021 is shown in the table below (in millions):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Stock options	$	0.3	$	0.4	$	0.9	$	1.5
Time-based restricted share units	3.1		2.5		8.6		6.8
Performance-based restricted share units	0.7		0.5		2.2		1.7
Employee stock purchase plan	—		0.1		0.2		0.2
Total stock-based compensation	$	4.1	$	3.5	$	11.9	$	10.2


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Note 8. Commitments and Contingencies

Legal Matters

We are subject to various legal proceedings, claims and governmental inspections, audits or investigations pertaining to issues such as contract disputes, product liability, tax matters, patents and trademarks, advertising, governmental regulations, employment and other matters. Under the terms of the distribution agreement we entered into with Kimberly-Clark Corporation (“Kimberly-Clark”) prior to our 2014 spin-off from Kimberly-Clark, legal proceedings, claims and other liabilities that are primarily related to our business are our responsibility and we are obligated to indemnify and hold Kimberly-Clark harmless for such matters.

Government Investigation

In June 2015, we were served with a subpoena from the Department of Veterans Affairs Office of the Inspector General (“VA OIG”) seeking information related to the design, manufacture, testing, sale and promotion of MicroCool and other surgical gowns produced by the Company. In July 2015, we became aware that the VA OIG subpoena and an earlier VA OIG subpoena served on Kimberly-Clark requesting information about gown sales to the federal government were related to a United States Department of Justice (“DOJ”) investigation. In May 2016, April 2017 and September 2018, we received additional subpoenas from the DOJ seeking further information related to the Company’s surgical gowns.

On July 6, 2021, we entered into a Deferred Prosecution Agreement (“DPA”) with the DOJ that resolved their criminal investigation related to our MicroCool surgical gowns. Pursuant to the terms of the DPA, in July 2021 the Company made a payment of $22.2 million. We continue to comply with the terms of the DPA.

Patent Litigation

We operate in an industry characterized by extensive patent litigation. Competitors may claim that our products infringe upon their intellectual property. Resolution of patent litigation or other intellectual property claims is typically time consuming and costly and can result in significant damage awards and injunctions that could prevent the manufacture and sale of the affected products or require us to make significant royalty payments in order to continue selling the affected products.

At any given time, we may be involved as either a plaintiff or a defendant in a number of patent infringement actions, the outcomes of which may not be known for prolonged periods of time.

General

While we maintain general and professional liability, product liability and other insurance, our insurance policies may not cover all of these matters and may not fully cover liabilities arising out of these matters. In addition, we may be obligated to indemnify our directors and officers against these matters.

We record provisions in the consolidated financial statements for pending litigation when we determine that an unfavorable outcome is probable and the amount of the loss can be reasonably estimated. For any matters that are reasonably possible to result in loss and for which no possible loss or range of loss is disclosed in this Form 10-Q, management has determined that it is unable to estimate the possible loss or range of loss because, in each case, at least the following facts applied: (a) the matter is at an early stage of the proceedings; (b) the damages are indeterminate, unspecified or determined to be immaterial; and (c) significant factual issues have yet to be resolved. At present, although the results of litigation and claims cannot be predicted with certainty, we believe that the ultimate resolution of any pending legal proceeding to which we are a party will not have a material adverse effect on our business, financial condition, results of operations or liquidity.

Environmental Compliance

We are subject to federal, state and local environmental protection laws and regulations with respect to our business operations. We believe we are operating in compliance with, or are taking action aimed at ensuring compliance with, these laws and regulations. None of our compliance obligations with environmental protection laws and regulations, individually or in the aggregate, is expected to have a material adverse effect on our business, financial condition, results of operations or liquidity.

Note 9. Earnings Per Share (“EPS”)

Basic EPS is calculated by dividing net income by the weighted average number of common shares outstanding during each period. Diluted earnings per share is calculated by dividing net income by the number of common shares outstanding and the effect of all dilutive common stock equivalents outstanding during each period, as determined using the treasury stock method.


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The calculation of basic and diluted earnings per share for the three and nine months ended September 30, 2022 and 2021 is set forth in the following table (in millions, except per share amounts):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Net income (loss)	$	15.7	$	(35.3)	$	33.6	$	(5.2)

Weighted Average Shares Outstanding:
Basic weighted average shares outstanding	46.6		48.1		47.1		48.1
Dilutive effect of stock options and restricted share unit awards	0.4		—		0.4		—
Diluted weighted average shares outstanding	47.0		48.1		47.5		48.1
Earnings (Loss) Per Share
Basic	$	0.34	$	(0.73)	$	0.71	$	(0.11)
Diluted	$	0.33	$	(0.73)	$	0.71	$	(0.11)

Restricted share units (“RSUs”) contain provisions allowing for the equivalent of any dividends paid on common stock during the restricted period to be reinvested into additional RSUs at the then fair market value of the common stock on the date the dividends are paid. Such awards are to be included in the EPS calculation under the two-class method. Currently, we do not anticipate any cash dividends for the foreseeable future and our outstanding RSU awards are not material in comparison to our weighted average shares outstanding. Accordingly, all EPS amounts reflect shares as if they were fully vested and the disclosures associated with the two-class method are not presented herein.

For the three and nine months ended September 30, 2022, 1.7 million and 1.8 million of potentially dilutive stock options and RSU awards were excluded from the computation of earnings per share as their effect would have been anti-dilutive.

Note 10. Business and Products Information

We conduct our business in one operating and reportable segment that provides our medical device products to healthcare providers and patients in more than 90 countries with manufacturing facilities in the United States and Mexico.

We provide a portfolio of innovative product offerings focused on chronic care and pain management to improve patient outcomes and reduce the cost of care. Our management evaluates net sales by product category within our single reportable segment as follows (in millions):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Chronic Care:
Digestive health	$	85.9	$	77.8	$	247.5	$	235.3
Respiratory health	29.8		39.3		100.0		118.9
Total Chronic Care	115.7		117.1		347.5		354.2
Pain Management:
Acute pain	$	38.9	$	40.7	$	118.8	$	121.6
Interventional pain	47.5		26.3		136.2		75.4
Total Pain Management	86.4		67.0		255.0		197.0
Total Net Sales	$	202.1	$	184.1	$	602.5	$	551.2

Chronic care is a portfolio of products including:

•Digestive health products such as our Mic-Key enteral feeding tubes, Corpak patient feeding solutions and NeoMed neonatal and pediatric feeding solutions; and

•Respiratory health products such as our closed airway suction systems and other airway management devices marketed under the Ballard, Microcuff and Endoclear brands.

Pain management is a portfolio of non-opioid pain solutions including:

•Acute pain products such as On-Q and ambIT surgical pain pumps and Game Ready cold and compression therapy systems; and


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•Interventional pain solutions, which provide minimally invasive pain relief therapies, such as our Coolief pain therapy and OrthogenRx’s pain relief injection products.

Liabilities for estimated returns, rebates and incentives are presented in the table below (in millions):


	September 30, 2022		December 31, 2021
Accrued rebates	$	12.3	$	14.3
Accrued customer incentives	11.3		10.2
Accrued rebates and customer incentives	23.6		24.5
Accrued sales returns(a)	0.1		0.1
Total estimated liabilities	$	23.7	$	24.6

__________________________________________________

(a)Accrued sales returns are included in “Other” in the accrued expenses table in Note 3, “Supplemental Balance Sheet Information.”

Due to the nature of our business, we receive purchase orders for products under supply agreements which are normally fulfilled within three to four weeks. Our performance obligations under purchase orders are satisfied and revenue is recognized at a point in time, which is upon shipment or upon delivery of our products, depending on shipping terms. Accordingly, we normally do not have transactions that give rise to material unfulfilled performance obligations.

Note 11. Share Repurchase Programs

On December 15, 2021, we announced that our Board of Directors had approved a share repurchase program authorizing us to repurchase up to $30.0 million of our common stock. We established a pre-arranged trading plan in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The Rule 10b5-1 trading plan permits common stock to be repurchased over a twelve-month period. In the fourth quarter of 2021, we repurchased $10.7 million of our common stock and during the first quarter of 2022, we repurchased an additional $19.3 million of our common stock.

On May 16, 2022, the Board of Directors approved a new one-year program under which we may repurchase up to $25.0 million of our common stock. Repurchases under this program will be made from time to time at management’s discretion on the open market or through privately negotiated transactions in compliance with Rule 10b-18 under the Exchange Act, subject to market conditions, applicable legal requirements and other relevant factors, and we have established a pre-arranged trading plan under Rule 10b5-1 of the Exchange Act. This share repurchase program does not obligate us to purchase any particular amount of common stock and may be suspended, modified or discontinued by us without prior notice.

For the nine months ended September 30, 2022, our repurchases of our common stock were as summarized in the table below.


	Shares Repurchased		Aggregate Purchase Price (in millions)		Average Price per Share		Amount Remaining in Program for Purchase (in millions)
	# of Shares	Program to Date
First quarter of 2022	588,293	911,433	$	19.3	$	32.85	$	—
Second quarter of 2022	522,162	522,162	14.1		27.00		10.9
Third quarter of 2022	399,957	922,119	10.9		27.25		—

In addition to the share repurchase program, we withheld 27,263 shares of common stock for $0.8 million in taxes associated with stock-based compensation transactions for the nine months ended September 30, 2022.


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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Introduction

This Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to provide investors with an understanding of our re cent performance, and should be read in conjunction with the condensed consolidated financial statements contained in Item 1, “Financial Statements” in this Form 10-Q and our audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2021. This MD&A contains forward-looking statements. Refer to “Information Concerning Forward-Looking Statements” at the beginning of this Form 10-Q for an explanation of these types of statements.

The following will be discussed and analyzed:

•Business Acquisition;

•Results of Operations and Related Information;

•Liquidity and Capital Resources; and

•Critical Accounting Policies and Use of Estimates.

Business Acquisition

On January 20, 2022, we acquired all of the equity voting interests and completed the acquisition of OrthogenRx, Inc. (“OrthogenRx”), which is focused on the development and commercialization of treatments for knee pain caused by osteoarthritis. We expect the acquisition of OrthogenRx will enhance our chronic pain portfolio. The initial purchase price was $130 million at closing less working capital adjustments, with up to an additional $30 million payable in contingent cash consideration based on OrthogenRx’s growth in net sales during 2022 and 2023. The purchase price was funded by available cash on hand and the proceeds of borrowings, including from the incurrence of a new incremental tranche of term loans of $125.0 million. The accompanying condensed consolidated income statements for the three and nine months ended September 30, 2022 includes $20.4 million and $56.9 million of net sales, respectively, from OrthogenRx since the closing of the acquisition. In the three and nine months ended September 30, 2022, we incurred $0.2 million and $1.6 million of costs in connection with the OrthogenRx acquisition, respectively, which are included in “Selling and general expenses.”

Results of Operations and Related Information

Use of Non-GAAP Measures

In this section, we present “Adjusted operating profit (loss),” which is a profitability measure that is not calculated in accordance with accounting principles generally accepted in the United States (“GAAP”) and is therefore referred to as non-GAAP financial measure. We provide this non-GAAP measure because we use it to measure our operational performance and provide greater insight into our ongoing business operations. This measure is not intended to be, and should not be, considered separately from, or an alternative to, the most directly comparable GAAP financial measures. A reconciliation of the non-GAAP measure to the most directly comparable GAAP financial measures is provided below under “Adjusted operating (loss) profit.”

Change in Accounting Principle

During the third quarter of 2022, we changed our method of accounting for certain inventory from the Last-In, First-Out (“LIFO”) method to the First-In, First-Out (“FIFO”) method. The FIFO method of accounting for inventory is preferable because it conforms our entire inventory to a single method of accounting and improves comparability with our peers. The effects of the change in accounting method from LIFO to FIFO have been retrospectively applied to all periods presented in all sections of this Form 10-Q, including Management's Discussion and Analysis. Refer to Note 1, “Accounting Policies” in Item 1 of this Form 10-Q for further information related to the change in accounting principle.


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Net Sales

Our net sales are summarized in the following table for the three and nine months ended September 30, 2022 and 2021 (in millions):


	Three Months Ended September 30,							Nine Months Ended September 30,
	2022		2021			Change		2022			2021			Change
Chronic Care:
Digestive health	$	85.9	$	77.8		10.4	%	$	247.5		$	235.3		5.2	%
Respiratory health	29.8		39.3			(24.2)	%	100.0			118.9			(15.9)	%
Total Chronic Care	115.7		117.1			(1.2)	%	347.5			$	354.2		(1.9)	%
Pain Management:
Acute pain	$	38.9	$	40.7		(4.4)	%	$	118.8		$	121.6		(2.3)	%
Interventional pain	47.5		26.3			80.6	%	136.2			75.4			80.6	%
Total Pain Management	86.4		67.0			29.0	%	255.0			197.0			29.4	%
Total Net Sales	$	202.1	$	184.1		9.8	%	$	602.5		$	551.2		9.3	%

			Total			Volume(a)		Pricing/Mix			Currency			Other(b)
Net sales - percentage change	QTD		9.8		%	11.6	%	0.8		%	(2.6)		%	—	%
Net sales - percentage change	YTD		9.3		%	10.5	%	0.6		%	(1.8)		%	—	%

______________________________

(a)Volume includes incremental revenue resulting from acquisitions.

(b)Other includes rounding.

Product Category Descriptions

Chronic care is a portfolio of products including:

•Digestive health products such as our Mic-Key enteral feeding tubes, Corpak patient feeding solutions and NeoMed neonatal and pediatric feeding solutions; and

•Respiratory health products such as our closed airway suction systems and other airway management devices marketed under the Ballard, Microcuff and Endoclear brands.

Pain management is a portfolio of non-opioid pain solutions including:

•Acute pain products such as On-Q and ambIT surgical pain pumps and Game Ready cold and compression therapy systems; and

•Interventional pain solutions, which provide minimally invasive pain relief therapies, such as our Coolief pain therapy and OrthogenRx’s pain relief injection products.

Third Quarter of 2022 Compared to Third Quarter of 2021

Net sales increased by 9.8% for the three months ended September 30, 2022 compared to the prior year period, primarily due to incremental revenue from the OrthogenRx acquisition and higher volume in digestive health products. In addition to volume, 0.8% of favorable pricing was offset by 2.6% of unfavorable foreign currency translation effects.

First Nine Months of 2022 Compared to the First Nine Months of 2021

Net sales increased by 9.3% for the nine months ended September 30, 2022 compared to the prior year period, primarily due to incremental revenue from the acquisition of OrthogenRx. Digestive health products experienced strong demand and volume, but was offset by decreased demand and volume in respiratory health products. In addition to volume, 0.6% of favorable pricing was offset by 1.8% of unfavorable foreign currency translation effects.


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Net Sales by Geographic Region

Net sales by region is presented in the table below (in millions):


	Three Months Ended September 30,						Nine Months Ended September 30,
	2022		2021		Change		2022		2021		Change
North America	$	159.5	$	140.3	13.7	%	$	477.2	$	412.3	15.7	%
Europe, Middle East and Africa	22.9		23.4		(2.1)		70.3		79.7		(11.8)
Asia Pacific and Latin America	19.7		20.4		(3.4)		55.0		59.2		(7.1)
Total net sales	$	202.1	$	184.1	9.8	%	$	602.5	$	551.2	9.3	%

Gross Profit (in millions)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2022			2021			2022			2021
Net sales	$	202.1		$	184.1		$	602.5		$	551.2
Cost of products sold	92.0			93.9			269.4			284.3
Gross profit	110.1			90.2			333.1			266.9
Gross profit margin	54.5		%	49.0		%	55.3		%	48.4		%

Third Quarter of 2022 Compared to Third Quarter of 2021

For the three months ended September 30, 2022 compared to the prior year period, gross profit margin improved primarily due to favorable product mix, as well as slightly improved manufacturing efficiencies that were partially offset by higher costs across our supply chain.

First Nine Months of 2022 Compared to the First Nine Months of 2021

For the nine months ended September 30, 2022 compared to the prior year period, gross profit margin was impacted by the same items noted above for the third quarter.

Research and Development (in millions)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2022			2021			2022			2021
Research and development	$	7.3		$	8.4		$	23.1		$	24.7
Percentage of net sales	3.6		%	4.6		%	3.8		%	4.5		%

Research and development consists primarily of compensation for personnel and expenses for product trial costs, outside laboratory and license fees, the cost of laboratory equipment and facilities and asset write-offs for equipment associated with unsuccessful product launches. Research and development has historically ranged between 4% and 6% of net sales.

Selling and General Expenses (in millions)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2022			2021			2022			2021
Selling and general expenses	$	82.1		$	75.0		$	259.3		$	225.1
Percentage of net sales	40.6		%	40.7		%	43.0		%	40.8		%

Selling and general expenses increased in both the three and nine months ended September 30, 2022 compared to the prior year periods, driven by higher selling costs, along with higher acquisition-related costs and compliance costs associated with the European Union Medical Device Regulation (“EU MDR”).


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Other Expense, net (in millions)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2022			2021			2022			2021
Other expense, net	$	2.0		$	3.4		$	2.9		$	33.7
Percentage of net sales	1.0		%	1.8		%	0.5		%	6.1		%

Other expense, net decreased in both the three and nine months ended September 30, 2022 compared to the prior year periods driven by lower legal costs. Legal costs in the nine months ended September 30, 2021 included amounts associated with a $22.2 million payment related to the Deferred Prosecution Agreement (“DPA”) with the United Sates Department of Justice described in Note 8, “Commitments and Contingencies” in Item 1 of this Form 10-Q.

Operating Profit (Loss) (in millions)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2022			2021			2022			2021
Operating profit (loss)	$	18.7		$	3.4		$	47.8		$	(16.6)
Operating profit margin	9.3		%	1.8		%	7.9		%	(3.0)		%

The items previously described drove operating profit to $18.7 million for the three months ended September 30, 2022 and $47.8 million for the nine months ended September 30, 2022, compared to an operating profit of $3.4 million and operating loss of $16.6 million for the three and nine months ended September 30, 2021, respectively.

Adjusted Operating Profit (Loss)

A reconciliation of adjusted operating profit (loss), a non-GAAP measure, to operating profit (loss) is provided in the table below (in millions):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Operating profit (loss), as reported (GAAP)	$	18.7	$	3.4	$	47.8	$	(16.6)
COVID-19 related expenses	—		—		—		0.2
2020 Restructuring charges	—		1.7		—		10.4
Post divestiture restructuring charges	—		2.9		—		5.5
Post divestiture transition charges	—		—		—		3.6
Acquisition and integration-related charges	0.2		0.1		3.0		0.7
EU MDR Compliance	2.2		1.2		5.4		2.4
Litigation and legal	—		3.3		—		28.5
Intangibles amortization	6.1		4.2		18.0		12.5
Adjusted operating profit (loss) (non-GAAP)	$	27.2	$	16.8	$	74.2	$	47.2

The items noted in the table above are described below:

COVID-19 related expenses: Incremental spending due to the COVID-19 pandemic was $0.2 million in the nine months ended September 30, 2021.

2020 Restructuring charges, post divestiture restructuring charges, and post divestiture transition charges: As previously described in the Form 10-K, these charges were associated with a multi-phase restructuring plan intended to align our organizational structure, IT platform, supply chain and distribution channels to be more appropriate for our business following the divestiture of our Surgical and Infection Prevention business. As of December 31, 2021, restructuring activities associated with the plan were substantially complete.

Acquisition and integration-related charges: Acquisition and integration-related charges were $0.2 million and $0.1 million for the three months ended September 30, 2022 and 2021, respectively, and $3.0 million and $0.7 million for the nine months ended September 30, 2022 and 2021, respectively. Expenses in the three and nine months ended September 30, 2022 were


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related to the acquisition of OrthogenRx. Expenses incurred in the prior year periods were related to integration activities for earlier acquisitions.

EU MDR Compliance: The EU MDR became effective in 2021 and brings significant new requirements for many of our medical devices. Incremental costs associated with EU MDR compliance are primarily related to re-certification of our products under the enhanced standards. We expect the activities resulting in incremental costs associated with our initial compliance with the EU MDR will continue into 2023.

Litigation and legal: We incurred $3.3 million and $28.5 million of expenses in the three and nine months ended September 30, 2021, respectively, for certain litigation matters which were included in “Other expense, net.” These costs included amounts associated with a $22.2 million payment related to the DPA.

Intangibles amortization: Intangibles amortization is related primarily to intangibles acquired in business acquisitions and was $6.1 million and $18.0 million for the three and nine months ended September 30, 2022, respectively, and $4.2 million and $12.5 million for the three and nine months ended September 30, 2021, respectively. The increase in amortization is due to incremental amortization of intangibles acquired with OrthogenRx earlier this year.

Interest Expense

Interest expense consists of interest accrued and amortization of debt issuance costs on our revolving credit facility net of interest capitalized on long-term capital projects. See Note 5, “Debt” in Item 1 of this Form 10-Q. Interest expense was $3.0 million and $7.0 million for the three and nine months ended September 30, 2022, respectively, compared to $0.9 million and $2.6 million, respectively, in the comparable periods last year. Our long-term debt outstanding balances were $254.0 million and $130.0 million as of September 30, 2022 and December 31, 2021, respectively.

Income Taxes

The income tax provision was $0.3 million and $7.7 million in the three and nine months ended September 30, 2022, respectively, compared to a provision of $38.0 million and benefit of $13.8 million in the three and nine months ended September 30, 2021, respectively. Our effective tax rate was 1.9% and 18.6% in the three and nine months ended September 30, 2022, respectively. For the three and nine months ended September 30, 2021, our effective tax rate was 1407.4% and 72.6%, respectively. The prior year income tax benefit and effective tax rates were due to the impact of non-deductible charges and progression of earnings in the first nine months of 2021.

Liquidity and Capital Resources

General

Our primary sources of liquidity are cash on hand provided by operating activities and amounts available with our revolving credit facility under our credit agreement. We expect our operating cash flow will be sufficient to meet our working capital requirements and fund capital expenditures in the next twelve months. In addition, with our borrowing capacity, we expect to have the ability to fund capital expenditures and other investments necessary to grow our business for the foreseeable future for both our domestic and international operations.

As of September 30, 2022, $58.0 million of our $117.0 million of cash and cash equivalents was held by foreign subsidiaries. We consider the undistributed earnings of our foreign subsidiaries to be indefinitely reinvested overseas and currently do not have plans to repatriate such earnings. We do not expect restrictions on repatriation of cash held outside of the United States to have a material effect on our overall liquidity, financial condition or results of operations for the foreseeable future.

Cash and cash equivalents decreased by $1.5 million to $117.0 million as of September 30, 2022 compared to $118.5 million as of December 31, 2021. The decrease was primarily driven by $116.1 million used in the acquisition of OrthogenRx and $45.1 million used to repurchase shares of our common stock, partially offset by $57.2 million provided by operating activities and $125.0 million in proceeds received from the issuance of incremental long-term debt.

In the prior year, cash and cash equivalents decreased by $13.7 million to $97.8 million as of September 30, 2021. The decrease was driven by $55.0 million repaid on our revolving credit facility, $16.3 million of capital expenditures and $3.1 million of unfavorable currency exchange effects partially offset by $35.2 million provided by operations, $20.0 million of proceeds from our revolving credit facility and $6.1 million of proceeds from the exercise of stock options.

Long-Term Debt


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million, with a letter of credit subfacility in an amount of $75.0 million (the “Revolving Credit Facility”). All obligations under the Credit Agreement and certain hedging agreements and cash management arrangements thereunder are: (i) guaranteed by each of the Company’s direct and indirect, existing and future, material wholly owned domestic subsidiaries (“Guarantors”) and (ii) secured by a first priority lien on substantially all the assets of the Company and the Guarantors. The Credit Agreement contains an accordion feature that allows us to incur incremental term loans under the Term Loan Facility or under new term loan facilities or to increase the amount of the commitments under the Revolving Credit Facility, including through the establishment of one or more tranches under the Revolving Credit Facility. The Credit Agreement will mature on June 24, 2027.

The Credit Agreement requires compliance with certain customary operational and financial covenants. As of September 30, 2022, we were in compliance with these covenants. In addition, the Credit Agreement contains certain other customary limitations on our ability to, among other things: incur additional indebtedness; pay dividends on or repurchase or redeem our capital stock; make loans, investments and acquisitions; sell, transfer or otherwise dispose of assets; guarantee other obligations; create or grant liens; and enter into certain types of transactions with affiliates. Notwithstanding such limitations, the Credit Agreement allows us to pay dividends, repurchase stock and make investments up to an “Available Amount,” as defined in the Credit Agreement, provided no event of default has occurred and certain financial ratios have been achieved on a pro forma basis. As of September 30, 2022, we had $130.0 million of borrowings under the Revolving Credit Facility.

See Note 5, “Debt” in Item 1 of this Form 10-Q for further details regarding our debt agreements.

Share Repurchase Programs

On December 15, 2021, we announced that our Board of Directors had approved a share repurchase program authorizing us to repurchase up to $30.0 million of our common stock. In the fourth quarter of 2021, we repurchased $10.7 million of our common stock, and during the first quarter of 2022, we repurchased an additional $19.3 million of our common stock.

On May 16, 2022, the Board of Directors approved a new one-year program under which we may repurchase up to $25.0 million of our common stock. Repurchases under this program will be made from time to time at management’s discretion on the open market or through privately negotiated transactions. This share repurchase program does not obligate us to purchase any particular amount of common stock and may be suspended, modified or discontinued by us without prior notice. Under this program, during the second quarter of 2022 we repurchased $14.1 million of our common stock, and during the third quarter of 2022 we repurchased the remaining $10.9 million.

For further information, see Note 11, “Share Repurchase Programs” in Item 1 of this Form 10-Q.

Critical Accounting Policies and Use of Estimates

Our financial statements are prepared by applying certain accounting policies. See Note 1, “Accounting Policies” in Item 8, “Financial Statements and Supplementary Data” in the Form 10-K, which describes our most significant accounting policies. In addition, our critical accounting policies and estimates are presented under the caption “Critical Accounting Policies and Use of Estimates” in Item 7, “Management's Discussion and Analysis of Financial Condition and Results of Operation” in the Form 10-K. Certain of these policies require management to make estimates or assumptions that may prove inaccurate or be subject to variations that may significantly affect our reported results and financial position for the period or in future periods. Management views these policies as critical accounting policies. See Note 1, “Accounting Policies” in Item 1 of this Form 10-Q for updates to our critical accounting policies and a discussion of recent accounting pronouncements. In the nine months ended September 30, 2022, there were no significant changes to our critical accounting estimates from those disclosed in Item 7, “Management's Discussion and Analysis of Financial Condition and Results of Operation” in the Form 10-K.


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Item 3. Quantitative and Qualitative Disclosures About Market Risk

There have been no material changes regarding our market risk position from the information provided under Item 7A – “Quantitative and Qualitative Disclosures About Market Risk” in the Form 10-K.

Item 4. Controls and Procedures

With the participation of management, our Chief Executive Officer (principal executive officer) and our Senior Vice President, and Chief Financial Officer (principal financial officer) carried out an evaluation, pursuant to Rule 13a-15(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) as of the end of the period covered by this report. Based upon that evaluation, our Chief Executive Officer and our Senior Vice President and Chief Financial Officer concluded that our disclosure controls and procedures were operating effectively as of September 30, 2022.

Changes in Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting that occurred during the three months ended September 30, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.


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PART II – OTHER INFORMATION

Item 1. Legal Proceedings

We are subject to various legal proceedings, claims and governmental inspections, audits or investigations pertaining to issues such as contract disputes, product liability, tax matters, patents and trademarks, advertising, governmental regulations, employment and other matters. At present, although the results of litigation and claims cannot be predicted with certainty, we believe that the ultimate resolution of any pending legal proceeding to which we are a party will not have a material adverse effect on our business, financial condition, results of operations or liquidity.

Item 1A. Risk Factors

There have been no material changes to the risk factors described in Part I, Item 1A, “Risk Factors,” of the Form 10-K, except as follows:

The ongoing conflict between Russia and Ukraine and the related implications could have a material adverse effect on our business and results of operations.

As a result of the ongoing military conflict between Russia and Ukraine, the United States and other countries have imposed significant sanctions on Russia and could impose even wider sanctions. Such sanctions could damage or disrupt international commerce and the global economy. We cannot predict the broader or longer-term consequences of the conflict or of the sanctions imposed to date, which could include embargoes, regional instability, geopolitical shifts, exchange rate fluctuations, financial market disruptions and economic recession. Further, the conflict could exacerbate supply chain challenges, lead to an increase in cyberattacks from Russia, affect the global price and availability of key commodities, reduce our sales and earnings or otherwise have an adverse effect on our business and results of operations.

In addition, the conflict between Russia and Ukraine may have the effect of heightening other risks disclosed in the Form 10-K, any of which could materially and adversely affect our business and results of operations. Such risks include but are not limited to interruptions in the transportation channels for the manufacture and global distribution of our products, heightened inflation, depressed levels of consumer and commercial spending, disruptions to our global technology infrastructure, adverse changes in international trade policies and relations, and the inability to implement and execute our business strategy. We are currently unable to predict the extent, nature or duration of any of these occurrences.

Supply chain disruptions could have a material adverse effect on our business.

We rely on a complex global supply chain composed of multiple external suppliers, some of which are single-source suppliers. These suppliers provide raw materials and other inputs for our production processes; supply certain components for our products; and deliver other goods and services used in our business. We cannot be certain that our current suppliers will continue to provide us with the quantities of materials that we require or satisfy our anticipated specifications and quality requirements on a timely basis or at all. In addition, any supply chain disruption in limited or sole sourced raw materials could materially harm our ability to manufacture our products until a new source of supply, if any, could be identified and qualified.

From time to time we may be negatively impacted by supply chain disruptions, including the following:

–Suppliers extending lead times, experiencing capacity constraints, limiting or canceling supply, allocating supply to other customers (including our competitors), delaying or canceling deliveries, going out of business or increasing prices;

–Supplier quality issues;

–The ongoing COVID-19 pandemic and other pandemics, epidemics or infectious disease outbreaks;

–Cybersecurity events, manmade or natural disasters, operational failures or other events that disrupt us or our suppliers;

–Long lead times to qualify alternate or additional suppliers, or the unavailability of qualified alternate suppliers; and

–Other events or occurrences that are beyond our control, including transportation delays, inflationary pricing pressures, work stoppages, labor shortages and governmental regulatory actions.

These and other supply chain issues can increase our costs, disrupt or reduce our production, delay our product shipments, prevent us from meeting customer demand and damage our customer relationships. They may keep us from successfully implementing our business strategy and could materially harm our business, results of operations, financial condition and cash flows.


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Our business, operating results, and cash flows may be adversely impacted by the rising rate of inflation.

Inflationary pressures have increased due to general macroeconomic factors as well as the global supply chain disruptions, labor shortages and other impacts of the ongoing COVID-19 pandemic. We expect those inflationary trends to continue for the foreseeable future. These inflationary pressures could affect our manufacturing costs, operating expenses (including wages) and other expenses. We may not be able to pass these cost increases on to our customers in a timely manner, which could have an impact on our gross margins and profitability. In addition, inflation has resulted in higher interest rates and could otherwise adversely impact the macroeconomic environment, which in turn could adversely impact our customers and their ability or willingness to purchase our products. Our inability to successfully manage the effects of inflation could have a material adverse effect on our business, results of operations and cash flows.

Any non-cash impairment of our long-lived assets, including intangible assets and goodwill, could have a material adverse impact on our results of operations.

We review long-lived assets, such as property, equipment and intangible assets for impairment whenever events or changes in circumstances indicate that their carrying values may not be recoverable. Goodwill is tested for impairment annually and whenever events and circumstances indicate that, more likely than not, impairment may have occurred. The evaluation of long-lived assets and goodwill requires us to form estimates and assumptions with respect to a number of factors, including future sales growth, cash flows, our weighted average cost of capital (WACC) and a terminal value. Our evaluation of goodwill also includes consideration of our current market capitalization. Unanticipated changes in any of the factors used in our evaluation could result in a non-cash charge for impairment in a future period, which may significantly affect our results of operations in the period of such charge.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Not applicable

Item 3. Defaults Upon Senior Securities

Not applicable

Item 4. Mine Safety Disclosures

Not applicable

Item 5. Other Information

None


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Item 6. Exhibits

(a)Exhibits


Exhibit Number						Description
3.1						Second Amended and Restated Certificate of Incorporation of the Company, incorporated by reference to Exhibit 3.1 of our Current Report on Form 8-K filed on May 6, 2020
3.2						Sixth Amended and Restated Bylaws of the Company, incorporated by reference to Exhibit 3.2 of our Current Report on Form 8-K filed on May 6, 2020
18						Change in Accounting Principle Preferability Letter, filed herewith
31(a)						Section 302 CEO Certification, filed herewith
31(b)						Section 302 CFO Certification, filed herewith
32(a)*						Section 906 CEO Certification, furnished herewith
32(b)*						Section 906 CFO Certification, furnished herewith
101.INS						XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document.
101.SCH						XBRL Taxonomy Extension Schema Document
101.CAL						XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF						XBRL Taxonomy Extension Definition Linkbase Document
101.LAB						XBRL Taxonomy Extension Label Linkbase Document
101.PRE						XBRL Taxonomy Extension Presentation Linkbase Document
104						Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)

* The certifications attached as Exhibit 32(a) and 32(b) that accompany this Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Avanos Medical, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.


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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.


	AVANOS MEDICAL, INC.
	(Registrant)

November 2, 2022	By:	/s/ Michael C. Greiner
		Michael C. Greiner
		Senior Vice President and Chief Financial Officer
		(Principal Financial Officer)

November 2, 2022	By:	/s/ John J. Hurley
		John J. Hurley
		Controller
		(Principal Accounting Officer)