Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the quarterly period ended: September 30, 2021March 31, 2022

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-37799

Tactile Systems Technology, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

3701 Wayzata Blvd, Suite 300

41-1801204

(State or other jurisdiction of

incorporation or organization)

Minneapolis, Minnesota 55416

(I.R.S. Employer

Identification No.)

(Address and zip code of principal executive offices)

(612) 355-5100

(Registrant’s telephone number, including area code)

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

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, Par Value $0.001 Per Share

TCMD

The Nasdaq Stock Market

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, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer 

Smaller reporting company 

Emerging growth 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

19,823,02219,939,296 shares of common stock, par value $0.001 per share, were outstanding as of November 4, 2021.April 28, 2022.

Table of Contents

TABLE OF CONTENTS

PART I—FINANCIAL INFORMATION

Item 1.

Financial Statements

4

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

2825

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

3933

Item 4.

Controls and Procedures

3933

 

PART II—OTHER INFORMATION

 

Item 1.

Legal Proceedings

4033

Item 1A.

Risk Factors

4033

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

4033

Item 3.

Defaults Upon Senior Securities

4134

Item 4.

Mine Safety Disclosures

4134

Item 5.

Other Information

4134

Item 6.

Exhibits

4134

2

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Forward-Looking Information

All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business, operations and financial performance and condition, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "target," "ongoing," "plan," "potential," "predict," "project," "should," "target," "will," "would," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this Quarterly Report on Form 10-Q. These risks, uncertainties and other factors include, but are not limited to:

the impacts of the COVID-19 pandemic on our business, financial condition and results of operations, and our inability to mitigate such impacts;
the adequacy of our liquidity to pursue our business objectives;
our ability to obtain reimbursement from third-party payers for our products;
loss or retirement of key executives, including prior to identifying a successor;
adverse economic conditions or intense competition;
loss of a key supplier;
entry of new competitors and products;
adverse federal, state and local government regulation;
technological obsolescence of our products;
technical problems with our research and products;
our ability to expand our business through strategic acquisitions;
our ability to integrate acquisitions and related businesses;
price increases for supplies and components;
the effects of current and future U.S. and foreign trade policy and tariff actions; and
the inability to carry out research, development and commercialization plans.

You should read the matters described in "Risk Factors" and the other cautionary statements made in our Annual Report on Form 10-K for the year ended December 31, 2020,2021, and in this Quarterly Report on Form 10-Q. We cannot assure you that the forward-looking statements in this report will prove to be accurate and therefore you are encouraged not to place undue reliance on forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. You are urged to carefully review and consider the various disclosures made by us in this report and in other filings with the Securities and Exchange Commission (the “SEC”) that advise of the risks and factors that may affect our business. Other than as required by law, we undertake no obligation to update or revise these forward-looking statements, even though our situation may change in the future. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make.

3

Table of Contents

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements

Tactile Systems Technology, Inc.

Tactile Systems Technology, Inc.

Tactile Systems Technology, Inc.

Condensed Consolidated Balance Sheets

Condensed Consolidated Balance Sheets

Condensed Consolidated Balance Sheets

(Unaudited)

(Unaudited)

(Unaudited)

    

September 30,

    

December 31,

    

March 31,

    

December 31,

(In thousands, except share and per share data)

    

2021

    

2020

    

2022

    

2021

Assets

Current assets

Cash and cash equivalents

$

22,401

$

47,855

$

21,150

$

28,229

Accounts receivable

 

44,257

 

43,849

 

45,927

 

49,478

Net investment in leases

 

12,385

 

10,708

 

12,307

 

12,482

Inventories

 

23,830

 

18,563

 

19,479

 

19,217

Prepaid expenses and other current assets

 

3,701

 

2,638

 

4,374

 

4,141

Total current assets

 

106,574

 

123,613

 

103,237

 

113,547

Non-current assets

Property and equipment, net

 

6,458

 

6,957

 

6,330

 

6,750

Right of use operating lease assets

 

23,919

 

20,132

 

23,315

 

23,984

Intangible assets, net

 

54,970

 

1,680

 

53,169

 

54,081

Goodwill

31,063

31,063

31,063

Accounts receivable, non-current

 

12,422

 

9,433

 

13,577

 

12,847

Deferred income taxes

 

11,907

 

10,198

Other non-current assets

 

2,082

 

2,074

 

2,321

 

1,998

Total non-current assets

 

142,821

 

50,474

 

129,775

 

130,723

Total assets

$

249,395

$

174,087

$

233,012

$

244,270

Liabilities and Stockholders' Equity

Current liabilities

Accounts payable

$

6,192

$

4,197

$

6,200

$

5,023

Note payable

2,210

2,964

2,960

Earn-out, current

9,150

3,250

Accrued payroll and related taxes

 

10,322

 

11,588

 

9,481

 

12,139

Accrued expenses

 

5,350

 

4,423

 

5,673

 

5,262

Income taxes payable

 

1,129

 

2,658

 

26

 

16

Operating lease liabilities

 

2,412

 

2,006

 

2,504

 

2,506

Other current liabilities

 

3,694

 

1,842

 

4,275

 

3,305

Total current liabilities

 

31,309

 

26,714

 

40,273

 

34,461

Non-current liabilities

Revolving line of credit, non-current

24,844

24,878

24,857

Note payable, non-current

27,673

23,199

26,933

Earn-out, non-current

6,400

3,500

2,950

Accrued warranty reserve, non-current

 

3,358

 

3,235

 

2,997

 

3,108

Income taxes payable, non-current

 

348

 

 

298

 

348

Operating lease liabilities, non-current

23,357

 

19,388

22,742

 

23,354

Deferred income taxes

147

32

Total non-current liabilities

 

85,980

 

22,623

 

77,761

 

81,582

Total liabilities

 

117,289

 

49,337

 

118,034

 

116,043

Commitments and Contingencies (see Note 11)

Commitments and Contingencies (see Note 10)

Stockholders’ equity:

Preferred stock, $0.001 par value, 50,000,000 shares authorized; NaN issued and outstanding as of September 30, 2021 and December 31,
2020

 

 

Common stock, $0.001 par value, 300,000,000 shares authorized; 19,797,723 shares issued and outstanding as of September 30, 2021; 19,492,718 shares issued and outstanding as of December 31, 2020

 

20

 

19

Preferred stock, $0.001 par value, 50,000,000 shares authorized; NaN issued and outstanding as of March 31, 2022 and December 31,
2021

 

 

Common stock, $0.001 par value, 300,000,000 shares authorized; 19,939,843 shares issued and outstanding as of March 31, 2022; 19,877,786 shares issued and outstanding as of December 31, 2021

 

20

 

20

Additional paid-in capital

 

116,346

 

104,675

 

122,281

 

119,962

Retained earnings

 

15,740

 

20,056

(Accumulated deficit) retained earnings

 

(7,323)

 

8,245

Total stockholders’ equity

 

132,106

 

124,750

 

114,978

 

128,227

Total liabilities and stockholders’ equity

$

249,395

$

174,087

$

233,012

$

244,270

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

4

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Tactile Systems Technology, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

(In thousands, except share and per share data)

    

2021

    

2020

    

2021

    

2020

Revenue

Sales revenue

$

44,460

$

42,573

$

124,215

$

109,714

Rental revenue

 

8,037

 

6,519

 

22,114

 

18,173

Total revenue

 

52,497

 

49,092

 

146,329

 

127,887

Cost of revenue

Cost of sales revenue

 

13,096

 

11,558

 

36,425

 

30,868

Cost of rental revenue

 

2,433

 

2,562

 

6,501

 

6,062

Total cost of revenue

 

15,529

 

14,120

 

42,926

 

36,930

Gross profit

Gross profit - sales revenue

 

31,364

 

31,015

 

87,790

 

78,846

Gross profit - rental revenue

 

5,604

 

3,957

 

15,613

 

12,111

Gross profit

 

36,968

 

34,972

 

103,403

 

90,957

Operating expenses

Sales and marketing

 

22,231

 

19,488

 

61,949

 

59,856

Research and development

 

1,409

 

1,102

 

3,885

 

3,891

Reimbursement, general and administrative

 

14,500

 

12,539

 

42,802

 

37,682

Intangible asset amortization

195

49

294

148

Total operating expenses

 

38,335

 

33,178

 

108,930

 

101,577

(Loss) income from operations

 

(1,367)

 

1,794

 

(5,527)

 

(10,620)

Other (expense) income

 

(120)

 

(121)

 

(154)

 

181

(Loss) income before income taxes

 

(1,487)

 

1,673

 

(5,681)

 

(10,439)

Income tax expense (benefit)

 

1,868

 

(751)

 

(1,365)

 

2,294

Net (loss) income

$

(3,355)

$

2,424

$

(4,316)

$

(12,733)

Net (loss) income per common share

Basic

$

(0.17)

$

0.12

$

(0.22)

$

(0.66)

Diluted

$

(0.17)

$

0.12

$

(0.22)

$

(0.66)

Weighted-average common shares used to compute net (loss) income per common share

Basic

19,790,838

19,415,640

19,676,749

19,309,344

Diluted

19,790,838

19,747,365

19,676,749

19,309,344

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

5

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Tactile Systems Technology, Inc.

Condensed Consolidated Statements of Comprehensive (Loss) Income

(Unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30, 

(In thousands)

    

2021

    

2020

    

2021

    

2020

Net (loss) income

$

(3,355)

$

2,424

$

(4,316)

$

(12,733)

Other comprehensive loss

 

  

 

  

 

  

 

  

Unrealized loss on marketable securities

 

 

(14)

 

 

(21)

Income tax related to items of other comprehensive loss

 

 

(15)

 

 

(5)

Total other comprehensive loss

 

 

(29)

 

 

(26)

Comprehensive (loss) income

$

(3,355)

$

2,395

$

(4,316)

$

(12,759)

Tactile Systems Technology, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

Three Months Ended

March 31,

(In thousands, except share and per share data)

    

2022

    

2021

Revenue

Sales revenue

$

41,170

$

36,125

Rental revenue

 

6,808

 

6,647

Total revenue

 

47,978

 

42,772

Cost of revenue

Cost of sales revenue

 

12,080

 

10,691

Cost of rental revenue

 

2,036

 

1,851

Total cost of revenue

 

14,116

 

12,542

Gross profit

Gross profit - sales revenue

 

29,090

 

25,434

Gross profit - rental revenue

 

4,772

 

4,796

Gross profit

 

33,862

 

30,230

Operating expenses

Sales and marketing

 

23,930

 

18,785

Research and development

 

1,520

 

1,270

Reimbursement, general and administrative

 

16,217

 

14,209

Intangible asset amortization and earn-out

7,096

50

Total operating expenses

 

48,763

 

34,314

Loss from operations

 

(14,901)

 

(4,084)

Other expense

 

(456)

 

(10)

Loss before income taxes

 

(15,357)

 

(4,094)

Income tax expense (benefit)

 

211

 

(1,828)

Net loss

$

(15,568)

$

(2,266)

Net loss per common share

Basic

$

(0.78)

$

(0.12)

Diluted

$

(0.78)

$

(0.12)

Weighted-average common shares used to compute net loss per common share

Basic

19,898,502

19,545,558

Diluted

19,898,502

19,545,558

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

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Tactile Systems Technology, Inc.

Tactile Systems Technology, Inc.

Tactile Systems Technology, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

Condensed Consolidated Statements of Stockholders’ Equity

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(Unaudited)

(Unaudited)

Accumulated

Additional

Other

Common Stock

Paid-In

Retained

Comprehensive

(Accumulated

Additional

Deficit)

Common Stock

Paid-In

Retained

(In thousands, except share data)

 

Shares

 

Par Value

 

Capital

 

Earnings

 

(Loss) Income

 

Total

 

Shares

 

Par Value

 

Capital

 

Earnings

 

Total

Balances, June 30, 2021

19,782,295

$

20

$

113,601

$

19,095

$

$

132,716

Balances, December 31, 2021

19,877,786

$

20

$

119,962

$

8,245

$

128,227

Stock-based compensation

2,588

2,588

2,228

2,228

Exercise of common stock options and vesting of performance and restricted stock units

16,366

199

199

62,057

91

91

Taxes paid for net share settlement of performance and restricted stock units

(938)

(42)

(42)

Comprehensive loss for the period

(3,355)

(3,355)

(15,568)

(15,568)

Balances, September 30, 2021

19,797,723

$

20

$

116,346

$

15,740

$

$

132,106

Balances, March 31, 2022

19,939,843

$

20

$

122,281

$

(7,323)

$

114,978

Balances, December 31, 2020

19,492,718

$

19

$

104,675

$

20,056

$

$

124,750

19,492,718

$

19

$

104,675

$

20,056

$

124,750

Stock-based compensation

7,703

7,703

2,457

2,457

Exercise of common stock options and vesting of performance and restricted stock units

284,829

1

3,583

3,584

167,375

1

1,295

1,296

Taxes paid for net share settlement of performance and restricted stock units

(21,918)

(1,157)

(1,157)

(20,980)

(1,115)

(1,115)

Common shares issued for employee stock purchase plan

42,094

1,542

1,542

Comprehensive loss for the period

(4,316)

(4,316)

(2,266)

(2,266)

Balances, September 30, 2021

19,797,723

$

20

$

116,346

$

15,740

$

$

132,106

Balances, June 30, 2020

19,411,404

$

19

$

97,818

$

5,519

$

29

$

103,385

Stock-based compensation

3,164

3,164

Exercise of common stock options and vesting of performance and restricted stock units

14,322

214

214

Taxes paid for net share settlement of performance and restricted stock units

(1,047)

(39)

(39)

Comprehensive income for the period

2,424

(29)

2,395

Balances, September 30, 2020

19,424,679

$

19

$

101,157

$

7,943

$

$

109,119

Balances, December 31, 2019

19,152,715

$

19

$

91,874

$

20,676

$

26

$

112,595

Stock-based compensation

8,288

8,288

Exercise of common stock options and vesting of performance and restricted stock units

259,406

762

762

Taxes paid for net share settlement of performance and restricted stock units

(31,095)

(1,592)

(1,592)

Common shares issued for employee stock purchase plan

43,653

1,825

1,825

Comprehensive loss for the period

(12,733)

(26)

(12,759)

Balances, September 30, 2020

19,424,679

$

19

$

101,157

$

7,943

$

$

109,119

Balances, March 31, 2021

19,639,113

$

20

$

107,312

$

17,790

$

125,122

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

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Tactile Systems Technology, Inc.

Tactile Systems Technology, Inc.

Tactile Systems Technology, Inc.

Condensed Consolidated Statements of Cash Flows

Condensed Consolidated Statements of Cash Flows

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(Unaudited)

(Unaudited)

Nine Months Ended September 30, 

Three Months Ended March 31, 

(In thousands)

    

2021

    

2020

    

2022

    

2021

Cash flows from operating activities

Net loss

$

(4,316)

$

(12,733)

$

(15,568)

$

(2,266)

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization

2,150

2,102

1,507

652

Net amortization of premiums and discounts on securities available-for-sale

(91)

Deferred income taxes

(1,709)

3,934

115

(1,828)

Stock-based compensation expense

7,703

8,288

2,228

2,457

Gain on other investments and maturities of marketable securities

10

Impairment losses

4,025

Loss on disposal of property and equipment

7

Change in fair value of earn-out liability

6,450

Changes in assets and liabilities, net of acquisition:

Accounts receivable

(408)

(2,589)

3,551

3,806

Net investment in leases

(1,677)

(1,304)

175

(546)

Inventories

(3,641)

(3,538)

(262)

(3,479)

Income taxes

(1,181)

773

(40)

Prepaid expenses and other assets

(1,133)

(1,553)

(556)

447

Right of use operating lease assets

588

509

55

49

Medicare accounts receivable, non-current

(2,989)

(2,916)

(730)

(1,294)

Accounts payable

1,995

938

1,177

5,022

Accrued payroll and related taxes

(1,266)

766

(2,658)

(3,041)

Accrued expenses and other liabilities

2,902

1,134

1,350

(779)

Net cash used in operating activities

(2,975)

(2,245)

(3,206)

(800)

Cash flows from investing activities

Proceeds from maturities of securities available-for-sale

22,500

Payments related to acquisition

(79,829)

Purchases of property and equipment

(1,221)

(1,623)

(131)

(249)

Intangible assets costs

(187)

(163)

Other investments

(30)

Net cash (used in) provided by investing activities

(81,237)

20,684

Intangible assets expenditures

(44)

(62)

Net cash used in investing activities

(175)

(311)

Cash flows from financing activities

Proceeds from issuance of note payable

30,000

Proceeds from revolving line of credit

25,000

Payment on note payable

(3,750)

Payment of deferred debt issuance costs

(211)

(39)

Taxes paid for net share settlement of performance and restricted stock units

(1,157)

(1,592)

(1,115)

Proceeds from exercise of common stock options

3,584

762

91

1,296

Proceeds from the issuance of common stock from the employee stock purchase plan

1,542

1,825

Net cash provided by financing activities

58,758

995

Net (decrease) increase in cash and cash equivalents

(25,454)

19,434

Net cash (used in) provided by financing activities

(3,698)

181

Net decrease in cash and cash equivalents

(7,079)

(930)

Cash and cash equivalents – beginning of period

47,855

22,770

28,229

47,855

Cash and cash equivalents – end of period

$

22,401

$

42,204

$

21,150

$

46,925

Supplemental cash flow disclosure

Cash paid for interest

$

413

$

Cash paid for taxes

$

1,541

$

475

$

12

$

13

Capital expenditures incurred but not yet paid

$

$

41

$

8

$

133

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

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Tactile Systems Technology, Inc.

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

Note 1. Nature of Business and Operations

Tactile Systems Technology, Inc. (“we,” “us,” and “our”)  is the sole manufacturermanufactures and distributor of the Flexitouch® and Entre™ systems,distributes medical devices that help control symptoms of lymphedema, a chronic and progressive medical condition. We provide these productsour Flexitouch® and Entre™ systems through our direct sales force for use in the home and sell or rent them through vascular, wound and lymphedema clinics throughout the United States.

On September 8, 2021, we acquired the assets of the AffloVest respiratory therapyairway clearance business (“AffloVest Acquisition”) from International Biophysics Corporation (“IBC”), a privately-held company which developed and manufactures AffloVest. AffloVest is a portable, wearable vest that treats patients with chronic respiratory conditions. TheWe sell this device is sold through home medical equipment and durable medical equipment providers throughout the United States. 

We were originally incorporated in Minnesota under the name Tactile Systems Technology, Inc. on January 30, 1995. During 2006, we established a merger corporation and subsequently, on July 21, 2006, merged with and into this merger corporation, resulting in our reincorporation as a Delaware corporation. The resulting corporation assumed the name Tactile Systems Technology, Inc. In September 2013, we began doing business as “Tactile Medical”.

On August 2, 2016, we closed the initial public offering of our common stock, which resulted in the sale of 4,120,000 shares of our common stock at a public offering price of $10.00 per share. We received net proceeds from the initial public offering of approximately $35.4 million, after deducting underwriting discounts and approximately $2.9 million of transaction expenses. In connection with the closing of the initial public offering, all of our outstanding redeemable convertible preferred stock automatically converted to common stock on August 2, 2016.

Our business is affected by seasonality. In the first quarter of each year, when most patients have started a new insurance year and have not yet met their annual out-of-pocket payment obligations, we experience substantially reduced demand for our products. We typically experience higher revenue in the third and fourth quarters of the year when patients have met their annual insurance deductibles, thereby reducing their out-of-pocket costs for our products, and because patients desire to exhaust their flexible spending accounts at year end. This seasonality applies only to purchases and rentals of our products by patients covered by commercial insurance and is not relevant to Medicare, Medicaid or the Veterans Administration, as those payers either do not have plans that have declining deductibles over the course of the plan year and/or do not have plans that include patient deductibles for purchases or rentals of our products. Further, seasonality trends in 2021have been, and may continue to be, significantly different than in prior yearshistorical trends as a result of the COVID-19 pandemic and related impacts.

Note 2. Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and pursuant to the rules and regulations of the SEC. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included.

The results for the ninethree months ended September 30, 2021,March 31, 2022, are not necessarily indicative of results to be expected for the year ending December 31, 2021,2022, or for any other interim period or for any future year. The condensed consolidated interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2020.2021.

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Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements include the accounts of Tactile Systems Technology, Inc. and its wholly owned subsidiary, Swelling Solutions, Inc. All intercompany balances and transactions have been eliminated in consolidation.

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Risks and Uncertainties

Coronavirus (COVID-19)

The United States economy in general and our business specifically have been negatively affected by the COVID-19 pandemic. We have seen adverse impacts as it relates to the decline in the number of patients that healthcare facilities and clinics are able to treat due to enhanced safety protocols, particularly during 2020 andIn the first quarter of 2021. While we saw some level of recovery in2022, the second quarter of 2021, the third quarter was negatively impacted by thecontinued prolonged recovery from COVID-19 and increased DeltaOmicron variant cases during the period, which resulted in restricted access to clinics and hospitals and disrupted the recovery in patient visits versus the pre-COVID environment. ThereThe adverse impacts in the first quarter of 2022 were similar to those we experienced during the first quarter of 2021. At this time, there are no reliable estimates of how long the pandemic will last, whether any recovery will be sustained or will reverse course, the severity of any resurgence of COVID-19 or variant strains of the virus, the effectiveness of vaccines and attitudes towards receiving them, or what ultimate effects the pandemic will have. For that reason, we are unable to reasonably estimate the long-term impact of the pandemic on our business at this time.

Since the onset of COVID-19, we have remained proactive to ensure we continue to adapt to the needs of our employees, clinicians and patients.patients

.We cannot assure you that these changes to our processes and practices will be successful in mitigating the impact of COVID-19 on our business. We continue to evaluate and, if appropriate, will adopt other measures in the future related to the ongoing safety of our employees, clinicians and patients.

In addition, we are closely monitoring mandatory vaccination requirements and related evolving guidance that is or may be applicable to us, including in our capacity as a U.S. government contractor. See See Part II, Item 1A. “Risk Factors” in this Form 10-Q for additional information about vaccine mandates and potential risks related thereto.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and to disclose contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.

Comprehensive (Loss) Income

Comprehensive (loss) income reflects the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Our comprehensive (loss) income represents net (loss) income adjusted for unrealized gains and losses on available-for-sale marketable securities and the related taxes.

Note 3. Summary of Significant Accounting Policies

Significant Accounting Policies  

There were no material changes in our significant accounting policies during the ninethree months ended September 30, 2021,March 31, 2022, except as set forth below. See Note 3 – “Summary of Significant Accounting Policies” to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2020,2021, for information regarding our significant accounting policies.

Business Segments

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We operate and report in only 1 operating and reportable segment. Our chief operating decision maker does not use financial information below revenue to allocate resources.

Goodwill

Goodwill represents the excess of the purchase price paid over the estimated fair value of the net assets acquired and liabilities assumed in the acquisition of a business. Goodwill is not amortized, but is tested for impairment at least annually or on an interim basis if an event occurs or circumstances change that would more likely than not reduce the fair value of a reporting unit below its carrying value. We plan to perform our annual assessment of goodwill for impairment as of July 1st of each fiscal year. See Note 7 – “Goodwill and Intangible Assets” for additional information.

Revenue Recognition for AffloVest

The AffloVest device is sold through home medical equipment and durable medical equipment providers (collectively, "distributors"). Revenue is recognized when control of the promised goods or services is transferred to the distributors, in an amount that reflects the consideration we expect to be entitled to in exchange for transferring those goods or providing services. We account for a contract when it has approval and commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance and collectability of consideration is probable. When determining whether the distributor has obtained control of the goods or services, we consider any future performance obligations. Generally, there is no post-shipment obligation on products sold other than warranty obligations in the normal and ordinary course of business.

In general, revenue from the sale of the AffloVest product is recognized at shipment, unless circumstances dictate that control has not yet passed to the distributor.

Certain of our contracts include volume-based incentives which involve rebates that are negotiated at or prior to the time of sale with the customer and are redeemable only if the customer achieves a specified cumulative level of sales or sales increase. Under these incentive programs, at the time of sale, we determine the most likely amount of the rebate to be paid based on forecasted sales levels. These forecasts are updated at least quarterly for each customer, and the transaction price is reduced for the anticipated cost of the rebate. If the forecasted sales for a customer change, the accrual for rebates is adjusted to reflect the new rebates expected to be earned by the customer.

Amounts billed to customers for shipping and handling activities after the customer obtains control are treated as a promised service performance obligation and recorded in revenue in the accompanying Consolidated Statements of Operations. Shipping and handling costs incurred for the delivery of goods to customers are considered a cost to fulfill the contract and are included in cost of revenue sold in the accompanying Consolidated Statements of Operations.

For a description of our revenue recognition policies related to our Flexitouch and Entre systems, see Note 3 – “Summary of Significant Accounting Policies” to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2020.

Accounting Pronouncement Not Yet Adopted

In March 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2020-04, “Reference Rate Reform (Topic 848) — Facilitation of the Effect of Reference Rate Reform on Financial Reporting” (“ASU 2020-04”), addressing the discontinuation of LIBOR, a widely used reference rate for pricing financial products. The ASU is intended to provide optional expedients and exceptions if certain criteria are met when accounting for contracts, hedging relationships and other transactions that reference LIBOR, or another reference rate expected to be discontinued because of reference rate reform. The application and adoption requirements of ASU 2020-04 are optional until December 31, 2022 and vary based on expedients elected. We have not elected any expedients to date and are currently evaluating any potential future impacts on the condensed consolidated financial statements.

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Recently Adopted Accounting Pronouncements

In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740) — Simplifying the Accounting for Income Taxes” (“ASU 2019-12”), which is intended to simplify various aspects of the accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. We adopted ASU 2019-12 as of January 1, 2021, and it did not have an impact on the condensed consolidated financial statements.

In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments — Credit Losses” (“ASU 2016-13”), which introduced a new model for recognizing credit losses on financial instruments based on an estimate of the current expected credit losses. The new current expected credit losses (“CECL”) model generally calls for the immediate recognition of all expected credit losses and applies to financial instruments and other assets, including accounts receivable and other financial assets measured at amortized cost, debt securities and other financial assets. This guidance replaced the previous incurred loss model for measuring expected credit losses and requires expected losses on available-for-sale debt securities to be recognized through an allowance for credit losses rather than as reductions in the amortized cost of the securities. We adopted ASU 2016-13 as of January 1, 2020, and it did not have an impact on the consolidated financial statements at that time. In connection with the AffloVest Acquisition, it was determined CECL did not have a material financial impact on the receivables related to the durable medical equipment channel.

Note 4. Acquisitions

On September 8, 2021, we entered into an Asset Purchase Agreement (“AffloVest APA”) to acquire the AffloVest therapyairway clearance business from International Biophysics Corporation.IBC. Under the terms of the AffloVest APA, we agreed to pay IBC a total of up to $100.0 million for the purchase of substantially all of the assets related to its branded high frequency chest wall oscillation vest therapy business, other than specifically identified excluded assets. We acquired AffloVest to further expand our position as a leader in treating patients with underserved chronic conditions in the home. The acquired assets included inventory, tooling, intellectual property, permits and approvals, data and records, and customer and supplier information. At closing, $80.0 million of the purchase price was paid, of which a total of $0.5 million was deposited into an escrow account at closing for purposes of satisfying certain post-closing purchase price adjustments and indemnification claims. Subsequent to closing, $0.2 milionmillion was returned to us as a result of working capital adjustments. The AffloVest acquisition was funded through a combination of cash on hand and proceeds from borrowings. 

 

NaN earn-out payments of up to $10.0 million each are potentially due to IBC under the AffloVest APA depending on the achievement of specified revenue targets, as follows:

Initial Earn-Out: Equal to 1.5 times the amount by which the AffloVest business’ U.S. revenues in the period from October 1, 2021 to September 30, 2022 (the “Initial Earn-Out Period”) exceed a specified amount; provided that in no event will the payment exceed $10.0 million; and
Second Earn-Out: Equal to 1.5 times the amount by which the AffloVest business’ U.S. revenues in the period from October 1, 2022 to September 30, 2023 exceed the revenues recognized during the Initial Earn-Out Period; provided that in no event will the payment exceed $10.0 million.

This liability was recorded on the Condensed Consolidated Balance Sheet at September 30, 2021 in the line item Earn-out, non-current, at an acquisition-dateThe fair value of the earn-out as of the acquisition date was $6.4 million. The fair value of the earn-out, reflecting management’s estimate of the likelihood of achieving these targets, was determined by employing a Monte Carlo Simulation model. This amount and the current versus non-current allocation will be re-measuredremeasured at the end of each reporting period until the payment requirement ends, with any adjustments reported in income from operations.operations (see Note 15 – “Fair Value Measurements”).

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On the date of AffloVest Acquisition, we allocated the assets acquired based on an estimate of their fair values. The following table summarizes the purchase price allocation:

(In millions)

    

Allocated Fair Value

Inventories

$

1.6

Property and equipment(1)

Intangible assets

53.5

Goodwill

31.1

Purchase price

$

86.2

(1) The purchase price included less than $0.1 million of property and equipment.

The goodwill reflects expected synergies of combining the acquired products and customer information with our existing operations, and is deductible for tax purposes over 15 years.

The following table reflects the allocation of purchase price to the acquired intangible assets and related estimated useful lives: 

(In millions)

    

Allocated Fair Value

Estimated Useful Life

Customer relationships

$

31.0

13 years

Developed technology

13.0

11 years

Tradenames

 

9.5

Indefinite

Total intangible assets

$

53.5

The weighted-average amortization period of the acquired intangible assets was 12.3 years.

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The fair market valuations associated with the assets acquired fall within Level 3 of the fair value hierarchy, due to the use of significant unobservable inputs to determine fair value. The fair value measurements were calculated using unobservable inputs, primarily using the income approach, specifically the discounted cash flow method. The amount and timing of future cash flows within our analysis was based on our due diligence models, most recent operational budgets, long-range strategic plans and other estimates.

Transaction costs, such as legal and other costs, related to the acquisition aggregated approximately $0.8 million. These costs have been expensed as incurred and are included in reimbursement, general and administrative expenses in our Condensed Consolidated Statements of Operations.

The Condensed Consolidated Statements of Operations reflect the AffloVest operations beginning September 9, 2021. The following unaudited pro forma information for the three and nine months ended September 30, 2021 and the three and nine months ended September 30, 2020 presents the revenues and net income assuming the acquisition of AffloVest had occurred as of January 1, 2020. This information has been prepared for comparative purposes only and is not indicative of what actual results would have been if the acquisition had taken place at the beginning of fiscal 2020, or of future results.

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

(In thousands)

    

2021

2020

2021

2020

Total revenue

$

56,249

$

53,068

$

157,686

$

139,130

Net income (loss)

$

628

$

(309)

$

1,369

$

1,770

These pro forma results include certain adjustments, primarly due to increases in amortization expense due to fair value adjustments of intangible assets, increases in interest expense due to additional borrowings incurred to finance the acquisition and amortization of debt issuance costs incurred to finance the transaction, acquisition related costs including transaction costs such as legal, accounting, valuation and other professional services, and related tax effects.

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Note 5. Marketable Securities

There were 0 investments in marketable securities at September 30, 2021 and December 31, 2020.

There were 0 net pre-tax unrealized gains for marketable securities at September 30, 2021. There were 0 sales of marketable securities during the nine months ended September 30, 2021.

There were 0 marketable securities in an unrealized loss position at September 30, 2021 and December 31, 2020.

Note 6.5. Inventories

Inventories consisted of the following:

(In thousands)

    

At September 30, 2021

    

At December 31, 2020

    

At March 31, 2022

    

At December 31, 2021

Finished goods

$

9,607

$

7,129

$

9,433

$

8,242

Component parts and work-in-process

 

14,223

 

11,434

 

10,046

 

10,975

Total inventories

$

23,830

$

18,563

$

19,479

$

19,217

Note 7.6. Goodwill and Intangible Assets

Goodwill

In the third quarter of fiscal 2021, we completed the AffloVest Acqusition.Acquisition. The purchase price of the AffloVest businessproduct line exceeded the net acquisition-date estimated fair value amounts of the identifiable assets acquired and the liabilities assumed by $31.1 million, which was assigned to goodwill. 

Intangible Assets

Our patents and other intangible assets are summarized as follows:

Weighted-

At September 30, 2021

Average

Gross

Amortization

Carrying

Accumulated

Net

(In thousands)

    

Period

Amount

Amortization

Amount

Definite-lived intangible assets:

Patents

12 years

$

537

$

97

$

440

Defensive intangible assets

3 years

1,125

550

575

Customer accounts

2 years

125

82

43

Customer relationships

13 years

31,000

146

30,854

Developed technology

11 years

13,000

72

12,928

Subtotal

45,787

947

44,840

Unamortized intangible assets:

Tradenames

9,500

9,500

Patents pending

630

630

Total intangible assets

$

55,917

$

947

$

54,970

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Weighted-

At December 31, 2020

Average

Gross

Amortization

Carrying

Accumulated

Net

(In thousands)

    

Period

Amount

Amortization

Amount

Definite-lived intangible assets:

Patents

11 years

$

413

$

65

$

348

Defensive intangible assets

4 years

1,125

421

704

Customer accounts

2 years

 

125

 

63

 

62

Subtotal

1,663

549

1,114

Unamortized intangible assets:

Patents pending

566

566

Total intangible assets

$

2,229

$

549

$

1,680

Amortization expense was $0.3 million and $0.1 million for the three months ended September 30, 2021 and 2020, respectively, and $0.4 million and $0.3 million for the nine months ended September 30, 2021 and 2020, respectively. Future amortization expenses are expected as follows:

(In thousands)

2021 (October 1 - December 31)

$

953

2022

3,811

2023

 

3,781

2024

 

3,759

2025

 

3,669

Thereafter

 

28,867

Total

$

44,840

Intangible Assets

Our patents and other intangible assets are summarized as follows:

Weighted-

At March 31, 2022

Average

Gross

Amortization

Carrying

Accumulated

Net

(In thousands)

    

Period

Amount

Amortization

Amount

Definite-lived intangible assets:

Patents

12 years

$

689

$

124

$

565

Defensive intangible assets

3 years

1,125

635

490

Customer accounts

1 year

125

95

30

Customer relationships

12 years

31,000

1,338

29,662

Developed technology

10 years

13,000

663

12,337

Subtotal

45,939

2,855

43,084

Unamortized intangible assets:

Tradenames

9,500

9,500

Patents pending

585

585

Total intangible assets

$

56,024

$

2,855

$

53,169

Weighted-

At December 31, 2021

Average

Gross

Amortization

Carrying

Accumulated

Net

(In thousands)

    

Period

Amount

Amortization

Amount

Definite-lived intangible assets:

Patents

12 years

$

666

$

109

$

557

Defensive intangible assets

3 years

1,125

592

533

Customer accounts

1 year

 

125

 

89

 

36

Customer relationships

13 years

31,000

742

30,258

Developed technology

11 years

13,000

368

12,632

Subtotal

45,916

1,900

44,016

Unamortized intangible assets:

Tradenames

9,500

9,500

Patents pending

565

565

Total intangible assets

$

55,981

$

1,900

$

54,081

Amortization expense was $1.0 million and $0.1 million for the three months ended March 31, 2022 and 2021, respectively. Future amortization expenses are expected as follows:

(In thousands)

2022 (April 1 - December 31)

$

2,867

2023

3,793

2024

 

3,771

2025

 

3,682

2026

 

3,617

Thereafter

 

25,354

Total

$

43,084

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Note 8.7. Accrued Expenses

Accrued expenses consisted of the following:

(In thousands)

    

At September 30, 2021

    

At December 31, 2020

    

At March 31, 2022

    

At December 31, 2021

Warranty

$

1,779

$

1,606

$

1,998

$

1,851

In-transit inventory

1,341

634

Legal and consulting

985

882

1,248

1,371

Travel

 

552

 

545

752

661

In-transit inventory

 

611

 

416

Clinical studies

135

67

122

113

Sales and use tax

109

193

71

106

Other

 

449

 

496

 

871

 

744

Total

$

5,350

$

4,423

$

5,673

$

5,262

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Note 9.8. Warranty Reserves

The activity in the warranty reserve during and as of the end of the reporting periods presented was as follows:

Three Months Ended

Nine Months Ended

Three Months Ended

September 30, 

September 30, 

March 31, 

(In thousands)

    

2021

    

2020

    

2021

    

2020

2022

    

2021

Beginning balance

$

5,117

$

4,208

$

4,841

$

3,759

$

4,959

$

4,841

Warranty provision

 

624

 

820

 

2,080

 

2,097

 

643

 

612

Processed warranty claims

 

(604)

 

(514)

 

(1,784)

 

(1,342)

 

(607)

 

(584)

Ending balance

$

5,137

$

4,514

$

5,137

$

4,514

$

4,995

$

4,869

Accrued warranty reserve, current

$

1,779

$

1,443

$

1,779

$

1,443

$

1,998

$

1,610

Accrued warranty reserve, non-current

3,358

3,071

3,358

3,071

2,997

3,259

Total accrued warranty reserve

$

5,137

$

4,514

$

5,137

$

4,514

$

4,995

$

4,869

Note 10.9. Credit Agreement

On August 3, 2018, we entered into a credit agreement with Wells Fargo Bank, National Association, which was amended by a First Amendment dated February 12, 2019, a Waiver and Second Amendment dated March 25, 2019, and a Third Amendment dated August 2, 2019 (collectively, the “2018 Credit Agreement”). On April 30, 2021, we entered into an Amended and Restated Credit Agreement (the “Restated Credit Agreement”) with the lenders from time to time party thereto, and Wells Fargo Bank, National Association, as Administrative Agent. The Restated Credit Agreement amended and restated in its entirety the 2018 Credit Agreement.our prior credit agreement.

On September 8, 2021, we entered into a First Amendment Agreement (the “Amendment”), which amends the Restated Credit Agreement (as amended by the Amendment, the “Credit Agreement”) with the lenders from time to time party thereto and Wells Fargo Bank, National Association, as administrative agent. The Amendment, among other things, adds a $30.0 million incremental term loan to the $25.0 million revolving credit facility provided by the Restated Credit Agreement. The term loan is reflected on our condensed consolidated financial statements as a note payable. The term loan and the revolving credit facility mature on September 8, 2024. The Credit Agreement provides that, subject to satisfaction of certain conditions, we may increase the amount of the revolving loans available under the Credit Agreement and/or add one or more term loan facilities in an amount not to exceed $25.0 million in the aggregate, such that the total aggregate principal amount of loans available under the Credit Agreement (including under the revolving credit facility) does not exceed $80.0 million.

 

On September 8, 2021, in connection with the closing of the AffloVest Acquisition, we borrowed the $30.0 million term loan and utilized that borrowing, together with a draw of $25.0 million under the revolving credit facility and cash on hand, to fund the purchase price.

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On February 22, 2022, we entered into a Second Amendment Agreement (the “Second Amendment”), which further amended the Credit Agreement, including with respect to the financial covenants.

The principal of the term loan is required to be repaid in quarterly installments of $750,000 commencing January 7, 2022, through July 8, 2024, with the remaining outstanding balance due on September 8, 20242024. Pursuant to the Second Amendment, we made a mandatory principal prepayment of the term loan of $3.0 million on February 22, 2022.

.

As of March 31, 2022, the outstanding balance of the term loan was $26.3 million and the outstanding balance under the revolving credit facility was $25.0 million. As of March 31, 2022, there was 0 availability under our Credit Agreement.

The term loan and amounts drawn under the revolving credit facility bear interest, at our option, at a rate equal to (a) the highest of (i) the prime rate, (ii) the federal funds rate plus 0.50% and (iii) LIBOR for an interest period of one month plus 1% (the “Base Rate”) plus an applicable margin or (b) LIBOR for an interest period of one, three or six months, at our option, plus the applicable margin. The applicable margin is 0.75% to 2.25% on loans bearing interest at the Base Rate and 1.75% to 3.25% on loans bearing interest at LIBOR, in each case depending on our consolidated total leverage ratio.ratio; except that, pursuant to the Second Amendment, during the period commencing on February 22, 2022 and ending on the last day of the fiscal quarter ending June 30, 2023, the applicable margin for LIBOR rate loans is 3.50%. At September 30, 2021,March 31, 2022, all outstanding borrowings were subject to interest at a rate calculated at LIBOR plus an applicable margin, equaling 2.8%for an interest rate of 3.70%. Undrawn portions of the revolving credit facility are subject to an unused line fee at a rate per annum from 0.300% to 0.375%, depending on our consolidated total leverage ratio.

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Maturities of the term loan for the next three years as of September 30, 2021,March 31, 2022, are as follows:

(In thousands)

    

Amount

    

Amount

2021 (October 1 - December 31)

$

2022

3,000

2022 (April 1 - December 31)

$

2,250

2023

3,000

3,000

2024

24,000

21,000

Total

$

30,000

$

26,250

Our obligations under the Credit Agreement are secured by a security interest in substantially all of our and our subsidiaries’ assets and are also guaranteed by our subsidiaries. The Credit Agreement contains a number of restrictions and covenants, including that we maintain compliance with a maximum leverage ratio, a minimum fixed charge coverage ratio, and a minimum consolidated EBITDA covenant, and a minimum liquidity covenant. As of September 30, 2021,March 31, 2022, we were in compliance with all financial covenants under the Credit Agreement.

Note 11.10. Commitments and Contingencies

Lease Obligations

We lease property and equipment under operating leases, typically with terms greater than 12 months, and determine if an arrangement contains a lease at inception. In general, an arrangement contains a lease if there is an identified asset and we have the right to direct the use of and obtain substantially all of the economic benefit from the use of the identified asset. We record an operating lease liability at the present value of lease payments over the lease term on the commencement date. The related right of use (“ROU”) operating lease asset reflects rental escalation clauses, as well as renewal options and/or termination options. The exercise of lease renewal and/or termination options are at our discretion and are included in the determination of the lease term and lease payment obligations when it is deemed reasonably certain that the option will be exercised. When available, we use the rate implicit in the lease to discount lease payments to present value; however, certain leases do not provide a readily determinable implicit rate. Therefore, we must estimate our incremental borrowing rate to discount the lease payments based on information available at lease commencement.

We classify our leases as buildings, vehicles or computer and office equipment and do not separate lease and nonlease components of contracts for any of the aforementioned classifications. In accordance with

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applicable guidance, we do not record leases with terms that are less than one year on the Condensed Consolidated Balance Sheet.Sheets.

None of our lease agreements contain material restrictive covenants or residual value guarantees.

Buildings

We lease certain office and warehouse space at various locations in the United States where we provide services. These leases are typically greater than one year with fixed, escalating rents over the noncancelable terms and, therefore, ROU operating lease assets and operating lease liabilities are recorded on the Condensed Consolidated Balance Sheet,Sheets, with rent expense to be recognized on a straight-line basis over the term of the lease. The remaining lease terms vary from approximately one to nineeight years as of September 30, 2021.March 31, 2022.

We entered into a lease (“initial lease”) in October 2018, for approximately 80,000 square feet of office space for our new corporate headquarters in Minneapolis, Minnesota. In December 2018, we amended the initial lease to add approximately 29,000 square feet of additional office space, which is accounted for as a separate lease (“second lease”) in accordance with ASU No. 2016-02, “Leases” (Topic 842) (“ASC 842”). In December 2019, we further amended the lease which extended the expiration date of the initial lease, extended the expiration date of and added approximately 4,000 square feet to the second lease, as well as added approximately 37,000 square feet of additional office space, accounted for as a separate lease (“third lease”) in accordance with ASC 842. The portion of the space covered under the initial lease was placed in service in September 2019. This portion was recognized as an operating lease and included in the ROU operating lease

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assets and operating lease liabilities on the Condensed Consolidated Balance Sheets. The portion of the space covered under the second lease commenced in September 2020. Finally, the portion of the space covered under the third lease commenced in September 2021.

Vehicles

We lease vehicles for certain members of our field sales organization under a vehicle fleet program whereby the initial, noncancelable lease is for a term of 367 days, thus more than one year. Subsequent to the initial term, the lease becomes a month-to-month, cancelable lease. As of September 30, 2021,March 31, 2022, we had approximately 4532 vehicles with agreements within the initial, noncancelable lease term that are recorded as ROU operating lease assets and operating lease liabilities. In addition to monthly rental fees specific to the vehicle, there are fixed monthly nonlease components that have been included in the ROU operating lease assets and operating lease liabilities. The nonlease components are not significant.

Computer and Office Equipment

We also have operating lease agreements for certain computer and office equipment. The remaining lease terms as of September 30, 2021,March 31, 2022, ranged from less than one year to approximately four years with fixed monthly payments that are included in the ROU operating lease assets and operating lease liabilities. The leases provide an option to purchase the related equipment at fair market value at the end of the lease. The leases will automatically renew as a month-to-month rental at the end of the lease if the equipment is not purchased or returned.

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Lease Position, Undiscounted Cash Flow and Supplemental Information

The table below presents information related to our ROU operating lease assets and operating lease liabilities that we have recorded:

(In thousands)

    

At September 30, 2021

    

At December 31, 2020

    

At March 31, 2022

    

At December 31, 2021

Right of use operating lease assets

$

23,919

$

20,132

$

23,315

$

23,984

Operating lease liabilities:

Current

$

2,412

$

2,006

$

2,504

$

2,506

Non-current

 

23,357

 

19,388

 

22,742

 

23,354

Total

$

25,769

$

21,394

$

25,246

$

25,860

Operating leases:

Weighted average remaining lease term

 

8.9 years

9.4 years

 

8.4 years

8.6 years

Weighted average discount rate

4.2%

4.4%

4.2%

4.2%

Nine Months Ended September 30,

Three Months Ended March 31,

2021

2020

2022

2021

Supplemental cash flow information for our operating leases:

Cash paid for operating lease liabilities

$

2,411

$

1,849

$

918

$

789

Non-cash right of use assets obtained in exchange for new operating lease obligations

$

6,146

$

6,664

$

41

$

124

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The table below reconciles the undiscounted cash flows underfor the periods presented to the operating lease liabilities recorded on the Condensed Consolidated Balance Sheet for the periods presented:as of March 31, 2022:

(In thousands)

2021 (October 1 - December 31)

$

908

2022

3,345

2022 (April 1 - December 31)

$

2,658

2023

 

3,274

3,425

2024

 

3,260

 

3,415

2025

 

3,359

 

3,516

2026

 

3,615

Thereafter

 

16,653

 

13,249

Total minimum lease payments

30,799

29,878

Less: Amount of lease payments representing interest

(5,030)

(4,632)

Present value of future minimum lease payments

25,769

25,246

Less: Current obligations under operating lease liabilities

(2,412)

(2,504)

Non-current obligations under operating lease liabilities

$

23,357

$

22,742

As of September 30, 2021, we have additional lease commitments of $0.8 million related to amendments to existing building leases that have not yet commenced. As the lessee we are involved in providing guidance to the lessor for related improvements, however these improvements are managed and owned by the lessor.

Operating lease costs were $0.9$1.0 million and $0.8 million for the three months ended September 30,March 31, 2022 and 2021, and 2020, respectively. Operating lease costs were $2.6 million and $2.1 million for the nine months ended September 30, 2021 and 2020, respectively.

Major Vendors

We had purchases from 2 vendors that accounted for 36%29% of our total purchases for the three months ended September 30, 2021. We had purchases from 1 vendor that accounted for 24% of our total purchases for the nine months ended September 30, 2021. We had purchasesMarch 31, 2022, and from 2 vendors that accounted for 31% and 33% of our total purchases for the three and nine months ended September 30, 2020, respectively.March 31, 2021.

Purchase Commitments

We issued purchase orders prior to September 30, 2021,March 31, 2022, totaling $28.4$38.8 million for goods that we expect to receive within the next year.

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Retirement Plan

We maintain a 401(k) retirement plan for our employees in which eligible employees can contribute a percentage of their pre-tax compensation. We recorded an expense related to our discretionary contributions to the 401(k) plan of $0.3$0.4 million and $0.1$0.3 million for the three months ended September 30,March 31, 2022 and 2021, and 2020, respectively, and $0.9 million and $0.2 million for the nine months ended September 30, 2021 and 2020, respectively.

Legal Proceedings

From time to time, we are subject to various claims and legal proceedings arising in the ordinary course of business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.

On February 13, 2019, we were served with a sealed amended complaint venued in the United States District Court for the Southern District of Texas, Houston Division, captioned United States ex rel Veterans First Medical Supply, LLC vs. Tactile Medical Systems Technology, Inc., Case No. 18-2871, which had been filed on January 23, 2019. The complaint is a qui tam action on behalf of the United States brought by one of our competitors. The United States has declined to intervene in this action. The complaint alleges that we violated

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the Federal Anti-Kickback Statute and the Federal False Claims Act, claiming that we submitted false claims and made false statements in connection with the Medicare and Medicaid programs, and that we engaged in unlawful retaliation in violation of the Federal False Claims Act. The complaint seeks damages, statutory penalties, attorneys’ fees, treble damages and costs. We filed a motion to dismiss on April 5, 2019. This motion was denied on February 21, 2020. On March 6, 2020, we filed our answer to the complaint and asserted counterclaims. On May 7, 2020, the plaintiff filed a motion to dismiss our counterclaims. On September 8, 2020, we filed a motion for Partial Summary Judgment. On January 2, 2021, the plaintiff filed a motion for Partial Summary Judgment. These motions were decided on March 29, 2021, wherein the court denied plaintiff’s motion to dismiss our counterclaims; granted our motion for Partial Summary Judgment and dismissed Counts I (standalone/direct violation of the Federal Anti-Kickback Statute) and III (violation of the retaliation provision of the Federal False Claims Act) of the complaint; and denied plaintiff’s motion for Partial Summary Judgment.  As a result, the remaining allegations consist of those in Count II (violations of the Federal False Claims Act) of the complaint. On August 13, 2021, we filed a motion for summary judgement on the remaining Count II. Plaintiff filed a motion for summary judgement on the counterclaims. These motions are currently pending. We believe the plaintiff’s remaining allegations are without merit and we intend to continue to vigorously defend against the lawsuit.

We and certain of our present or former officers werehave been sued in a purported securities class action lawsuit that was filed in the United States District Court for the District of Minnesota on September 29, 2020, and that is pending under the captionBrian Mart v. Tactile Systems Technology, Inc., et al.al., File No. 0:20-cv-02074-NEB-BRT. On April 19, 2021, the plaintiff filed an Amended Complaint against us and eight of our present and former officers and directors. Plaintiff seeks to represent a class consisting of investors who purchased our common stock in the market during the time period from May 7, 2018 through June 8, 2020 (“alleged class period”). The Amended Complaint alleges the following claims under the Securities Exchange Act of 1934, as amended (the “Exchange Act”): (1) that we and certain officer defendants made materially false or misleading public statements about our business, operational and compliance policies, and results during the alleged class period in violation of Section 10(b) of the Exchange Act; (2) that we and the individual defendants engaged in a scheme to defraud investors in order to allow the individual defendants to sell our stock in violation of Section 10(b) of the Exchange Act; (3) that the individual defendants engaged in improper insider trading of our stock in violation of Section 20A of the Exchange Act; and (4) that we and the individual defendants are liable under Section 20(a) of the Exchange Act because each defendant is a controlling person. On June 18, 2021, we and the individual defendants filed a motion to dismiss the Amended Complaint. On March 31, 2022, the court granted in part, and denied in part, the defendants’ motion to dismiss. All claims against three individual defendants were dismissed, and most claims against four other individual defendants were dismissed. The motion has not been decided yet.Company remains a defendant on alleged Sections 10(b) and 20(a) claims. We are defending the action as it proceeds.

Note 12.11. Stockholders' Equity

Stock-Based Compensation

Our 2016 Equity Incentive Plan (the “2016 Plan”) authorizes us to grant stock options, stock appreciation rights, restricted stock, stock units and other stock-based awards to employees, non-employee directors and certain consultants and advisors. There were up to 4,800,000 shares of our common stock initially reserved for issuance pursuant to the 2016 Plan. The 2016 Plan provides that the number of shares reserved and available for issuance under the 2016 Plan will automatically increase annually on January 1 of each calendar year, commencing in 2017 and ending on and including January 1, 2026, by an amount equal to the lesser of: (a) 5% of the number of common shares of stock outstanding as of December 31 of the immediately preceding calendar year, or (b) 2,500,000 shares; provided, however, that our Board of Directors may determine that any annual increase be a lesser number. In addition, all awards granted under our 2007 Omnibus Stock Plan and our 2003 Stock Option Plan that were outstanding when the 2016 Plan became effective and that are forfeited, expired, cancelled, settled for cash or otherwise not issued, will become available for issuance under the 2016 Plan. Pursuant to the automatic increase feature of the 2016 Plan, 972,591 and 952,697 shares were added as available for issuance thereunder on January 1, 2021 and 2020, respectively.2021. Our Board of Directors exercised its prerogative to forego the automatic increase on January 1, 2022. As of September 30, 2021, 6,366,806March 31, 2022, 5,919,092 shares were available for future grant pursuant to the 2016 Plan.

Upon adoption and approval of the 2016 Plan, all of our previous equity incentive compensation plans were terminated. However, existing awards under those plans continue to vest in accordance with the original vesting schedules and will expire at the end of their original terms.

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In the second fiscal quarter of 2020, our Board of Directors appointed a new President and Chief Executive Officer (“CEO”), effective June 8, 2020. In conjunction with the acceptance of the written offer, our CEO received both restricted stock units and stock option awards under our 2016 Plan during the third fiscal quarter of 2020 and the stock options have a seven year term. A portion of the awards vested on June 30, 2021, with the remaining portion of the awards vesting over a period of three years from the date of grant. Further, the stock options were valued at the date of grant using the Monte Carlo Simulation model due to a market condition that required that our stock price exceed $40.15 for 20 consecutive trading days during the term of the option in order to vest. This condition was satisfied in the first quarter of 2021.

We recorded stock-based compensation expense of $2.6$2.2 million and $3.2$2.5 million for the three months ended September 30,March 31, 2022 and 2021, and 2020, respectively, and $7.7 million and $8.3 million for the nine months ended September 30, 2021 and 2020, respectively. This expense was allocated as follows:

Three Months Ended

Nine Months Ended

Three Months Ended

September 30, 

September 30, 

March 31, 

(In thousands)

    

2021

    

2020

    

2021

    

2020

    

2022

    

2021

Cost of revenue

$

171

$

171

$

455

$

358

$

102

$

111

Sales and marketing expenses

1,081

1,436

2,979

3,915

1,027

978

Research and development expenses

68

87

224

269

83

97

Reimbursement, general and administrative expenses

1,268

1,470

4,045

3,746

1,016

1,271

Total stock-based compensation expense

$

2,588

$

3,164

$

7,703

$

8,288

$

2,228

$

2,457

Stock Options

Stock options issued to participants other than non-employees typically vest over three or four years and typically have a contractual term of seven or ten years. Stock-based compensation expense included in the Condensed Consolidated Statements of Operations for stock options was $1.0$0.7 million and $1.1$1.2 million for the three months ended September 30,March 31, 2022 and 2021, and 2020, respectively, and $3.3 million and $3.0 million for the nine months ended September 30, 2021 and 2020, respectively. At September 30, 2021,March 31, 2022, there was approximately $6.4$4.0 million of total unrecognized pre-tax stock option expense under our equity compensation plans, which is expected to be recognized on a straight-line basis over a weighted-average period of 1.91.6 years.

Our stock option activity for the ninethree months ended September 30, 2021,March 31, 2022, was as follows:

    

Weighted-

Weighted-

    

Weighted-

Weighted-

Average

Average

Aggregate

Average

Average

Aggregate

Options

Exercise Price

Remaining

Intrinsic

Options

Exercise Price

Remaining

Intrinsic

(In thousands except options and per share data)

Outstanding

Per Share (1)

Contractual Life

Value (2)

Outstanding

Per Share (1)

Contractual Life

Value (2)

Balance at December 31, 2020

1,039,709

$

36.43

5.6 years

$

13,381

Balance at December 31, 2021

915,224

$

39.33

5.0 years

$

2,068

Granted

174,755

$

50.88

$

Exercised

(138,586)

$

25.85

$

3,863

(18,034)

$

5.06

$

235

Forfeited

(68,797)

$

48.64

(22,280)

$

48.78

Cancelled/Expired

(30,005)

$

61.13

(22,504)

$

43.13

Balance at September 30, 2021

977,076

$

38.90

5.2 years

$

10,208

Balance at March 31, 2022

852,406

$

39.71

4.8 years

$

1,956

Options exercisable at September 30, 2021

508,184

$

30.45

4.4 years

$

9,229

Options exercisable at March 31, 2022

576,134

$

36.57

4.4 years

$

1,956

(1)The exercise price of each option granted during the period shown was equal to the market price of the underlying stock on the date of grant.
(2)The aggregate intrinsic value of options exercised represents the difference between the exercise price of the option and the closing stock price of our common stock on the date of exercise. The aggregate intrinsic value of options outstanding represents the difference between the exercise price of the option and the closing stock price of our common stock on the last trading day of the period.

Options exercisable of 461,138546,067 as of September 30, 2020,March 31, 2021, had a weighted-average exercise price of $23.35$30.27 per share.

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Time-Based Restricted Stock Units

We have granted time-based restricted stock units to certain participants under the 2016 Plan that are stock-settled with common shares. Time-based restricted stock units granted under the 2016 Plan vest over one to three years. Stock-based compensation expense included in the Condensed Consolidated Statements of Operations for time-based restricted stock units was $1.2$1.4 million and $1.4$1.3 million for the three months ended September 30,March 31, 2022 and 2021, and 2020, respectively, and $3.7 million and $4.0 million for the nine months ended September 30, 2021 and 2020, respectively. At September 30, 2021,March 31, 2022, there was approximately $6.6$11.2 million of total unrecognized pre-tax compensation expense related to outstanding time-based restricted stock units that is expected to be recognized over a weighted-average period of 1.92.3 years.

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Our time-based restricted stock unit activity for the ninethree months ended September 30, 2021,March 31, 2022, was as follows:

Weighted-

Weighted-

    

    

Average Grant

    

Aggregate

    

    

Average Grant

    

Aggregate

Units

Date Fair Value

Intrinsic

Units

Date Fair Value

Intrinsic

(In thousands except unit and per unit data)

Outstanding

Per Unit

Value (1)

Outstanding

Per Unit

Value (1)

Balance at December 31, 2020

211,469

$

48.29

$

9,503

Balance at December 31, 2021

259,147

$

42.32

$

4,932

Granted

91,001

$

51.56

286,396

$

18.54

Vested

(94,517)

$

47.99

(42,170)

$

54.40

Cancelled

(24,161)

$

51.29

(13,199)

$

35.74

Balance at September 30, 2021

183,792

$

49.66

$

8,170

Balance at March 31, 2022

490,174

$

27.57

$

9,882

Deferred and unissued at September 30, 2021(2)

6,469

$

38.94

$

288

Deferred and unissued at March 31, 2022(2)

6,469

$

38.94

$

130

(1)The aggregate intrinsic value of restricted stock units outstanding was based on our closing stock price on the last trading day of the period.
(2)For the ninethree months ended September 30, 2021,March 31, 2022, there were 0 restricted stock units granted to non-employee directors in lieu of their quarterly cash retainer payments. As of September 30, 2021,March 31, 2022, there were 6,469 outstanding restricted stock units that had been previously granted to non-employee directors in lieu of their quarterly cash retainer payments.

Performance-Based Restricted Stock Units

We have granted performance-based restricted stock units (“PSUs”) to certain participants under the 2016 Plan. These PSUs have both performance-based and time-based vesting features. The PSUs granted in 2018 were earned to the extent performance goals based on revenue and adjusted EBITDA were achieved in 2019. The PSUs granted in 20192020 would have been earned to the extent performance goals based on revenue and adjusted EBITDA were achieved in 2020,2021, but none were so earned. The PSUs granted in 2020 will be earned if and to the extent performance goals based on revenue and adjusted EBITDA are achieved in 2021. The PSUs granted in 2021 will be earned if and to the extent performance goals based on revenue and adjusted EBITDA are achieved in 2022. The PSUs granted in 2022 will be earned if and to the extent performance goals based on revenue change and adjusted EBITDA margin are achieved in 2023. The number of PSUs earned will depend on the level at which the performance targets are achieved and can range from 50% of target if the minimum performance threshold is achieved and up to 150% of target if maximum performance is achieved. One-third of the earned PSUs will vest on the date the Compensation and Organization Committee certifies the number of PSUs earned, and the remaining two-thirds of the earned PSUs will vest on the first anniversary of that certification date. All earned and vested PSUs will be settled in shares of common stock.

Stock-based compensation expense recognized for PSUs was an expensea benefit of $0.2$0.1 million and $0.4$0.3 million for the three months ended September 30,March 31, 2022 and 2021, and 2020, respectively, and less than $0.1 million and $0.5 million for the nine months ended September 30, 2021 and 2020, respectively. The stock-based compensation expensebenefit for the ninethree months ended September 30,March 31, 2022 reflected a $0.2 million benefit due to a change in the estimated payout associated with PSUs granted in 2021 being below the performance target threshold level, as defined, partially offset by an expense of $0.1 million related to the PSUs granted in 2022. The stock-based compensation benefit for the three months ended March 31, 2021 reflected a $0.5 million benefit due to a change in the estimated payout associated with PSUs granted in 2020 being below the minimum performance target threshold level, as defined, partially offset by an expense of $0.5$0.2 million related to the PSUs granted in 2018 and 2021. At September 30, 2021,March 31, 2022, there was approximately $1.5$2.8 million of total unrecognized pre-tax compensation expense related to outstanding PSUs that is expected to be recognized over a weighted average period of 2.42.7 years.

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Our performance-based restricted stock unit activity for the ninethree months ended September 30, 2021,March 31, 2022, was as follows:

Performance-

Weighted-

Performance-

Weighted-

    

Based

    

Average Grant

    

Aggregate

    

Based

    

Average Grant

    

Aggregate

Units

Date Fair Value

Intrinsic

Units

Date Fair Value

Intrinsic

(In thousands except unit and per unit data)

Outstanding

Per Unit

Value (1)

Outstanding

Per Unit

Value (1)

Balance at December 31, 2020

79,303

$

47.83

$

3,564

Balance at December 31, 2021

54,317

$

50.22

$

1,034

Granted

39,419

$

51.82

131,710

$

18.54

Vested

(34,159)

$

33.98

(1,853)

$

19.03

Cancelled

(23,936)

$

65.43

(20,147)

$

32.26

Balance at September 30, 2021

60,627

$

51.28

$

2,695

Balance at March 31, 2022

164,027

$

25.11

$

3,307

(1)The aggregate intrinsic value of performance-based restricted stock units outstanding was based on our closing stock price on the last trading day of the period.

Employee Stock Purchase Plan

Our employee stock purchase plan (“ESPP”), which was approved by our Board of Directors on April 27, 2016, and by our stockholders on June 20, 2016, allows participating employees to purchase shares of our common stock at a discount through payroll deductions. The ESPP is available to all of our employees and employees of participating subsidiaries. Participating employees may purchase common stock, on a voluntary after-tax basis, at a price equal to 85% of the lower of the closing market price per share of our common stock on the first or last trading day of each stock purchase period. The ESPP provides for six-month purchase periods, beginning on May 16 and November 16 of each calendar year.

A total of 1,600,000 shares of common stock was initially reserved for issuance under the ESPP. This share reserve will automatically be supplemented each January 1, commencing in 2017 and ending on and including January 1, 2026, by an amount equal to the least of (a) 1% of the shares of our common stock outstanding on the immediately preceding December 31, (b) 500,000 shares or (c) such lesser amount as our Board of Directors may determine. Pursuant to the automatic increase feature of the ESPP, 194,518 and 190,539 shares were added as available for issuance thereunder on January 1, 2021 and 2020, respectively.2021. Our Board of Directors exercised its prerogative to forego the automatic increase on January 1, 2022. As of September 30, 2021, 1,740,328March 31, 2022, 1,708,760 shares were available for future issuance under the ESPP. We recognized stock-based compensation expense associated with the ESPP of $0.2 million and $0.3 million for the three months ended September 30,March 31, 2022 and 2021, and 2020, respectively, and $0.6 million and $0.8 million for the nine months ended September 30, 2021 and 2020, respectively.

Note 12. Revenue

We derive our revenue from the sale and rental of our products to our customers in the United States. The following table presents our revenue, inclusive of sales and rental revenue, disaggregated by product line:

Three Months Ended

March 31,

(In thousands)

2022

2021

Revenue

Lymphedema products

$

40,654

$

42,772

Airway clearance products

7,324

Total

$

47,978

$

42,772

Percentage of total revenue

Lymphedema products

 

85%

 

100%

Airway clearance products

15%

— %

Total

 

100%

 

100%

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Note 13. Revenue

We derive our revenue from the sale and rental of our products to our customers in the United States. The following table presents our revenue, inclusive of sales and rental revenue, disaggregated by product categories:

Three Months Ended

Nine Months Ended

September 30,

September 30,

(In thousands)

    

2021

2020

2021

2020

Revenue

Flexitouch system

$

44,014

$

42,908

$

126,544

$

112,621

Entre system

 

7,622

 

6,184

 

18,924

 

15,266

AffloVest

861

861

Total

$

52,497

$

49,092

$

146,329

$

127,887

Percentage of total revenue

Flexitouch system

 

84%

 

87%

 

86%

 

88%

Entre system

 

14%

 

13%

 

13%

 

12%

AffloVest

2%

— %

1%

— %

Total

 

100%

 

100%

 

100%

 

100%

Our revenue by channel, inclusive of sales and rental revenue, for the three and nine months ended September 30,March 31, 2022 and 2021, and 2020, are summarized in the following table:

Three Months Ended

Nine Months Ended

Three Months Ended

September 30,

September 30,

March 31,

(In thousands)

    

2021

2020

2021

2020

2022

2021

Private insurers and other payers

$

36,034

$

34,554

$

99,665

$

90,459

$

26,566

$

28,283

Veterans Administration

6,737

6,788

19,905

18,168

5,635

5,846

Medicare

8,865

7,750

25,898

19,260

8,453

8,643

Durable medical equipment distributors

861

861

7,324

Total

$

52,497

$

49,092

$

146,329

$

127,887

$

47,978

$

42,772

Our rental revenue is derived from rent-to-purchase arrangements that typically range from three to ten months.months. As title transfers to the patient, with whom we have the contract, upon the termination of the lease term and because collectability is probable, under ASC 842, these are recognized as sales-type leases. Each rental agreement contains two components, the controller and related garments, both of which are interdependent and recognized as one lease component.

The revenue and associated cost of revenue of sales-type leases are recognized on the lease commencement date and a net investment in leases is recorded on the Condensed Consolidated Balance Sheet. We bill the patients’ insurance payers monthly over the duration of the rental term. We record the net investment in leases and recognize revenue upon commencement of the lease in the amount of the expected consideration to be received through the monthly payments. Similar to our sales revenue, the transaction price is impacted by multiple factors, including the terms and conditions contracted by third partythird-party payers. As the rental contract resides with the patients, we have elected the portfolio approach, at the payer level, to determine the expected consideration, which considers the impact of early terminations. While the contract is with the patient, in certain circumstances, the third partythird-party payer elects an initial rental period with an option to extend. We assess the likelihood of extending the lease at the onset of the lease to determine if the option is reasonably certain to be exercised. As the lease is short-term in nature, we anticipate collection of substantially all of the net investment within the first year of the lease agreement. Completion of these payments represents the fair market value of the equipment, and as such, interest income is not applicable.

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Rental revenue for the three and nine months ended September 30,March 31, 2022 and 2021, and 2020, was primarily from private insurers. Sales-type lease revenue and the associated cost of revenue for the three and nine months ended September 30,March 31, 2022 and 2021, and 2020, was:

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

(In thousands)

2021

2020

2021

2020

2022

2021

Sales-type lease revenue

$

8,037

$

6,519

$

22,114

$

18,173

$

6,808

$

6,647

Cost of sales-type lease revenue

 

2,433

 

2,562

 

6,501

 

6,062

 

2,036

 

1,851

Gross profit

$

5,604

$

3,957

$

15,613

$

12,111

$

4,772

$

4,796

Note 14.13. Income Taxes

We record our interim provision for income taxes by applying our estimated annual effective tax rate to our year-to-date pre-tax income and adjusting for discrete tax items recorded in the period. Deferred income taxes result from temporary differences between the reporting of amounts for financial statement purposes and income tax purposes. These differences relate primarily to different methods used for income tax reporting purposes, including for depreciation and amortization, warranty and vacation accruals, and deductions related to allowances for doubtful accounts receivable and inventory reserves. Our provision for income taxes included current federal and state income tax expense, as well as deferred federal and state income tax expense.

21

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The effective tax rate for the three months ended September 30, 2021,March 31, 2022, was an expense of 126%1.4%, compared to a benefit of 55%44.6% for the three months ended September 30, 2020.March 31, 2021. The primary driver of the change in our effective tax rate is primarily attributable to a changefull valuation allowance being recorded for net deferred tax assets for the current year period, whereas no valuation allowance was recorded for the same period in projected taxable income.2021. We recorded an income tax expense of $1.9$0.2 million and a benefit of $0.8$1.8 million for the three months ended September 30,March 31, 2022 and 2021, and 2020, respectively.

The effective tax rate for the nine months ended September 30, 2021, was a benefit of 24%, compared to an expense of 17% for the nine months ended September 30, 2020. The primary driver of the change in our effective tax rate is attributable to recording a benefit in the nine months ended September 30, 2021, to recognize a tax credit for a research and development credit study conducted for tax years 2017-2020 as well as a change in deductibility of business meals to 100% in 2021 compared to 50% in 2020. We recorded an income tax benefit of $1.4 million and an expense of $2.3 million for the nine months ended September 30, 2021 and 2020, respectively.

We recognize the financial statement benefit of a tax position only after determining that the relevant tax authority is more-likely-than-not to sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the condensed consolidated financial statements is the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the relevant tax authority. As of September 30, 2021, tax contingencies related to federal and state credits recorded within the Condensed Consolidated Balance Sheets were $0.5 million. Changes in tax laws, regulations, administrative practices, principles, and interpretations may impact our tax contingencies. The timing of the resolution of income tax controversies is highly uncertain, and the amounts ultimately paid, if any, upon resolution of the issues raised by the taxing authorities may differ from the amounts accrued.

We are currently under examination by the New York Department of Taxation and Finance for tax years 2017, 2018, and 2019. The examination may lead to proposed adjustments to our taxes or our net operating losses with respect to years under examination as well as subsequent periods. In the event of any future tax assessments, we have elected to record the income taxes and any related interest and penalties as income tax expense on our statementCondensed Consolidated Statements of operations.Operations. The Company is not under examination in any other jurisdictions.

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Note 15.14. Net (Loss) IncomeLoss Per Share

The following table sets forth the computation of our basic and diluted net (loss) incomeloss per share:

Three Months Ended

Nine Months Ended

Three Months Ended

September 30,

September 30,

March 31,

(In thousands, except share and per share data)

    

2021

    

2020

    

2021

    

2020

2022

    

2021

Net (loss) income

$

(3,355)

$

2,424

$

(4,316)

$

(12,733)

Net loss

$

(15,568)

$

(2,266)

Weighted-average shares outstanding

19,790,838

19,415,640

19,676,749

19,309,344

19,898,502

19,545,558

Dilutive effect of stock-based awards

331,725

Weighted-average shares used to compute diluted net (loss) income per share

19,790,838

19,747,365

19,676,749

19,309,344

Net (loss) income per share - Basic

$

(0.17)

$

0.12

$

(0.22)

$

(0.66)

Net (loss) income per share - Diluted

$

(0.17)

$

0.12

$

(0.22)

$

(0.66)

Weighted-average shares used to compute diluted net loss per share

19,898,502

19,545,558

Net loss per share - Basic

$

(0.78)

$

(0.12)

Net loss per share - Diluted

$

(0.78)

$

(0.12)

The following common stock equivalents were excluded from the computation of diluted net (loss) incomeloss per share for the periods presented because including them would have been anti-dilutive:

Three Months Ended

Nine Months Ended

Three Months Ended

September 30,

September 30,

March 31,

    

2021

    

2020

    

2021

    

2020

2022

    

2021

Restricted stock units

190,261

104,786

190,261

223,776

496,643

201,767

Common stock options

977,076

594,117

977,076

982,182

852,406

1,101,500

Performance stock units

60,627

38,666

60,627

113,646

164,027

62,041

Employee stock purchase plan

38,325

60,196

33,931

48,360

84,808

41,278

Total

1,266,289

797,765

1,261,895

1,367,964

1,597,884

1,406,586

Note 16.15. Fair Value Measurements

We determine the fair value of our assets and liabilities based on the exchange price that would be received for an asset or paid to transfer a liability (exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. We use a fair value hierarchy with three levels of inputs, of which the first two are considered observable and the last unobservable, to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets or liabilities (Level 1). The next highest

22

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priority is based on quoted prices for similar assets or liabilities in active markets or quoted prices for identical or similar assets or liabilities in non-active markets or other observable inputs (Level 2). The lowest priority is given to unobservable inputs (Level 3).

We have obligations to pay up to $20.0 million in earn-out payments in cash if certain future U.S. revenues of the AffloVest are met. The earn-out liability was valued by employing a Monte Carlo Simulation model in a risk-neutral framework, which is a Level 3 input. The underlying simulated variable includes recognized revenue. The recognized revenue volatility estimate was based on a study of historical asset volatility for a set of comparable public companies. The model includes other assumptions including the market price of risk, which was calculated as the weighted average cost of capital less the long-term risk-free rate. The earn-out liability will be adjusted to fair value at each reporting date until settled. Changes in fair value will be included in intangible asset amortization and earn-out expenses in our Condensed Consolidated Statements of Operations.

Changes in the earn-out liability measured at fair value using Level 3 inputs were as follows:

(In thousands)

Earn-out liability at December 31, 2021

$

6,200

Addition for acquisition

Fair value adjustments

6,450

Earn-out liability at March 31, 2022

$

12,650

As of September 30, 2021, we no longer had any money market mutal funds.March 31, 2022, the fair value of the earn-out liability totaled $12.7 million, of which $3.5 million was non-current.

The following provides information regarding fair value measurements for our cash equivalentsearn-out liability as of March 31, 2022, and December 31, 2020,2021, according to the three-level fair value hierarchy:

At December 31, 2020

At March 31, 2022

    

Quoted Prices

    

    

    

    

Quoted Prices

    

    

    

in Active

Significant

in Active

Significant

Markets for

Other

Significant

Markets for

Other

Significant

Identical

Observable

Unobservable

Identical

Observable

Unobservable

Assets

Inputs

Inputs

Assets

Inputs

Inputs

(In thousands)

(Level 1)

(Level 2)

(Level 3)

Total

(Level 1)

(Level 2)

(Level 3)

Total

Recurring Fair Value Measurements:

Money market mutual funds

$

16,188

$

$

$

16,188

Earn-out liability

$

 

$

12,650

$

12,650

Total

$

16,188

$

$

$

16,188

$

$

$

12,650

$

12,650

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At December 31, 2021

    

Quoted Prices

    

    

    

in Active

Significant

Markets for

Other

Significant

Identical

Observable

Unobservable

Assets

Inputs

Inputs

(In thousands)

(Level 1)

(Level 2)

(Level 3)

Total

Recurring Fair Value Measurements:

Earn-out liability

$

$

$

6,200

$

6,200

Total

$

$

$

6,200

$

6,200

During the three and nine months ended September 30, 2021, there were 0 transfers within the three-level hierarchy. A significant transfer is recognized when the inputs used to value a security have been changed, which merits a transfer between the disclosed levels of the valuation hierarchy.

The fair value of our money market mutual funds is determined based on valuations provided by external investment managers who obtain them from a variety of industry standard data providers.

The carrying amounts of financial instruments such as cash equivalents, accounts receivable, other assets, accounts payable, accrued expenses and other liabilities approximate their related fair values due to the short-term maturities of these items. Non-financial assets, such as equipment and leasehold improvements, and intangible assets are subject to non-recurring fair value measurements if they are deemed impaired. As of June 30, 2020, we re-measured the value of our intangible assets related to the Airwear wrap product line to their fair value, which was deemed to be $0.

We have obligations to pay up to $20.0 million in earn-out payments in cash if certain future financial results of the AffloVest business are met. The earn-out liability was valued using Level 3 inputs. The fair value of the earn-out was determined by employing a Monte Carlo Simulation model in a risk-neutral framework. The underlying simulated variable includes recognized revenue. The recognized revenue volatility estimate was based on a study of historical asset volatility for a set of comparable public companies. The model includes other assumptions including the market price of risk, which was calculated as the weighted average cost of capital less the long-term risk free rate.

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

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and the accompanying notes thereto included elsewhere in this report.

Coronavirus (COVID-19)

The United States economy in general and our business specifically have been negatively affected by the COVID-19 pandemic. We have seen adverse impacts as it relates to the decline in the number of patients that healthcare facilities and clinics are able to treat due to enhanced safety protocols, particularly during 2020 andIn the first quarter of 2021. While we saw some level of recovery in2022, the second quarter of 2021, the third quarter was negatively impacted by thecontinued prolonged recovery from COVID-19 and increased DeltaOmicron variant cases during the period, which resulted in restricted access to clinics and hospitals and disrupted the recovery in patient visits versus the pre-COVID environment. ThereThe adverse impacts in the first quarter of 2022 were similar to those we experienced during the first quarter of 2021. At this time, there are no reliable estimates of how long the pandemic will last, whether any recovery will be sustained or will reverse course, the severity of any resurgence of COVID-19 or variant strains of the virus, the effectiveness of vaccines and attitudes towards receiving them, or what ultimate effects the pandemic will have. For that reason, we are unable to reasonably estimate the long-term impact of the pandemic on our business at this time.

Since the onset of COVID-19, we have remained proactive to ensure we continue to adapt to the needs of our employees, clinicians and patients. For a detailed listing of the changes to our business practices since the onset of the pandemic, refer to previous reports filed with the Securities and Exchange Commission. Continued modifications to our business include, but are not limited to:

Incorporating remote and flexible work arrangements for employees whenever possible, including real-time, online training of our new sales representatives. In addition,However, we are actively developing our long-term in-office and remote work strategy with the goal of launching it in 2022.
Eliminating employee travel restrictions in alignment with the opening of healthcare facilities and clinics while also continuing to maintain social distancing contact restrictions to reduce exposure.
Utilizing a mix of employee trainers and independent healthcare practitioners to educate patients on the proper use of our solutions virtually or in-person.
Continuing to host large virtual medical education programs, while also beginning to schedule smaller in-person meetings.
Supporting clinicians and patients by using rigorous infection control practices when in-person visits are required.
Following government guidelines related to vaccinations of our staff, as well as the needs of our patients and customers.

We cannot assure you that these changes to our processes and practices will be successful in mitigating the impact of COVID-19 on our business. We continue to evaluate and, if appropriate, will adopt other measures in the future related to the ongoing safety of our employees, clinicians and patients. Additional information related to the COVID-19 pandemic is included in the MD&A sections below.

In addition, we are closely monitoring mandatory vaccination requirements and related evolving guidance that is or may be applicable to us, including in our capacity as a U.S. government contractor.  See See Part II, Item 1A. “Risk Factors” in this Form 10-Q for additional information about vaccine mandates and potential risks related thereto.

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Overview

We are a medical technology company that develops and provides innovative medical devices for the treatment of underserved chronic diseases. Our mission is to help people suffering from chronic diseases live better and care for themselves at home. We focus our efforts on advancing the standard of care in treating underserved chronic diseases in the home setting to improve patient outcomes and quality of life and help control rising healthcare expenditures. Our areas of therapeutic focus are (1) vascular disease, with a goal of advancing the standard of care in treating lymphedema and chronic venous insufficiency, (2) oncology, where lymphedema is a common consequence among cancer survivors and (3) providing airway clearance therapy for those suffering from chronic respiratory conditions. We possess a unique, scalable platform to deliver at-home healthcare solutions throughout the United States. This evolving home care delivery model is recognized by policy-makerspolicymakers and insurance payers as a key for controlling rising healthcare costs. Our solutions deliver cost-effective, clinically proven, long-term treatment for people with these chronic diseases.

Our current lymphedema products are the Flexitouch system,and Entre systemsystems and our airway clearance product the AffloVest. A predecessor to our Flexitouch system received 510(k) clearance from the U.S. Food and Drug Administration (the “FDA”) in July 2002, and we introduced the system to address the many limitations of self-administered home-based manual lymphatic drainage therapy. We began selling our more advanced Flexitouch system after receiving 510(k) clearance from the FDA in October 2006. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. In June 2017, we announced that we received 510(k) clearance from the FDA for the Flexitouch Plus, the third-generation version of our Flexitouch system. In December 2020, we received 510(k) clearance for two new indications for our Flexitouch Plus system: phlebolymphedema and lipedema. We derive the vast majority of our revenue from our Flexitouch system. Sales and rentals of our Flexitouch system represented 86% and 88% of our revenue in the nine months ended September 30, 2021 and 2020, respectively.

We introduced our Entre system in the United States in February 2013. The Entre system is sold or rented to patients who need a simple pump or who do not yet qualify for insurance reimbursement for an advanced compression device such as our Flexitouch system. ForWe derive the nine months ended September 30, 2021 and 2020, salesvast majority of our revenue from our lymphedema product line. Sales and rentals of our Entre systemlymphedema products represented 13%85% and 12%100% of our revenue in the three months ended March 31, 2022 and 2021, respectively.

On September 8, 2021, we acquired the assets of the AffloVest respiratory therapyairway clearance product line from International Biophysics Corporation (“IBC”),IBC, a privately-held company which developed and manufactures AffloVest. AffloVest is a portable, wearable vest that treatsprovides airway clearance to treat patients with chronic respiratory conditions such as COPD-associated breathing conditions like bronchiectasis or

25

Table of Contents

conditions resulting from neuromuscular disorders and cystic fibrosis, by managing airway clearance.disorders. For the ninethree months ended September 30, 2021,March 31, 2022, sales of our AffloVest represented 1%15% our revenue.

In October 2018, we licensed, from Sun Scientific, Inc., the intellectual property rights related to the Airwear Gradient Compression Wrap, or the Airwear wrap, in the United States and Canada, for use in all medical applications, including but not limited to swelling/edema and ulcers (including lymphedema and chronic venous insufficiency conditions), but excluding the use of the intellectual property in the field of prophylaxis for deep vein thrombosis. In the second quarter of 2020, we reevaluated the Airwear wrap go-to market plan, and determined to focus our strategy on more advanced solutions within our core, long-standing Flexitouch and Entre franchises. Accordingly, we made the strategic decision to discontinue the Airwear wrap in the second quarter of 2020. Due to the planned discontinuation of the product line, we recorded a $4.0 million non-cash impairment charge to fully write-off the inventory and long-lived assets of the Airwear wrap in the quarter ended June 30, 2020. Further, effective July 31, 2020, Sun Scientific, Inc. terminated the license agreement with us related to the Airwear wrap.See Note 8 - “Intangible Assets” to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2020 for more information regarding this impairment charge and discontinuation.

To support the growth of our business, we invest heavily in our commercial infrastructure, consisting of our direct sales force, training resources, reimbursement capabilities and clinical expertise. We market our Flexitouch and Entrelymphedema products in the United States using a direct-to-patient and -provider model. Our field commercial team consists of our direct sales force and a team of Field Support Specialists. The AffloVest device is sold through home medical equipment andrespiratory durable medical equipment providers throughout the United

29

Table States that service patients and bill third-party payers for the product. We also employ a small group of Contents

States.Inrespiratory specialists, who educate DME provider representatives, provide product demonstrations for targeted clinicians and support technical questions related to the quarter ended September 30, 2021, our direct sales force experienced increased turnover and difficulty in recruiting qualified replacements.AffloVest. As of March 31, 2022, we employed a result, we had fewer directfield staff of 268 Tactile employees, made up of sales representatives, on September 30, 2021 comparedas well as managers, who provide support throughout the United States for our lymphedema and respiratory therapies. This compares to September 30, 2020. We believe this to be a temporary condition. Our collective field commercial team, including our respiratory sales force, has grown to over 335 employees244 as of September 30, 2021, compared to 285 employees as of DecemberMarch 31, 2020.2021.

As it relates to the impact of COVID-19 on our commercial processes, in the first halfquarter of 2021, we2022, the continued prolonged recovery from COVID-19 and increased Omicron variant cases resulted in restricted access to see restrictions loosen,clinics and hospitals and disrupted the recovery in line withpatient visits versus the applicable governmental regulations. Conversely,pre-COVID environment. The adverse impacts in the thirdfirst quarter of 2021,2022 were similar to those we were adversely impacted byexperienced during the resurgencefirst quarter of the Delta variant resulting in renewed patient cancellations, absenteeism of staff and access limitations implemented by clinics and health systems. As a result, we continue to engage in virtual interactions if possible. We expect these virtual interactions with clinicians and patients to continue into the future until the pandemic subsides, and perhaps as a best practice in the future. To that end, we plan to continue to work towards expanding our commercial organization through the remainder of 2021 and into 2022 by adding to our overall commercial team.  2021.

We invest substantial resources in our reimbursement function to improve operational efficiencies and enhance individual payer expertise, while continuing our strategic focus of payer development. Our payer relations function focuses on payer policy development, education, contract negotiations, and data analysis. Our reimbursement operations function is responsible for verifying patient insurance benefits, individual patient case development, prior authorization submissions, case follow-up, and appeals when necessary. Since the onset of COVID-19, our reimbursement function has been actively working with Medicare and a broad base of private payers to understand the ever-changing reimbursement criteria being introduced. We have seen increased flexibility in coverage criteria with select payers in which they now allow the use of virtual patient interactions in place of the previously required in-person interactions. However, as these circumstances are ever-changing, the extent to which these changes will remain in place and the impact on our business in the future are not determinable at this time.

We also have a clinical team, consisting of a scientific advisory board, in-house therapists and nurses, and a Chief Medical Officer, (part-time), that serves as a resource to clinicians and patients and guides the development of clinical evidence in support of our products. Most clinical studies require observation and interaction with clinicians and patients to monitor results and progress. Given the impact of COVID-19, patient recruitment for our clinical studies involving our products and clinical outcomes had previously been suspended in 2020. In 2021, all of our clinical trials have resumed research activities, including study visits and new patient enrollments, albeit more slowly than the targeted enrollment rates.

We rely on third party contract manufacturers for the sourcing of parts, the assembly of our controllers and the manufacturing of the garments used with our systems. We conduct final assembly of the garments used with our Flexitouch system,lymphedema products, perform quality assurance and ship our products from our facility in Minneapolis, Minnesota. The AffloVest device is currentlycontinued to be manufactured and shipped by a third party, IBC on our behalf pursuant to a Transition Services Agreement.Agreement through April 30, 2022. We plan for IBC to continue to manufacturewill be manufacturing and shipping the product on our behalf through the first half of 2022 and we will begin to take over the shipping of products in the fourth quarter of 2021.AffloVest device going forward.

To date, our supply chain has not been materially impacted by COVID-19. We continue to receive our product on time and believe that we have enough safety stock to meet our short and mid-term demand. However, we cannot assure you that our supply chain will not be materially impacted in the future.

For the three months ended September 30, 2021,March 31, 2022, we generated revenue of $52.5$48.0 million and had a net loss of $3.4$15.6 million, compared to revenue of $49.1$42.8 million and a net incomeloss of $2.4$2.3 million for the three months ended September 30, 2020. For the nine months ended September 30, 2021, we generated revenue of $146.3 million and had a net loss of $4.3 million, compared to revenue of $127.9 million and a net loss of $12.7 million for the nine months ended September 30, 2020.March 31, 2021. Our primary sources of capital since inceptionour initial public offering in 2016 have been from operating income private placements of our capital stock and capital raised in our initial public offering, which closed on August 2, 2016.bank financing.

We operate in one segment for financial reporting purposes.

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Results of Operations

Comparison of the Three and Nine Months Ended September 30,March 31, 2022 and 2021 and 2020

The following tables presenttable presents our results of operations for the periods indicated:

Three Months Ended

September 30,

Change

(In thousands)

2021

2020

$

%

Condensed Consolidated Statement

% of

% of

of Operations Data:

revenue

revenue

Revenue

Sales revenue

$

44,460

85

%

$

42,573

87

%

$

1,887

4

%

Rental revenue

8,037

15

%

6,519

13

%

1,518

23

%

Total revenue

52,497

100

%

49,092

100

%

3,405

7

%

Cost of revenue

Cost of sales revenue

13,096

25

%

11,558

24

%

1,538

13

%

Cost of rental revenue

2,433

5

%

2,562

5

%

(129)

(5)

%

Total cost of revenue

15,529

30

%

14,120

29

%

1,409

10

%

Gross profit

Gross profit - sales revenue

31,364

60

%

31,015

63

%

349

1

%

Gross profit - rental revenue

5,604

10

%

3,957

8

%

1,647

42

%

Gross profit

36,968

70

%

34,972

71

%

1,996

6

%

Operating expenses

Sales and marketing

22,231

42

%

19,488

40

%

2,743

14

%

Research and development

1,409

3

%

1,102

2

%

307

28

%

Reimbursement, general and administrative

14,500

28

%

12,539

26

%

1,961

16

%

Intangible asset amortization

195

%

49

%

146

N.M.

%

Total operating expenses

38,335

73

%

33,178

68

%

5,157

16

%

(Loss) income from operations

(1,367)

(3)

%

1,794

3

%

(3,161)

(176)

%

Other expense

(120)

%

(121)

%

1

(1)

%

(Loss) income before income taxes

(1,487)

(3)

%

1,673

3

%

(3,160)

(189)

%

Income tax expense (benefit)

1,868

3

%

(751)

(2)

%

2,619

N.M.

%

Net (loss) income

$

(3,355)

(6)

%

$

2,424

5

%

$

(5,779)

N.M.

%

Three Months Ended

March 31,

Change

(In thousands)

2022

2021

$

%

Condensed Consolidated Statement

% of

% of

of Operations Data:

revenue

revenue

Revenue

Sales revenue

$

41,170

86

%

$

36,125

84

%

$

5,045

14

%

Rental revenue

6,808

14

%

6,647

16

%

161

2

%

Total revenue

47,978

100

%

42,772

100

%

5,206

12

%

Cost of revenue

Cost of sales revenue

12,080

25

%

10,691

25

%

1,389

13

%

Cost of rental revenue

2,036

4

%

1,851

4

%

185

10

%

Total cost of revenue

14,116

29

%

12,542

29

%

1,574

13

%

Gross profit

Gross profit - sales revenue

29,090

61

%

25,434

59

%

3,656

14

%

Gross profit - rental revenue

4,772

10

%

4,796

12

%

(24)

(1)

%

Gross profit

33,862

71

%

30,230

71

%

3,632

12

%

Operating expenses

Sales and marketing

23,930

50

%

18,785

44

%

5,145

27

%

Research and development

1,520

3

%

1,270

3

%

250

20

%

Reimbursement, general and administrative

16,217

34

%

14,209

33

%

2,008

14

%

Intangible asset amortization and earn-out

7,096

15

%

50

%

7,046

N.M.

%

Total operating expenses

48,763

102

%

34,314

80

%

14,449

42

%

Loss from operations

(14,901)

(31)

%

(4,084)

(9)

%

(10,817)

N.M.

%

Other expense

(456)

(1)

%

(10)

%

(446)

N.M.

%

Loss before income taxes

(15,357)

(32)

%

(4,094)

(9)

%

(11,263)

N.M.

%

Income tax expense (benefit)

211

%

(1,828)

(4)

%

2,039

(112)

%

Net loss

$

(15,568)

(32)

%

$

(2,266)

(5)

%

$

(13,302)

N.M.

%

“N.M.” Not Meaningful

31

Table of Contents

Nine Months Ended

September 30,

Change

(In thousands)

2021

2020

$

%

Condensed Consolidated Statement

% of

% of

of Operations Data:

revenue

revenue

Revenue

Sales revenue

$

124,215

85

%

$

109,714

86

%

$

14,501

13

%

Rental revenue

22,114

15

%

18,173

14

%

3,941

22

%

Total revenue

146,329

100

%

127,887

100

%

18,442

14

%

Cost of revenue

Cost of sales revenue

36,425

25

%

30,868

24

%

5,557

18

%

Cost of rental revenue

6,501

4

%

6,062

5

%

439

7

%

Total cost of revenue

42,926

29

%

36,930

29

%

5,996

16

%

Gross profit

Gross profit - sales revenue

87,790

60

%

78,846

62

%

8,944

11

%

Gross profit - rental revenue

15,613

11

%

12,111

9

%

3,502

29

%

Gross profit

103,403

71

%

90,957

71

%

12,446

14

%

Operating expenses

Sales and marketing

61,949

42

%

59,856

47

%

2,093

3

%

Research and development

3,885

3

%

3,891

3

%

(6)

(0)

%

Reimbursement, general and administrative

42,802

30

%

37,682

29

%

5,120

14

%

Intangible asset amortization

294

%

148

%

146

99

%

Total operating expenses

108,930

75

%

101,577

79

%

7,353

7

%

Loss from operations

(5,527)

(4)

%

(10,620)

(8)

%

5,093

(48)

%

Other (expense) income

(154)

%

181

%

(335)

(185)

%

Loss before income taxes

(5,681)

(4)

%

(10,439)

(8)

%

4,758

(46)

%

Income tax (benefit) expense

(1,365)

(1)

%

2,294

2

%

(3,659)

(160)

%

Net loss

$

(4,316)

(3)

%

$

(12,733)

(10)

%

$

8,417

(66)

%

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Revenue

Revenue increased $3.4$5.2 million, or 7%12%, to $52.5$48.0 million in the three months ended September 30, 2021,March 31, 2022, compared to $49.1$42.8 million in the three months ended September 30, 2020.March 31, 2021. The increase in total revenue was attributable to an increase$7.3 million in sales of $1.1the airway clearance product line, which includes the AffloVest product acquired on September 8, 2021, partially offset by a decrease of $2.1 million, or 3%5%, in sales and rentals of the Flexitouch system, an increase of $1.4 million, or 23%, in sales and rentals of the Entre system and $0.9 million in sales of the recently acquired AffloVestlymphedema product line in the quarter ended September 30, 2021. ThirdMarch 31, 2022, compared to the 2021 first quarter. First quarter 2021 revenue benefited from effective virtual education events and an increase in Medicare patients served. Third quarter 20212022 revenue was negatively impacted by the prolonged recovery from COVID-19, including the resurgence due to the DeltaOmicron variant during the period, which resulted in restricted access to clinics and hospitals and disrupted the recovery in patient visits versus the pre-COVID environment. In addition, the challenging labor market impacted our abilitycontinued to recruit and retain quality candidates for our direct sales force.

Revenue increased $18.4 million, or 14%, to $146.3 million in the nine months ended September 30, 2021, compared to $127.9 million in the nine months ended September 30, 2020. The increase was primarily attributable to an increase of $13.9 million, or 12%, in sales and rentals of our Flexitouch system, an increase of $3.7 million, or 24%, in sales and rentals of the Entre system and $0.9 million in sales of the recently acquired AffloVest for the nine months ended September 30, 2021. Revenue for the first half of 2021 benefited from the initial stages of recovery from the COVID-19 pandemic, with a portion of healthcare facilities and clinics relaxing restrictions and increasing patient throughput, as well as an expanded prescriber base. However, in the third quarter of 2021 revenue was negatively impacted by the prolonged recovery from COVID-19, including the resurgence due to the Delta variant during the period, which resulted in restricted access to clinics and hospitals and disrupted the recovery in patient visits versus the pre-COVID environment. In addition, the challenging labor market impactedimpact our ability to recruit and retain quality candidates for our direct sales force.

Revenue from the Veterans Administration represented 13%12% and 14% of total revenue in the three months ended September 30,March 31, 2022 and 2021, and 2020, respectively. Revenue from the Veterans Administration represented 14% of total revenue in each of the nine months ended September 30, 2021 and 2020. Revenue from Medicare represented 17%18% and 16%20% of total revenue in the three months ended September 30,March 31, 2022 and 2021, and 2020, respectively. Revenue from Medicare represented 18% and 15% of total revenue in the nine months ended September 30, 2021 and 2020, respectively.

The following table summarizes our revenue by product line for the three and nine months ended September 30,March 31, 2022 and 2021, and 2020, both in dollars and percentage of total revenue:

Three Months Ended

September 30,

Change

(In thousands)

    

2021

2020

$

%

Revenue

Flexitouch system

$

44,014

$

42,908

$

1,106

3%

Entre system

 

7,622

 

6,184

 

1,438

23%

AffloVest

861

861

N.M.

Total

$

52,497

$

49,092

$

3,405

7%

Percentage of total revenue

Flexitouch system

 

84%

 

87%

 

Entre system

 

14%

 

13%

 

AffloVest

2%

0%

Total

 

100%

 

100%

 

Three Months Ended

March 31,

Change

(In thousands)

2022

2021

$

%

Revenue

Lymphedema products

$

40,654

$

42,772

$

(2,118)

(5)%

Airway clearance products

7,324

7,324

N.M.

Total

$

47,978

$

42,772

$

5,206

12%

Percentage of total revenue

Lymphedema products

 

85%

 

100%

 

Airway clearance products

15%

— %

Total

 

100%

 

100%

 

“N.M.” Not Meaningful

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Nine Months Ended

September 30,

Change

(In thousands)

    

2021

2020

$

%

Revenue

Flexitouch system

$

126,544

$

112,621

$

13,923

12%

Entre system

 

18,924

 

15,266

 

3,658

24%

AffloVest

861

861

N.M.

Total

$

146,329

$

127,887

$

18,442

14%

Percentage of total revenues

Flexitouch system

 

86%

 

88%

 

Entre system

 

13%

 

12%

 

AffloVest

1%

0%

Total

 

100%

 

100%

 

“N.M.” Not Meaningful

Our business is affected by seasonality. In the first quarter of each year, when most patients have started a new insurance year and have not yet met their annual out-of-pocket payment obligations, we experience substantially reduced demand for our products. We typically experience higher revenue in the third and fourth quarters of the year when patients have met their annual insurance deductibles, thereby reducing their out-of-pocket costs for our products, and because patients desire to exhaust their flexible spending accounts at year end. This seasonality applies only to purchases and rentals of our products by patients covered by commercial insurance and is not relevant to Medicare, Medicaid or the Veterans Administration, as those payers either do not have plans that have declining deductibles over the course of the plan year and/or do not have plans that include patient deductibles for purchases or rentals of our products. Further, seasonality trends in 2021have been, and may continue to be, significantly different than in prior yearshistorical trends as a result of the COVID-19 pandemic and related impacts.

Cost of Revenue and Gross Margin

Cost of revenue increased $1.4$1.6 million, or 10%13%, to $15.5 million in the three months ended September 30, 2021, compared to $14.1 million in the three months ended September 30, 2020. Cost of revenue increased $6.0 million, or 16%,March 31, 2022, compared to $42.9$12.5 million in the ninethree months ended September 30, 2021, compared to $36.9 million in the nine months ended September 30, 2020.March 31, 2021. The increase in cost of revenue in both periods was primarily attributable to an increase in the number of Flexitouch and Entre systems sold and rented, the additional contribution of AffloVest sales and an increase in inbound freight costs.

The total gross margin rate was 70% and 71% of sales in the three months ended September 30, 2021 and 2020, respectively, and 71% of sales in each of the ninethree months ended September 30, 2021March 31, 2022 and 2020.2021.

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Sales and Marketing Expenses

Sales and marketing expenses increased $2.7$5.1 million, or 14%27%, to $22.2$23.9 million in the three months ended September 30, 2021,March 31, 2022, compared to $19.5$18.8 million in the three months ended September 30, 2020.March 31, 2021. The increase was primarily attributable to a:

$1.3 million increase in personnel-related compensation expense as a result of the increased headcount in the collective field commercial team, including sales personnel associated with the AffloVest acquisition; and
$1.4 million increase in other selling expenses, driven mostly by increased meetings, travel and entertainment expenses.

Sales and marketing expenses increased $2.1 million, or 3%, to $61.9 million in the nine months ended September 30, 2021, compared to $59.9 million in the nine months ended September 30, 2020. The increase was primarily attributable to a:

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$3.34.6 million increase in personnel-related compensation expense as a result of the increased headcount in the collective field commercial team;
$1.11.0 million increase in travel and entertainment expense due to eased restrictions on travel; and
$0.40.3 million increase in demo equipment expense.sales meetings and tradeshows.

These increases were partially offset by a:a $0.8 million decrease in external patient training expense as a result of transitioning to employee trainers.

$2.0 million decrease in expenses due to reduced sales meetings, tradeshows and professional services; and
$0.7 million decrease in external patient training expense.

Research and Development Expenses

Research and development (“R&D”) expenses increased $0.3 million, or 28%20%, to $1.4$1.5 million in the three months ended September 30, 2021,March 31, 2022, compared to $1.1$1.3 million in the three months ended September 30, 2020,March 31, 2021, which was primarily attributable to an increase in professional services.

personnel-related compensation expense and R&D expenses were $3.9 million in each of the nine months ended September 30, 2021 and 2020.supplies.

Reimbursement, General and Administrative Expenses

Reimbursement, general and administrative expenses increased $2.0 million, or 16%14%, to $14.5$16.2 million in the three months ended September 30, 2021,March 31, 2022, compared to $12.5$14.2 million in the three months ended September 30, 2020.March 31, 2021. This increase was primarily attributable to a:

$1.01.2 million increase in occupancy costs, depreciation expense, and legal and professional fees; and
$0.8 million increase in transaction-related costs related to the acquisition of AffloVest; and
$0.3 million increase in personnel-related compensation expense as a result of increased headcount in our reimbursement operations, payer relations and corporate functions.

Reimbursement, general and administrative expenses increased $5.1 million, or 14%, to $42.8 million in the nine months ended September 30, 2021, compared to $37.7 million in the nine months ended September 30, 2020. The increase was primarily attributable to a:

$4.5 million increase in occupancy costs, depreciation expense, legal and professional fees;
$3.6 million increase in personnel-related compensation expense as a result of increased headcount in our reimbursement operations, payer relations and corporate functions;
$0.8 million increase in transaction-related costs related to the acquisition of AffloVest; partially offset by a
$3.6 million impairment charge related to the write-off of our Airwear wrap-related long-lived assets recorded in the second quarter of 2020.

Intangible Asset Amortization and Earn-out Expense

Intangible asset amortization and earn-out expense increased $0.1$7.0 million to $0.2$7.1 million in the three months ended September 30, 2021,March 31, 2022, compared to $0.1 million in the three months ended September 30, 2020, whichMarch 31, 2021. The increase in intangible asset amortization and earn-out expense was primarily attributable to the amortization recognized related toincrease in the assets recorded as a resultestimated fair value of the acquisition of AffloVest.our earn-out liability.

Other Expense, Net

Intangible asset amortization expenses increased $0.1Other expense, net was $0.5 million to $0.3 million in the nine months ended September 30, 2021, compared to $0.2 million inand $10 thousand for the three months ended September 30, 2020, whichMarch 31, 2022 and 2021, respectively. Other expense was primarily attributable to an increase in interest expense.

Income Taxes

We recorded an income tax expense of $0.2 million and an income tax benefit of $1.8 million for the amortization recognized relatedthree months ended March 31, 2022 and 2021, respectively. The difference relates to a full valuation allowance being recorded against all deferred tax assets in the assets recorded as a result of the acquisition of AffloVest.current year.

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Other (Expense) Income, Net

Other (expense) income, net was an expense of $0.1 million for each of the three months ended September 30, 2021 and 2020, and was an expense of $0.2 million and income of $0.2 million for the nine months ended September 30, 2021 and 2020, respectively. Other (expense) income was primarily impacted by interest income realized on marketable securities, the gain and loss on cost method investments and an increase in interest expense recognized in the third quarter of 2021.

Income Taxes

We recorded an income tax expense of $1.9 million and an income tax benefit of $0.8 million for the three months ended September 30, 2021 and 2020, respectively. The increase in income tax expense was primarily due to a change in our effective tax rate, which was attributable to a change in projected taxable income.

We recorded an income tax benefit of $1.4 million and an income tax expense of $2.3 million for the nine months ended September 30, 2021 and 2020, respectively. The primary driver of the change was a tax benefit related to a research and development credit recognized in the second quarter of 2021 as well as 100% deductibility of business meals in 2021 as compared to 50% deductibility in 2020.

Liquidity and Capital Resources

Cash Flows

At September 30, 2021,March 31, 2022, our principal sources of liquidity were cash and cash equivalents of $22.4$21.2 million and net accounts receivable of $44.3$59.5 million. This compares to cash and cash equivalents of $47.9$28.2 million and net accounts receivable of $43.8$62.3 million at September 30, 2020.December 31, 2021.

The following table summarizes our cash flows for the periods indicated:

Nine Months Ended

September 30,

(In thousands)

    

2021

    

2020

Net cash (used in) provided by:

Operating activities

 

$

(2,975)

$

(2,245)

Investing activities

(81,237)

20,684

Financing activities

58,758

995

Net (decrease) increase in cash and cash equivalents

 

$

(25,454)

$

19,434

Three Months Ended

March 31,

(In thousands)

    

2022

    

2021

Net cash (used in) provided by:

Operating activities

 

$

(3,206)

$

(800)

Investing activities

(175)

(311)

Financing activities

(3,698)

181

Net decrease in cash and cash equivalents

 

$

(7,079)

$

(930)

Operating Activities

Net cash used in operating activities during the ninethree months ended September 30, 2021,March 31, 2022, was $3.0$3.2 million, resulting from a net loss of $4.3$15.6 million and a net decrease in operating assets and liabilities net of acquisition, of $6.8$2.1 million, which was partially offset by non-cash net income (loss) adjustments of $8.1$10.3 million. The non-cash net income (loss) adjustments consisted primarily of $7.7$6.5 million related to a change in fair value of earn-out liability, $2.2 million of stock-based compensation expense, $2.1$1.5 million of depreciation and amortization expense and a $1.7$0.1 million increase inof deferred taxes.income tax expense. The uses of cash related to changes in operating assets primarily consisted of increases in inventories of $3.6 million,decreases in accounts receivable of $3.4$2.8 million and in net investment in leases of $1.7$0.2 million, in income taxes of $1.2 million, andpartially offset by increases in prepaid expenses and other assets of $1.1$0.6 million and in inventories of $0.3 million. The changes in operating liabilities consisted of increases in accrued expenses and other liabilities of $2.9 million and accounts payable of $2.0 million, partially offset by a decrease in accrued payroll and related taxes of $1.3$2.7 million, partially offset by increases in accrued expenses and other liabilities of $1.4 million and accounts payable of $1.2 million.

Net cash used in operating activities during the ninethree months ended September 30, 2020,March 31, 2021, was $2.2$0.8 million, resulting from a net loss of $12.7$2.3 million which was offset by non-cash net income (loss) adjustments of $1.4 million and a net increasedecrease in operating assets and liabilities of $7.9 million, which were offset by non-cash net income adjustments of $18.2$0.1 million. The non-cash net income (loss) adjustments consisted primarily of $8.3$2.5 million of stock-based compensation expense, a $4.0$1.8 million impairment

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loss charge related to the write-off of our Airwear wrap product line, a $3.9 million decrease in deferred taxes and $2.1$0.7 million of depreciation and amortization expense. The uses of cash related to changes in operating assets primarily consisted of increases in accounts receivable of $5.5 million, in inventories of $3.5 million and net investment in leases of $0.5 million, partially offset by decreases in accounts receivable of $2.5 million and prepaid expenses and other assets of $1.6 million and in net investment in leases of $1.3 million, partially offset by a decrease in income taxes receivable of $0.7$0.4 million. The changes in operating liabilities consisted primarily of increases in accrued expenses and other liabilities of $1.1 million,an increase in accounts payable of $0.9$5.0 million, andpartially offset by decreases in accrued payroll and related taxes of $3.0 million and accrued expenses and other liabilities of $0.8 million.million.

Investing Activities

Net cash used in investing activities during the ninethree months ended September 30, 2021,March 31, 2022, was $81.2$0.2 million, primarily consisting of acquisition-related payments of $79.8 million associated with the purchase of the AffloVest business and $1.4 million in purchases of property and equipment, and patent costs.

Net cash provided byused in investing activities during the ninethree months ended September 30, 2020,March 31, 2021, was $20.7$0.3 million primarily consisting of $22.5 million in proceeds from maturities of marketable securities, partially offset by $1.8 million in purchases of property and equipment, and patent costs.

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Financing Activities

Net cash used by financing activities during the three months ended March 31, 2022, was $3.7 million, primarily consisting of payments of $3.8 million made on our term loan, slightly offset by $0.1 million in proceeds from exercise of common stock options.

Net cash provided by financing activities during the ninethree months ended September 30,March 31, 2021, was $58.8$0.2 million, primarily consisting of borrowings of $54.8 million net of debt issuance costs incurred and $5.1$1.3 million in proceeds from the exercise of common stock options, and the issuance of common stock under the ESPP, partially offset by $1.2$1.1 million in taxes paid for the net share settlement of performance and restricted stock units.units

Net cash provided by financing activities during the nine months ended September 30, 2020, was $1.0 million, consisting of $2.6 million in proceeds from the exercise of common stock options and the issuance of common stock under the ESPP, partially offset by $1.6 million in taxes paid for the net share settlement of performance and restricted stock units..

Credit Agreement

On August 3, 2018, we entered into a credit agreement with Wells Fargo Bank, National Association, which was amended by a First Amendment dated February 12, 2019, a Waiver and Second Amendment dated March 25, 2019, and a Third Amendment dated August 2, 2019 (collectively, the “2018 Credit Agreement”). On April 30, 2021, we entered into an Amended and Restated Credit Agreement (the “Restated Credit Agreement”) with the lenders from time to time party thereto, and Wells Fargo Bank, National Association, as Administrative Agent. The Restated Credit Agreement amended and restated in its entirety the 2018 Credit Agreement.our prior credit agreement.

On September 8, 2021, we entered into a First Amendment Agreement (the “Amendment”), which amends the Restated Credit Agreement (as amended by the Amendment, the “Credit Agreement”) with the lenders from time to time party thereto and Wells Fargo Bank, National Association, as administrative agent. The Amendment, among other things, adds a $30.0 million incremental term loan to the $25.0 million revolving credit facility provided by the Restated Credit Agreement. The term loan is reflected on our condensed consolidated financial statements as a note payable. The term loan and the revolving credit facility mature on September 8, 2024. The Credit Agreement provides that, subject to satisfaction of certain conditions, we may increase the amount of the revolving loans available under the Credit Agreement and/or add one or more term loan facilities in an amount not to exceed $25.0 million in the aggregate, such that the total aggregate principal amount of loans available under the Credit Agreement (including under the revolving credit facility) does not exceed $80.0 million.

On September 8, 2021, in connection with the closing of the AffloVest Acquisition, we borrowed the $30.0 million term loan and utilized that borrowing, together with a draw of $25.0 million under the revolving credit facility and cash on hand, to fund the purchase price.

On February 22, 2022, we entered into a Second Amendment Agreement (the “Second Amendment”), which further amends the Credit Agreement, including with respect to the financial covenants.

The principal of the term loan is required to be repaid in quarterly installments of $750,000 commencing January 7, 2022, through July 8, 2024, with the remaining outstanding balance due on September 8, 2024. Pursuant to the Second Amendment, we made a mandatory principal prepayment of the term loan of $3.0 million on February 22, 2022.

As of March 31, 2022, the outstanding balance of the term loan was $26.3 million and the outstanding balance under the revolving credit facility was $25.0 million. As of March 31, 2022, there was no availability under our Credit Agreement.

Our obligations under the Credit Agreement are secured by a security interest in substantially all of our and our subsidiaries’ assets and are also guaranteed by our subsidiaries. The Credit Agreement contains a number of restrictions and covenants, including that we maintain compliance with a maximum leverage ratio, a minimum fixed charge coverage ratio, and a minimum consolidated EBITDA covenant and a minimum liquidity covenant. As of September 30, 2021,March 31, 2022, we were in compliance with all financial covenants under the Credit Agreement.

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On September 8, 2021, in connection with the closing of the acquisition of the AffloVest business, we borrowed the $30.0 million term loan and utilized that borrowing, together with a draw of $25.0 million under the revolving credit facility and cash on hand, to fund the purchase price. The principal of the term loan is required to be repaid in quarterly installments of $750,000 commencing January 7, 2022, through July 8, 2024, with the remaining outstanding balance due on September 8, 2024.

As of September 30, 2021, we had outstanding borrowings of $55.0 million under the Credit Agreement, comprised of $30.0 million under the term loan and $25.0 million under the revolving credit facility.

For additional information regarding the Credit Agreement, including interest rates, fees and maturities, see Note 109 – “Credit Agreement” of the condensed consolidated financial statements contained in this report.

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Future Cash Requirements

For a discussion of our material estimated future cash requirements under our contractual obligations and commercial commitments, in total and disaggregated into current and long-term, see “Future Cash Requirements” included in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2021. There have been no material changes since December 31, 2021.

Adequacy of Capital Resources

Our future capitalcash requirements may vary significantly from those now planned and will depend on many factors, including:

the impact and duration of the COVID-19 pandemic on our business;
sales and marketing resources needed to further penetrate our market;
increased inflation-related costs associated with labor and/or suppliers;
expansion of our operations domestically and/or internationally;
response of competitors to our solutions and applications;
costs associated with clinical research activities;
increases in interest rates;
labor shortages and wage inflation;
costs to develop and implement new products; and
use of capital for acquisitions or licenses, if any.

Historically, we have experienced increases in our expenditures consistent with the growth in our revenue, operations and personnel, and we anticipate that our expenditures will continue to increase as we expand our business.

Although the impact of the COVID-19 pandemic isand other factors such as inflation and rising interest rates are difficult to predict, we believe our cash, cash equivalents and cash flows from operations together with availability under the Credit Agreement will be sufficient to meet our working capital, and capital expenditure, debt repayment and related interest, and other cash requirements for at least the next twelve months.

Coronavirus Aid, Relief, and Economic Security (CARES) Act

On March 27, 2020 the CARES Act was signed into law. The CARES Act is a tax-and-spending package intended to provide economic relief to address the impact of the COVID-19 pandemic. The CARES Act includes several tax provisions that, among other things, allow businesses to carry back net operating losses (“NOLs”) arising in 2018, 2019, and 2020 to the prior five tax years. In the third quarter of 2020, we collected $2.9 million related to the carry back of our NOLs arising from these prior tax years.

In addition, the CARES Act provided $100 billion in relief funds to hospitals and other healthcare providers on the front lines of the COVID-19 pandemic. An initial $30 billion of the funds were released for immediate infusion and were distributed to all facilities and providers that received Medicare fee-for-service (“FFS”) reimbursements in 2019. On April 10, 2020, we received $1.2 million of the initial allotment to all facilities and providers which was determined to be our proportionate share. Within 45 days of each reporting period end, we are required to comply with reporting requirements confirming funds were utilized in a manner

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described within the terms and conditions outlined by the U.S. Department of Health & Human Services. As of December 31, 2020, we recognized all of the funds received in the initial allotment as other income.

Contractual and Commercial Commitments Summary

For a discussion on our contractual and commercial commitments, see “Contractual and Commercial Commitments Summary,” included in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2020. There have been no material changes since December 31, 2020.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements, investments in special purpose entities or undisclosed borrowings or debt. Additionally, we are not a party to any derivative contracts or synthetic leases.

Recent Accounting Pronouncements

Refer to Note 3 – “Summary of Significant Accounting Policies” of the condensed consolidated financial statements contained in this report for a description of recently issued accounting pronouncements that are applicable to our business.

Critical Accounting Policies and Estimates

A “criticalCritical accounting policy” is oneestimates are those that is both importantinvolve a significant level of estimation uncertainty and have had or are reasonably likely to the portrayal ofhave a material impact on our financial condition and results and requires management’s most subjective or complex judgments, often as a result of the need to make estimates about the effect of items that are inherently uncertain.operations. For additional information, please see the discussion of our significantmost critical accounting policiesestimates under “Critical Accounting Policies and Significant Estimates” in Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2020.2021.

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

For a discussion on our market risks, see Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” included in our Annual Report on Form 10-K for the year ended December 31, 2020.2021. There have been no material changes since December 31, 2020.2021.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2021.March 31, 2022. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2021,March 31, 2022, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

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Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, that occurred during the quarter ended September 30, 2021,March 31, 2022, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

Information pertaining to certain legal proceedings in which we are involved can be found in Note 1110 – “Commitments and Contingencies” to our condensed consolidated financial statements included in Part I, Item 1 of this report and is incorporated herein by reference.

Item 1A. Risk Factors.

In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the factors discussed in “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020,2021, which could materially affect our business, financial condition or future results. There have been no material changes in our risk factors from those disclosed in that report, except as set forth below.

The following risk factor is added:

The U.S. government’s pending rules and regulations concerning mandatory COVID-19 vaccination could materially and adversely affect our business, financial condition and results of operations.

On September 9, 2021, President Biden issued an executive order requiring all employers with U.S. government contracts to ensure that their U.S.-based employees, contractors and subcontractors, that work on or in support of U.S. government contracts, are fully vaccinated against COVID-19 by a specified deadline, which is being extended to January 4, 2022. The executive order includes on-site and remote U.S.-based employees, contractors and subcontractors and provides for limited medical and religious exceptions. As a government contractor, we are taking steps to analyze and implement required actions, including as provided in guidance related to the executive order that was recently issued by the Safer Federal Workforce Task Force, as well as any and all other guidance that is issued.

In addition, on September 9, 2021, President Biden announced that he has directed the Occupational Safety and Health Administration (“OSHA”) to develop an Emergency Temporary Standard (“ETS”) mandating either the full vaccination against COVID-19 or weekly testing of employees for employers with 100 or more employees. On November 4, 2021, OSHA issued the ETS and we are currently reviewing its provisions and potential impacts on us.

Further, our suppliers may be subject to, or voluntarily impose, vaccine mandates, which could result in disruptions in our business and supply chain.

It is currently not possible to predict with certainty the impact the executive order, the OSHA ETS, and other vaccine mandates will have on our workforce. Additional vaccine mandates may be announced in jurisdictions in which we operate or by healthcare facilities and clinics. Our implementation of any of these or other requirements may result in employee attrition, including attrition of critically skilled workforce, and difficulty securing future workforce needs, which could have a material adverse effect on our business, financial condition, and results of operations.report.

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

Recent Sales of Unregistered Securities

(a)Issuances of Preferred Stock

None.

(b)Issuances of Common Stock

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None.

(b)Issuances of Common Stock

None.

Item 3. Defaults Upon Senior Securities.

Not applicable.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

None.

Item 6. Exhibits.

The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index below.

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EXHIBIT INDEX

Incorporated by Reference

Incorporated by Reference

Exhibit

  

Exhibit

  

Filed

  

Exhibit

  

Filed

Number

Description of Exhibit

Form

  

Date of Filing

Number

Herewith

Description of Exhibit

Form

  

Date of Filing

Number

Herewith

2.1

Asset Purchase Agreement, dated as of September 8, 2021, among Tactile Systems Technology, Inc., International Biophysics Corporation and H. David Shockley, Jr.

8-K

09/08/2021

2.1

3.1

Amended and Restated Certificate of Incorporation, as amended through May 9, 2019

8-K

05/09/2019

3.2

Amended and Restated Certificate of Incorporation, as amended through May 9, 2019

8-K

05/09/2019

3.2

3.2

Amended and Restated By-laws, effective March 10, 2021

8-K

03/12/2021

3.1

Amended and Restated By-laws, effective March 10, 2021

8-K

03/12/2021

3.1

10.1

First Amendment Agreement, dated as of September 8, 2021, among Tactile Systems Technology, Inc., the Lenders signatory thereto and Wells Fargo Bank, National Association, as administrative agent

8-K

09/08/2021

10.1

Second Amendment Agreement, dated as of February 22, 2022, among Tactile Systems Technology, Inc., the Lenders signatory thereto and Wells Fargo Bank, National Association, as administrative agent

10-K

02/23/2022

10.37

31.1

Certification of Principal Executive Officer pursuant to Rule 13a-14(a) / 15d-14(a) of the Securities Exchange Act of 1934, as amended

X

Certification of Principal Executive Officer pursuant to Rule 13a-14(a) / 15d-14(a) of the Securities Exchange Act of 1934, as amended

X

31.2

Certification of Principal Financial Officer pursuant to Rule 13a-14(a) / 15d-14(a) of the Securities Exchange Act of 1934, as amended

X

Certification of Principal Financial Officer pursuant to Rule 13a-14(a) / 15d-14(a) of the Securities Exchange Act of 1934, as amended

X

32.1

Certification of Principal Executive Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

X

Certification of Principal Executive Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

X

32.2

Certification of Principal Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

X

Certification of Principal Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

X

101.1

The following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, formatted in Inline XBRL: (i) Balance Sheets, (ii) Statements of Operations, (iii) Statements of Comprehensive Income (Loss), (iv) Statements of Stockholders’ Equity, (v) Statements of Cash Flows, and (vi) Notes to the Condensed Consolidated Financial Statements

X

The following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, formatted in Inline XBRL: (i) Balance Sheets, (ii) Statements of Operations, (iii) Statements of Stockholders’ Equity, (iv) Statements of Cash Flows, and (v) Notes to the Condensed Consolidated Financial Statements

X

104.1

Cover page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101.1)

X

Cover page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101.1)

X

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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.

Tactile Systems Technology, Inc.

Date: November 8, 2021May 2, 2022

By:

/s/ Brent A. Moen

Brent A. Moen

Chief Financial Officer

(Principal financial and accounting officer)

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