p

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended June 30, 2020March 31, 2021

or

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

Commission File Number: 0-23837

 

Surmodics, Inc.

(Exact name of registrant as specified in its charter)

 

Minnesota

41-1356149

(State or other jurisdiction of incorporation or organization)

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

9924 West 74th Street, Eden Prairie, Minnesota 55344

(Address of principal executive offices) (Zip Code)

 

(952) 500-7000

(Registrant’s telephone number, including area code)

 

 

 

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

 

Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock, $0.05 par value

SRDX

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

 

Large accelerated filer

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  

The number of shares of the registrant’s Common Stock, $0.05 par value per share, as of July 31, 2020April 23, 2021 was 13,650,235.13,868,000.

 

 

 

 


TABLE OF CONTENTS

 

PART I.   FINANCIAL INFORMATION

 

Item 1.

Unaudited Condensed Financial Statements

3

Item 2.

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

2218

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

3127

Item 4.

Controls and Procedures

3228

 

PART II.   OTHER INFORMATION

 

Item 1.

Legal Proceedings

3329

Item 1A.

Risk Factors

3329

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

3429

Item 3.

Defaults Upon Senior Securities

3429

Item 4.

Mine Safety Disclosures

3429

Item 5.

Other Information

3429

Item 6.

Exhibits

3530

SIGNATURES

 

3631

 

2


Table of Contents

PART I. FINANCIAL INFORMATION

Item 1. Unaudited Condensed Financial Statements

Surmodics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

 

 

June 30,

 

 

September 30,

 

 

March 31,

 

 

September 30,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

(in thousands, except share and per share data)

 

(Unaudited)

 

(In thousands, except per share data)

 

(Unaudited)

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

36,386

 

 

$

30,361

 

 

$

48,159

 

 

$

30,785

 

Available-for-sale securities

 

 

24,178

 

 

 

24,931

 

 

 

17,792

 

 

 

30,313

 

Accounts receivable, net of allowance for doubtful accounts of $133 and $200 as of

June 30, 2020 and September 30, 2019, respectively

 

 

8,657

 

 

 

8,993

 

Accounts receivable, net of allowances of $118 and $130 as of

March 31, 2021 and September 30, 2020, respectively

 

 

9,096

 

 

 

7,675

 

Contract assets — royalties and license fees

 

 

4,248

 

 

 

8,210

 

 

 

6,622

 

 

 

6,108

 

Inventories, net

 

 

5,872

 

 

 

4,501

 

 

 

6,309

 

 

 

5,966

 

Income tax receivable

 

 

4,867

 

 

 

558

 

 

 

1,657

 

 

 

2,391

 

Prepaids and other

 

 

3,594

 

 

 

3,866

 

 

 

3,406

 

 

 

3,370

 

Total Current Assets

 

 

87,802

 

 

 

81,420

 

 

 

93,041

 

 

 

86,608

 

Property and equipment, net

 

 

28,939

 

 

 

29,748

 

 

 

29,745

 

 

 

30,103

 

Available-for-sale securities

 

 

4,071

 

 

 

 

Deferred income taxes

 

 

5,585

 

 

 

6,176

 

 

 

6,507

 

 

 

7,315

 

Intangible assets, net

 

 

12,585

 

 

 

14,226

 

 

 

12,028

 

 

 

13,283

 

Goodwill

 

 

26,563

 

 

 

26,171

 

 

 

27,190

 

 

 

27,185

 

Other assets

 

 

5,024

 

 

 

2,124

 

 

 

4,513

 

 

 

4,269

 

Total Assets

 

$

166,498

 

 

$

159,865

 

 

$

177,095

 

 

$

168,763

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,375

 

 

$

2,085

 

 

$

1,593

 

 

$

1,515

 

Accrued liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Compensation

 

 

4,320

 

 

 

4,581

 

 

 

4,437

 

 

 

6,630

 

Accrued other

 

 

4,703

 

 

 

4,790

 

 

 

4,162

 

 

 

5,547

 

Deferred revenue

 

 

5,229

 

 

 

5,553

 

 

 

5,507

 

 

 

5,200

 

Contingent consideration

 

 

 

 

 

3,200

 

Total Current Liabilities

 

 

15,627

 

 

 

20,209

 

 

 

15,699

 

 

 

18,892

 

Deferred revenue, less current portion

 

 

12,423

 

 

 

11,628

 

 

 

11,763

 

 

 

10,796

 

Other long-term liabilities

 

 

7,865

 

 

 

5,512

 

 

 

7,552

 

 

 

8,020

 

Total Liabilities

 

 

35,915

 

 

 

37,349

 

 

 

35,014

 

 

 

37,708

 

Commitments and Contingencies (Note 16)

 

 

 

 

 

 

 

 

Commitments and Contingencies (Note 17)

 

 

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Series A Preferred stock — $.05 par value, 450,000 shares authorized; 0 shares

issued and outstanding

 

 

 

 

 

 

Common stock — $.05 par value, 45,000,000 shares authorized; 13,645,174 and

13,504,102 shares issued and outstanding as of June 30, 2020 and

September 30, 2019, respectively

 

 

682

 

 

 

675

 

Series A Preferred stock — $.05 par value, 450 shares authorized; 0 shares

issued and outstanding

 

 

 

 

 

 

Common stock — $.05 par value, 45,000 shares authorized; 13,868 and

13,672 shares issued and outstanding as of March 31, 2021 and

September 30, 2020, respectively

 

 

693

 

 

 

684

 

Additional paid-in capital

 

 

13,658

 

 

 

10,740

 

 

 

18,516

 

 

 

15,369

 

Accumulated other comprehensive income

 

 

1,469

 

 

 

396

 

 

 

3,231

 

 

 

3,174

 

Retained earnings

 

 

114,774

 

 

 

110,705

 

 

 

119,641

 

 

 

111,828

 

Total Stockholders’ Equity

 

 

130,583

 

 

 

122,516

 

 

 

142,081

 

 

 

131,055

 

Total Liabilities and Stockholders’ Equity

 

$

166,498

 

 

$

159,865

 

 

$

177,095

 

 

$

168,763

 

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

3


Table of Contents

Surmodics, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

June 30,

 

 

June 30,

 

 

March 31,

 

 

March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

(In thousands, except per share data)

 

(Unaudited)

 

(Unaudited)

 

 

(Unaudited)

 

(Unaudited)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

$

11,987

 

 

$

9,870

 

 

$

33,731

 

 

$

29,508

 

 

$

11,783

 

 

$

11,770

 

 

$

21,885

 

 

$

21,744

 

Royalties and license fees

 

 

12,398

 

 

 

11,624

 

 

 

30,767

 

 

 

31,652

 

 

 

20,052

 

 

 

8,221

 

 

 

29,386

 

 

 

18,369

 

Research, development and other

 

 

2,498

 

 

 

2,850

 

 

 

7,823

 

 

 

8,101

 

 

 

3,160

 

 

 

2,831

 

 

 

6,021

 

 

 

5,325

 

Total revenue

 

 

26,883

 

 

 

24,344

 

 

 

72,321

 

 

 

69,261

 

 

 

34,995

 

 

 

22,822

 

 

 

57,292

 

 

 

45,438

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product costs

 

 

4,443

 

 

 

3,364

 

 

 

11,415

 

 

 

9,980

 

 

 

4,170

 

 

 

3,769

 

 

 

7,913

 

 

 

6,972

 

Research and development

 

 

13,324

 

 

 

13,321

 

 

 

37,401

 

 

 

38,362

 

 

 

12,875

 

 

 

11,935

 

 

 

23,757

 

 

 

24,077

 

Selling, general and administrative

 

 

7,416

 

 

 

5,939

 

 

 

21,092

 

 

 

16,764

 

 

 

7,907

 

 

 

6,733

 

 

 

14,930

 

 

 

13,676

 

Acquired intangible asset amortization

 

 

536

 

 

 

599

 

 

 

1,671

 

 

 

1,809

 

 

 

560

 

 

 

541

 

 

 

1,116

 

 

 

1,135

 

Contingent consideration expense (gain)

 

 

 

 

 

104

 

 

 

 

 

 

(248

)

Total operating costs and expenses

 

 

25,719

 

 

 

23,327

 

 

 

71,579

 

 

 

66,667

 

 

 

25,512

 

 

 

22,978

 

 

 

47,716

 

 

 

45,860

 

Operating income

 

 

1,164

 

 

 

1,017

 

 

 

742

 

 

 

2,594

 

Operating income (loss)

 

 

9,483

 

 

 

(156

)

 

 

9,576

 

 

 

(422

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income, net

 

 

124

 

 

 

269

 

 

 

584

 

 

 

850

 

 

 

28

 

 

 

210

 

 

 

69

 

 

 

460

 

Interest expense

 

 

(29

)

 

 

(38

)

 

 

(99

)

 

 

(112

)

 

 

(59

)

 

 

(30

)

 

 

(119

)

 

 

(70

)

Foreign exchange (loss) gain

 

 

(48

)

 

 

(42

)

 

 

(125

)

 

 

99

 

Impairment loss on strategic investment

 

 

 

 

 

 

 

 

(479

)

 

 

 

Other

 

 

 

 

 

 

 

 

1

 

 

 

9

 

Foreign exchange gain (loss)

 

 

73

 

 

 

(30

)

 

 

(107

)

 

 

(77

)

Impairment loss on strategic investment and other

 

 

 

 

 

(479

)

 

 

 

 

 

(478

)

Other income (expense)

 

 

47

 

 

 

189

 

 

 

(118

)

 

 

846

 

 

 

42

 

 

 

(329

)

 

 

(157

)

 

 

(165

)

Income before income taxes

 

 

1,211

 

 

 

1,206

 

 

 

624

 

 

 

3,440

 

Income tax benefit

 

 

1,248

 

 

 

260

 

 

 

3,445

 

 

 

598

 

Income (loss) before income taxes

 

 

9,525

 

 

 

(485

)

 

 

9,419

 

 

 

(587

)

Income tax (provision) benefit

 

 

(1,438

)

 

 

1,947

 

 

 

(1,606

)

 

 

2,197

 

Net income

 

$

2,459

 

 

$

1,466

 

 

$

4,069

 

 

$

4,038

 

 

$

8,087

 

 

$

1,462

 

 

$

7,813

 

 

$

1,610

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net income per share

 

$

0.18

 

 

$

0.11

 

 

$

0.30

 

 

$

0.30

 

 

$

0.59

 

 

$

0.11

 

 

$

0.57

 

 

$

0.12

 

Diluted net income per share

 

$

0.18

 

 

$

0.11

 

 

$

0.30

 

 

$

0.29

 

 

$

0.58

 

 

$

0.11

 

 

$

0.56

 

 

$

0.12

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

13,601

 

 

 

13,394

 

 

 

13,577

 

 

 

13,384

 

 

 

13,746

 

 

 

13,507

 

 

 

13,699

 

 

 

13,474

 

Diluted

 

 

13,786

 

 

 

13,726

 

 

 

13,775

 

 

 

13,776

 

 

 

13,981

 

 

 

13,751

 

 

 

13,915

 

 

 

13,779

 

 

 

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

4


Table of Contents

Surmodics, Inc. and Subsidiaries

Condensed Consolidated Statements of Comprehensive Income

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

June 30,

 

 

June 30,

 

 

March 31,

 

 

March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

(In thousands)

 

(Unaudited)

 

 

(Unaudited)

 

 

(Unaudited)

 

 

(Unaudited)

 

Net income

 

$

2,459

 

 

$

1,466

 

 

$

4,069

 

 

$

4,038

 

 

$

8,087

 

 

$

1,462

 

 

$

7,813

 

 

$

1,610

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized holding gains on available-for-

sale securities, net of tax

 

 

185

 

 

 

13

 

 

 

6

 

 

 

57

 

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net changes related to available-for-sale securities, net of tax

 

 

(7

)

 

 

(174

)

 

 

(7

)

 

 

(179

)

Foreign currency translation adjustments

 

 

794

 

 

 

520

 

 

 

1,067

 

 

 

(798

)

 

 

(1,768

)

 

 

(768

)

 

 

64

 

 

 

273

 

Other comprehensive income (loss)

 

 

979

 

 

 

533

 

 

 

1,073

 

 

 

(741

)

Other comprehensive (loss) income

 

 

(1,775

)

 

 

(942

)

 

 

57

 

 

 

94

 

Comprehensive income

 

$

3,438

 

 

$

1,999

 

 

$

5,142

 

 

$

3,297

 

 

$

6,312

 

 

$

520

 

 

$

7,870

 

 

$

1,704

 

 

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

5


Table of Contents

Surmodics, Inc. and Subsidiaries

Condensed Consolidated Statements of Stockholders’ Equity

 

 

Three Months Ended June 30, 2020 and 2019

 

 

Three Months Ended March 31, 2021 and 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

(Unaudited)

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Retained

 

 

Stockholders’

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Retained

 

 

Stockholders’

 

(In thousands)

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

Earnings

 

 

Equity

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

Earnings

 

 

Equity

 

Balance at March 31, 2020

 

 

13,609

 

 

$

680

 

 

$

11,481

 

 

$

490

 

 

$

112,315

 

 

$

124,966

 

Balance at December 31, 2020

 

 

13,739

 

 

$

687

 

 

$

16,160

 

 

$

5,006

 

 

$

111,554

 

 

$

133,407

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,459

 

 

 

2,459

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,087

 

 

 

8,087

 

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

979

 

 

 

 

 

 

979

 

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

(1,775

)

 

 

 

 

 

(1,775

)

Issuance of common stock

 

 

3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8

 

 

 

 

 

 

296

 

 

 

 

 

 

 

 

 

296

 

Common stock options exercised, net

 

 

33

 

 

 

2

 

 

 

849

 

 

 

 

 

 

 

 

 

851

 

 

 

122

 

 

 

6

 

 

 

2,228

 

 

 

 

 

 

 

 

 

2,234

 

Purchase of common stock to pay employee taxes

 

 

 

 

 

 

 

 

(12

)

 

 

 

 

 

 

 

 

(12

)

 

 

(1

)

 

 

 

 

 

(1,597

)

 

 

 

 

 

 

 

 

(1,597

)

Stock-based compensation

 

 

 

 

 

 

 

 

1,340

 

 

 

 

 

 

 

 

 

1,340

 

 

 

 

 

 

 

 

 

1,429

 

 

 

 

 

 

 

 

 

1,429

 

Balance at June 30, 2020

 

 

13,645

 

 

$

682

 

 

$

13,658

 

 

$

1,469

 

 

$

114,774

 

 

$

130,583

 

Balance at March 31, 2021

 

 

13,868

 

 

$

693

 

 

$

18,516

 

 

$

3,231

 

 

$

119,641

 

 

$

142,081

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31, 2019

 

 

13,489

 

 

$

674

 

 

$

7,510

 

 

$

1,444

 

 

$

105,685

 

 

$

115,313

 

Balance at December 31, 2019

 

 

13,593

 

 

$

680

 

 

$

10,361

 

 

$

1,432

 

 

$

110,853

 

 

$

123,326

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,466

 

 

 

1,466

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,462

 

 

 

1,462

 

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

533

 

 

 

 

 

 

533

 

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

(942

)

 

 

 

 

 

(942

)

Issuance of common stock

 

 

1

 

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

5

 

 

 

 

 

 

218

 

 

 

 

 

 

 

 

 

218

 

Common stock options exercised, net

 

 

1

 

 

 

 

 

 

12

 

 

 

 

 

 

 

 

 

12

 

 

 

12

 

 

 

 

 

 

9

 

 

 

 

 

 

 

 

 

9

 

Purchase of common stock to pay employee taxes

 

 

(1

)

 

 

 

 

 

(12

)

 

 

 

 

 

 

 

 

(12

)

 

 

(1

)

 

 

 

 

 

(411

)

 

 

 

 

 

 

 

 

(411

)

Stock-based compensation

 

 

 

 

 

 

 

 

1,319

 

 

 

 

 

 

 

 

 

1,319

 

 

 

 

 

 

 

 

 

1,304

 

 

 

 

 

 

 

 

 

1,304

 

Balance at June 30, 2019

 

 

13,490

 

 

$

675

 

 

$

8,829

 

 

$

1,977

 

 

$

107,151

 

 

$

118,632

 

Balance at March 31, 2020

 

 

13,609

 

 

$

680

 

 

$

11,481

 

 

$

490

 

 

$

112,315

 

 

$

124,966

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended June 30, 2020 and 2019

 

 

Six Months Ended March 31, 2021 and 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

(Unaudited)

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Retained

 

 

Stockholders’

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Retained

 

 

Stockholders’

 

(In thousands)

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

Earnings

 

 

Equity

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

Earnings

 

 

Equity

 

Balance at September 30, 2020

 

 

13,672

 

 

$

684

 

 

$

15,369

 

 

$

3,174

 

 

$

111,828

 

 

$

131,055

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,813

 

 

 

7,813

 

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

57

 

 

 

 

 

 

57

 

Issuance of common stock

 

 

89

 

 

 

4

 

 

 

292

 

 

 

 

 

 

 

 

 

296

 

Common stock options exercised, net

 

 

125

 

 

 

6

 

 

 

2,234

 

 

 

 

 

 

 

 

 

2,240

 

Purchase of common stock to pay employee taxes

 

 

(18

)

 

 

(1

)

 

 

(2,241

)

 

 

 

 

 

 

 

 

(2,242

)

Stock-based compensation

 

 

 

 

 

 

 

 

2,862

 

 

 

 

 

 

 

 

 

2,862

 

Balance at March 31, 2021

 

 

13,868

 

 

$

693

 

 

$

18,516

 

 

$

3,231

 

 

$

119,641

 

 

$

142,081

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2019

 

 

13,504

 

 

$

675

 

 

$

10,740

 

 

$

396

 

 

$

110,705

 

 

$

122,516

 

 

 

13,504

 

 

$

675

 

 

$

10,740

 

 

$

396

 

 

$

110,705

 

 

$

122,516

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,069

 

 

 

4,069

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,610

 

 

 

1,610

 

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

1,073

 

 

 

 

 

 

1,073

 

 

 

 

 

 

 

 

 

 

 

 

94

 

 

 

 

 

 

94

 

Issuance of common stock

 

 

133

 

 

 

7

 

 

 

211

 

 

 

 

 

 

 

 

 

218

 

 

 

130

 

 

 

7

 

 

 

211

 

 

 

 

 

 

 

 

 

218

 

Common stock options exercised, net

 

 

53

 

 

 

2

 

 

 

949

 

 

 

 

 

 

 

 

 

951

 

 

 

20

 

 

 

 

 

 

100

 

 

 

 

 

 

 

 

 

100

 

Purchase of common stock to pay employee taxes

 

 

(45

)

 

 

(2

)

 

 

(2,279

)

 

 

 

 

 

 

 

 

(2,281

)

 

 

(45

)

 

 

(2

)

 

 

(2,267

)

 

 

 

 

 

 

 

 

(2,269

)

Stock-based compensation

 

 

 

 

 

 

 

 

4,037

 

 

 

 

 

 

 

 

 

4,037

 

 

 

 

 

 

 

 

 

2,697

 

 

 

 

 

 

 

 

 

2,697

 

Balance at June 30, 2020

 

 

13,645

 

 

$

682

 

 

$

13,658

 

 

$

1,469

 

 

$

114,774

 

 

$

130,583

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2018

 

 

13,398

 

 

$

670

 

 

$

7,607

 

 

$

2,718

 

 

$

97,615

 

 

$

108,610

 

Net impact from adoption of ASC Topic 606

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,498

 

 

 

5,498

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,038

 

 

 

4,038

 

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

(741

)

 

 

 

 

 

(741

)

Issuance of common stock

 

 

135

 

 

 

7

 

 

 

203

 

 

 

 

 

 

 

 

 

210

 

Common stock options exercised, net

 

 

3

 

 

 

 

 

 

67

 

 

 

 

 

 

 

 

 

67

 

Purchase of common stock to pay employee taxes

 

 

(46

)

 

 

(2

)

 

 

(2,557

)

 

 

 

 

 

 

 

 

(2,559

)

Stock-based compensation

 

 

 

 

 

 

 

 

3,509

 

 

 

 

 

 

 

 

 

3,509

 

Balance at June 30, 2019

 

 

13,490

 

 

$

675

 

 

$

8,829

 

 

$

1,977

 

 

$

107,151

 

 

$

118,632

 

Balance at March 31, 2020

 

 

13,609

 

 

$

680

 

 

$

11,481

 

 

$

490

 

 

$

112,315

 

 

$

124,966

 

 

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

6


Table of Contents

Surmodics, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

 

 

Nine Months Ended

 

 

Six Months Ended

 

 

June 30,

 

 

March 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

(in thousands)

 

(Unaudited)

 

(In thousands)

 

(Unaudited)

 

Operating Activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

4,069

 

 

$

4,038

 

 

$

7,813

 

 

$

1,610

 

Adjustments to reconcile net income to net cash provided by (used in) operating activities:

 

 

 

 

 

 

 

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

5,390

 

 

 

5,462

 

 

 

3,766

 

 

 

3,600

 

Stock-based compensation

 

 

4,037

 

 

 

3,509

 

 

 

2,862

 

 

 

2,697

 

Payment of contingent consideration obligations in excess of acquisition-date value

 

 

(608

)

 

 

(2,041

)

 

 

 

 

 

(608

)

Contingent consideration gain

 

 

 

 

 

(248

)

Deferred taxes

 

 

592

 

 

 

(979

)

 

 

808

 

 

 

1,388

 

Losses (gains) on strategic investments

 

 

479

 

 

 

(7

)

Provision for bad debts

 

 

30

 

 

 

142

 

Loss on strategic investment

 

 

 

 

 

479

 

Provision for credit losses

 

 

(12

)

 

 

137

 

Other

 

 

176

 

 

 

(11

)

 

 

170

 

 

 

108

 

Change in operating assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts receivable and contract asset

 

 

4,303

 

 

 

(1,009

)

 

 

(1,908

)

 

 

1,914

 

Inventories

 

 

(1,333

)

 

 

(148

)

 

 

(349

)

 

 

(1,233

)

Prepaids and other

 

 

(432

)

 

 

(2,184

)

 

 

(409

)

 

 

(622

)

Accounts payable

 

 

(489

)

 

 

(219

)

 

 

(303

)

 

 

(128

)

Accrued liabilities

 

 

116

 

 

 

(5,143

)

 

 

(2,705

)

 

 

(1,826

)

Income taxes

 

 

(4,105

)

 

 

196

 

 

 

739

 

 

 

(3,615

)

Deferred revenue

 

 

471

 

 

 

(5,840

)

 

 

1,273

 

 

 

(2,644

)

Net cash provided by (used in) operating activities

 

 

12,696

 

 

 

(4,482

)

Net cash provided by operating activities

 

 

11,745

 

 

 

1,257

 

Investing Activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(2,627

)

 

 

(4,135

)

 

 

(1,973

)

 

 

(2,311

)

Payment for acquisition of intangible assets

 

 

(1,000

)

 

 

 

Purchases of available-for-sale securities

 

 

(45,766

)

 

 

(26,117

)

 

 

(22,875

)

 

 

(35,863

)

Maturities of available-for-sale securities

 

 

46,522

 

 

 

51,458

 

 

 

31,318

 

 

 

27,425

 

Cash proceeds from sales of property and equipment

 

 

 

 

 

10

 

Cash received from sale of strategic investment

 

 

 

 

 

7

 

Net cash (used in) provided by investing activities

 

 

(1,871

)

 

 

21,223

 

Net cash provided by (used in) investing activities

 

 

5,470

 

 

 

(10,749

)

Financing Activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock

 

 

1,169

 

 

 

277

 

 

 

2,536

 

 

 

318

 

Payments for taxes related to net share settlement of equity awards

 

 

(2,385

)

 

 

(2,688

)

 

 

(2,243

)

 

 

(2,373

)

Payment of contingent consideration obligations

 

 

(2,592

)

 

 

(9,064

)

 

 

 

 

 

(2,592

)

Payments for acquisition of in process research and development

 

 

(1,000

)

 

 

 

Net cash used in financing activities

 

 

(4,808

)

 

 

(11,475

)

Effect of exchange rate changes on cash and cash equivalents

 

 

8

 

 

 

(18

)

Payments for acquisition of in-process research and development

 

 

(150

)

 

 

(1,000

)

Net cash provided by (used in) financing activities

 

 

143

 

 

 

(5,647

)

Effect of exchange rate changes on cash

 

 

16

 

 

 

(14

)

Net change in cash and cash equivalents

 

 

6,025

 

 

 

5,248

 

 

 

17,374

 

 

 

(15,153

)

Cash and Cash Equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Beginning of period

 

 

30,361

 

 

 

23,668

 

 

 

30,785

 

 

 

30,361

 

End of period

 

$

36,386

 

 

$

28,916

 

 

$

48,159

 

 

$

15,208

 

Supplemental Information:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash paid for income taxes

 

$

9

 

 

$

155

 

 

$

16

 

 

$

6

 

Noncash transactions from investing and financing activities:

 

 

 

 

 

 

 

 

Noncash investing and financing activities:

 

 

 

 

 

 

 

 

Acquisition of property and equipment, net of refundable credits in other current assets

and liabilities

 

 

395

 

 

 

180

 

 

 

641

 

 

 

87

 

Right of use assets obtained in exchange for new operating lease liabilities

 

 

1,012

 

 

 

 

Right-of-use assets obtained in exchange for new operating lease liabilities

 

 

44

 

 

 

597

 

 

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

7


Table of Contents

Surmodics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

Period Ended June 30, 2020March 31, 2021

(Unaudited)

 

1. Basis of Presentation

Overview

Surmodics, Inc. and subsidiaries (“Surmodics,” the “Company,” “we,” “us,” “our” and other like terms) is a leading provider of surface modification technologies for intravascular medical devices and chemical components for in vitro diagnostic (“IVD”) immunoassay tests and microarrays. Surmodics is pursuing development and commercialization of highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development, and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota.

Basis of Presentation

The accompanying unaudited interim condensed consolidated financial statements include all accounts and wholly-owned subsidiaries and have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S.”) (“GAAP”) and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, needed to fairly present the financial results of Surmodics, Inc. and subsidiaries (referred to as “Surmodics”, the “Company”, “we,” “us,” “our” and other like terms) for the periods presented.. All intercompany transactions have been eliminated. The Company operates on a fiscal year ending on September 30. In accordance with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”), the Company has omitted footnote disclosures that would substantially duplicate the disclosures contained in the audited consolidated financial statements of the Company. These unaudited condensed consolidated financial statements should be read together with the audited consolidated financial statements for the fiscal year ended September 30, 2019,2020, and footnotesnotes thereto included in the Company’sour Annual Report on Form 10-K as filed with the SEC on December 3, 2019.SEC.

TheseThe preparation of consolidated financial statements include amounts that are based on management’s bestin conformity with GAAP requires management to make estimates and judgments. These estimates may be adjusted as more information becomes available,assumptions that affect the reported amounts of assets and any adjustmentliabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenue and expenses during the reporting period. Ultimate results could be significant. The impact of any change in estimates is included in the determination of net income in the period in which the change in estimate is identified.differ from those estimates. The results of operations for the three and ninesix months ended June 30, 2020March 31, 2021 are not necessarily indicative of the results that may be expected for the entire 20202021 fiscal year.

RisksRisk and Uncertainties

We are subject to risks and uncertainties as a result of theThe COVID-19 pandemic caused by a novel strain of coronavirus first identified in Wuhan, China in December 2019. On March 18, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released guidance for U.S. healthcare providers to limit non-emergent elective medical procedures other than high acuity treatments in order to conserve personal protective equipmentis having, and limit exposure to COVID-19. On April 16, 2020, the White House issued “Guidelines for Opening Up America Again” (the “White House Guidelines”) that described a phased resumption of economic activities with gating conditions for a region or state to move from one phase to another. On June 9, 2020, CMS issued recommendations for regions and states in Phase II of the White House Guidelines that non-emergent, non-COVID-19 care should be offered to patients, as clinically appropriate, in localities or facilities that have the resources to provide such care, as well as the ability to quickly respond to a surge in COVID-19 cases, if necessary.

Since the White House Guidelines and related CMS recommendations were issued, rates of COVID-19 have vacillated by region and state, in some cases surging. Accordingly, consistent with the CMS recommendations, the degree to which elective medical procedures have been offered varies by region, state, and even between healthcare systems within a state.Where elective procedures have been offered, and even for emergency procedures, some people appear to have avoided healthcare facilities, presumably out of concern for contracting COVID-19. In addition, hospitals and other healthcare providers vary in the degree to which they are permitting access to their facilities during the pandemic. Further, the COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains and healthcare delivery, led to social distancing recommendations, and created significant volatility in financial markets.

Many of our customers use our licensed technology and purchased materials to manufacture products used in elective procedures. In addition, our customers and business partners need access to healthcare providers and facilities to effectively market, distribute and sell products incorporating our coating and device technologies, as well as our whole-product solutions. Likewise, we and our business partners need access to healthcare providers and facilities to conduct clinical trials and other activities required to achieve regulatory clearing for our products under development.

We believe differences in the rates of delivery and utilization of elective procedures in response to CMS recommendations and the pandemic have had, and willmay continue to have, an adverse impact, which may be material,effect on the Company'sour business, results of operations, financial condition, liquidity and results of operations.cash flows, and its future impacts remain highly uncertain and unpredictable. The severity ofCompany has considered the disruptions caused by COVID-19, including lower than forecasted sales and customer demand and macroeconomic factors, that may impact its estimates. The Company has assessed the potential impact of the COVID-19 pandemic on our business will depend on a number of factors,certain accounting matters including, but not limited to, the duration and severity of the pandemicestimated sales-based royalties revenue; allowance for credit losses; inventory reserves; and the extentvaluation of goodwill, intangible assets, other long-lived assets and severityinvestments, as of March 31, 2021 and through the impactdate of this Quarterly Report on our customers, all of which are uncertain and cannot be predicted.Form 10-Q. As of the date of issuance of these unaudited condensed consolidated financial statements, the extent to which the COVID-19 pandemic may materially impact the Company's financial condition, liquidity or results of operations is uncertain. For further information, refer to “Risk Factors” in Part II, Item 1A of this Quarterlyour Annual Report on Form 10-Q.10-K for the fiscal year ended September 30, 2020.

8


New Accounting Pronouncements

Recently Adopted

In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) ASU 2016-02, Leases (“ASC Topic 842”). The update maintains two classifications of leases: finance leases, which replace capital leases, and operating leases. Lessees recognize a right-of-use asset and a lease liability on the consolidated balance sheets for those leases previously classified as operating leases under the previous guidance. The liability is equal to the present value of lease payments, while the asset is based on the liability, subject to adjustment, such as for direct costs.

Effective October 1, 2019, the Company adopted the new lease accounting standard using the optional transition method which allowed us to continue to apply the guidance under the lease standard in effect at the time in the comparative periods presented. In addition, the Company elected the package of practical expedients, including opting not to reassess whether any existing contracts contain a lease, historical lease classification as operating or finance leases, or initial direct costs. The Company has also elected the practical expedient to not separate the lease and non-lease components for all classes of underlying assets. The Company elected the short-term lease recognition exemption for all leases that qualified and has accordingly excluded short-term leases from the recognition of right-of-use assets and lease liabilities.

As a result of adoption of ASC Topic 842, we recorded operating lease right-of-use assets and corresponding operating lease liabilities of approximately $1.7 million and $2.9 million, respectively, as of October 1, 2019 with no impact on retained earnings. In addition, deferred rent liabilities related to escalating rent payments and tenant incentives totaling approximately $1.2 million were eliminated upon adoption, as these items are netted against right-of-use assets. The condensed consolidated balance sheets for reporting periods beginning on or after October 1, 2019 are presented under the new guidance, while prior period amounts are not adjusted and continue to be reported in accordance with previous guidance.

Not Yet Adopted

In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses, Measurement of Credit Losses on Financial Statements. This ASU requires a financial asset (or a group of financial assets) measured at an amortized cost basis to be presented at the net amount expected to be collected. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial asset(s) to present the net carrying value at the amount expected to be collected on the financial asset. The accounting standard will be effective forWe adopted this guidance using the Company beginningmodified retrospective method in the first quarter of fiscal 2021 (October 1, 2020), using a modified retrospective approach. We have evaluated the impact2021. The adoption of this standardguidance did not have a material impact on the Company’s resultscondensed consolidated financial statements.

8


Table of operations, cash flows and financial position, including accounting policies, processes and systems. We continue to monitor economic implications of the COVID-19 pandemic; however, based on current market conditions, we do not expect the impact to be material upon adoption.Contents

In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes, which eliminates certain exceptions related to the approach for intraperiod tax allocation and to the methodology for calculating taxes during the quarters, as well as clarifies the accounting for enacted changes in tax laws. The accounting standard will beWe adopted by the Companythis guidance using a prospective approach in the first quarter of fiscal 2021 (October 1, 2020) using a prospective approach. We have evaluated the impact2021. The adoption of this standardguidance did not have a material impact on the Company’s results of operations, cash flows andcondensed consolidated financial position, and we do not expect the impact to be material upon adoption.statements.

No other new accounting pronouncement issued or effective has had, or is expected to have, a material impact on the Company’s condensed consolidated financial statements.

9


2. Revenue

The following table presents the Company’s revenues disaggregated by product classification and by operating segment, excluding sales taxes collected and remitted to governmental authorities.reportable segment.

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

June 30,

 

 

June 30,

 

 

March 31,

 

 

March 31,

 

(Dollars in thousands)

 

2020

 

 

2019

 

 

2020

 

 

2019

 

(In thousands)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Medical Device

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

$

5,763

 

 

$

4,500

 

 

$

16,240

 

 

$

13,836

 

 

$

5,410

 

 

$

5,455

 

 

$

9,971

 

 

$

10,477

 

Royalties

 

 

4,752

 

 

 

9,605

 

 

 

20,365

 

 

 

25,603

 

 

 

7,474

 

 

 

6,714

 

 

 

15,383

 

 

 

15,613

 

Research, development and other

 

 

2,353

 

 

 

2,821

 

 

 

7,215

 

 

 

8,016

 

 

 

2,445

 

 

 

2,628

 

 

 

4,746

 

 

 

4,862

 

License fees

 

 

7,646

 

 

 

2,019

 

 

 

10,402

 

 

 

6,049

 

 

 

12,578

 

 

 

1,507

 

 

 

14,003

 

 

 

2,756

 

Total Revenue — Medical Device

 

 

20,514

 

 

 

18,945

 

 

 

54,222

 

 

 

53,504

 

 

 

27,907

 

 

 

16,304

 

 

 

44,103

 

 

 

33,708

 

In Vitro Diagnostics

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

 

6,224

 

 

 

5,370

 

 

 

17,491

 

 

 

15,672

 

 

 

6,373

 

 

 

6,315

 

 

 

11,914

 

 

 

11,267

 

Other

 

 

145

 

 

 

29

 

 

 

608

 

 

 

85

 

Research, development and other

 

 

715

 

 

 

203

 

 

 

1,275

 

 

 

463

 

Total Revenue — In Vitro Diagnostics

 

 

6,369

 

 

 

5,399

 

 

 

18,099

 

 

 

15,757

 

 

 

7,088

 

 

 

6,518

 

 

 

13,189

 

 

 

11,730

 

Total Revenue

 

$

26,883

 

 

$

24,344

 

 

$

72,321

 

 

$

69,261

 

 

$

34,995

 

 

$

22,822

 

 

$

57,292

 

 

$

45,438

 

Contract Assets, Deferred Revenueassets totaled $6.6 million and Remaining Performance Obligations

Contract asset balances consist$6.1 million as of estimatedMarch 31, 2021 and September 30, 2020, respectively. Fluctuations in the balance of contract assets result primarily from changes in sales-based and minimum royalties earned, but not collected at each balance sheet date due to payment timing and are subject to timing fluctuations atcontractual changes in the endnormal course of a given period. The Company’s deferred revenue, orbusiness. For discussion of contract liability is primarily related to(deferred revenue) balances and remaining performance obligations, see Note 3 Collaborative Arrangements.

3. Collaborative Arrangement

On February 26, 2018, the upfront and milestone payments received pursuant to the collaborative license and commercializationCompany entered into an agreement (the “Abbott Agreement”) with Abbott Vascular, Inc. (“Abbott”) for the Company’s SurVeil™ drug-coated balloon product (“SurVeil DCB”) discussed in Note 3.

As of June 30, 2020, the estimated revenue expected to be recognized in future periods related to performance obligations that are unsatisfied for executed contracts with an original duration of one year or more totaled approximately $17.5 million. These remaining performance obligations relate to thewhereby Abbott Agreement (Note 3), exclude contingent milestone payments under the Abbott Agreement, and are expected to be recognized over the next five years through fiscal 2025 as services, principally the TRANSCEND clinical trial, are completed.

3. Collaborative Arrangement

Under the Abbott Agreement, Abbott will havehas exclusive worldwide commercialization rights for the Surmodics' SurVeilTM drug-coated balloon (“DCB”) (the “Abbott Agreement”). Our SurVeil DCB is used to treat peripheral arterial disease in the superficialupper leg (superficial femoral artery,artery) and is currently being evaluated in our TRANSEND pivotal clinical trial. Abbott also received the option to negotiate an agreement for Surmodics' below-the-knee SundanceTM DCB product, which is currently being evaluated in a U.S. pivotal clinicalfirst-in-human trial. Separately, Abbott also received options to negotiate agreements for Surmodics' below-the-knee and arteriovenous (“AV”) fistula drug-coated balloon (“DCB”) products. The below-the-knee DCB, our SundanceTM DCB, is currently in pre-clinical development. A first-in-human clinical study has been completed for the AV fistula DCB, our AvessTM DCB, and Abbott has informed the Company that it has elected not to negotiate for distribution rights for this product. Surmodics is responsible for conducting all necessary clinical trials and other activities required to achieve U.S. and European Union regulatory clearancesclearance for the SurVeilDCB, including completion of the ongoing TRANSCEND pivotal clinical trial. Abbott and Surmodics participate on a joint development committee charged with providing guidance on the Company’s clinical and regulatory activities with regard to the SurVeil DCB product.

Upon receipt of regulatory approval for the SurVeil DCB, Abbott will have the right to purchase commercial units from the Company and Surmodics will realize revenue from product sales to Abbott at an agreed-upon transfer price, as well as a share of net profits resulting from third-party product sales by Abbott. To account for the Abbott Agreement, the Company applied the guidance in ASC Topic 808 (Collaborative Arrangements) as the parties are active participants and are exposed to significant risks and rewards dependent on commercial success of the collaborative activity.

Under the Abbott Agreement,9


Table of Contents

As of March 31, 2021, the Company has received payments totaling $45.8$60.8 million under the Abbott Agreement, which consistedconsist of the following: $25 million upfront fee in fiscal 2018, $10.0$10 million milestone payment in the fourth quarter of fiscal 2019, and $10.8 million milestone payment in the third quarter of fiscal 2020. The2020, and $15 million milestone payment in the second quarter of fiscal 2021 upon receipt by Abbott of the clinical study report and related materials from the TRANSCEND pivotal trial that demonstrated the primary safety and primary clinical endpoints are non-inferior to the control device. As of March 31, 2021, the Company may receive an additional contingent milestone payment of up to $45$30 million, pursuant to the terms of additional payments under the Abbott Agreement, upon premarket approval (“PMA”) of our SurVeil DCB by the U.S. Food and Drug Administration. As of March 31, 2021, consideration from this potential regulatory milestone was fully constrained and excluded from the contract price, due to the high level of uncertainty of achievement as of certain clinical and regulatory milestones. March 31, 2021.

Revenue recognized from the Abbott agreement totaled $7.6$12.5 million and $2.0$1.5 million infor the three months ended June 30,March 31, 2021 and 2020, and 2019, respectively, and $10.4$13.8 million and $5.9$2.8 million infor the ninesix months ended June 30,March 31, 2021 and 2020, and 2019, respectively. RevenueThe amount of revenue recognized from the Abbott Agreement whichthat was included in the respective beginning of fiscal year balances of deferred revenue inon the condensed consolidated balance sheets totaled $3.7$3.0 million and $5.9$2.8 million for the ninesix months ended June 30,March 31, 2021 and 2020, and 2019, respectively.

As of June 30, 2020March 31, 2021 and September 30, 2019,2020, deferred

10


revenue from the upfront and milestone payments received under the Abbott Agreement of $17.5$17.1 million and $17.1$15.9 million, respectively, was recorded in the condensed consolidated balance sheets.Upon

As of March 31, 2021, the commercialization of the SurVeil DCB, Surmodics will be responsible for the manufacture and supply of clinical and commercial quantities of the product. Revenue from these product sales, including a per-unit transfer price and a share of net profits resulting from third-party sales by Abbott, willestimated revenue expected to be recognized when these productsin future periods related to performance obligations that are shipped and control is transferredunsatisfied for executed contracts with an original duration of one year or more totaled $17.1 million. These remaining performance obligations relate to the customer.

Abbott Agreement, exclude the potential contingent milestone payment under the Abbott Agreement, and are expected to be recognized over the next five years through fiscal 2025 as services, principally the TRANSCEND clinical trial, are completed.

4. Fair Value Measurements

The accounting guidance on fair value measurements defines fair value, establishes a framework for measuring fair value under GAAP, and expands disclosures about fair value measurements. The guidance is applicable for all financial assets and financial liabilities and for all nonfinancial assets and nonfinancial liabilities recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). Fair value is defined as the exchange price that would be received from selling an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required or permitted to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and also considers assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions and risk of nonperformance.

Fair Value Hierarchy

Accounting guidance on fair value measurements requires that assetsAssets and liabilities carried at fair value beare classified and disclosed in one of the following three categories:

Level 1 — Quoted (unadjusted) prices in active markets for identical assets or liabilities.

The Company did not have any Level 1 assets as of June 30, 2020 and September 30, 2019.

Level 2 — Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability.

The Company’s Level 2 assets as of June 30, 2020 and September 30, 2019 consisted of money market funds, commercial paper instruments and corporate bonds.

Level 3 — Unobservable inputs to the valuation methodology that are supported by little or no market activity and that are significant to the measurement of the fair value of the assets or liabilities. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques, as well as significant management judgment or estimation. In valuing Level 3 assets and liabilities, the Company is required to maximize the use of quoted market prices and minimize the use of unobservable inputs.

The Company’s Level 3 liability as of September 30, 2019 consisted of contingent consideration obligations related to the fiscal 2016 acquisition of NorMedix, Inc. (“NorMedix”).

Assets and Liabilities Measured at Fair Value on a Recurring Basis

In instances where the inputs used to measure fair value fall into different levels of the fair value hierarchy, the fair value measurement has been determined based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular item to the fair value measurement in its entirety requires judgment, including the consideration of inputs specific to the asset or liability.

11


Assets and liabilities measured at fair value on a recurring basis by level of the fair value hierarchy were as follows:

 

 

June 30, 2020

 

 

March 31, 2021

 

(Dollars in thousands)

 

Quoted Prices in

Active Markets

for Identical

Instruments

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

 

Total

Fair Value

 

(In thousands)

 

Quoted Prices in

Active Markets

for Identical

Instruments

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

 

Total

Fair Value

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

$

 

 

$

29,714

 

 

$

 

 

$

29,714

 

 

$

 

 

$

31,135

 

 

$

 

 

$

31,135

 

Available-for-sale securities

 

 

 

 

 

24,178

 

 

 

 

 

 

24,178

 

 

 

 

 

 

21,863

 

 

 

 

 

 

21,863

 

Total assets

 

$

 

 

$

53,892

 

 

$

 

 

$

53,892

 

 

$

 

 

$

52,998

 

 

$

 

 

$

52,998

 

10

 

 

September 30, 2019

 

(Dollars in thousands)

 

Quoted Prices in

Active Markets

for Identical

Instruments

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

 

Total

Fair Value

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

$

 

 

$

24,375

 

 

$

 

 

$

24,375

 

Available-for-sale securities

 

 

 

 

 

24,931

 

 

 

 

 

$

24,931

 

Total assets

 

$

 

 

$

49,306

 

 

$

 

 

$

49,306

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contingent consideration

 

$

 

 

$

 

 

$

(3,200

)

 

$

(3,200

)

Total liabilities

 

$

 

 

$

 

 

$

(3,200

)

 

$

(3,200

)


Table of Contents

 

Changes in the contingent consideration liabilities measured at fair value using Level 3 inputs were as follows:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

June 30,

 

 

June 30,

 

(Dollars in thousands)

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Beginning balance

 

$

 

 

$

3,009

 

 

$

3,200

 

 

$

14,466

 

Additions

 

 

 

 

 

 

 

 

 

 

 

 

Fair value adjustments

 

 

 

 

 

57

 

 

 

 

 

 

(454

)

Settlements

 

 

 

 

 

 

 

 

(3,200

)

 

 

(10,979

)

Interest accretion

 

 

 

 

 

47

 

 

 

 

 

 

206

 

Foreign currency translation loss (gain)

 

 

 

 

 

 

 

 

 

 

 

(126

)

Ending balance

 

$

 

 

$

3,113

 

 

$

 

 

$

3,113

 

 

 

September 30, 2020

 

(In thousands)

 

Quoted Prices in

Active Markets

for Identical

Instruments

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

 

Total

Fair Value

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

$

 

 

$

18,634

 

 

$

 

 

$

18,634

 

Available-for-sale securities

 

 

 

 

 

30,313

 

 

 

 

 

$

30,313

 

Total assets

 

$

 

 

$

48,947

 

 

$

 

 

$

48,947

 

Settlements of contingent consideration liabilities consisted of payments to the sellers of NorMedix for revenue and value-creating milestones achieved. For the nine months ended June 30, 2020, acquisition-related contingent consideration payments totaling $3.2 million were classified as $0.6 million and $2.6 million in cash flows used in operating and financing activities, respectively, in the condensed consolidated statements of cash flows. For the nine months ended June 30, 2019, acquisition-related contingent consideration payments totaling $11.0 million were classified as $2.0 million and $9.0 million in cash flows used in operating and financing activities, respectively, in the condensed consolidated statements of cash flows.

There were 0 transfers of assets or liabilities between amounts measured using Level 1, Level 2, or Level 3 fair value measurements in fiscal 2020during the six months ended March 31, 2021 and fiscal 2019.

Valuation Techniques

The valuation techniques used to measure the fair value of assets are as follows:

Cash equivalents — These assets are classified as Level 2 and are carried at historical cost, which is a reasonable estimate of fair value because of the relatively short time between origination of the instrument and its expected realization.

12


Available-for-sale securities — Fair market values for these assets are based on quoted vendor prices and broker pricing in active markets underlying the securities where all significant inputs are observable. To ensure the accuracy of quoted vendor prices and broker pricing, the Company performs regular reviews of investment returns to industry benchmarks and sample tests of individual securities to validate quoted vendor prices with other available market data.

2020.

5. Investments

Investments consisted principally of commercial paper and corporate bond securities and are classified as available-for-sale as of June 30, 2020 and September 30, 2019. These available-for-sale securities are reported at fair value with unrealized gains and losses, net of tax, excluded from the condensed consolidated statements of operations and reported in the condensed consolidated statements of comprehensive income as well as a separate component of stockholders’ equity in the condensed consolidated balance sheets, except for other-than-temporary impairments, which are reported as a charge to current earnings as they occur. A loss would be recognized when there is an other-than-temporary impairment in the fair value of any individual security classified as available-for-sale, with the associated net unrealized loss reclassified out of accumulated other comprehensive income with a corresponding adjustment to other income. This adjustment would result in a new cost basis for the investment. Interest earned on debt securities, including amortization of premiums and accretion of discounts, is included in investment income, net within other income. Realized gains and losses from the sales of debt securities, which are included in other income, are determined using the specific identification method. Investment purchases are accounted for on the date the trade is executed, which may not be the same as the date the transaction is cash settled.

The amortized cost, unrealized holding gains and losses, and fair value of available-for-sale securities were as follows:

 

 

 

June 30, 2020

 

(Dollars in thousands)

 

Amortized

Cost

 

 

Unrealized

Gains

 

 

Unrealized

Losses

 

 

Fair

Value

 

Commercial paper and corporate bonds

 

$

24,161

 

 

$

17

 

 

$

 

 

$

24,178

 

Total

 

$

24,161

 

 

$

17

 

 

$

 

 

$

24,178

 

 

 

March 31, 2021

 

 

 

Valuation

 

 

Balance Sheet Classification

 

(In thousands)

 

Amortized

Cost

 

 

Unrealized

Gains

 

 

Unrealized

Losses

 

 

Fair

Value

 

 

Current Assets

 

 

Noncurrent Assets

 

Commercial paper and

    corporate bonds

 

$

21,870

 

 

$

1

 

 

$

(8

)

 

$

21,863

 

 

$

17,792

 

 

$

4,071

 

Total

 

$

21,870

 

 

$

1

 

 

$

(8

)

 

$

21,863

 

 

$

17,792

 

 

$

4,071

 

 

 

 

September 30, 2019

 

(Dollars in thousands)

 

Amortized

Cost

 

 

Unrealized

Gains

 

 

Unrealized

Losses

 

 

Fair

Value

 

Commercial paper and corporate bonds

 

$

24,918

 

 

$

13

 

 

$

 

 

$

24,931

 

Total

 

$

24,918

 

 

$

13

 

 

$

 

 

$

24,931

 

 

 

September 30, 2020

 

 

 

Valuation

 

 

Balance Sheet Classification

 

(In thousands)

 

Amortized

Cost

 

 

Unrealized

Gains

 

 

Unrealized

Losses

 

 

Fair

Value

 

 

Current Assets

 

 

Noncurrent Assets

 

Commercial paper and

    corporate bonds

 

$

30,313

 

 

$

19

 

 

$

(19

)

 

$

30,313

 

 

$

30,313

 

 

$

 

Total

 

$

30,313

 

 

$

19

 

 

$

(19

)

 

$

30,313

 

 

$

30,313

 

 

$

 

 

6. Inventories

Inventories are principally stated at the lower of cost or market using the specific identification method and include direct labor, materials and overhead, with cost of product sales determined on a first-in, first-out basis. Inventories consisted of the following components:

 

 

June 30,

 

 

September 30,

 

 

March 31,

 

 

September 30,

 

(Dollars in thousands)

 

2020

 

 

2019

 

(In thousands)

 

2021

 

 

2020

 

Raw materials

 

$

3,394

 

 

$

2,034

 

 

$

3,758

 

 

$

3,758

 

Work-in process

 

 

1,057

 

 

 

892

 

 

 

1,151

 

 

 

817

 

Finished products

 

 

1,421

 

 

 

1,575

 

 

 

1,400

 

 

 

1,391

 

Total

 

$

5,872

 

 

$

4,501

 

 

$

6,309

 

 

$

5,966

 

 

7. Other Assets

Other assets consisted of the following:

 

 

June 30,

 

 

September 30,

 

 

March 31,

 

 

September 30,

 

(Dollars in thousands)

 

2020

 

 

2019

 

ViaCyte, Inc.

 

$

 

 

$

479

 

(In thousands)

 

2021

 

 

2020

 

Operating lease right-of-use assets

 

 

2,580

 

 

 

 

 

 

2,406

 

 

 

2,508

 

Other noncurrent assets

 

 

2,444

 

 

 

1,645

 

 

 

2,107

 

 

 

1,761

 

Other assets

 

$

5,024

 

 

$

2,124

 

 

$

4,513

 

 

$

4,269

 

The Company invested a total11


Table of $5.3 million in ViaCyte, Inc. (“ViaCyte”), a privately-held California-based biotechnology firm that is developing a unique treatment for diabetes using coated islet cells, the cells that produce insulin in the human body. As of September 30, 2019, the balance of the investment of $0.5 million, which was net of previously recorded other-than-temporary impairments of $4.8 million, was accounted for under the cost method and represented less than a 1% ownership interest. The Company does not exert significant influence over ViaCyte’s operating or financial activities.Contents

The carrying value of each cost method investment is reviewed quarterly for changes in circumstances or the occurrence of events that suggest the Company’s investment may not be recoverable. The fair value of cost method investments is not adjusted if there are no identified events or changes in circumstances that may have a material effect on the fair value of the investment. In the nine months ended June 30, 2020, the Company recorded a $0.5 million other-than-temporary impairment loss based on a current financing round and market valuations to reduce the carrying value of the investment in ViaCyte to 0.

Operating lease right-of-use assets as of June 30, 2020 are recorded in accordance with ASC Topic 842, which we adopted as of October 1, 2019. Other noncurrent assets include prepaid expenses related to our ongoing clinical trials and a receivable related to refundable Irish research and development tax credits.

8. Intangible Assets

Intangible assets consist principallyconsisted of acquired patents and technology, customer lists and relationships, licenses, and trademarks. the following:

 

 

March 31, 2021

 

(In thousands)

 

Weighted Average Original Life (Years)

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net

 

Definite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer lists and relationships

 

 

8.9

 

 

$

13,359

 

 

$

(8,283

)

 

$

5,076

 

Developed technology

 

 

11.5

 

 

 

9,686

 

 

 

(4,659

)

 

 

5,027

 

Patents and other

 

 

14.1

 

 

 

3,551

 

 

 

(2,206

)

 

 

1,345

 

Total definite-lived intangible assets

 

 

 

 

 

 

26,596

 

 

 

(15,148

)

 

 

11,448

 

Unamortized intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

 

 

580

 

 

 

 

 

 

580

 

Total intangible assets

 

 

 

 

 

$

27,176

 

 

$

(15,148

)

 

$

12,028

 

 

 

September 30, 2020

 

(In thousands)

 

Weighted Average Original Life (Years)

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net

 

Definite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer lists and relationships

 

 

8.9

 

 

$

13,356

 

 

$

(7,594

)

 

$

5,762

 

Developed technology

 

 

11.5

 

 

 

9,685

 

 

 

(4,200

)

 

 

5,485

 

Patents and other

 

 

14.1

 

 

 

3,551

 

 

 

(2,095

)

 

 

1,456

 

Total definite-lived intangible assets

 

 

 

 

 

 

26,592

 

 

 

(13,889

)

 

 

12,703

 

Unamortized intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

 

 

580

 

 

 

 

 

 

580

 

Total intangible assets

 

 

 

 

 

$

27,172

 

 

$

(13,889

)

 

$

13,283

 

Intangible asset amortization expense was $0.6 million and $0.7 million for both the three months ended June 30,March 31, 2021 and 2020 and 2019, respectively, and $1.8 million and $2.0$1.3 million for both the ninesix months ended June 30, 2020March 31, 2021 and 2019, respectively.

Intangible assets consisted of the following:

 

 

June 30, 2020

 

(Dollars in thousands)

 

Weighted Average Original Life (Years)

 

 

Gross

Carrying

Amount

 

 

Accumulated Amortization

 

 

Net

 

Definite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer lists and relationships

 

 

8.9

 

 

$

17,698

 

 

$

(11,847

)

 

$

5,851

 

Developed technology

 

 

11.5

 

 

 

9,565

 

 

 

(3,904

)

 

 

5,661

 

Non-compete

 

 

5.0

 

 

 

230

 

 

 

(230

)

 

 

 

Patents and other

 

 

16.5

 

 

 

2,321

 

 

 

(1,828

)

 

 

493

 

Total definite-lived intangible assets

 

 

 

 

 

 

29,814

 

 

 

(17,809

)

 

 

12,005

 

Unamortized intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

 

 

580

 

 

 

 

 

 

580

 

Total intangible assets

 

 

 

 

 

$

30,394

 

 

$

(17,809

)

 

$

12,585

 

 

 

September 30, 2019

 

(Dollars in thousands)

 

Weighted Average Original Life (Years)

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Net

 

Definite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer lists and relationships

 

 

8.9

 

 

$

17,374

 

 

$

(10,661

)

 

$

6,713

 

Developed technology

 

 

11.5

 

 

 

9,490

 

 

 

(3,196

)

 

 

6,294

 

Non-compete

 

 

5.0

 

 

 

230

 

 

 

(196

)

 

 

34

 

Patents and other

 

 

16.5

 

 

 

2,321

 

 

 

(1,716

)

 

 

605

 

Total definite-lived intangible assets

 

 

 

 

 

 

29,415

 

 

 

(15,769

)

 

 

13,646

 

Unamortized intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

 

 

580

 

 

 

 

 

 

580

 

Total intangible assets

 

 

 

 

 

$

29,995

 

 

$

(15,769

)

 

$

14,226

 

14


2020. Based on the intangible assets in service as of June 30, 2020,March 31, 2021, estimated amortization expense for the remainder of fiscal 20202021 and each of the next five fiscal years is as follows (in thousands):

follows:

Remainder of 2020

 

$

591

 

2021

 

 

2,321

 

(In thousands)

 

 

 

 

Remainder of 2021

 

$

1,232

 

2022

 

 

2,281

 

 

 

2,449

 

2023

 

 

1,701

 

 

 

1,844

 

2024

 

 

1,612

 

 

 

1,751

 

2025

 

 

1,575

 

 

 

1,712

 

2026

 

 

754

 

Future amortization amounts presented above are estimates. Actual future amortization expense may be different as a result of future acquisitions, impairments, changes in amortization periods, foreign currency translation rates, or other factors.

12


Table of Contents

 

9. Goodwill

Goodwill represents the excess of the cost of an acquired entity over the fair value assigned to the assets purchased and liabilities assumed in connection with a business acquisition. Goodwill is not amortized but is subject, at a minimum, to annual tests for impairment in accordance with accounting guidance for goodwill. The carrying amount of goodwill is evaluated annually, and between annual evaluations if events occur or circumstances change and indicate that the carrying amount of goodwill may be impaired.

Goodwill in the Medical Device reporting unit represents the gross value from the fiscal 2016 acquisitions of Creagh Medical Limited (“Creagh Medical”) and NorMedix. Goodwill in the In Vitro Diagnostics reporting unit represents the gross value from the acquisition of BioFX Laboratories, Inc. (“BioFX”) in fiscal 2007.

Goodwill was not impaired in either reporting unit based on the outcome of the fiscal 2019 annual impairment test which utilized a quantitative assessment. The carrying amount of goodwill was evaluated as of June 30, 2020 with consideration of macroeconomic, industry and Company-specific events and circumstances. As of and for the nine months ended June 30, 2020, there have been no events or circumstances that have occurred to indicate it is more likely than not that goodwill was impaired for either of the Company's reporting units.

Changes in the carrying amount of goodwill by segment were as follows:

 

(Dollars in thousands)

 

In Vitro

Diagnostics

 

 

Medical

Device

 

 

Total

 

Balance as of September 30, 2019

 

$

8,010

 

 

$

18,161

 

 

$

26,171

 

Currency translation adjustment

 

 

 

 

 

392

 

 

 

392

 

Balance as of June 30, 2020

 

$

8,010

 

 

$

18,553

 

 

$

26,563

 

(In thousands)

 

In Vitro

Diagnostics

 

 

Medical

Device

 

 

Total

 

Goodwill as of September 30, 2020

 

$

8,010

 

 

$

19,175

 

 

$

27,185

 

Currency translation adjustment

 

 

 

 

 

5

 

 

 

5

 

Goodwill as of March 31, 2021

 

$

8,010

 

 

$

19,180

 

 

$

27,190

 

 

10. Accrued Other Liabilities

Accrued other liabilities consisted of the following:

 

 

June 30,

 

 

September 30,

 

 

March 31,

 

 

September 30,

 

(Dollars in thousands)

 

2020

 

 

2019

 

(In thousands)

 

2021

 

 

2020

 

Accrued professional fees

 

$

232

 

 

$

434

 

 

$

403

 

 

$

239

 

Accrued clinical study expense

 

 

2,588

 

 

 

2,163

 

 

 

1,708

 

 

 

2,206

 

Accrued purchases

 

 

686

 

 

 

679

 

 

 

810

 

 

 

647

 

Acquisition of in process research and development

 

 

146

 

 

 

989

 

Acquisition of in-process research and development and

intangible assets

 

 

482

 

 

 

1,148

 

Due to customers

 

 

438

 

 

 

19

 

 

 

7

 

 

 

321

 

Construction-in-progress

 

 

 

 

 

272

 

Operating lease liability, current portion

 

 

397

 

 

 

 

 

 

464

 

 

 

436

 

Deferred rent, current portion

 

 

 

 

 

130

 

Other

 

 

216

 

 

 

376

 

 

 

288

 

 

 

278

 

Accrued other liabilities

 

$

4,703

 

 

$

4,790

 

Total accrued other liabilities

 

$

4,162

 

 

$

5,547

 

 

1511. Debt

On September 14, 2020, the Company entered into a secured revolving credit facility pursuant to a Loan and Security Agreement (the "Loan Agreement") with Bridgewater Bank (the “Bank”). The Loan Agreement provides for availability under a secured revolving line of credit of up to $25 million (the "Loan"). The outstanding balance on the Loan was 0 as of March 31, 2021 and September 30, 2020.

Availability under the Loan is subject to a borrowing base that equals 80% of the margin value of securities collateral that has been pledged to the Bank. The Loan will initially mature on September 14, 2021, but the maturity date may be extended by the Company for up to two extension periods of twelve months subject to certain conditions set forth in the Loan Agreement. The Company's obligations under the Loan Agreement are secured by substantially all of the Company’s and its material subsidiaries' assets, other than intellectual property, real estate and foreign assets, including equity in foreign subsidiaries. The Company has also pledged the stock of certain of its subsidiaries to secure such obligations. Interest under the Loan Agreement accrues at a rate per annum equal to the greater of (i) 3.25% per annum and (ii) the 90-day interest rate yield for U.S. Government Treasury Securities plus 2.75% per annum. A facility fee is payable on unused commitments at a rate of 0.075% quarterly. For the six months ended March 31, 2021, unused commitment fees, reported within interest expense on the condensed consolidated statements of operations, totaled less than $0.1 million.

The Loan Agreement contains affirmative and negative covenants customary for a transaction of this type which, among other things, require the Company to meet certain financial tests, including (i) minimum liquidity, (ii) minimum current ratio, (iii) minimum adjusted EBITDA, and (iv) minimum tangible net worth. The Loan Agreement also contains covenants which, among other things, limit the Company's ability to incur additional debt, make certain investments, create or permit certain liens, create or permit restrictions on the ability of subsidiaries to pay dividends or make other distributions, consolidate or merge and engage in other activities customarily restricted in such agreements, in each case subject to exceptions permitted by the Loan Agreement. The Loan Agreement also contains customary events of default, the occurrence of which would permit the Bank to terminate its commitment and accelerate the Loan.

13


11.Table of Contents

12. Stock-based Compensation Plans

The Company has stock-based compensation plans approved by its shareholders under which it grants stock options, restricted stock awards, performance share awards, restricted stock units and deferred stock units. The Company recognizes share-based payments as an operating expense, based on their fair values, over the requisite service period.

units to officers, directors and key employees. Stock-based compensation expense was reported as follows in the condensed consolidated statements of operations:

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

June 30,

 

 

June 30,

 

 

March 31,

 

 

March 31,

 

(Dollars in thousands)

 

2020

 

 

2019

 

 

2020

 

 

2019

 

(In thousands)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Product costs

 

$

34

 

 

$

34

 

 

$

82

 

 

$

98

 

 

$

32

 

 

$

15

 

 

$

69

 

 

$

48

 

Research and development

 

 

189

 

 

 

225

 

 

 

619

 

 

 

617

 

 

 

305

 

 

 

168

 

 

 

589

 

 

 

430

 

Selling, general and administrative

 

 

1,117

 

 

 

1,060

 

 

 

3,336

 

 

 

2,794

 

 

 

1,092

 

 

 

1,121

 

 

 

2,204

 

 

 

2,219

 

Total

 

$

1,340

 

 

$

1,319

 

 

$

4,037

 

 

$

3,509

 

 

$

1,429

 

 

$

1,304

 

 

$

2,862

 

 

$

2,697

 

As of June 30, 2020,March 31, 2021, approximately $8.5$10.1 million of total unrecognized compensation costs related to non-vested awards is expected to be recognized over a weighted average period of approximately 2.32.5 years.

Stock Option Awards

TheDuring the six months ended March 31, 2021 and 2020, the Company uses the Black-Scholes option pricing modelawarded 234,000 and 261,000 options to determine theofficers, directors and key employees with a weighted average grant date fair value per option of stock options granted. Stock option fair value assumptions$13.86 and the weighted average fair value of stock options granted were as follows:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

 

June 30,

 

 

June 30,

 

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

Stock option fair value assumptions:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Risk-free interest rates

 

 

0.3

%

 

 

2.2

%

 

 

1.5

%

 

 

2.8

%

 

Expected life (years)

 

 

4.7

 

 

 

4.6

 

 

 

4.6

 

 

 

4.5

 

 

Expected volatility

 

 

42.5

%

 

 

36.0

%

 

 

38.4

%

 

 

33.6

%

 

Dividend yield

 

 

%

 

 

%

 

 

%

 

 

%

 

Weighted average grant date fair value of stock

    options granted

 

$

13.00

 

 

$

13.38

 

 

$

14.13

 

 

$

17.91

 

 

The risk-free interest rate assumption was based on the U.S. Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the awards. The expected life of options granted was determined based on the Company’s experience. Expected volatility was based on the Company’s stock price movement over a period approximating the expected term. Based on management’s judgment, dividend yields were expected to be 0 for the expected life of the options. The Company also estimated forfeitures of options granted, which were based on historical experience.

Non-qualified stock options are granted at fair market value on the date of grant. Non-qualified stock options expire in seven years, or upon termination of employment or service as a Board member. With respect to members of our Board, non-qualified stock options generally become exercisable on a monthly pro-rata basis within the one-year period following the date of grant. With respect to our employees, non-qualified stock options generally become exercisable with respect to 25% of the shares on each of the first four anniversaries following the grant date. The stock-based compensation expense table above includes stock option expenses recognized related to these awards, which totaled $0.6 million for each of the three months ended June 30, 2020 and 2019 and $1.8 million and $1.6 million for the nine months ended June 30, 2020 and 2019,$14.24, respectively.

The total pre-tax intrinsic value of options exercised was $0.4 million and less than $0.1 million for the three months ended June 30, 2020 and 2019, respectively, and $1.5 million and $0.1 million for the nine months ended June 30, 2020 and 2019, respectively. Intrinsic value represents the difference between the Company’s common stock fair market value on the date of exercise and the option’s exercise price.

Restricted Stock Awards

The Company has entered into restricted stock agreements with certain key employees, covering the issuance of common stock (“Restricted Stock”). Under accounting guidance, these shares are considered to be non-vested shares. The Restricted Stock is

16


released to the key employees if they are employed by the Company at the end of the vesting period. Restricted Stock vesting periods range from one to three years. During the ninesix months ended June 30,March 31, 2021 and 2020, and 2019, the Company awarded 64,39065,000 and 45,049 Restricted Stock60,000 restricted stock shares, respectively, to certain key employees and officers. Forfeiture of 14,289 and 800 Restricted Stock shares occurred during the nine months ended June 30, 2020 and 2019, respectively. As of June 30, 2020 and September 30, 2019, 97,473 and 90,409 Restricted Stock shares were outstanding, respectively. Compensation expense has been recognized for the estimatedofficers with a weighted average grant date fair value of the common shares, net of estimated forfeitures, and is being charged to operating expenses over the vesting term. The stock-based compensation expense table includes Restricted Stock expenses recognized related to these awards, which totaled $0.5 million for each of the three months ended June 30, 2020 and 2019 and $1.5 million and $1.3 million for the nine months ended June 30, 2020 and 2019, respectively.

Performance Share Awards

In fiscal 2017, the Company entered into performance share agreements with certain key employees covering the issuance of common stock (“Performance Shares”). The Organization and Compensation Committee of the Board of Directors (the “Committee”) established cumulative revenue and cumulative earnings before interest, income taxes, depreciation and amortization (“EBITDA”) for the three-year performance period as the performance objectives for the fiscal 2017 awards. The fiscal 2017 awards also included performance objectives related to achievement of the Company’s strategic initiatives. Awards granted in fiscal 2017 were finalized in the first quarter of fiscal 2020 and resulted in the issuance of 67,653 shares, with a value of $2.8 million, based on the performance objectives relative to actual results achieved during the performance period. The per share compensation cost for each award was fixed on the grant date. The stock-based compensation expense table includes Performance Shares expense recognized related to these awards, which totaled $0.1 million for both the threeof $37.48 and nine months ended June 30, 2019. Performance Shares expense recognized in the three and nine months ended June 30, 2020 was insignificant as all Performances Shares were vested as of September 30, 2019.

The fair values of the Performance Shares, at target, were $1.2 million for awards granted in fiscal 2017. There have been no Performance Share awards granted subsequent to fiscal 2017.$41.88, respectively.

Restricted Stock Units and Deferred Stock UnitsUnit Awards

During the ninesix months ended June 30,March 31, 2021 and 2020, and 2019, the Company awarded 18,37612,000 and 11,87117,000 restricted stock units, (“RSUs”), respectively, to non-employee directors and certainto key employees in foreign jurisdictions. RSU awards are not considered issued or outstanding common stock of the Company until they vest. As of June 30, 2020 and September 30, 2019, outstanding, unvested RSUs totaled 69,320 and 62,242, respectively. Compensation expense has been recognized for the estimatedjurisdictions with a weighted average grant date fair value per unit of the common shares$45.13 and is being charged to operating expenses over the vesting term. The estimated fair value of the RSUs was calculated based on the closing market price of Surmodics’ common stock on the grant date. The stock-based compensation expense table includes RSU expenses recognized related to these awards, which totaled $0.1 million for each of the three months ended June 30, 2020 and 2019 and $0.4 million for each of the nine months ended June 30, 2020 and 2019.$40.73, respectively.

Directors may elect to receive their annual fees for services to the Board in deferred stock units (“DSUs”). Directors may elect this option annually. During the nine months ended June 30, 2020 and 2019, 2,634 and 2,099 units, respectively, were issued with a total fair value of $0.1 million and less than $0.1 million in each respective period. Outstanding, fully vested DSUs totaled 32,363 and 29,729 as of June 30, 2020 and September 30, 2019, respectively. Stock-based compensation expense related to DSU awards totaled less than $0.1 million for each of the three months ended June 30, 2020 and 2019 and $0.1 million for each of the nine months ended June 30, 2020 and 2019.

1999 Employee Stock Purchase Plan

UnderOur U.S. employees are eligible to participate in the amended 1999 Employee Stock Purchase Plan (“Employee Stock Purchase Plan”ESPP”), approved by our shareholders. Shares issued under the Company is authorized to issue up to 600,000 shares of common stock. All full-timeESPP totaled 8,000 and part-time U.S. employees can choose to contribute up to 10% of their annual compensation, with a limit of $25,000, to purchase7,000 for the Company’s common stock at purchase prices defined within the provisions of the Employee Stock Purchase Plan. Employee contributions to the Employee Stock Purchase Plan included in accrued liabilities in the condensed consolidated balance sheets totaled $0.2 million and less than $0.1 million as of June 30, 2020 and September 30, 2019, respectively. Stock-based compensation expense recognized related to the Employee Stock Purchase Plantotaled less than $0.1 million for each of the threesix months ended June 30,March 31, 2021 and 2020, and 2019 and $0.1 million and less than $0.1 million for the nine months ended June 30, 2020 and 2019, respectively. The stock-based compensation expense table includes the Employee Stock Purchase Plan expenses.

17


12.13. Net Income Per Share Data

Basic net income per common share is calculated by dividing net income by the weighted average number of common shares outstanding during the period. Diluted net income per common share is computed by dividing net income by the weighted average number of common and dilutive common equivalent shares outstanding during the period. The Company’s potentially dilutive common shares are those that result from dilutive common stock options and non-vested stock relating to restricted stock awards and restricted stock units, and deferred stock units, as well as performanceunits.

The following table sets forth the calculation of diluted weighted average shares in years prior to fiscal 2020. Options to purchase sharesoutstanding:

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

March 31,

 

 

March 31,

 

(In thousands)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Basic weighted average shares outstanding

 

 

13,746

 

 

 

13,507

 

 

 

13,699

 

 

 

13,474

 

Dilutive effect of outstanding stock options,

    non-vested restricted stock, and non-vested

    restricted stock units

 

 

235

 

 

 

244

 

 

 

216

 

 

 

305

 

Diluted weighted average shares outstanding

 

 

13,981

 

 

 

13,751

 

 

 

13,915

 

 

 

13,779

 

14


Table of common stock as well as unvested restricted stock and performance stock units are considered to be potentially dilutive common shares.Contents

The calculation of weighted average diluted shares outstanding excludes outstanding stock options associated with the right to purchase less than 0.1 million and 0.2 million shares of common stock for both the three months ended June 30,March 31, 2021 and 2020 and 2019, respectively,0.1 million and less than 0.1 million and 0.1 million shares of common stock for the ninesix months ended June 30,March 31, 2021 and 2020, and 2019, respectively, as their inclusion would have had an antidilutive effect on diluted net income per share for those periods.the period.

The following table sets forth the denominator for the computation of basic and diluted net income per share (in thousands):

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net income available to common shareholders

 

$

2,459

 

 

$

1,466

 

 

$

4,069

 

 

$

4,038

 

Basic weighted average shares outstanding

 

 

13,601

 

 

 

13,394

 

 

 

13,577

 

 

 

13,384

 

Dilutive effect of outstanding stock options,

   non-vested restricted stock, restricted stock

   units, deferred stock units and performance

   shares

 

 

185

 

 

 

332

 

 

 

198

 

 

 

392

 

Diluted weighted average shares outstanding

 

 

13,786

 

 

 

13,726

 

 

 

13,775

 

 

 

13,776

 

The Company’s Board of Directors has authorized the repurchase of up to $25.3 million of the Company’s outstanding common stock. This authorization does not have an expiration date.

13.14. Income Taxes

For interim income tax reporting, the Company estimates its annual effective tax rate and applies it to fiscal year-to-date pretax income (loss), excluding unusual or infrequently occurring discrete items. Tax jurisdictions with losses for which tax benefits cannot be realized are excluded. The Company recorded anincome tax expense of $(1.4) million and income tax benefit of $1.2 million and $0.3$1.9 million for the three months ended June 30,March 31, 2021 and 2020, and 2019, respectively, and $3.4income tax expense of $(1.6) million and $0.6income tax benefit of $2.2 million for the ninesix months ended June 30,March 31, 2021 and 2020, respectively. For the three and 2019, respectively. In the ninesix months ended June 30,March 31, 2020, the income tax benefit includes a discrete tax benefit of $1.8 million as a result of our ability under the Coronavirus Aid, ReliefRelieve and Economic Security Act (the “CARES Act”), enacted in March 2020, to carry back NOLsnet operating losses (“NOLs”) incurred to periods when the statutory tax rate was 35% versus ourthe current tax rate of 21%.

The CARES Act was enacted on March 27, 2020 and includes significant business tax provisions. In particular, the CARES Act modified the rules associated with net operating losses (“NOLs”) and made technical corrections to tax depreciation methods for qualified improvement property. Under the temporary provisions of CARES Act, NOL carryforwards and carrybacks may offset 100% of taxable income for taxable years beginning before 2021. In addition, NOLs arising in 2018, 2019 and 2020 taxable years may be carried back to each of the preceding five years to generate a refund.

The effective income tax rate for the three and ninesix months ended June 30,March 31, 2021 and 2020 and 2019 differs from the U.S. federal statutory tax rate of 21% primarily due to the discrete tax benefits recognized under the CARES Act forin the nine-month period,second quarter of fiscal 2020, favorable impacts of the U.S. federal research and development tax credits, in both periods, stock award activity, in the nine-month period, and operating results of our Irish subsidiary, where tax benefit is offset by a valuation allowance. The Company recognized discrete tax benefits related to stock-based compensation awards vested, expired, cancelled and exercised of $0.7 million and less than $0.1 million in each ofthe three months ended June 30,March 31, 2021 and 2020, respectively and 2019$0.7 million and $0.3 million and $0.5 million in the ninesix months ended June 30,March 31, 2021 and 2020, and 2019, respectively.

The total amount of unrecognized tax benefits, excluding interest and penalties that, if recognized, would affect the effective tax rate was $2.8$3.1 million and $2.1$2.7 million as of June 30, 2020March 31, 2021 and September 30, 2019,2020, respectively. Interest and penalties related to unrecognized tax benefits are recorded in the income tax benefit.

For interim income tax reporting, the Company estimates its annual effective tax rate and applies it to year-to-date pretax income, excluding unusual or infrequently occurring discrete items. Tax jurisdictions with losses for which tax benefits cannot be realized are

18


excluded. The Company files income tax returns, including returns for its subsidiaries, in the U.S. federal jurisdiction and in various state jurisdictions as well as several non-U.S. jurisdictions. Uncertain tax positions are related to tax years that remain subject to examination. U.S. income tax returns for years prior to fiscal 2017 are no longer subject to examination by federal tax authorities. For tax returns for state and local jurisdictions, the Company is no longer subject to examination for tax years generally before fiscal 2009. For tax returns for non-U.S. jurisdictions, the Company is no longer subject to income tax examination for years prior to 2014. Additionally, the Company has been indemnified of liability for any taxes relating to Creagh Medical and NorMedix for periods prior to their respective acquisition dates, pursuant to the terms of the related share purchase agreements. There were 0 undistributed earnings in foreign subsidiaries as of June 30, 2020March 31, 2021 and September 30, 2019.2020.

 

14.15. Segment Information

TheOperating segments are components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker, who is the Company’s management evaluates performanceChief Executive Officer, in deciding how to allocate resources and allocates resources based on reported results forin assessing performance. We operate 2 reportable segments, as follows: (1) the Medical Device unit, which designs, develops and manufactures interventional medical devices, primarily for the peripheral vascular market; surfacesegments:

Medical Device: Surface modification coating technologies to improve access, deliverability, and predictable deployment of medical devices, as well as drug-delivery coating technologies to provide site-specific drug-delivery from the surface of a medical device, with end markets that include coronary, peripheral, neuro-vascular, and structural heart, among others; and the design, development, and manufacture of interventional medical devices, primarily balloons and catheters, including drug-coated balloons, for peripheral arterial disease treatment and other applications; and

In Vitro Diagnostics (“IVD”): Design, development and manufacture of component products and technologies for diagnostic immunoassay, as well as molecular tests and biomedical research applications, with products that include protein stabilization reagents, substrates, surface coatings and antigens.

15


Table of medical devices; as well as drug-delivery coating technologies to provide site-specific drug-delivery from the surface of a medical device, with end markets that include coronary, peripheral, neuro-vascular and urology, among others, and (2) the In Vitro Diagnostics unit, which consists of component products and technologies for diagnostic test kits and biomedical research applications, with products that include protein stabilization reagents, substrates, antigens and surface coatings.Contents

Segment revenue, operating income (loss), and depreciation and amortization were as follows:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

June 30,

 

 

June 30,

 

 

March 31,

 

 

March 31,

 

(Dollars in thousands)

 

2020

 

 

2019

 

 

2020

 

 

2019

 

(In thousands)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Medical Device

 

$

20,514

 

 

$

18,945

 

 

$

54,222

 

 

$

53,504

 

 

$

27,907

 

 

$

16,304

 

 

$

44,103

 

 

$

33,708

 

In Vitro Diagnostics

 

 

6,369

 

 

 

5,399

 

 

 

18,099

 

 

 

15,757

 

 

 

7,088

 

 

 

6,518

 

 

 

13,189

 

 

 

11,730

 

Total revenue

 

$

26,883

 

 

$

24,344

 

 

$

72,321

 

 

$

69,261

 

 

$

34,995

 

 

$

22,822

 

 

$

57,292

 

 

$

45,438

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Medical Device

 

$

532

 

 

$

753

 

 

$

(1,344

)

 

$

1,087

 

 

$

8,564

 

 

$

(1,453

)

 

$

7,971

 

 

$

(1,876

)

In Vitro Diagnostics

 

 

3,254

 

 

 

2,475

 

 

 

9,315

 

 

 

7,845

 

 

 

3,809

 

 

 

3,462

 

 

 

7,029

 

 

 

6,061

 

Total segment operating income

 

 

3,786

 

 

 

3,228

 

 

 

7,971

 

 

 

8,932

 

 

 

12,373

 

 

 

2,009

 

 

 

15,000

 

 

 

4,185

 

Corporate

 

 

(2,622

)

 

 

(2,211

)

 

 

(7,229

)

 

 

(6,338

)

 

 

(2,890

)

 

 

(2,165

)

 

 

(5,424

)

 

 

(4,607

)

Total operating income

 

$

1,164

 

 

$

1,017

 

 

$

742

 

 

$

2,594

 

Total operating income (loss)

 

$

9,483

 

 

$

(156

)

 

$

9,576

 

 

$

(422

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Medical Device

 

$

1,424

 

 

$

1,481

 

 

$

4,318

 

 

$

4,315

 

 

$

1,721

 

 

$

1,439

 

 

$

3,373

 

 

$

2,894

 

In Vitro Diagnostics

 

 

112

 

 

 

120

 

 

 

331

 

 

 

353

 

 

 

88

 

 

 

109

 

 

 

193

 

 

 

219

 

Corporate

 

 

254

 

 

 

286

 

 

 

741

 

 

 

794

 

 

 

97

 

 

 

248

 

 

 

200

 

 

 

487

 

Total depreciation and amortization

 

$

1,790

 

 

$

1,887

 

 

$

5,390

 

 

$

5,462

 

 

$

1,906

 

 

$

1,796

 

 

$

3,766

 

 

$

3,600

 

The Corporate category includes expenses that are not fully allocated to Medical Device and In Vitro Diagnostics segments. These Corporate costs are related to administrative corporate functions, such as executive management, corporate accounting, legal, human resources and Board of Directors. Corporate may also include expenses, such as litigation, which are not specific to a segment and thus not allocated to the operating segments.

Asset information by operating segment is not presented because the Company does not provide its chief operating decision maker assets by operating segment, as the data is not readily available or significant to the decision-making process.available.

15.16. Leases

The Company leases facilities for research, office, manufacturing and warehousing. The Company determines whether a contract is aOperating lease or contains a lease at inception date. Upon commencement, the Company recognizes a right-of-use asset and lease liability based on the net present value of the future minimum lease payments over the lease term at the commencement date. The net present value of future minimum lease payments recorded upon lease commencement is reduced by the discounted value of any leasehold improvement incentives payable to the Company considered to be in-substance fixed payments. The unamortized balance

19


of leasehold improvement incentives in the form of tenant allowances represents the primary difference between the balance of the right-of-use assets and operating lease liabilities. As the Company’s leases typically do not provide an implicit rate, the Company’s lease liabilities are measured on a discounted basis using the Company's incremental borrowing rate. Lease terms used in the recognition of right-of-use assets and lease liabilities include only options to extendwere as follows:

 

 

March 31,

 

 

September 30,

 

(In thousands)

 

2021

 

 

2020

 

Right-of-use assets:

 

 

 

 

 

 

 

 

Other assets

 

$

2,406

 

 

$

2,508

 

 

 

 

 

 

 

 

 

 

Operating lease liabilities:

 

 

 

 

 

 

 

 

Other accrued liabilities

 

$

464

 

 

$

436

 

Other long-term liabilities

 

 

3,293

 

 

 

3,340

 

Total operating lease liabilities

 

$

3,757

 

 

$

3,776

 

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Table of Contents

As of March 31, 2021, operating lease maturities for the lease that are reasonably certain to be exercised. The condensed consolidated balance sheets do not include recognized assets or liabilities for leases that, atremainder of fiscal 2021 and each of the commencement date, have a term of twelve months or less and do not include an option to purchase the underlying asset that is reasonably certain to be exercised. The Company recognizes such leases in the condensed consolidated statements of income on a straight-line basis over the lease term.

The Company’s leases include one or more options to renew and extend the lease term at the Company’s discretion. These renewal options are not included in right-of-use assets and lease liabilitiesnext five fiscal years were as they are not reasonably certain of exercise. The Company regularly evaluates renewal options, and when they are reasonably certain to be exercised, the renewal period is included in the lease term.follows:

(In thousands)

 

 

 

 

Remainder of 2021

 

$

303

 

2022

 

 

612

 

2023

 

 

625

 

2024

 

 

638

 

2025

 

 

651

 

2026

 

 

595

 

Thereafter

 

 

894

 

Total expected operating lease payments

 

 

4,318

 

Less: Imputed interest

 

 

(561

)

Total operating lease liabilities

 

$

3,757

 

Operating lease cost was $0.2 million and $0.5$0.1 million for the three and nine months ended June 30,March 31, 2021 and 2020, respectively, and $0.4 million and $0.3 million for the six months ended March 31, 2021 and 2020, respectively. Cash paid for operating lease liabilities approximated operating lease cost for the three and nine monthssix month periods ended June 30,March 31, 2021 and 2020.

Operating lease right-of-use assets and lease liabilities were as follows:

 

 

June 30,

 

(Dollars in thousands)

 

2020

 

Right-of-use assets:

 

 

 

 

Other assets

 

$

2,580

 

 

 

 

 

 

Operating lease liabilities:

 

 

 

 

Other accrued liabilities

 

$

397

 

Other long-term liabilities

 

 

3,286

 

Total operating lease liabilities

 

$

3,683

 

As of June 30, 2020, operating lease maturities for the remainder of fiscal 2020 and each of the next five fiscal years are as follows (in thousands):

Remainder of 2020

 

$

114

 

2021

 

 

586

 

2022

 

 

612

 

2023

 

 

625

 

2024

 

 

638

 

2025

 

 

651

 

Thereafter

 

 

1,521

 

Total expected operating lease payments

 

 

4,747

 

Less: Imputed interest

 

 

(1,064

)

Total operating lease liabilities

 

$

3,683

 

As of June 30, 2020, the weighted average remaining lease term for operating leases was 7.6 years and the weighted average discount rate used to determine operating lease liabilities was 4.0%.

16.17. Commitments and Contingencies

Litigation. From time to time, the Company may become involved in various legal actions involving its operations, products and technologies, including intellectual property and employment disputes. The outcomes of these legal actions are not within the Company’s complete control and may not be known for prolonged periods of time. In some actions, the claimants seek damages as well as other relief, including injunctions barring the sale of products that are the subject of the lawsuit, which if granted, could require significant expenditures or result in lost revenue. The Company records a liability in the condensed consolidated financial statements for these actions when a loss is known or considered probable and the amount can be reasonably estimated. If the reasonable estimate of a known or probable loss is a range, and no amount within the range is a better estimate, the minimum amount of the range is accrued.

20


If a loss is possible but not known or probable, and can be reasonably estimated, the estimated loss or range of loss is disclosed. In most cases, significant judgment is required to estimate the amount and timing of a loss to be recorded. 

InnoCore Technologies BV. In fiscal 2006, the Company entered into a license agreement whereby the Company obtained an exclusive license to a drug deliverydrug-delivery coating for licensed products within the vascular field, which included peripheral, coronary and neurovascular biodurable stent products. The license requires the Company to make an annual, minimum payment of 200,000 euros (equivalent to $225,000 using a euroapproximately $0.2 million (at the Euro to US dollar exchange rate of $1.1228 to the Euro as of June 30, 2020)March 31, 2021) until the last patent expires, which is currently estimated to be SeptemberMay 2027. The total minimum future payments associated with this license are approximately $1.7$1.5 million as of June 30, 2020.March 31, 2021. The license is currently utilized by one of the Company’s drug delivery customers.

Clinical Trials. The Company has engaged clinical trial clinical research organization (“CRO”) consultants to assist with the administration of its ongoing clinical trials. The Company has executed separate contracts with two CROs for services rendered in connection with the TRANSCEND pivotal clinical trial for the SurVeil DCB, including pass-through expenses paid by the CROs, of up to approximately $26$29 million in the aggregate. As of June 30, 2020,March 31, 2021, an estimated $10$8 million remains to be paid by the Company on these contracts, which may vary depending on actual pass-through expenses incurred to execute the trial. The Company estimates that the total cost of the TRANSCEND clinical trial will be in the range of $35 million to $40 million from inception to completion. In the event the Company were to terminate any trial, it may incur certain financial penalties which would become payable to the CRO for costs to wind down the terminated trial.

Asset Acquisitions. In the fourth quarter of fiscal 2019, the Company acquired certain intellectual property assets supporting ongoing development of the Company’s medical device pipeline and paid the sellers $0.8 million. In addition,million in fiscal 2019 and $0.2 million in the Companyfirst quarter of fiscal 2021. An additional $1.1 million in payments is obligated to pay up to $1.3 million of additional considerationcontingent upon achievement of certain strategic milestones within a contingency period ending in 2022, of which $0.2 million is guaranteed to be paid in fiscal 2021.2022.

In fiscal 2018, the Company acquired certain intellectual property assets of Embolitech, LLC (the “Embolitech Transaction”). As part of the Embolitech Transaction, the Company paid the sellers $5.0 million in fiscal 2018, and $1.0 million in the second quarter of fiscal 2020.2020, and $1.0 million in the first quarter of fiscal 2021. The Company is obligated to pay additional installments totaling $2.5 million in fiscal 2022 through fiscal 2024. These payments may be accelerated upon the occurrence of certain sales and regulatory milestones. An additional $2.0$1.0 million payment is contingent upon the achievement of certain regulatory milestones within a contingency period ending in 2033.

As of June 30, 2020, $0.1March 31, 2021, $0.5 million and $2.2$1.8 million related to these asset acquisitions is includedwas recorded in other accrued liabilities and other long-term liabilities, respectively, on the condensed consolidated balance sheets. As of September 30, 2019, $1.02020, $1.1 million and $2.1$2.2 million related to these asset acquisitions is includedwas reported in other accrued liabilities and other long-term liabilities, respectively, on the condensed consolidated balance sheets.

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Table of Contents

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

The following discussion and analysis provides information management believes is useful in understanding the operating results, cash flows and financial condition of Surmodics, Inc. and subsidiaries (referred to as “Surmodics,” the “Company,” “we,” “us,” “our” and other like terms).Surmodics. The discussion should be read in conjunction with both the unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and related notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations, each included in our Annual Report on Form 10-K for the fiscal year ended September 30, 2019.2020. This discussion contains various “Forward-Looking Statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We refer readers to the statement entitled “Forward-Looking Statements” located at the end of this Item 2.

Overview

Surmodics, Inc. and subsidiaries (referred to as “Surmodics,” the “Company,” “we,” “us,” “our” and other like terms) is a leading provider of surface modification technologies for intravascular medical devicedevices and chemical components for in vitro diagnostic technologies(“IVD”) immunoassay tests and microarrays. Surmodics is pursuing development and commercialization of highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the healthcare industry,most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with theenhanced device design, development, and manufacturing capabilities. The Company mission of improvingremains to improve the detection and treatment of disease. We remain committed to developing medical device products and platforms leveraging the technologies and manufacturing capabilities in our Medical Device business unit for the treatment of peripheral arterial disease (“PAD”) and other vascular diseases. Our primary focus has been the continued development of our drug-coated balloon (“DCB”) platform, our radial access device platform, and our thrombectomy device platform.

COVID-19 Pandemic Update

A novel strain of coronavirus was first identified in Wuhan, China in December 2019. The disease caused by it, COVID-19, was declared a global pandemic by the World Health Organization in March 2020. On March 18, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released guidance for U.S. healthcare providers to limit non-emergent elective medical procedures other than high acuity treatments in order to conserve personal protective equipment and limit exposure to COVID-19. On April 16, 2020, the White House issued “Guidelines for Opening Up America Again” (the “White House Guidelines”) that described a phased resumption of economic activities with gating conditions for a region or state to move from one phase to another. On June 9, 2020, CMS issued recommendations for regions and states in Phase II of the White House Guidelines that non-emergent, non-COVID-19 care should be offered to patients, as clinically appropriate, in localities or facilities that have the resources to provide such care, as well as the ability to quickly respond to a surge in COVID-19 cases, if necessary.

Since the White House Guidelines and related CMS recommendations were issued, rates of COVID-19 have vacillated by region and state, in some cases surging. Accordingly, consistent with the CMS recommendations, the degree to which elective medical procedures have been offered varies by region, state, and even between healthcare systems within a state. Where elective procedures have been offered, and even for emergency procedures, some people appear to have avoided healthcare facilities, presumably out of concern for contracting COVID-19. In addition, hospitals and other healthcare providers vary in the degree to which they are permitting access to their facilities during the pandemic. Further, the COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains and healthcare delivery, led to social distancing recommendations, and created significant volatility in financial markets.

In response to the pandemic and business disruptions, first and foremost, we have prioritized the health and safety of our employees, customers, suppliers and others with whom we partner in our business activities. We have instructed employees to work from home when possible and to maintain recommended physical distancing when working in our facilities. We also have eliminated non-essential in-person contact with customers, suppliers and other third parties.

Many of our customers use our licensed technology and purchased materials to manufacture products used in elective procedures. In addition, our customers and business partners need access to healthcare providers and facilities to effectively market, distribute and sell products incorporating our coating and device technologies, as well as our whole-product solutions. Likewise, we and our business partners need access to healthcare providers and facilities to conduct clinical trials and other activities required to achieve regulatory clearing for our products under development. We are carefully monitoring rapidly evolving changes in healthcare delivery systems and may adjust our operating and product development plans accordingly.

Given the unprecedented and dynamic nature of the COVID-19 pandemic, we cannot reasonably estimate the impacts it may have on our financial condition, results of operations or cash flows in the future. However, we expect that differences in the rates of delivery and utilization of elective procedures in response to CMS recommendations and the pandemic will have an adverse impact, which may be material, on our future revenues, profitability and cash flows. The extent and duration of that impact will depend upon the extent of procedure postponements and the duration of the pandemic.


22


Product Development

Our business model for our whole-product solutions strategy within our Medical Device segment is to design, develop and manufacture highly differentiated products that incorporate our proprietary catheter, balloon, thrombectomy and/or surface modification coating technologies to improve patient outcomes and reduce procedure costs, while maintaining patient safety. We are focused on developing devices that considermeet the needs of variousa spectrum of care settings ranging from hospitals, to ambulatory surgery centers, to office-based interventional labs in order to provide improved care and address unmet needs in the treatment of PADperipheral artery disease (“PAD”) and other vascular diseases. Our strategy has been built on our investment in proprietary device technologies, as well as state-of-the-art medical device design, development and manufacturing capabilities. Over the past several years, we have made investments to enhance our clinical and regulatory capabilities, and in fiscal 2020, we have continued to make additional investments to obtain clinical data, reduce the time from product development to commercialization, and drive clinician engagement with our products after approval to optimize adoption.

Below is a brief summary of our pipeline of medical device products under development and recently commercialized, grouped by product family. All discussions of expectations and targeted timelines are subject to the uncertainty surrounding the COVID-19 pandemic.platform.

Drug-coated balloons

SurVeilTM DCBpaclitaxel-coated DCBdrug-coated balloon (“DCB”) to treat PAD in the superficialupper leg (superficial femoral artery.artery). In fiscal 2018, we entered into an agreement (“the Abbott(the “Abbott Agreement”) with Abbott Vascular, Inc. (“Abbott”) that providedprovides Abbott with exclusive worldwide commercialization rights to the SurVeilDCB product. Our SurVeil DCB product. Full enrollment in the TRANSCEND pivotal clinical trial of the SurVeil DCB was completed in the fourth quarter of fiscal year 2019. As of the third quarter of fiscal 2020, patient follow-up visits are ongoing. We continueutilizes a proprietary paclitaxel drug-excipient formulation for a durable balloon coating and is manufactured using an innovative process to engage with the FDA to determine how to treat data for the population of patients who are unable to complete their visit within the specified follow-up window as a result of COVID-19.improve coating uniformity.

InWe announced in January 2021 that our TRANSCEND clinical trial, the third quarter of fiscal 2020, we received Conformité Européenne Mark (“CE Mark”) approval prerequisitepivotal trial for commercialization of the SurVeil DCB, met both the primary safety and primary efficacy endpoints, and the SurVeil DCB was found to be non-inferior in those endpoints to the European Union.Medtronic IN.PACT® Admiral® DCB, while delivering a substantially lower drug dose. In the second half of fiscal 2021, we expect to submit the PMA clinical report to the Food and Drug Administration (“FDA”) for premarket approval (“PMA”), including certain long-term vital status data required by the FDA.

In the second quarter of fiscal 2021, we delivered to Abbott the written clinical report and related materials that demonstrated the primary safety endpoint and primary efficacy endpoint for the TRANSCEND clinical study were met. As a result, we received a $10.8$15 million milestone payment from Abbott in the thirdsecond quarter of fiscal 2020,2021, of which $6.7$10.8 million was recognized as license fee revenue in the period. As of the third quarter of fiscal 2020, the timeline for commercialization of the SurVeil DCB in the European Union is to be determined subject to the discretion of our partner, Abbott.

AvessTMSundance™ DCB – sirolimus-coated DCB to treat below-the-knee PAD. We commenced the SWING first-in-human, 35-patient clinical study of our Sundance DCB in the third quarter of fiscal 2020. In the second quarter of fiscal 2021, we completed enrollment in the SWING clinical study. We expect six-month results from the SWING clinical study to be available in the first quarter of fiscal 2022.

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Table of Contents

Avess™ DCB – paclitaxel-coated DCB for the treatment of arteriovenous (“AV”) fistulae commonly associated with hemodialysis. WeIn fiscal 2019, we commenced and completed enrollment in a first-in-humanfirst in-human, 12-patient clinical study of our Avess DCB in DCB. In fiscal 2019. Initial2020, initial study results were received in the third quarter of fiscal 2020and demonstrated promising early safety data and performance insights. Asinsights, with greater than 90% of treated patients free from revascularization at six months. In fiscal 2021, we are completing the build out of the third quarterfull matrix of fiscal 2020, we continue to explore avenues with the study’s principal investigators to publish study results. The Abbott Agreement includes options to negotiate further agreements for our Avess and SundanceTM DCB products. Abbott has informed the Company that it has elected not to negotiate for distribution rights for the Avess DCB product. We are currently assessing commercialization opportunities for our Avess DCB. We are targeting fiscal 2021 for the next regulatory milestone for our Avess DCB, attainment of the FDA investigational device exemption required to commence a pivotal clinical trial for this product.

Sundance DCB – sirolimus-coated DCB for the treatment of below-the-knee PAD.balloon sizes. In the third quarter of fiscal 2020, we commenced enrollment in a first-in-human clinical study of this product. As of the third quarter of fiscal 2020, we are targeting completion of enrollment in this trial for the second half of fiscal 2021.2021, we plan tobegin process and product validation efforts and to continue to assess the optimal regulatory and clinical strategy for our Avess DCB.

Thrombectomy

Pounce™thrombectomy platform– mechanical thrombectomy technology designed to remove thrombus or emboli (clots) from the vasculature. The Pounce technology platform has the potential to extend to other vascular indications beyond arterial with further development.

In the fourth quarter of fiscal 2020, we received FDA 510(k) clearance on our first thrombectomy device, the Pounce Thrombus Retrieval System, intended for the non-surgical removal of thrombi and emboli (clots) from the peripheral arterial vasculature. We expect to initiate limited product evaluation activities for our Pounce Thrombus Retrieval System in the second half of fiscal 2021 to assess human-use factors and product performance prior to commercialization.

Radial access

Sublime™ radial access platform – access and therapeutic devices designed to provide radial (wrist) access to and treat the peripheral vasculature via the radial (wrist) artery.vasculature. In fiscal 2019, we received FDA 510(k) clearance for our Sublimeguide sheath, which enables the deliveryperformance of lower extremity interventions from the radial artery. In the third quarter of fiscal 2020, we received FDA 510(k) clearance for the Sublime radial-access 0.014” percutaneous transluminal angioplasty (“PTA”) balloon catheter.catheter for treatment of lesions in arteries below the knee. An important precursor to commercialization of our radial access platform is establishment of clinical use within a market evaluationproduct performance experience through physician evaluations in real-world case settings. These evaluations are designed to assess the human use factors and clinical performance of these devices. AsPhysician evaluations of the third quarter of fiscal 2020, we expect to begin market evaluation activities forboth our Sublime guide sheath and 0.014” PTA balloon catheter products began in the second quarter of fiscal 2021 and are expected to continue through the second half of fiscal 2021.

23In the third quarter of fiscal 2021, we submitted to the FDA for 510(k) clearance for our Sublime 0.018” PTA balloon catheter for treatment of lesions above the knee. Upon receipt of FDA clearance, we are targeting the first half of fiscal 2022 to initiate product evaluation activities for this product.


Thrombectomy

Pounce™thrombectomy platform– mechanical thrombectomy device designed to remove difficult, organized blood clots with potential applications for multiple vascular indications. Our goal is to expand our thrombectomy platform beyond arterial to include devices designed to treat deep vein thrombosis and pulmonary embolism. As of the third quarter of fiscal 2020, we have filed for FDA 510(k) clearance for our first indication, treatment of clots in the peripheral arteries, and are in review with the FDA. We are targeting 510(k) clearance for this first indication in fiscal 2020.

Specialty catheters

TelemarkTelemark™ coronary/peripheral support microcatheter. InThis product was commercialized in fiscal 2019, we executed2020 pursuant to an agreement with Medtronic plc (“Medtronic”) to distribute our Telemark microcatheterfor distribution in the U.S.U.S. and Europe.Europe for coronary applications. Shipment of initial U.S. orders of our Telemark microcatheter commenced early in fiscal 2020. In the third quarter of fiscal 2020, we obtained CE Mark for our Telemark microcatheter and shipped initial European orders.

0.014” and 0.018” low-profile PTA balloon dilation cathetersspecialtyspecialty PTA balloon catheters for difficult-to-treat lesions. InThese products were commercialized in fiscal 2019, we executed2020 pursuant to an agreement with Cook Medical for worldwide distribution, excluding Japan, of these products.Japan. Shipment of initial orders and the U.S. commercial launch commenced in the third quarter of fiscal 2020.

For more information regarding our product development and commercialization strategy, see Part I, Item 1 of our Annual Report on Form 10-K for the fiscal year ended September 30, 2019.2020.

PhotolinkTM Fourth-GenerationCoating Technology Patents

Our fourth-generation PhotoLinkWe generate royalties revenue from licensing our proprietary surface coating technology to customers. Medical Device royalties revenue was 30%, 35% and 38% of our total revenue for fiscal 2020, 2019 and 2018, respectively. The most significant source of royalties revenue was derived from our hydrophilic coating technology. The latest generation of our hydrophilic coating technology, our Serene™ hydrophilic coating, is protected by a family of patents that begin to expire in 2033. Royalties revenue associated with our Serene hydrophilic coating technology increased approximately 27% in fiscal 2020, compared to the prior year, driven by customer product launches and resulting market share increases associated with customer device applications that incorporate this next-generation coating technology.

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The family of patents that protected our fourth-generation PhotoLink™ hydrophilic coating technology expired in the first quarter of fiscal 2020 in all countries where patent coverage existed for this technology. Thethe technology, except in Japan, where the relevant patent expired in the first quarter of fiscal 2021. Medical Device business royalties revenue associated with our fourth-generation hydrophilic coating technology was approximately 14%, 21% and 21% of our total revenue for fiscal 2020, 2019 revenue.and 2018, respectively. Of the license agreements using our fourth-generation and early-generationPhotolink technologies, most continue to generate royalties revenue for know-how and other proprietary rights, at a reduced royalty rate, beyond patent expiration. The remainderamount of the decline in royalties and license fee revenue in fiscal 2020, compared to the prior year, related specifically to the expiration of fourth-generation hydrophilic coating patents was approximately $5.5 million. In fiscal 2021, we expect a decline of less than $2.0 million in royalties and license fee revenue, compared to the prior year, specific to the tail-end impact of these fourth-generation patent expirations, which reflects the mitigating impact of growth among our fourth-generation coating customers. In addition, we expect the decline in fourth-generation coating royalties to be more than offset by continued growth in our next-generation Serene hydrophilic coating royalties portfolio.

COVID-19 Pandemic

Our business, operations and financial condition and results have been and may continue to be impacted by the COVID-19 pandemic. In fiscal 2020, we experienced significant and unpredictable reductions in both royalties and license fee revenue and product sales, primarily in our Medical Device business, as our customers were negatively impacted by the decline in the volume of elective procedures that resulted from the global healthcare system’s response to COVID-19. As fiscal 2021 has progressed, we are derived fromseeing a diminishing degree of Covid-related impacts to our other coatingsreported revenue. However, the extent to which the COVID-19 pandemic continues to impact the Company’s results of operations and financial condition will depend on future developments that are protected by a numberhighly uncertain and cannot be predicted, including new information that may emerge concerning the severity and longevity of patentsCOVID-19 and its variants, the resurgence of COVID-19 in regions that extendhave begun to at least fiscal 2035.

Critical Accounting Policies and Significant Estimates

Critical accounting policies are those policies that requirerecover from the application of management’s most challenging, subjective or complex judgment, often as a resultinitial impact of the needpandemic, the impact of COVID-19 on economic activity, and the actions to make estimates aboutcontain its impact on public health and the effectglobal economy. For further information, refer to “Risk Factors” in Part II, Item 1A of matters that are inherently uncertain and may change in subsequent periods. Critical accounting policies involve judgments and uncertainties that are sufficiently likely to result in materially different results under different assumptions and conditions. For the nine months ended June 30, 2020, there were no significant changes in our critical accounting policies. For a detailed description of our other critical accounting policies and significant estimates, see Management’s Discussion and Analysis of Financial Condition and Results of Operations under Item 7 in our Annual Report on Form 10-K for the fiscal year ended September 30, 2019.2020.

Results of Operations

Three and NineSix Months Ended June 30, 2020March 31, 2021

Revenue. Revenue for the thirdsecond quarter of fiscal 20202021 was $26.9$35.0 million, an increase of 10.4%53.3%, as compared withto the thirdsecond quarter of fiscal 2019.2020. Revenue for the ninefirst six months ended June 30, 2020of fiscal 2021 was $72.3$57.3 million, an increase of 4.4%26.1%, as compared with the nine months ended June 30, 2019.to same prior-year period. The following is a summary of revenue by operating segment.segment:

 

 

Three Months Ended June 30,

 

 

Nine Months Ended June 30,

 

 

Three Months Ended March 31,

 

 

Six Months Ended March 31,

 

 

 

 

 

 

 

 

 

 

%

 

 

 

 

 

 

 

 

 

 

%

 

 

 

 

 

 

 

 

 

 

%

 

 

 

 

 

 

 

 

 

 

%

 

(Dollars in thousands)

 

2020

 

 

2019

 

 

Change

 

 

2020

 

 

2019

 

 

Change

 

(In thousands)

 

2021

 

 

2020

 

 

Change

 

 

2021

 

 

2020

 

 

Change

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Medical Device

 

$

20,514

 

 

$

18,945

 

 

 

8.3

%

 

$

54,222

 

 

$

53,504

 

 

 

1.3

%

 

$

27,907

 

 

$

16,304

 

 

 

71.2

%

 

$

44,103

 

 

$

33,708

 

 

 

30.8

%

In Vitro Diagnostics

 

 

6,369

 

 

 

5,399

 

 

 

18.0

%

 

 

18,099

 

 

 

15,757

 

 

 

14.9

%

 

 

7,088

 

 

 

6,518

 

 

 

8.7

%

 

 

13,189

 

 

 

11,730

 

 

 

12.4

%

Total Revenue

 

$

26,883

 

 

$

24,344

 

 

 

10.4

%

 

$

72,321

 

 

$

69,261

 

 

 

4.4

%

 

$

34,995

 

 

$

22,822

 

 

 

53.3

%

 

$

57,292

 

 

$

45,438

 

 

 

26.1

%

 

24


Medical Device. Medical Device revenue was $20.5$27.9 million in the thirdsecond quarter of fiscal 2020,2021, an increase of 8.3% as71.2% compared with $18.9to $16.3 million for the thirdsecond quarter of fiscal 2019.2020. Medical Device revenue for the ninesix months ended June 30, 2020March 31, 2021 was $54.2$44.1 million, an increase of 1.3%30.8% as compared with $53.5$33.7 million for the ninesix months ended June 30, 2019.March 31, 2020.

Product sales increased 28.1%, or $1.3 million, for the third quarter20


Table of fiscal 2020 as compared with the prior-year quarter and increased 17.4%, or $2.4 million, for the first nine months of fiscal 2020 compared to the same prior-year period. This increase was due primarily to the fiscal 2020 impact from recently commercialized medical device products, partly offset by the impact of a decline in legacy balloon catheter sales as a result of COVID-19 procedure reductions.Contents

RoyaltiesMedical Device royalties and license fee revenue increased 6.7%143.9%, or $0.8$11.8 million, for the thirdsecond quarter of fiscal 20202021 and decreased 2.8%increased 60.0%, or $(0.9)$11.0 million, for the first ninesix months of fiscal 2020, as2021, compared withto the same prior yearprior-year periods. Abbott Agreement license fee revenue increased to $7.6$12.5 million infor the thirdsecond quarter of fiscal 2020, as2021, compared to $2.0$1.5 million in the prior-year quarter, driven primarily by $6.7$10.8 million in revenue recognized from a $10.8the $15 million milestone payment received in the thirdsecond quarter of fiscal 2020. In2021. For the first ninesix months of fiscal 20202021 and 2019,2020, Abbott Agreement license revenue was $10.4$13.8 million and $5.9$2.8 million, respectively. Royalties revenue increased 11.3% to $7.5 million for the third quarter and first nine months of fiscal 2020 was significantly impacted by the reduction in procedures as a result of COVID-19. In addition, royalties revenue for the third quarter and first nine months of fiscal 2020 was negatively impacted by the previously communicated expiration of our fourth-generation hydrophilic patents, as well as by $1.0 million in revenue recognized in the thirdsecond quarter of fiscal 2019 associated with a license extension.

Research, development2021, compared to $6.7 million in the prior-year quarter, and otherroyalties revenue decreased $0.5 million for the third quarter of fiscal 2020 and decreased $0.8declined 1.5% to $15.4 million for the first ninesix months of fiscal 20202021, compared to $15.6 million in the same prior-year period. Royalties revenue benefited from broad-based, year-over-year growth, most notably from our Serene coating customers. For the first six months of fiscal 2021, the year-over-year impact of the expiration our fourth-generation hydrophilic coatings was approximately $1.0 million, largely in the first quarter. With respect to the impacts of COVID-19, in the second quarter of fiscal 2021, we experienced the lowest degree of impact to royalties revenue since the onset of the pandemic.

Medical Device product sales of $5.4 million for the second quarter of fiscal 2021 were essentially flat compared to the same prior-year period. For the first six months of fiscal 2021, Medical Device product sales declined 4.8% to $10.0 million, compared to the same prior-year period. For both the second quarter and first six months of fiscal 2021, product sales benefited from recently commercialized medical device products, compared to the prior year, periods. These decreasesand conversely, were dueunfavorably impacted by softness in legacy balloon catheter sales volume. Products sales of chemical reagents in the second quarter of fiscal 2021 were consistent with the prior year. For the first six months of fiscal 2021, product sales were unfavorably impacted by lower demand for chemical reagents early in the fiscal period as our customers managed inventory levels that had previously been increased in response to the timing of new product development projects with several of our contract R&D customers, as well as by a decline in coating services order volume as a result of COVID-19.

In Vitro Diagnostics. In Vitro Diagnostics revenue increased 18.0%, or $1.08.7% to a record $7.1 million for the thirdsecond quarter of fiscal 20202021 and increased 14.9%, or $2.312.4% to $13.2 million for the first ninesix months of fiscal 2020, as2021, compared withto the same prior yearrespective prior-year periods. ForRevenue growth in both the third quarter of fiscal 2020, the increase in revenuethree- and six-month periods was driven by continuedbroad-based demand for our microarray DNA slideslide/surface products and development projects, as well as by growth offor our protein stabilizerstabilization and BioFXTMcolorimetric substrate reagent products. For the first nine monthssecond quarter of fiscal 2020, revenue2021, this growth was drivenpartly offset by increases inunfavorable order timing for our microarray DNA slide products, distributed antigen products.BioFX slide products and antigens.

Operating costs and expenses. Major costs and expenses as a percentage of total revenue were as follows:

 

 

Three Months Ended June 30,

 

 

Nine Months Ended June 30,

 

 

Three Months Ended March 31,

 

 

Six Months Ended March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

(Dollars in thousands)

 

Amount

 

 

% Total

Revenue

 

 

Amount

 

 

% Total

Revenue

 

 

Amount

 

 

% Total

Revenue

 

 

Amount

 

 

% Total

Revenue

 

(In thousands)

 

Amount

 

 

% Total

Revenue

 

 

Amount

 

 

% Total

Revenue

 

 

Amount

 

 

% Total

Revenue

 

 

Amount

 

 

% Total

Revenue

 

Product costs

 

$

4,443

 

 

 

17

%

 

$

3,364

 

 

 

14

%

 

$

11,415

 

 

 

16

%

 

$

9,980

 

 

 

14

%

 

$

4,170

 

 

 

12

%

 

$

3,769

 

 

 

17

%

 

$

7,913

 

 

 

14

%

 

$

6,972

 

 

 

15

%

Research and development

 

 

13,324

 

 

 

50

%

 

 

13,321

 

 

 

55

%

 

 

37,401

 

 

 

52

%

 

 

38,362

 

 

 

55

%

 

 

12,875

 

 

 

37

%

 

 

11,935

 

 

 

52

%

 

 

23,757

 

 

 

42

%

 

 

24,077

 

 

 

53

%

Selling, general and administrative

 

 

7,416

 

 

 

28

%

 

 

5,939

 

 

 

24

%

 

 

21,092

 

 

 

29

%

 

 

16,764

 

 

 

24

%

 

 

7,907

 

 

 

23

%

 

 

6,733

 

 

 

30

%

 

 

14,930

 

 

 

26

%

 

 

13,676

 

 

 

30

%

Acquired intangible asset amortization

 

 

536

 

 

 

2

%

 

 

599

 

 

 

2

%

 

 

1,671

 

 

 

2

%

 

 

1,809

 

 

 

3

%

 

 

560

 

 

 

2

%

 

 

541

 

 

 

2

%

 

 

1,116

 

 

 

2

%

 

 

1,135

 

 

 

3

%

Product costs. Product gross marginmargins (defined as product revenuesales less related product costs) was 62.9% and 65.9%costs, as a percentage of product revenuesales) were 65% and 68% for the thirdsecond quarter of fiscal 20202021 and 2019,2020, respectively, and 66.2% of product revenue64% and 68% for both the first ninesix months of fiscal 2021 and 2020, and 2019.respectively. For the thirdsecond quarter of fiscal 2020,2021, product gross margins were impacted unfavorably by product mix with a shift to lower margin product lines. For the first six months of fiscal 2021, product gross margin was unfavorably impacted by the shift inlower Medical Device business product mix as growth in revenue volume from newly commercialized medical device products more than offset reductionsa Covid-related decline in order volume as a resultsales of COVID-19 procedure reductions. Incoating reagents early in the third quarter of fiscal 2020, this decreaseperiod. This was offset, in part, by the favorable impact of In Vitro Diagnostics from both product mix and leverage on higher revenue volume. Gross margin forvolume and product mix in the first ninesix months of fiscal 2020 was impacted by the same factors, however to a lesser degree by the unfavorable impact from Medical Device business product mix.2021.

Research and development (R&D) expenses.(“R&D”) expense. R&D expenses forFor the thirdsecond quarter of fiscal 2021, R&D expense increased 7.9%, or $0.9 million, compared the same prior-year quarter. For the first six months of fiscal 2021, R&D expense declined 1.3%, or $(0.3) million, compared the same prior-year period. R&D expense as a percentage of revenue was 37% and 52% for the second quarter of fiscal 2021 and 2020, were essentially flatrespectively, and 42% and 53% for the first six months of fiscal 2021 and 2020, respectively. The decline in R&D expense as a percentage of revenue reflects the impact of higher revenue in the second quarter and first six months of fiscal 2021, principally from the $10.8 million in license fee revenue recognized in the period upon receipt of the $15 million clinical report

21


Table of Contents

milestone payment under the Abbott Agreement. Clinical trial spending and other costs related to our SurVeil DCB declined for both the second quarter and first six months of fiscal 2021, compared to the same respective prior-year quarter and were 50%periods, with the progression of revenue, as compared with 55% of revenue for the same prior-year period. For the first nine months of fiscal 2020, R&D expenses decreased $1.0 million to 52% of revenue, as compared to 55% of revenue for the same prior-year period. Clinical trial spending decreased in the third quarter and first nine months of fiscal 2020, principally for the TRANSCEND clinical trial for our SurVeil DCB with the progression from active enrollment in fiscal 2019 to patient follow up in fiscal 2020. This decrease was partly offset by increased R&D expenses for personnel investments2020 to preparation of the clinical report and PMA submission in quality, technical, regulatory,fiscal 2021. For both the second quarter and

25


proprietary product development, as well as current-year clinical trial expenses for first six months of fiscal 2021, thefirst-in-human clinical study for our Sundance DCB. prior-year fiscal 2020 period is an unfavorable comparison with respect to incentive compensation resulting from the uncertainty in the prior year at the onset of the Covid pandemic.

Selling, general and administrative (SG&A) expenses.(“SG&A”) expense. SG&A expenses increased $1.5 million to 28% of revenue for the third quarter of fiscal 2020, as compared with 24% of revenue for the same prior-year period. For the first nine months of fiscal 2020, SG&A expenses increased $4.3 million to 29% of revenue, as compared with 24% of revenue for the same prior-year period. The increase in SG&A expenses for the third quarter and first nine months of fiscal 2020 was primarily driven by personnel and other investments to support product development and strategic initiatives. Also contributing to the increase in SG&A expense or the year-to-date period was a $0.6 million reduction to expense in the second quarter of fiscal 20192021, SG&A expense increased 17%, or $1.2 million, compared the same prior year quarter. For the first six months of fiscal 2021, SG&A expense increased 9%, or $1.3 million, compared the same prior-year period. SG&A expense as a percentage of revenue was 23% and 30% for the second quarter of fiscal 2021 and 2020, respectively, and 26% and 30% for the first six months of fiscal 2021 and 2020, respectively. The decline in SG&A expense as a percentage of revenue reflects the impact of higher revenue in the second quarter and first six months of fiscal 2021, principally from the $10.8 million in license fee revenue recognized in the period upon receipt of the $15 million clinical report milestone payment under the Abbott Agreement. For both the second quarter and first six months of fiscal 2021, the prior-year fiscal 2020 period is an unfavorable comparison with respect to incentive compensation resulting from a claim that was settled for less than the amount we had reserved.uncertainty in the prior year at the onset of the Covid pandemic.

Acquired intangible asset amortization. As part of our fiscal 2016 acquisitions in our Medical Device business, weWe have previously acquired certain intangible assets which are being amortized over periods ranging from 4 to 14 years. In addition, we own certainthrough business combinations. Amortization expense on acquired intangible assets related to the fiscal 2007 BioFx acquisition. Amortization expense was consistent with the prior-year period for both the thirdsecond quarter and first ninesix months of fiscal 2020.2021, compared the same respective prior-year periods.

Contingent consideration expense (gain)Other income (expense). We recorded net expense ofOther income was less than $0.1 million and net gain of $(0.2) million in the three and nine months ended June 30, 2019, respectively, related to contingent consideration liabilities from prior-year acquisitions. Fiscal 2019 gains related to changes in estimated probabilities of achievement of certain revenue and strategic milestones, partly offset by accretion expense. In the first quarter of fiscal 2020, we completed the final contingent consideration payment of $3.2 million to the sellers of NorMedix, Inc. (“NorMedix”).

Other (expense) income. Other (expense) income totaled less than $(0.1) million and $(0.2) million for the third quarter of fiscal 2020 and 2019, respectively, and $(0.1) million and $0.8 million for the first nine months of fiscal 2020 and 2019, respectively. In the second quarter of fiscal 2021, compared to other expense of $(0.3) million for the second quarter of fiscal 2020.Other expense was $(0.2) million for both the first six months of fiscal 2021 and 2020. The second quarter and first six months of fiscal 2020 we recognizedincludes a $0.5 million impairment loss on oura strategic investment in ViaCyte, Inc. to reduce the carrying value to zero. InInvestment income declined in the thirdsecond quarter and first ninesix months of fiscal 2020, investment income declined2021 relative to the prior year commensurate with lower current-yeara decline in interest rates. Additionally, forForeign currency gains (losses) were $0.1 million in gains in the second quarter of fiscal 2021, compared to less than $(0.1) million in losses in the same prior year quarter. For both the first ninesix months of fiscal 2021 and 2020, foreign currency losses were approximately $(0.1) million. Foreign currency gains (losses) result primarily from the impact of U.S. dollar to Euro foreignexchange rate fluctuations on certain intercompany obligations. Foreign currency fluctuations resultedgains (losses) reflect weakening (strengthening) of the Euro relative to the U.S. dollar in losses ineach respective period.

Income tax (provision) benefit. For the currentsecond quarter of fiscal year and gains2021, income tax expense was $(1.4) million, compared to income tax benefit of $1.9 million in the same prior-year period.

Income tax benefit.quarter. For the third quarterfirst six months of fiscal 2020 and 2019, we recorded an2021, income tax expense was $(1.6) million, compared to income tax benefit of $1.2$2.2 million and $0.3 million, respectively. Forin the first nine monthssame prior-year period. The fiscal 2021 tax expense aligns with the year-over-year increase in pretax income, primarily driven by the receipt of fiscal 2020 and 2019, we recorded an income tax benefit of $3.4 million and $0.6 million, respectively. The Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was enacted on March 27, 2020 and includes significant business tax provisions. In particular, the CARES Act modified the rules associated with net operating losses (“NOLs”).Abbott milestone payment. In the second quarter of fiscal 2020, we recorded a discrete tax benefit of $1.8 million as result of our ability under the CARESCoronavirus Aid, Relief and Economic Security Act (the “CARES Act”), enacted in March 2020, to carry back NOLsnet operating losses incurred to periods when the statutory tax rate was 35% versus our current tax rate of 21%.

The Company’s effective tax rate reflects the impact of state income taxes, permanent tax items and discrete tax benefits, as well as operating results in Ireland, where tax expense or benefit is offset by a valuation allowance. The tax benefits(expense) benefit recognized in the threesecond quarter and ninefirst six months ended June 30,of fiscal 2021 and 2020 and 2019 reflect expected full-year pre-tax operating results, impacted by our estimated U.S. federal R&D tax credit and by excess tax benefits related to stock-based compensation due to equity award exercise activity.

Segment Operating Results

Operating results for each of our reportable segments were as follows:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

Six Months Ended

 

 

June 30,

 

 

June 30,

 

 

March 31,

March 31,

 

(Dollars in thousands)

 

2020

 

 

2019

 

 

% Change

 

 

2020

 

 

2019

 

 

% Change

 

Operating income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In thousands)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Medical Device

 

$

532

 

 

$

753

 

 

 

(29

)%

 

$

(1,344

)

 

$

1,087

 

 

 

(224

)%

 

$

8,564

 

 

$

(1,453

)

 

$

7,971

 

 

$

(1,876

)

In Vitro Diagnostics

 

 

3,254

 

 

 

2,475

 

 

 

32

%

 

 

9,315

 

 

 

7,845

 

 

 

19

%

 

 

3,809

 

 

 

3,462

 

 

 

7,029

 

 

 

6,061

 

Total segment operating income

 

 

3,786

 

 

 

3,228

 

 

 

 

 

 

 

7,971

 

 

 

8,932

 

 

 

 

 

 

 

12,373

 

 

 

2,009

 

 

 

15,000

 

 

 

4,185

 

Corporate

 

 

(2,622

)

 

 

(2,211

)

 

 

19

%

 

 

(7,229

)

 

 

(6,338

)

 

 

14

%

 

 

(2,890

)

 

 

(2,165

)

 

 

(5,424

)

 

 

(4,607

)

Total operating income

 

$

1,164

 

 

$

1,017

 

 

 

15

%

 

$

742

 

 

$

2,594

 

 

 

(71

)%

Total operating income (loss)

 

$

9,483

 

 

$

(156

)

 

$

9,576

 

 

$

(422

)

22


Table of Contents

 

26


Medical Device. Our Medical Device business reported operating income of $0.5$8.6 million and $0.8an operating loss of $(1.5) million for the thirdsecond quarter of fiscal 20202021 and 2019,2020, respectively, representing 2.6%30.7% and 4.0%(8.9)% of revenue, respectively. For the first ninesix months of fiscal 2021 and 2020, theour Medical Device business reported operating lossesincome of $(1.3)$8.0 million or (2.5)and an operating loss of $(1.9) million, respectively, representing 18.1% and (5.6)% of revenue, as compared withrespectively. The year-over-year increase in royalties and license fees contributed $11.8 million and $11.0 million to operating income of $1.1 million, or 2.0% of revenue, in the same prior-year period.

Product gross margins declined to 54.2% and 62.1% for the thirdsecond quarter and first ninesix months of fiscal 2020,2021, respectively, primarily as compared with 66.7%result of the Abbott milestone payment as previously discussed.

Medical Device product gross margins were 58.8% and 62.6% in66.9% for the same prior-year respective periods, due primarily to the unfavorable impact of fiscal 2020 product mix. In the thirdsecond quarter of fiscal 2021 and 2020, certain legacy medical device customers reduced order volume as a resultrespectively, and 56.5% and 66.5% for the first six months of COVID-19,fiscal 2021 and 2020, respectively. For the second quarter of fiscal 2021, product gross margins were unfavorably impacted by product mix. For the first six months of fiscal 2021, product gross margins were unfavorably impacted by leverage on lower revenue volume increased from initial orders of newly developed specialty catheter products.Operatingand by product mix. Medical Device operating expenses, excluding product costs, increased $0.7$1.2 million and $2.2decreased $(0.3) million for the thirdsecond quarter and first ninesix months of fiscal 2021 and 2020, respectively. Forrespectively, compared to the third quarter and first nine months of fiscal 2020, increases in SG&A to support our whole product solutions strategy wereprior year, primarily driven by increased incentive compensation expense, partly offset by a decline in SurVeil-related R&D from higher clinical study costs in fiscal 2019. SG&A increased in fiscal 2020 as we continue to invest in commercial infrastructure to support upstream marketing and clinical evaluation activities associated with our cleared products, including additional headcount, to support our whole-product solutions strategy. For the first nine-months of fiscal 2020, the increase in SG&A expenses also reflects the impacts of the prior-year $0.6 million expense reduction from a claim settlement and the prior-year $0.3 contingent consideration gain.expense.

In Vitro Diagnostics. Our In Vitro Diagnostics business reported operating income of $3.3$3.8 million and $2.5$3.5 million for the thirdsecond quarter of fiscal 20202021 and 2019,2020, respectively, representing 51.1%53.7% and 45.8%53.1% of revenue, respectively. For the first ninesix months of fiscal 2021 and 2020, and 2019,our In Vitro Diagnostics business reported operating income totaled $9.3of $7.0 million and $7.8$6.1 million, respectively, representing 51.5%53.3% and 49.8%51.7% of revenue, respectively. Product gross margins were 71.0%69.5% and 69.9%68.9% in the thirdsecond quarter fiscal 2021 and 2020, respectively, and 70.0% and 69.3% for the first ninesix months of fiscal 2021 and 2020, respectively, compared to 65.3% and 69.3% inrespectively. For the same prior-year respective periods. Productsecond quarter of fiscal 2021, product margins benefited from the favorable impact of product mix. For the first six months of fiscal 2021, product gross margins were favorably impacted by a shift in revenue mix towards products with relatively higher gross margins, as well as bybenefited from leverage on higher revenue growth.volume and the favorable impact of product mix.

Corporate. The Corporate category includes expenses for administrative corporate functions, such as executive, corporate accounting, legal, human resources and Board of Directors related fees and expenses, which have not been fully allocated to the Medical Device and In Vitro DiagnosticsIVD segments. Corporate also includesoperating expenses such as litigation, which are not specificincreased by $0.7 million and $0.8 million in the second quarter and first six months of fiscal 2021, respectively, compared to a segment and thus not allocatedthe same prior-year periods, related primarily to our operating segments.incentive compensation.

Liquidity and Capital Resources

As of June 30, 2020,March 31, 2021, working capital totaled $72.2$77.3 million, an increase of $11.0$9.6 million from September 30, 2019.2020. Working capital is defined by us as current assets minus current liabilities. Cash and cash equivalents and available-for-sale investments totaled $60.6$70.0 million as of June 30, 2020,March 31, 2021, an increase of $5.3$8.9 million from $55.3$61.1 million as of September 30, 2019.2020. This change was primarily driven by the $10.8$15 million SurVeil DCBclinical report milestone payment received fromunder the Abbott less the $3.2Agreement, partly offset by $2.7 million contingent consideration payment related to the NorMedix acquisition, $2.6payments of accrued liabilities, $2.0 million in capital expenditures, $2.4million cash payments for taxes related to net share settlement of equity awards, and the $1.0 million payment to Embolitech, LLC as a result of the achievement of a contingent milestone in fiscal 2020.

Surmodics maintains access to capital to support liquidity and continued growth. In fiscal 2020, the Company entered into a secured revolving credit facility pursuant to a Loan and Security Agreement (the ‘‘Loan Agreement’’). The Loan Agreement provides for acquisitionavailability of in process R&D.

Inup to $25 million under a secured revolving line of credit. The outstanding balance on the third quarterrevolving credit facility was zero as of March 31, 2021. In fiscal 2020, the Company filed a universal shelf registration statement with the SEC as a matter of standard corporate governance to provide the flexibility to access public capital markets in order to respond to future business needs and opportunities. The shelf registration statement became effective on May 29, 2020 and allows the Company to offer potentially offer up to $200 million in debt securities, common stock, preferred stock, warrants, and other securities or any such combination of such securities in amounts, at prices, and on terms announced if and when the securities are ever offered.

The Company’s investment policy excludes ownership of collateralized mortgage obligations, mortgage-backed derivatives and other derivative securities without prior written approval of the Board of Directors. Our investments primarily consist of money market, corporate bond and commercial paper securities and are reported at fair value as available-for-sale investments totaling $53.9$21.9 million as of June 30, 2020.March 31, 2021. Our investment policy requires that no more than 5% of investments be held in any one credit or issue, excluding U.S. government and government agency obligations. The primary investment objective of the portfolio is to provide for the safety of principal and appropriate liquidity, while generating an above-benchmark (Barclays Short Treasury 1-3 Month Index) total rate of return on a pre-tax basis. Management plans to continue to direct its investment advisors to manage the Company’s securities investments primarily for the safety

23


Table of principal and the enhancement of liquidity for the time being as it continues to assess the impact of the COVID-19 pandemic on the Company, its business and its cash flows.Contents

We believe that our existing cash and cash equivalents and available-for-sale investments, which totaled $60.6$70.0 million as of June 30, 2020,March 31, 2021, together with cash flow from operations, will provide liquidity sufficient to meet our cash needs and fund our operations and planned capital expenditures for the next twelve months. There can be no assurance, however, that our business will continue to generate cash flows at historic levels. Uncertainty related to the COVID-19 pandemic may cause us to seek additional funding to meet our operating needs. We cannot be certain that additional funding will be available on acceptable terms, if at all. If we do not have, or

27


are not able to obtain, sufficient funds, we may have to delay development or commercialization of our products or otherwise curtail our operations.

Cash Flow Operating Results.ResultsThe following table is a summary of cash provided by (used in) operating, investing, and financing activities, the effect of exchange rate changes on cash and cash equivalents, and the net change in cash and cash equivalents:. Cash flow results were are as follows:

 

 

Nine Months Ended

 

 

Six Months Ended

 

 

June 30,

 

 

March 31,

 

(Dollars in thousands)

 

2020

 

 

2019

 

(In thousands)

 

2021

 

 

2020

 

Cash provided by (used in):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating activities

 

 

12,696

 

 

 

(4,482

)

 

$

11,745

 

 

$

1,257

 

Investing activities

 

 

(1,871

)

 

 

21,223

 

 

 

5,470

 

 

 

(10,749

)

Financing activities

 

 

(4,808

)

 

 

(11,475

)

 

 

143

 

 

 

(5,647

)

Effect of exchange rates on changes in cash and cash equivalents

 

 

8

 

 

 

(18

)

 

 

16

 

 

 

(14

)

Net change in cash and cash equivalents

 

$

6,025

 

 

$

5,248

 

 

$

17,374

 

 

$

(15,153

)

Operating Activities. Cash provided by operating activities totaled $12.7$11.7 million for the first nine monthshalf of fiscal 2020,2021, compared to cash usedprovided of $4.5$1.3 million in the same prior-year period. Net income was $4.1$7.8 million and $4.0$1.6 million duringfor the first ninesix months of fiscal 20202021 and 2019,2020, respectively. Net changes in operating assets and liabilities reduced cash flows from operating activities by $1.5$3.7 million and $14.3$8.2 million during the first ninesix months of fiscal 20202021 and 2019,2020, respectively. Significant changes in operating assets and liabilities affecting cash flows during these periods included:

Cash provided by deferred revenue was $0.5$1.3 million for the ninefirst six months of fiscal 2020, as2021, compared withto cash used of $5.8$(2.6) million in the same prior-year period, due to the $10.8$15 million milestone payment received from Abbott in the second quarter of fiscal 2020.2021.

Cash (used in) provided by accounts receivable and contract asset totaled $4.3$(1.9) million cash used in the first ninesix months of fiscal 2020, as2021, compared withto cash usedprovided of $1.0 million in the same prior-year period, due to the current-year reduction in contract asset related to reduced royalty payments receivable from customers.

Cash provided by accrued liabilities totaled $0.1 million in the first nine months of fiscal 2020, as compared with cash used of $5.1$1.9 million in the same prior-year period. The decrease in cash used isThis was primarily due to accrued clinical trial expensestiming fluctuations in accounts receivable balances and other accrued expenses, including accruals atin contract asset balances, which were unfavorable to cash flow in the inception ofcurrent-year quarter and favorable to cash flow in the prior fiscal year that were paid or settled during the prior year for both construction in progress and a $1.0 claim settlement.prior-year quarter.

IncomeIn the prior-year period, income taxes also impacted cash provided by operating activities. Primarily asAs a result of the NOL carryback provisions of the CARES Act, enacted in March 2020, income tax receivable increased to $4.9$4.3 million as of June 30,March 31, 2020, as compared withto $0.6 million as of September 30, 2019, and deferred income taxes decreased to $5.6$4.8 million as of March 31, 2020, compared withto $6.2 million as of September 30, 2019. In the current-year fiscal 2021 period, income tax receivable decreased to $1.7 million as of March 31, 2021, compared to $2.4 million as of September 30, 2020, and deferred income taxes decreased to $6.5 million as of March 31, 2021, compared to $7.3 million as of September 30, 2020.

Additionally, the portion of acquisition-related contingent consideration and other payments classified as reduction of cash flows from operations was $0.6 million and $2.0 million in the first ninesix months of fiscal 2020, and 2019, respectively, as it related to accretion expense, which increased these obligations from the acquisition date through settlement.

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Investing Activities. Cash used in investing activities totaled $1.9 million in the first nine months of fiscal 2020, as compared with cash provided by investing activities totaled $5.5 million for the first six months of $21.2fiscal 2021, compared to cash used of $(10.7) million in the same prior-year period. In the first nine months of fiscal 2020 and 2019, netNet purchases and maturities of available-for-sale investments were a source of cash of $0.8$8.4 million in the first six months of fiscal 2021 and $25.3a use of cash of $(8.4) million respectively.in the first six months of fiscal 2020. In the first quarter of fiscal 2021, the Company paid $1.0 million for acquisition of intangible assets (patents) to the sellers of Embolitech, LLC as a result of the achievement of a contingent milestone in fiscal 2020. Capital expenditures for property, plant and equipment totaled $2.6$2.0 million and $4.1$2.3 million infor the first ninesix months of fiscal 20202021 and 2019,2020, respectively.

Financing Activities. Cash used inprovided by financing activities totaled $4.8$0.1 million and $11.5for the first six months of fiscal 2021, compared to cash used of $(5.6) million in the same prior-year period. Issuance of common stock upon the exercise of stock options and vesting of other stock awards was a source of cash of $2.5 million and $0.3 million for the first ninesix months of fiscal 20202021 and 2019,2020, respectively. Contingent consideration payments of $3.2 million inIn the first ninesix months of fiscal 2021 and 2020, related to the NorMedix acquisition, with $0.6we paid $2.2 million and $2.6 million classified as cash used by operating and financing activities, respectively. In the first nine months of fiscal 2019, we paid contingent consideration of $11.0 million related to the Creagh Medical acquisition, with $2.0 million and $9.1 million classified as cash used by operating and financing activities, respectively. In the first nine months of fiscal 2020 and 2019, we paid $2.4 million and $2.7 million, respectively, to purchase common stock to pay employee taxes resulting from the exercise of stock options and vesting of other stock awards.In the first ninesix months of fiscal 2020, we paid $1.0contingent consideration payments totaled $3.2 million to Embolitech, LLC related to our fiscal 2018the acquisition of NorMedix, Inc., with $0.6 million and $2.6 million classified as cash used in process R&D.operating and financing activities, respectively.

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Table of Contents

Customer Concentrations

We have agreements with a diverse base of customers and certain customers have multiple products using our technology. Abbott and Medtronic are our largest customers, comprising 19% and 14%, respectively, of our consolidated revenue for fiscal 2019.2020. These same customers each comprised 20%30% and 13%11%, respectively, of our consolidated revenue for the ninesix months ended June 30, 2020, respectively.March 31, 2021. Revenue generated under our SurVeil DCB license agreement with Abbott represented 24% of total revenue for the six months ended March 31, 2021. Apart from the SurVeil DCB license, Abbott has several separately licensed products including the SurVeil DCB license, which generate royalties revenue for Surmodics, none of which represented more than 15%3% of total revenue for the ninesix months ended June 30, 2020.March 31, 2021. Medtronic has several separately licensed products that generate royalties revenue for Surmodics, none of which represented more than 4%of our total revenue for the ninesix months ended June 30, 2020.March 31, 2021. No other individual customer constitutes more than 10% of Surmodics’ total fiscal 20202021 to date or fiscal 20192020 revenue.

Share Purchase Activity

Our Board of Directors has authorized the repurchase of up to an additional $25.3 million of the Company’s outstanding common stock in open-market purchases, privately negotiated transactions, block trades, accelerated share repurchase transactions, tender offers or by any combination of such methods. The authorization has no fixed expiration date.date. No shares were repurchased in the six months ended March 31, 2021.

Off-Balance Sheet Arrangements

As of June 30, 2020March 31, 2021 and September 30, 2019,2020, we did not have any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

29Critical Accounting Policies and Significant Estimates

Critical accounting policies are those policies that require the application of management’s most challenging, subjective or complex judgment, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods. Critical accounting policies involve judgments and uncertainties that are sufficiently likely to result in materially different results under different assumptions and conditions. For the six months ended March 31, 2021, there were no significant changes in our critical accounting policies. For a detailed description of our other critical accounting policies and significant estimates, see Management’s Discussion and Analysis of Financial Condition and Results of Operations under Item 7 in our Annual Report on Form 10-K for the fiscal year ended September 30, 2020.

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Forward-LookingTable of Contents

Forward-looking Statements

This Quarterly Report on Form 10-Q, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 2, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, expectations concerning: the impacts, duration and severity of the global COVID-19 pandemicpandemic; clinical studies, the expected timing of their results, and the effectspotential timing of responses to it on healthcare systems, the general economy,future clinical studies; our business partners, and our operations; clinical studies; our growth strategy, including our ability to sign new license agreements, conduct market evaluations, and bring new products to market; investments to obtain clinical data, reduce the time from product development to commercialization, and drive clinician engagement with our products after approval to optimize adoption; the development of future products and receipttheir anticipated attributes; anticipated regulatory submissions and approvals, including the expected timing thereof; the initiation or pursuitcontinuation of product evaluation activities; revenue potential related to the potential commercial launch of the SurVeil™ drug-coated balloon (“DCB”) following its regulatory clearance forapproval; estimated revenue expected to be recognized in future products; estimatedperiods; future revenue recognition;growth and our future success; future gross margins and operating expenses; estimated future amortization expense; future operating lease maturities; recognition of unrecognized compensation costs; the impact ofanticipated patent expirations and their potential impacts on our hydrophilic coatings royalties revenue; expectation regarding specific product development programs; variousroyalties portfolios; potential future customer actions; the potential for a future milestone achievements;payment under our agreement with Abbott; research and development plans and expenses, including the estimated cost associated with the TRANSCEND clinical trial; future cash flow and sources of funding, and their ability together with existing cash, cash equivalents, and investments to provide liquidity sufficient to meet our cash needs and fund our operations and planned capital expenditures for the next twelve months; extension of our revolving credit facility; future property and equipment investment levels; plans regarding our securities investments; the impact of potential lawsuits or claims; the impact of potential change in raw material prices; the impact of Abbott, Medtronic, as well as other significant customers; our ability to recognize the expected benefits of our acquisitionsacquisitions; our estimated tax rate for fiscal 2021; the future impact of off-balance sheet arrangements and the Company’s strategycontractual obligations, including future payments to transformclinical research organizations; estimated revenue expected to a provider of whole-product solutions; the timing, impact, and success of the clinical evaluation of the SurVeil DCB; fiscal 2020 income tax (benefit) expense;be recognized in future periods related to performance obligations that are unsatisfied for executed contracts; and the impact of the adoption of new accounting pronouncements. Without limiting the foregoing, words or phrases such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “project,” “will” and similar terminology, generally identify forward-looking statements. Forward-looking statements may also represent challenging goals for us. These statements, which represent the Company’sour expectations or beliefs concerning various future events, are based on current expectations that involve a number of risks and uncertainties that could cause actual results to differ materially from those of such forward-looking statements. We caution that undue reliance should not be placed on such forward-looking statements, which speak only as of the date made. Some of the factors which could cause results to differ from those expressed in any forward-looking statement are set forth under “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q and under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2019.2020. We disclaim any intent or obligation to update publicly these forward-looking statements, whether because of new information, future events or otherwise.

Although it is not possible to create a comprehensive list of all factors that may cause actual results to differ from our forward-looking statements, such factors include, among others:

the impacts, duration and severity of the global COVID-19 pandemic, which has impacted, and may continue to impact, our revenue, operations, the conduct of clinical studies, and our ability to access healthcare professionals and facilities;

our reliance on a small number of significant customers, including our largest customers, Abbott and Medtronic, which causes our financial results and stock price to be subject to factors affecting those significant customers and their products, the timing of market introduction of their or competing products, product safety or efficacy concerns and intellectual property litigation impacting such customers, which could adversely affect our growth strategy and the royalties revenue we derive;

clinical and regulatory developments relating to the evaluation of risks associated with paclitaxel-coated products, which developments may adversely impact our ability to complete our TRANSCEND clinical trial on any particular time frame, obtain marketing approval (or the timing of any such approval) for our SurVeilDCB and other paclitaxel-coated products, to treat PADperipheral artery disease in the femoral and/or popliteal arteries;

our ability to successfully develop, obtain regulatory approval for, and commercialize our SurVeilDCB product, including our reliance on clinical research organizations to manage the TRANSCEND clinical trial and uncertainty related to the impacts of any clinical research relative to drug-coated balloons, including our Avess™ DCB, other DCB products and other catheter and balloon-based products, which will impact our ability to receive additional milestone payments under our agreement with Abbott;

general economic conditions whichthat are beyond our control, such as the impact of recession, customer mergers and acquisitions, business investment, changes in consumer confidence, and medical epidemics or pandemics such as the COVID-19 pandemic, which has negatively impacted, and will likely continue to negatively impact, our business and results from operations (as further described under “Part II, Item 1A. Risk Factors” of this Quarterly Report on Form 10-Q);operations;

a decrease in our available cash or failure to generate cash flows from operations, which could impact short-term liquidity requirements and expected capital and other expenditures;

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Table of Contents

our ability to comply with the covenants in our credit facility;

the difficulties and uncertainties associated with the lengthy and costly new product development and foreign and domestic regulatory approval processes, such as delays, difficulties or failures in achieving acceptable clinical results or obtaining foreign

30


or FDAUnited Stated (“U.S.”) Food and Drug Administration (“FDA”) marketing clearances or approvals, which may result in lost market opportunities, failure to bring new products to market or postpone or preclude product commercialization by licensees or ourselves;

whether operating expenses that we incur related to the development and commercialization of new technologies and products or technologies by competitors, technological obsolescence and other changes in competitive factors;are effective;

our ability to perform successfully with respect to certainperform product development activities, the related R&D expense impact and governmental and regulatory compliance activities, which we have not previously undertaken in any significant manner;

our ability to successfully convert our customers from the fourth generation of our PhotoLinkTM hydrophilic technology protected by a family of patents which expired in the first quarter of fiscal 2020 (in the U.S.) to one of our advanced generation technologies or extend the royalty-bearing term of the customer license agreements, and to offset any decline in revenue from customers that we are unable to convert;

our ability to identify and execute new acquisition opportunities as well asand successfully managing the process of integrating acquired businesses poses numerous risks including anassociated with acquisitions, which include the potential inability to integrate acquired operations, personnel, technology, information systems, and internal control systems and products; a lack of understanding of tax, legal and cultural differences;differences for non-U.S. acquisitions; diversion of management’s attention; difficulties and uncertainties in transitioning the customers or other business relationships from the acquired entity to us; the loss of key employees of acquired companies; and potential impacts on cash flows; and

other factors described under “Risk Factors” in Part II,I, Item 1A of this Quarterly Report on Form 10-Q and in “Risk Factors” and other sections of our Annual Report on Form 10-K, for the fiscal year ended September 30, 2019, which you are encouraged to read carefully.

Many of these factors are outside theour control and knowledge of us and could result in increased volatility in period-to-period results. Investors are advised not to place undue reliance upon our forward-looking statements and to consult any further disclosures by us on this subject in our filings with the SEC.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our investment policy requires investments with high credit quality issuers and limits the amount of credit exposure to any one issuer. Our investments consist principally of interest-bearing corporate debt securities with varying maturity dates, which are less than one year. Because of the credit criteria of our investment policies, the primary market risk associated with these investments is interest rate risk. We do not use derivative financial instruments to manage interest rate risk or to speculate on future changes in interest rates. As of June 30, 2020,March 31, 2021, we held $24.2$21.9 million in available-for-sale debt securities, all withof which $17.8 million had maturity dates of less than one year, thereforeyear. Therefore, interest rate fluctuations would have an insignificant impact on our results of operations or cash flows. Our policy also allows the Company to hold a substantial portion of funds in cash and cash equivalents, which are defined as financial instruments with original maturities of three months or less and may include money market instruments, certificates of deposit, repurchase agreements corporate bonds and commercial paper instruments.

Management believes that a reasonable change in raw material prices would not have a material impact on future earnings or cash flows because the Company’s inventory exposure is not material.

We are exposed to increasing Euro currency risk with respect to our manufacturing operations in Ireland. In a period where the U.S. dollar is strengthening or weakening as compared withrelative to the Euro, our revenue and expenses denominated in Euro currency are translated into U.S. dollars at a lower or higher value, respectively, than they would be in an otherwise constant currency exchange rate environment. All sales transactions are denominated in U.S. dollars or Euros. We generate royalties revenue from the sale of customer products in foreign jurisdictions. Royalties generated in foreign jurisdictions by customers are converted and paid in U.S. dollars per contractual terms. Substantially all of our purchasing transactions are denominated in U.S. Dollars or Euros. To date, we have not entered into any foreign currency forward exchange contracts or other derivative financial instruments to hedge the effects of adverse fluctuations in foreign currency exchange.exchange rates.

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Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

The Company maintains disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The Company’s management, under the supervision and with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, referred to collectively herein as the Certifying Officers, carried out an evaluation of the effectiveness of the design and operation of the Company’s disclosure controls and procedures as of June 30, 2020.March 31, 2021. Based on that evaluation, the Company’s Certifying Officers concluded that, as of the end of the period covered by this report, the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) were effective to ensure that information required to be disclosed by the Company in reports that it files under the Exchange Act is recorded, processed, summarized and reported within the time period specified in the Securities and Exchange Commission rules and forms, and to ensure that information required to be disclosed by the Company in the reports the Company files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its Certifying Officers, as appropriate, to allow timely decisions regarding required disclosures.

Changes in Internal Controls over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) during the three months ended June 30, 2020March 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II — OTHER INFORMATION

From time to time, the Company has been involved in various legal actions involving its operations, products and technologies, including intellectual property and employment disputes.

Item 1A. Risk Factors

The risks described below and those identified inIn our Annual Report on Form 10-K for the fiscal year ended September 30, 2019,2020, filed with the SEC on December 3, 2019,2, 2020, we identify under “PartPart 1, Item 1A. Risk1A, “Risk Factors” important factors which could affect our financial performance and could cause our actual results for future periods to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statements made in this Quarterly Report on Form 10-Q.

The COVID-19 pandemic has had an adverse effect on our business and results of operations and is expected to continue toThere have further adverse effects, which could bebeen no material on our business, results of operations, financial condition, liquidity, and capital investments.

On March 11, 2020, the World Health Organization declared the COVID-19 outbreak a global pandemic. The COVID-19 pandemic has negatively impacted the global economy, disrupted supply chains and created significant volatility in financial markets. We have implemented business policies intended to protect our employees from the spread of COVID-19. Those policies include employees working from home when possible and employeeschanges in our facilities increasing physical distancing.

On March 18, 2020,risk factors subsequent to the Centers for Medicare & Medicaid Services (“CMS”) released guidance for U.S. healthcare providers to limit non-emergent elective medical procedures other than high acuity treatments in order to conserve personal protective equipment and limit exposure to COVID-19. On April 16, 2020, the White House issued “Guidelines for Opening Up America Again” (the “White House Guidelines”) that described a phased resumption of economic activities with gating conditions for a region or state to move from one phase to another. On June 9, 2020, CMS issued recommendations for regions and states in Phase II of the White House Guidelines that non-emergent, non-COVID-19 care should be offered to patients, as clinically appropriate, in localities or facilities that have the resources to provide such care, as well as the ability to quickly respond to a surge in COVID-19 cases, if necessary.

Since the White House Guidelines and related CMS recommendations were issued, rates of COVID-19 have vacillated by region and state, in some cases surging. Accordingly, consistent with the CMS recommendations, the degree to which elective medical procedures have been offered varies by region, state, and even between healthcare systems within a state. Where elective procedures have been offered, and even for emergency procedures, some people appear to have avoided healthcare facilities, presumably out of concern for contracting COVID-19. Manyfiling of our customers use our licensed technology and purchased materials to manufacture products used in procedures impacted by the guidance and recommendations. BasedAnnual Report on the CMS guidance and recommendations, as well as industry data regarding elective procedures volumes, we adjusted the assumptions used in our royalties revenue recognitionForm 10-K for the quartersfiscal year ended March 31, 2020 and JuneSeptember 30, 2020, which resulted in reduced in royalties revenue in both periods relative to the revenue that would have been recognized under our prior assumptions. In addition to limiting medical procedures, hospitals and other healthcare providers vary in the degree to which they are permitting access to their facilities during the pandemic.2020.

In early July 2020, we suspended production for one week in one production work cell in our facility in Eden Prairie when two of the employees in the cell were identified as having COVID-19. The production suspension did not have a material impact on our operations and the cell has since resumed normal operations.

We cannot predict the duration or scope of the pandemic, actions that may be taken by governments and businesses in response to the pandemic, or the impacts of the pandemic on healthcare systems. The impacts of the pandemic may include, but not be limited to:

Reduced revenues from our customers, including our major customers, whose products are impacted by reductions in the delivery of elective medical procedures or patients’ unwillingness to visit healthcare facilities for medical procedures;

Diminished ability or willingness of third parties to market, distribute and sell products incorporating our coating and device technologies, as well as our whole-product solutions, due to reduced demand from, or lack of access to, healthcare facilities and providers;

Diminished ability, or inability, to complete clinical trials and other activities required to achieve regulatory clearing for our products under development due to lack of access to healthcare facilities, healthcare providers and patients;

33


Diminished or lost access to third party service providers that we use in our research and development or marketing efforts;

Loss of manufacturing capacity, which could lead to failures to meet product delivery commitments, or increased operating costs if our facilities were to experience additional incidents of COVID-19;

Reduced cash flow from our operations due to reductions in revenues or collections from our customers and increases in operating costs related to actions we have taken in response to the pandemic;

Reduced business productivity due to inefficiencies in employees working from home or increasing physical distancing and other pandemic response protocols in our production facilities;

Increased susceptibility to the risk of information technology security breaches and other disruptions due to increased volumes of remote access to our information systems from our employees working at home;

Inability to source sufficient components used in our products due to disruptions in supply chains;

Diminished ability to identify, evaluate and acquire, or effectively integrate, complementary businesses, products, materials or technologies due to travel restrictions, physical distancing protocols, and lack of access to third party service providers related to our development activities;

Difficulties in assessing and securing intellectual property rights due to lack of access to, or delayed responsiveness of, third party service providers or governmental agencies;

Impairment of goodwill or other assets due to reductions in the fair value of our reporting units;

Diminished ability to retain personnel over concerns about workplace exposure to COVID-19, or to hire and effectively train new personnel, due to physical distancing protocols; and

Increased volatility in our stock price due to financial market instability.

These and other factors relating to, or arising from, the pandemic could have material adverse effects on our business, results of operations, cash flows, financial condition, and capital investments. Actual or anticipated adverse effects on our cash flows or financial condition may lead us to seek additional funding. Any future debt financing into which we enter may impose upon us covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. We cannot be certain that additional funding will be available on acceptable terms, if at all. If we do not have, or are not able to obtain, sufficient funds, we may have to delay development or commercialization of our products or otherwise curtail our operations. Any of these events could materially harm our business and operating results.

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

(c) Issuer Purchases of Equity Securities

The Company did not purchase any of its common stock during the three months ended June 30, 2020.March 31, 2021. As of June 30, 2020,March 31, 2021, the Company had an aggregate of $25.3 million available for future common stock repurchases under an authorization approved by the Board of Directors for up to $20.0 million on November 6, 2015, all of which is remaining, and an authorization approved by the Board of Directors on November 5, 2014 of which $5.3 million is remaining. These authorizations for share repurchases do not have a fixed expiration date.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not Applicable.

Item 5. Other Information

None.

29


Table of Contents

 


Item 6. Exhibits

EXHIBIT INDEX

Exhibit

 

Description

 

 

 

  2.1

Agreement of Merger dated January 18, 2005 among Surmodics, Inc., SIRx, InnoRx, et al. — incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K dated January 24, 2005.

2.2

 

Share Purchase Agreement by and among Surmodics, Inc. and the shareholders of Creagh Medical Ltd. dated as of November 20, 2015 — incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed ondated November 27, 2015, SEC File No. 0-23837.

2.2

Put and Call Option Agreement by and among Surmodics, Inc. and the shareholders of Creagh Medical Ltd. dated as of November 20, 2015 — incorporated by reference to Exhibit 2.2 to the Company’s 8-K filed on November 27, 2015, SEC File No. 0-23837.2015.

 

 

 

  2.3

 

Stock Purchase Agreement, dated January 8, 2016, by and among Surmodics, Inc. and the shareholders of NorMedix, Inc. and Gregg Sutton as Seller’s Agent — incorporated by reference to Exhibit 2.1 to the Company’s Form Current Report on Form 8-K filed on January 13, 2016, SEC File No. 0-23837.2016.

 

 

 

  3.1

 

Restated Articles of Incorporation, as amended — incorporated by reference to Exhibit 3.1 of the Company’s Quarterly Report on Form 10-Q filed on July 29, 2016, SEC File No. 0-23837.2016.

 

 

 

  3.2

 

Restated Bylaws of Surmodics, Inc., as amended December 18, 2015 — incorporated by reference to Exhibit 3.2 of the Company’s Current Report on Form 8-K filed on December 23, 2015, SEC File No. 0-238372015..

 

 

 

31.1*

 

Certification of Chief Executive Officer pursuant to 18 U.S.C. Sec. 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

31.2*

 

Certification of Chief Financial Officer pursuant to 18 U.S.C. Sec. 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.1*

 

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

 

 

 

32.2*

 

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

 

 

 

101.INS*

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File as its XBRL tags are embedded within the inline XBRL document.

 

 

 

101.SCH*

 

Inline XBRL Taxonomy Extension Schema.

 

 

 

101.CAL*

 

Inline XBRL Taxonomy Extension Calculation Linkbase.

 

 

 

101.DEF*

 

Inline XBRL Taxonomy Extension Definition Linkbase.

 

 

 

101.LAB*

 

Inline XBRL Taxonomy Extension Label Linkbase.

 

 

 

101.PRE*

 

Inline XBRL Taxonomy Extension Presentation Linkbase.

 

 

 

104*

 

Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).

 

*

Filed herewith

35



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.

 

August 5, 2020April 28, 2021

Surmodics, Inc.

 

 

 

 

By:

/s/ Timothy J. Arens

 

 

Timothy J. Arens

 

 

Senior Vice President of Finance and Chief Financial Officer

 

 

 

 

 

(duly authorized signatory and principal financial officer)

 

3631