f 18

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended September 30, 20192020

OR

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

For the transition period from to

Commission file number: 001-36709

 

SIENTRA, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

(State or Other Jurisdiction of

Incorporation or Organization)

 

20-5551000

(I.R.S. Employer

Identification No.)

 

420 South Fairview Avenue, Suite 200

Santa Barbara, California

(Address of Principal Executive Offices)

 

93117

(Zip Code)

 

(805) 562-3500

(Registrant’s Telephone Number, Including Area Code)

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

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.01 per share

 

SIEN

 

The Nasdaq Stock Market LLC

 

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  

 

As of November 1, 2019,2, 2020, the number of outstanding shares of the registrant’s common stock, par value $0.01 per share, was 49,481,559.50,454,122.

 

 

 


 

SIENTRA, INC.

FORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 20192020

TABLE OF CONTENTS

 

 

 

Page

 

 

 

Part I — Financial Information

 

1

 

 

 

Item 1. Condensed Consolidated Financial Statements - Unaudited

 

1

Condensed Consolidated Balance Sheets as of September 30, 20192020 and December 31, 20182019

 

1

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 20192020 and 20182019

 

2

Condensed Consolidated Statement of Stockholders' Equity for the Period from December 31, 2018 through September 30, 2019 and December 31, 2019 through September 30, 2020

                  

3

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 20192020 and 20182019

 

4

Notes to the Condensed Consolidated Financial Statements

 

5

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

 

25

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

3336

Item 4. Controls and Procedures

 

3436

 

 

 

Part II — Other Information

 

3538

 

 

 

Item 1. Legal Proceedings

 

3538

Item 1A. Risk Factors

 

3538

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

 

3943

Item 3. Defaults Upon Senior Securities

 

3943

Item 4. Mine Safety Disclosures

 

3943

Item 5. Other Information

 

3943

Item 6. Exhibits

 

4144

 

“Sientra”, “Sientra Platinum20”, “Sientra Full Circle”, “OPUS”, “Allox”, “Allox2”, “BIOCORNEUM”, “Curve”, “Dermaspan”, “Luxe”, “Softspan”, “Silishield”, “miraDry”, “Miramar Labs”, “miraDry and Design”, “miraDry Fresh”, “bioTip”, “The Sweat Stops Here”, “No Sweat No Stress”, “Sweat Less Live More”, “Drop Design”, “miraWave”, “miraSmooth”, “miraFresh”, “freshRewards”, “freshNet”, “freshEquity”, “freshConnect”, and “ML Stylized mark” are trademarks of our company. Our logo and our other trade names, trademarks and service marks appearing in this document are our property. Other trade names, trademarks and service marks appearing in this document are the property of their respective owners. Solely for convenience, our trademarks and trade names referred to in the document, appear without the TM or the (R) symbol, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the rights of the applicable licensor to these trademarks and trade names.

 


 

PART I — FINANCIALFINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

SIENTRA, INC.

Condensed Consolidated Balance Sheets

(In thousands, except per share and share amounts)

(Unaudited)

 

 

September 30,

 

 

December 31,

 

 

September 30,

 

 

December 31,

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

120,915

 

 

$

86,899

 

 

$

63,483

 

 

$

87,608

 

Accounts receivable, net of allowances of $3,302 and $2,428 at September 30, 2019 and December 31, 2018, respectively

 

 

24,791

 

 

 

22,527

 

Accounts receivable, net of allowances of $4,893 and $3,835 at September 30, 2020 and December 31, 2019, respectively

 

 

23,637

 

 

 

27,548

 

Inventories, net

 

 

30,374

 

 

 

24,085

 

 

 

48,467

 

 

 

39,612

 

Prepaid expenses and other current assets

 

 

3,144

 

 

 

2,612

 

 

 

2,113

 

 

 

2,489

 

Total current assets

 

 

179,224

 

 

 

136,123

 

 

 

137,700

 

 

 

157,257

 

Property and equipment, net

 

 

3,980

 

 

 

2,536

 

 

 

12,742

 

 

 

12,314

 

Goodwill

 

 

4,878

 

 

 

12,507

 

 

 

9,202

 

 

 

9,202

 

Other intangible assets, net

 

 

9,779

 

 

 

16,495

 

 

 

9,719

 

 

 

17,390

 

Other assets

 

 

22,021

 

 

 

698

 

 

 

8,441

 

 

 

8,241

 

Total assets

 

$

219,882

 

 

$

168,359

 

 

$

177,804

 

 

$

204,404

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current portion of long-term debt

 

$

7,352

 

 

$

6,866

 

 

$

928

 

 

$

6,508

 

Accounts payable

 

 

8,738

 

 

 

13,184

 

 

 

4,071

 

 

 

9,352

 

Accrued and other current liabilities

 

 

28,741

 

 

 

27,697

 

 

 

26,679

 

 

 

32,551

 

Legal settlement payable

 

 

 

 

 

410

 

Customer deposits

 

 

11,686

 

 

 

9,936

 

 

 

15,490

 

 

 

13,943

 

Sales return liability

 

 

7,563

 

 

 

6,048

 

 

 

10,079

 

 

 

8,116

 

Total current liabilities

 

 

64,080

 

 

 

64,141

 

 

 

57,247

 

 

 

70,470

 

Long-term debt

 

 

38,117

 

 

 

27,883

 

 

 

63,330

 

 

 

38,248

 

Derivative liability

 

 

24,520

 

 

 

 

Deferred and contingent consideration

 

 

364

 

 

 

6,481

 

 

 

5,342

 

 

 

5,177

 

Warranty reserve and other long-term liabilities

 

 

21,054

 

 

 

2,976

 

 

 

9,281

 

 

 

8,627

 

Total liabilities

 

 

123,615

 

 

 

101,481

 

 

 

159,720

 

 

 

122,522

 

Commitments and contingencies (Note 14)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred stock, $0.01 par value – Authorized 10,000,000 shares; none

issued or outstanding

 

 

 

 

 

 

Common stock, $0.01 par value — Authorized 200,000,000 shares; issued 49,534,414 and 28,701,494 and outstanding 49,461,687 and 28,628,767 shares at September 30, 2019 and December 31, 2018 respectively

 

 

495

 

 

 

286

 

Preferred stock, $0.01 par value – Authorized 10,000,000 shares; NaN issued or outstanding

 

 

 

 

 

 

Common stock, $0.01 par value — Authorized 200,000,000 shares; issued 50,507,635 and 49,612,907 and outstanding 50,434,908 and 49,540,180 shares at September 30, 2020 and December 31, 2019, respectively

 

 

504

 

 

 

495

 

Additional paid-in capital

 

 

544,700

 

 

 

428,949

 

 

 

555,465

 

 

 

550,562

 

Treasury stock, at cost (72,727 shares at September 30, 2019 and December 31, 2018)

 

 

(260

)

 

 

(260

)

Treasury stock, at cost (72,727 shares at September 30, 2020 and December 31, 2019)

 

 

(260

)

 

 

(260

)

Accumulated deficit

 

 

(448,668

)

 

 

(362,097

)

 

 

(537,625

)

 

 

(468,915

)

Total stockholders’ equity

 

 

96,267

 

 

 

66,878

 

 

 

18,084

 

 

 

81,882

 

Total liabilities and stockholders’ equity

 

$

219,882

 

 

$

168,359

 

 

$

177,804

 

 

$

204,404

 

 

See accompanying notes to condensed consolidated financial statements.


SIENTRA, INC.

Condensed Consolidated Statements of Operations

(In thousands, except per share and share amounts)

(Unaudited)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

September 30,

 

 

September 30,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net sales

 

$

22,412

 

 

$

16,875

 

 

 

60,489

 

 

 

49,104

 

 

$

19,217

 

 

$

22,412

 

 

 

48,597

 

 

 

60,489

 

Cost of goods sold

 

 

9,754

 

 

 

6,398

 

 

 

24,041

 

 

 

19,154

 

 

 

8,391

 

 

 

9,754

 

 

 

20,733

 

 

 

24,041

 

Gross profit

 

 

12,658

 

 

 

10,477

 

 

 

36,448

 

 

 

29,950

 

 

 

10,826

 

 

 

12,658

 

 

 

27,864

 

 

 

36,448

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

18,668

 

 

 

15,254

 

 

 

60,987

 

 

 

45,990

 

 

 

12,872

 

 

 

18,668

 

 

 

37,614

 

 

 

60,987

 

Research and development

 

 

3,201

 

 

 

2,881

 

 

 

9,526

 

 

 

7,930

 

 

 

2,060

 

 

 

3,201

 

 

 

7,747

 

 

 

9,526

 

General and administrative

 

 

12,249

 

 

 

11,904

 

 

 

37,538

 

 

 

31,419

 

 

 

10,238

 

 

 

12,249

 

 

 

27,500

 

 

 

37,538

 

Goodwill and other intangible impairment

 

 

 

 

 

 

 

 

12,674

 

 

 

 

Restructuring

 

 

(386

)

 

 

 

 

 

1,849

 

 

 

 

Impairment

 

 

 

 

 

 

 

 

6,432

 

 

 

12,674

 

Total operating expenses

 

 

34,118

 

 

 

30,039

 

 

 

120,725

 

 

 

85,339

 

 

 

24,784

 

 

 

34,118

 

 

 

81,142

 

 

 

120,725

 

Loss from operations

 

 

(21,460

)

 

 

(19,562

)

 

 

(84,277

)

 

 

(55,389

)

 

 

(13,958

)

 

 

(21,460

)

 

 

(53,278

)

 

 

(84,277

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

510

 

 

 

133

 

 

 

1,083

 

 

 

214

 

 

 

5

 

 

 

510

 

 

 

203

 

 

 

1,083

 

Interest expense

 

 

(1,344

)

 

 

(953

)

 

 

(3,276

)

 

 

(2,474

)

 

 

(2,059

)

 

 

(1,344

)

 

 

(7,289

)

 

 

(3,276

)

Change in fair value of derivative liability

 

 

10,090

 

 

 

 

 

 

(8,420

)

 

 

 

Other income (expense), net

 

 

(139

)

 

 

(163

)

 

 

(101

)

 

 

(347

)

 

 

101

 

 

 

(139

)

 

 

74

 

 

 

(101

)

Total other income (expense), net

 

 

(973

)

 

 

(983

)

 

 

(2,294

)

 

 

(2,607

)

 

 

8,137

 

 

 

(973

)

 

 

(15,432

)

 

 

(2,294

)

Loss before income taxes

 

 

(22,433

)

 

 

(20,545

)

 

 

(86,571

)

 

 

(57,996

)

 

 

(5,821

)

 

 

(22,433

)

 

 

(68,710

)

 

 

(86,571

)

Income tax (benefit) expense

 

 

 

 

 

 

 

 

 

 

 

 

Income tax

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(22,433

)

 

$

(20,545

)

 

 

(86,571

)

 

 

(57,996

)

 

$

(5,821

)

 

$

(22,433

)

 

 

(68,710

)

 

 

(86,571

)

Basic and diluted net loss per share attributable to

common stockholders

 

$

(0.45

)

 

$

(0.72

)

 

 

(2.30

)

 

 

(2.39

)

 

$

(0.12

)

 

$

(0.45

)

 

 

(1.37

)

 

 

(2.30

)

Weighted average outstanding common shares used for

net loss per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

49,401,094

 

 

 

28,462,975

 

 

 

37,671,215

 

 

 

24,312,300

 

 

 

50,394,858

 

 

 

49,401,094

 

 

 

50,155,623

 

 

 

37,671,215

 

 

See accompanying notes to condensed consolidated financial statements.

 


SIENTRA, INC.

Condensed Consolidated Statement of Stockholders' Equity

(In thousands, except share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Total

 

 

Preferred stock

 

 

Common stock

 

 

Treasury stock

 

 

paid-in

 

 

Accumulated

 

 

stockholders'

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

capital

 

 

deficit

 

 

equity

 

Balances at December 31, 2017

 

 

 

 

$

 

 

 

19,474,702

 

 

$

194

 

 

 

72,727

 

 

$

(260

)

 

$

307,159

 

 

$

(279,470

)

 

$

27,623

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,548

 

 

 

 

 

 

2,548

 

Employee stock purchase program (ESPP)

 

 

 

 

 

 

 

 

62,491

 

 

 

1

 

 

 

 

 

 

 

 

 

390

 

 

 

 

 

 

391

 

Vested restricted stock

 

 

 

 

 

 

 

 

271,936

 

 

 

3

 

 

 

 

 

 

 

 

 

(3

)

 

 

 

 

 

 

Shares withheld for tax obligations on vested RSUs

 

 

 

 

 

 

 

 

(92,760

)

 

 

(1

)

 

 

 

 

 

 

 

 

(1,295

)

 

 

 

 

 

(1,296

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

(19,423

)

 

 

(19,423

)

Balances at March 31, 2018

 

 

 

 

 

 

 

 

19,716,369

 

 

$

197

 

 

 

72,727

 

 

$

(260

)

 

$

308,799

 

 

$

(298,893

)

 

$

9,843

 

Proceeds from follow-on offering, net of costs

 

 

 

 

 

 

 

 

8,518,519

 

 

 

85

 

 

 

 

 

 

 

 

 

107,466

 

 

 

 

 

 

107,551

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,138

 

 

 

 

 

 

3,138

 

Stock option exercises

 

 

 

 

 

 

 

 

61,203

 

 

 

1

 

 

 

 

 

 

 

 

 

409

 

 

 

 

 

 

410

 

Vested restricted stock

 

 

 

 

 

 

 

 

94,180

 

 

 

1

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,028

)

 

 

(18,028

)

Balances at June 30, 2018

 

 

 

 

$

 

 

 

28,390,271

 

 

$

284

 

 

 

72,727

 

 

$

(260

)

 

$

419,811

 

 

$

(316,921

)

 

$

102,914

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,391

 

 

 

 

 

 

4,391

 

Stock option exercises

 

 

 

 

 

 

 

 

86,260

 

 

 

 

 

 

 

 

 

 

 

 

738

 

 

 

 

 

 

738

 

Employee stock purchase program (ESPP)

 

 

 

 

 

 

 

 

83,125

 

 

 

 

 

 

 

 

 

 

 

 

601

 

 

 

 

 

 

602

 

Vested restricted stock

 

 

 

 

 

 

 

 

98,391

 

 

 

1

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

Shares withheld for tax obligations on vested RSUs

 

 

 

 

 

 

 

 

(7,103

)

 

 

 

 

 

 

 

 

 

 

 

(123

)

 

 

 

 

 

(123

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(20,545

)

 

 

(20,545

)

Balances at September 30, 2018

 

 

 

 

$

 

 

 

28,650,944

 

 

 

285

 

 

 

72,727

 

 

 

(260

)

 

 

425,417

 

 

 

(337,466

)

 

 

87,976

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Total

 

 

Preferred stock

 

 

Common stock

 

 

Treasury stock

 

 

paid-in

 

 

Accumulated

 

 

stockholders'

 

 

Preferred stock

 

 

Common stock

 

 

Treasury stock

 

 

paid-in

 

 

Accumulated

 

 

stockholders'

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

capital

 

 

deficit

 

 

equity

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

capital

 

 

deficit

 

 

equity

 

Balances at December 31, 2018

 

 

 

 

$

 

 

 

28,701,494

 

 

$

286

 

 

 

72,727

 

 

$

(260

)

 

$

428,949

 

 

$

(362,097

)

 

$

66,878

 

 

 

 

 

$

 

 

 

28,701,494

 

 

$

286

 

 

 

72,727

 

 

$

(260

)

 

$

428,949

 

 

$

(362,097

)

 

$

66,878

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,772

 

 

 

 

 

 

3,772

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,772

 

 

 

 

 

 

3,772

 

Stock option exercises

 

 

 

 

 

 

 

 

45,453

 

 

 

 

 

 

 

 

 

 

 

 

106

 

 

 

 

 

 

106

 

 

 

 

 

 

 

 

 

 

 

45,453

 

 

 

 

 

 

 

 

 

 

 

 

106

 

 

 

 

 

 

106

 

Employee stock purchase program (ESPP)

 

 

 

 

 

 

 

 

68,899

 

 

 

1

 

 

 

 

 

 

 

 

 

682

 

 

 

 

 

 

683

 

 

 

 

 

 

 

 

 

68,899

 

 

 

1

 

 

 

 

 

 

 

 

 

682

 

 

 

 

 

 

683

 

Vested restricted stock

 

 

 

 

 

 

 

 

671,245

 

 

 

7

 

 

 

 

 

 

 

 

 

(7

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

671,245

 

 

 

7

 

 

 

 

 

 

 

 

 

(7

)

 

 

 

 

 

 

Shares withheld for tax obligations on vested RSUs

 

 

 

 

 

 

 

 

(212,714

)

 

 

(2

)

 

 

 

 

 

 

 

 

(2,723

)

 

 

 

 

 

(2,725

)

 

 

 

 

 

 

 

 

(212,714

)

 

 

(2

)

 

 

 

 

 

 

 

 

(2,723

)

 

 

 

 

 

(2,725

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(26,484

)

 

 

(26,484

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(26,484

)

 

 

(26,484

)

Balances at March 31, 2019

 

 

 

 

 

 

 

 

29,274,377

 

 

$

292

 

 

 

72,727

 

 

$

(260

)

 

$

430,779

 

 

$

(388,581

)

 

$

42,230

 

 

 

 

 

 

 

 

 

29,274,377

 

 

$

292

 

 

 

72,727

 

 

$

(260

)

 

$

430,779

 

 

$

(388,581

)

 

$

42,230

 

Proceeds from follow-on offering, net of costs

 

 

 

 

 

 

 

 

20,000,000

 

 

 

200

 

 

 

 

 

 

 

 

 

107,534

 

 

 

 

 

 

107,734

 

 

 

 

 

 

 

 

 

20,000,000

 

 

 

200

 

 

 

 

 

 

 

 

 

107,534

 

 

 

 

 

 

107,734

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,963

 

 

 

 

 

 

2,963

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,963

 

 

 

 

 

 

2,963

 

Vested restricted stock

 

 

 

 

 

 

 

 

88,454

 

 

 

1

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

88,454

 

 

 

1

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

Shares withheld for tax obligations on vested RSUs

 

 

 

 

 

 

 

 

(12,565

)

 

 

 

 

 

 

 

 

 

 

 

(100

)

 

 

 

 

 

(100

)

 

 

 

 

 

 

 

 

(12,565

)

 

 

 

 

 

 

 

 

 

 

 

(100

)

 

 

 

 

 

(100

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(37,654

)

 

 

(37,654

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(37,654

)

 

 

(37,654

)

Balances at June 30, 2019

 

 

 

 

$

 

 

 

49,350,266

 

 

$

493

 

 

 

72,727

 

 

$

(260

)

 

$

541,175

 

 

$

(426,235

)

 

$

115,173

 

 

 

 

 

$

 

 

 

49,350,266

 

 

$

493

 

 

 

72,727

 

 

$

(260

)

 

$

541,175

 

 

$

(426,235

)

 

$

115,173

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,115

 

 

 

 

 

 

3,115

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,115

 

 

 

 

 

 

3,115

 

Stock option exercises

 

 

 

 

 

 

 

 

3,271

 

 

 

 

 

 

 

 

 

 

 

 

9

 

 

 

 

 

 

9

 

 

 

 

 

 

 

 

 

3,271

 

 

 

 

 

 

 

 

 

 

 

 

9

 

 

 

 

 

 

9

 

Employee stock purchase program (ESPP)

 

 

 

 

 

 

 

 

106,725

 

 

 

1

 

 

 

 

 

 

 

 

 

533

 

 

 

 

 

 

534

 

 

 

 

 

 

 

 

 

106,725

 

 

 

1

 

 

 

 

 

 

 

 

 

533

 

 

 

 

 

 

534

 

Vested restricted stock

 

 

 

 

 

 

 

 

92,676

 

 

 

1

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

92,676

 

 

 

1

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

Shares withheld for tax obligations on vested RSUs

 

 

 

 

 

 

 

 

(18,524

)

 

 

 

 

 

 

 

 

 

 

 

(131

)

 

 

 

 

 

(131

)

 

 

 

 

 

 

 

 

(18,524

)

 

 

 

 

 

 

 

 

 

 

 

(131

)

 

 

 

 

 

(131

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,433

)

 

 

(22,433

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,433

)

 

 

(22,433

)

Balances at September 30, 2019

 

 

 

 

$

 

 

 

49,534,414

 

 

$

495

 

 

 

72,727

 

 

$

(260

)

 

$

544,700

 

 

$

(448,668

)

 

$

96,267

 

 

 

 

 

$

 

 

 

49,534,414

 

 

$

495

 

 

 

72,727

 

 

$

(260

)

 

$

544,700

 

 

$

(448,668

)

 

$

96,267

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Total

 

 

Preferred stock

 

 

Common stock

 

 

Treasury stock

 

 

paid-in

 

 

Accumulated

 

 

stockholders'

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

capital

 

 

deficit

 

 

equity

 

Balances at December 31, 2019

 

 

 

 

$

 

 

 

49,612,907

 

 

$

495

 

 

 

72,727

 

 

$

(260

)

 

$

550,562

 

 

$

(468,915

)

 

$

81,882

 

Issuance of common stock through ATM

 

 

 

 

 

 

 

 

37,000

 

 

 

1

 

 

 

 

 

 

 

 

 

263

 

 

 

 

 

 

264

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,000

 

 

 

 

 

 

2,000

 

Employee stock purchase program (ESPP)

 

 

 

 

 

 

 

 

113,615

 

 

 

1

 

 

 

 

 

 

 

 

 

533

 

 

 

 

 

 

534

 

Vested restricted stock

 

 

 

 

 

 

 

 

472,914

 

 

 

5

 

 

 

 

 

 

 

 

 

(5

)

 

 

 

 

 

 

Shares withheld for tax obligations on vested RSUs

 

 

 

 

 

 

 

 

(157,412

)

 

 

(2

)

 

 

 

 

 

 

 

 

(1,199

)

 

 

 

 

 

(1,201

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(28,612

)

 

 

(28,612

)

Balances at March 31, 2020

 

 

 

 

 

 

 

 

50,079,024

 

 

$

500

 

 

 

72,727

 

 

$

(260

)

 

$

552,154

 

 

$

(497,527

)

 

$

54,867

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,718

 

 

 

 

 

 

1,718

 

Stock option exercises

 

 

 

 

 

 

 

 

5,454

 

 

 

 

 

 

 

 

 

 

 

 

13

 

 

 

 

 

 

13

 

Employee stock purchase program (ESPP)

 

 

 

 

 

 

 

 

(1,012

)

 

 

 

 

 

 

 

 

 

 

 

(5

)

 

 

 

 

 

(5

)

Vested restricted stock

 

 

 

 

 

 

 

 

363,795

 

 

 

4

 

 

 

 

 

 

 

 

 

(4

)

 

 

 

 

 

 

Shares withheld for tax obligations on vested RSUs

 

 

 

 

 

 

 

 

(91,529

)

 

 

(1

)

 

 

 

 

 

 

 

 

(226

)

 

 

 

 

 

(227

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,277

)

 

 

(34,277

)

Balances at June 30, 2020

 

 

 

 

$

 

 

 

50,355,732

 

 

$

503

 

 

 

72,727

 

 

$

(260

)

 

$

553,650

 

 

$

(531,804

)

 

$

22,089

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,574

 

 

 

 

 

 

1,574

 

Stock option exercises

 

 

 

 

 

 

 

 

727

 

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Employee stock purchase program (ESPP)

 

 

 

 

 

 

 

 

91,125

 

 

 

1

 

 

 

 

 

 

 

 

 

306

 

 

 

 

 

 

307

 

Vested restricted stock

 

 

 

 

 

 

 

 

85,255

 

 

 

1

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

Shares withheld for tax obligations on vested RSUs

 

 

 

 

 

 

 

 

(25,204

)

 

 

(1

)

 

 

 

 

 

 

 

 

(67

)

 

 

 

 

 

(68

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,821

)

 

 

(5,821

)

Balances at September 30, 2020

 

 

 

 

$

 

 

 

50,507,635

 

 

$

504

 

 

 

72,727

 

 

$

(260

)

 

$

555,465

 

 

$

(537,625

)

 

$

18,084

 

 

See accompanying notes to condensed consolidated financial statements.

 


SIENTRA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

Nine Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(86,571

)

 

$

(57,996

)

 

$

(68,710

)

 

$

(86,571

)

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

 

 

 

 

 

 

 

 

Goodwill impairment

 

 

7,629

 

 

 

 

Intangible asset impairment

 

 

5,045

 

 

 

 

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

 

 

 

 

 

 

 

 

Impairment

 

 

6,432

 

 

 

12,674

 

Depreciation and amortization

 

 

2,538

 

 

 

2,500

 

 

 

2,996

 

 

 

2,538

 

Provision for doubtful accounts

 

 

1,804

 

 

 

996

 

 

 

4,665

 

 

 

1,804

 

Provision for warranties

 

 

843

 

 

 

2

 

 

 

711

 

 

 

843

 

Provision for inventory

 

 

2,209

 

 

 

708

 

 

 

1,774

 

 

 

2,209

 

Amortization of acquired inventory step-up

 

 

 

 

 

106

 

Amortization of right-of-use assets

 

 

3,546

 

 

 

 

Lease liability accretion

 

 

1,385

 

 

 

 

Change in fair value of warrants

 

 

(110

)

 

 

333

 

Change in fair value of deferred consideration

 

 

9

 

 

 

18

 

Change in fair value of contingent consideration

 

 

590

 

 

 

2,178

 

Change in deferred revenue

 

 

504

 

 

 

275

 

Non-cash portion of debt extinguishment loss

 

 

53

 

 

 

 

Fair value adjustments to derivative liability

 

 

8,420

 

 

 

 

Fair value adjustments of other liabilities held at fair value

 

 

29

 

 

 

480

 

Amortization of debt discount and issuance costs

 

 

223

 

 

 

132

 

 

 

3,430

 

 

 

223

 

Stock-based compensation expense

 

 

9,681

 

 

 

10,077

 

 

 

5,465

 

 

 

9,681

 

Loss on disposal of property and equipment

 

 

119

 

 

 

 

Payments of contingent consideration liability in excess of acquisition-date fair value

 

 

(1,968

)

 

 

 

 

 

 

 

 

(1,968

)

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Other non-cash adjustments

 

 

198

 

 

 

181

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(4,068

)

 

 

(9,476

)

 

 

(720

)

 

 

(4,068

)

Inventories

 

 

(8,329

)

 

 

(2,827

)

 

 

(10,801

)

 

 

(8,329

)

Prepaid expenses, other current assets and other assets

 

 

(811

)

 

 

(2,168

)

 

 

537

 

 

 

2,735

 

Insurance recovery receivable

 

 

 

 

 

33

 

Accounts payable

 

 

(2,797

)

 

 

6,780

 

Accrued and other liabilities

 

 

(7,882

)

 

 

3,789

 

Legal settlement payable

 

 

(410

)

 

 

(590

)

Accounts payable, accrueds, and other liabilities

 

 

(10,642

)

 

 

(8,790

)

Customer deposits

 

 

1,750

 

 

 

2,283

 

 

 

1,547

 

 

 

1,750

 

Sales return liability

 

 

1,515

 

 

 

1,429

 

 

 

1,930

 

 

 

1,515

 

Legal settlement payable

 

 

 

 

 

(410

)

Net cash used in operating activities

 

 

(73,503

)

 

 

(41,418

)

 

 

(52,739

)

 

 

(73,503

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(3,180

)

 

 

(414

)

 

 

(3,192

)

 

 

(3,180

)

Net cash used in investing activities

 

 

(3,180

)

 

 

(414

)

 

 

(3,192

)

 

 

(3,180

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from option exercises and employee stock purchase plan

 

 

852

 

 

 

1,332

 

Net proceeds from issuance of common stock

 

 

107,734

 

 

 

107,551

 

 

 

264

 

 

 

107,734

 

Proceeds from exercise of stock options

 

 

115

 

 

 

1,149

 

Proceeds from issuance of common stock under ESPP

 

 

1,217

 

 

 

993

 

Tax payments related to shares withheld for vested restricted stock units (RSUs)

 

 

(2,956

)

 

 

(1,419

)

 

 

(1,496

)

 

 

(2,956

)

Gross borrowings under the Term Loan

 

 

5,000

 

 

 

10,000

 

 

 

 

 

 

5,000

 

Repayments under the Term Loan

 

 

(25,000

)

 

 

 

Gross borrowings under the PPP loan

 

 

6,652

 

 

 

 

Gross borrowings under the Revolving Loan

 

 

15,788

 

 

 

12,109

 

 

 

 

 

 

15,788

 

Repayment of the Revolving Loan

 

 

(8,436

)

 

 

(12,109

)

 

 

(6,508

)

 

 

(8,436

)

Net proceeds from issuance of the Convertible Note

 

 

60,000

 

 

 

 

Payments of contingent consideration up to acquisition-date fair value

 

 

(5,766

)

 

 

 

 

 

 

 

 

(5,766

)

Deferred financing costs

 

 

(1,997

)

 

 

(22

)

 

 

(2,958

)

 

 

(1,997

)

Net cash provided by financing activities

 

 

110,699

 

 

 

118,252

 

 

 

31,806

 

 

 

110,699

 

Net increase in cash, cash equivalents and restricted cash

 

 

34,016

 

 

 

76,420

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

(24,125

)

 

 

34,016

 

Cash, cash equivalents and restricted cash at:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Beginning of period

 

 

87,242

 

 

 

26,931

 

 

 

87,951

 

 

 

87,242

 

End of period

 

$

121,258

 

 

$

103,351

 

 

$

63,826

 

 

$

121,258

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of cash, cash equivalents, and restricted cash to the consolidated balance sheets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

120,915

 

 

$

103,008

 

 

$

63,483

 

 

$

120,915

 

Restricted cash included in other assets

 

 

343

 

 

 

343

 

 

 

343

 

 

 

343

 

Total cash, cash equivalents and restricted cash

 

$

121,258

 

 

$

103,351

 

 

$

63,826

 

 

$

121,258

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest paid

 

$

3,015

 

 

$

2,526

 

 

$

3,781

 

 

$

3,015

 

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Property and equipment in accounts payable and accrued liabilities

 

$

1,113

 

 

$

1,900

 

 

$

114

 

 

$

1,113

 

Non-cash deferred consideration settlement

 

 

 

 

 

1,000

 

Non-cash settlement of assets held for sale in accounts payable

 

 

 

 

 

2,674

 

 

See accompanying notes to condensed consolidated financial statements.


SIENTRA, INC.

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

1.

Formation and BusinessSummary of the CompanySignificant Accounting Policies

 

a.

Formation

Sientra, Inc. (“Sientra”, the “Company,” “we,” “our” or “us”), was incorporated in the State of Delaware on August 29, 2003 under the name Juliet Medical, Inc. and subsequently changed its name to Sientra, Inc. in April 2007. The Company acquired substantially all the assets of Silimed, Inc. on April 4, 2007. The purpose of the acquisition was to acquire the rights to the silicone breast implant clinical trials, related product specifications and pre-market approval, or PMA, assets. Following this acquisition, the Company focused on completing the clinical trials to gain FDA approval to offer its silicone gel breast implants in the United States.

In March 2012, the Company announced it had received approval from the FDA for its portfolio of silicone gel breast implants, and in the second quarter of 2012 the Company began commercialization efforts to sell its products in the United States. The Company, based in Santa Barbara, California, is a medical aesthetics company that focuses on serving board-certified plastic surgeons and offers a portfolio of silicone shaped and round breast implants, scar management, tissue expanders, and body contouring products.

In November 2014, the Company completed an initial public offering, or IPO, and its common stock is listed on the Nasdaq Stock Exchange under the symbol “SIEN.”

b.

Regulatory Review of Vesta Manufacturing

The Company has engaged Vesta Intermediate Funding, Inc., or Vesta, a Lubrizol Lifesciences company, for the manufacture and supply of the Company’s breast implants. On March 14, 2017, the Company announced it had submitted a site-change pre-market approval, or PMA, supplement to the FDA for the manufacture of the Company’s PMA-approved breast implants at the Vesta manufacturing facility. On January 30, 2018, the Company announced the FDA has granted approval of the site-change supplement for the Company’s contract manufacturer, Vesta, to manufacture its silicone gel breast implants.  In support of the move to the Vesta manufacturing facility, the Company also implemented new manufacturing process improvements which, in consultation with the FDA, required three (3) additional PMA submissions.  In addition to approving the manufacturing site-change PMA supplement, the FDA approved the Company’s three (3) process enhancement submissions on January 10, 2018, January 19, 2018 and April 17, 2018.

c.

Follow-On Offering

On May 7, 2018, the Company completed an underwritten follow-on public offering of 7,407,408 shares of its common stock at $13.50 per share, as well as 1,111,111 additional shares of its common stock pursuant to the full exercise of the over-allotment option granted to the underwriters. Net proceeds to the Company were approximately $107.6 million after deducting underwriting discounts and commissions of $6.9 million and offering expenses of approximately $0.5 million.

On June 7, 2019, the Company completed an underwritten follow-on public offering of 17,391,305 shares of its common stock at $5.75 per share, as well as 2,608,695 additional shares of its common stock pursuant to the full exercise of the over-allotment option granted to the underwriters. Net proceeds to the Company were approximately $107.7 million after deducting underwriting discounts and commissions of $6.9 million and offering expenses of approximately $0.4 million.


2.

Summary of Significant Accounting Policies

a.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of Sientra, Inc. (“Sientra”, the “Company”, “we”, “our”, or “us”) in this Quarterly Report on Form 10-Q have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and the rules and regulations of the U.S. Securities and Exchange Commission, or SEC. Accordingly, they do not include certain footnotes and financial presentations normally required under accounting principles generally accepted in the United States of America for complete financial reporting. The interim financial information is unaudited, but reflects all normal adjustments and accruals which are, in the opinion of management, considered necessary to provide a fair presentation for the interim periods presented. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 20182019 filed with the SEC on March 14, 2019,16, 2020, or the Annual Report. The results for the three and nine months ended September 30, 20192020 are not necessarily indicative of results to be expected for the year ending December 31, 2019,2020, any other interim periods, or any future year or period.

 

b.

Liquidity

Since the Company’s inception, it has incurred significant net operating losses and the Company anticipates that losses will continue in the near term. TheAlthough the Company expects its operating expenses will continuebegin to growdecrease with the implementation of the organizational efficiency initiative announced on November 7, 2019, and other measures introduced as they expand operations.  Theannounced in the Company’s filing on Form 8-K on April 7, 2020, the Company will need to generate significant net sales to achieve profitability. To date, the Company has funded operations primarily with proceeds from the sales of preferred stock, borrowings under term loans and the convertible note, sales of products since 2012, and the proceeds from the sale of common stock in public offerings.

The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which implies the Company will continue to realize its assets and discharge its liabilities in the normal course of business. As of September 30, 2019, the Company had cash and cash equivalents of $120.9 million. Since inception, the Company has incurred recurring losses from operations and cash outflows from operating activities. The continuation of the Company as a going concern is dependent upon many factors including liquidity and the ability to raise capital.The Company received FDA approval of their PMA supplement on April 17, 2018 and was then able to access a $10.0 million term loan pursuant to an amendment to

During the credit agreement with MidCap Financial Trust, or MidCap. In addition, in February 2018,nine months ended September 30, 2020, the Company entered into an sold 37,000 shares of its common stock under the At-The-Market Equity Offering Sales Agreement with Stifel, Nicolaus & Company, Incorporated, or Stifel, as sales agent pursuant to which the Company may sell, from time to time, through Stifel, shares of our common stock having an aggregate gross offering price of up to $50.0 million. AsThe sales of September 30, 2019, the Company has not sold any common stock pursuant to the sales agreement. Further, on May 7, 2018 and June 7, 2019, the Company completed public offerings of its common stock, raising approximately $107.6 million and $107.7 million, respectively,resulted in net proceeds after deducting underwriting discounts and commissions and other offering expenses.of approximately $0.3 million.

On July 1, 2019,March 11, 2020, the Company entered into a facility agreement with Deerfield Partners, L.P., issuing $60.0 million in principal amount of 4.0% unsecured and subordinated convertible notes upon the terms and conditions set forth in the facility agreement. Further on May 11, 2020, the Company amended certain credit agreements with Midcap Financial Trust pursuant to which the Company repaid certain amounts of its existing indebtedness under its Loan Agreement and the outstanding commitment fee was cancelled.indebtedness. See Note 10 – Long-Term Debt and Revolving Loan for further discussion.

As of September 30, 2020, the Company had cash and cash equivalents of $63.5 million. The Company believes that its cash and cash equivalents will be sufficient to fund its operations for at least the next 12 months. To fund ongoing operating and capital needs, the Company may need to raise additional capital in the future through the sale of equity securities and incremental debt financing.


 

c.

Use of Estimates

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


 

d.

Recent Accounting Pronouncements

Recently Adopted Accounting Standards

 

In February 2016,August 2018, the FASB issued Accounting Standards Update,ASU 2018-13, Fair Value Measurement (Topic 820) - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement. The amendment modifies, removes, and adds certain disclosure requirements on fair value measurements. The ASU is effective for annual periods, including interim periods within those annual periods, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or ASU, 2016-02, Leases (Topic 842). This ASU requires a company to recognize lease assets and liabilities arising from operating leasesannual period presented in the statementinitial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption was permitted. The Company adopted the applicable amendments within ASU 2018-13 prospectively in the first quarter of 2020 and there was no material impact on its condensed consolidated financial position. Thisstatements from the adoption.

In August 2018, the FASB issued ASU does2018-15, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40) - Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract. The amendment aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal use software license). The accounting for the service element of a hosting arrangement that is a service contract is not significantly changeaffected by the previous lease guidance for how a lessee should recognize the recognition, measurement, and presentation of expenses and cash flows arising from a lease. Additionally, the criteria for classifying a finance lease versus an operating lease are substantially the same as the previous guidance. Thisamendment. The ASU is effective for annual periods, including interim periods within those annual periods, beginning after December 15, 2019. Early adoption was permitted. The Company adopted ASU 2018-15 prospectively in the first quarter of 2020 and there was no material impact on its condensed consolidated financial statements from the adoption.


Recently Issued Accounting Standards

In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. The amendment eliminates certain accounting models and simplifies the accounting for convertible instruments and enhances disclosures for convertible instruments and earnings per share. The amendments are effective for public entities excluding smaller reporting companies for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2018,2023 including interim periods within those fiscal years and early adoption wasis permitted. The Company is currently evaluating the impact that adoption of the standard will have on the consolidated financial statements.  

In July 2018,March 2020, the FASB issued ASU 2018-11, Leases2020-04, Reference Rate Reform (Topic 842) Targeted Improvements, amending certain aspects848)-Facilitation of the new leasing standard.Effects of Reference Rate Reform on Financial Reporting. The amendment allowedprovides optional expedients and exceptions for contract modifications that replace a reference rate affected by reference rate reform. The amendments are effective for all entities as of March 12, 2020 through December 31, 2022, and entities may elect to apply by Topic as of any date from the beginning of an additional optional transition method wherebyinterim period that includes or is subsequent to March 12, 2020, or prospectively from a date within an entity records a cumulative effect adjustmentinterim period that includes or is subsequent to opening retained earnings inMarch 12, 2020, up to the year of adoption without restating prior periods.date that the financial statements are available to be issued. The Company adopted Topic 842 on January 1, 2019 electingis currently evaluating the package of practical expedients permitted underimpact the transition guidance, which allowed the Company to carry forward the historical lease classification, the assessment on whether a contract is or contains a lease, and the initial direct costs for any leases that exist prior to adoptionelection of the new standard. The Company has not restated prior periods underoptional expedient will have on the optional transition method. The adoption of ASU 2016-02 on January 1, 2019 resulted in the recognition of right-of-use assets of approximately $22.7 million, lease liabilities of approximately $22.9 million and no cumulative-effect adjustment on retained earnings on its Condensed Consolidated Balance Sheets. Refer to Note 9 - Leases for further details.

consolidated financial statements.

In February 2018,December 2019, the FASB issued ASU 2018-02, 2019-12, Income Taxes (Topic 740), which allows: Simplifying the Accounting for an entityIncome Taxes. The amendment removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation, and calculating income taxes in interim periods. The amendment also adds guidance to electreduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to reclassify the income tax effects on items within accumulated other comprehensive income resulting from U.S. Tax Cuts and Jobs Act to retained earnings.members of a consolidated group. The guidanceASU is effective for annual and interim periods in fiscal years beginning after December 15, 2018 with early2020.Early adoption permitted, including interim periods within those years.is permitted. The Company adopted ASC 2018-02 and elected to not reclassifyis currently evaluating the income tax effects under ASU 2018-02, as it does notimpact that adoption of the standard will have a material impact on the condensed consolidated financial statements.

 

 

e.

Risks and Uncertainties

The rapid, global spread of COVID-19 has resulted in significant economic uncertainty, significant declines in business and consumer confidence and global demand in the non-essential healthcare industry (among others), a global economic slowdown, and could lead to a global recession. The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, and employee-related amounts, will depend on future developments that are highly uncertain. The Company continues to monitor and assess new information related to the COVID-19 pandemic, the actions taken to contain or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets.

As an aesthetics company, surgical procedures involving the Company's products are susceptible to local and national government restrictions, such as social distancing, “shelter in place” orders and business closures, due to the economic and logistical impacts these measures have on consumer demand as well as the practitioners’ ability to administer such procedures. The inability or limited ability to perform such non-emergency procedures significantly harmed the Company’s revenues during the three months ended June 30, 2020 and continued to harm the Company’s revenues during the three months ended September 30, 2020. While some states have lifted certain restrictions on non-emergency procedures during the three months ended September 30, 2020, the Company will likely continue to experience future harm to its revenues while existing or new restrictions remain in place.

Further, the spread of COVID-19 has caused the Company to modify workforce practices, and the Company may take further actions determined to be in the best interests of the Company’s employees or as required by governments. In addition, capital markets and economies worldwide have also been negatively impacted by the COVID-19 pandemic, and it is possible that this can lead to a local and/or global economic recession, which may result in further harm to the aesthetics market. Such economic disruption could adversely affect the Company’s


business. The continued spread of COVID-19, or another infectious disease, could also result in delays or disruptions in the Company’s supply chain or adversely affect the Company’s manufacturing facilities and personnel. Further, trade and/or national security protection policies may be adjusted as a result of the COVID-19 pandemic, such as actions by governments that limit, restrict or prevent the movement of certain goods into a country and/or region, and current U.S./China trade relations may be further exacerbated by the pandemic.

The estimates used for, but not limited to, determining the collectability of accounts receivable, fair value of long-lived assets and goodwill, and sales returns liability required could be impacted by the pandemic. While the full impact of COVID-19 is unknown at this time, the Company has made appropriate estimates based on the facts and circumstances available as of the reporting date. These estimates may change as new events occur and additional information is obtained.

f.

Reclassifications

 

Certain reclassifications have been made to prior year amounts to conform to the current year presentation.

3.2.

RevenueRestructuring

On November 7, 2019, the Company announced an organizational efficiency initiative, or the Plan, designed to reduce spending and simplify operations. Under the Plan, the Company is implementing numerous initiatives to reduce spending, including closing the Santa Clara offices of miraDry, Inc. and consolidating a number of business support services via a shared services organization at the Company’s Santa Barbara headquarters.

Under the Plan, the Company intends to reduce its workforce by terminating approximately 70 employees. The Company expects to incur total charges of approximately $2.5 million in connection with one-time employee termination costs, retention costs and other benefits. In addition, the Company expects to incur estimated charges of approximately $0.5 million related to duplicate operating costs and other associated costs. In total, the Plan is estimated to cost approximately $3.0 million, excluding non-cash charges, with related cash payments expected to be substantially paid out with cash on hand by the end of 2020.

The following table details the amount of the liabilities related to the Plan included in "Accrued and other current liabilities" in the condensed consolidated balance sheet as of September 30, 2020 (amounts in thousands):

 

 

Severance costs

 

 

Other associated costs

 

 

Duplicate operating costs

 

Balance at December 31, 2019

 

$

894

 

 

$

 

 

$

 

Costs charged to expense

 

 

1,467

 

 

 

208

 

 

 

174

 

Costs paid or otherwise settled

 

 

(1,995

)

 

 

(208

)

 

 

(174

)

Balance at September 30, 2020

 

$

366

 

 

$

 

 

$

 

The following table details the charges by reportable segment, recorded in "Restructuring" under operating expenses in the condensed consolidated statements of operations for the nine months ended September 30, 2020 (amounts in thousands):

 

 

Year Ended

 

 

Nine Months Ended

 

 

Cumulative Restructuring

 

 

 

December 31, 2019

 

 

September 30, 2020

 

 

Charges

 

Breast Products

 

$

499

 

 

$

389

 

 

$

888

 

miraDry

 

 

584

 

 

 

1,460

 

 

 

2,044

 

Total

 

$

1,083

 

 

$

1,849

 

 

$

2,932

 


The Company anticipates incurring approximately $0.1 million of additional restructuring costs during the remainder of 2020 attributable to the miraDry segment. As the development of the Plan is completed, the Company will update its costs by reportable segment as needed.

3.Revenue

Revenue Recognition

The Company generates revenue primarily through the sale and delivery of promised goods or services to customers and recognizes revenue when control is transferred to customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for the goods or services.

Performance obligations typically include the delivery of promised products, such as breast implants, tissue expanders, BIOCORNEUM, miraDry Systems and bioTips, along with service-type warranties and deliverables under certain marketing programs. Other deliverables are sometimesmay be promised but are ancillary and insignificant in the context of the contract as a whole. Sales prices are documented in the executed sales contract, purchase order or order acknowledgement prior to the transfer of control to the customer. Customers may enter into a separate extended service agreement to purchase an extended warranty for miraDry products from the Company whereby the payment is due at the inception of the agreement. Typical payment terms are 30 days for Breast Products and direct sales of consumable miraDry products, and tend to be longer for capital sales of miraDry Systems and sales to miraDry distributors, but do not extend beyond one year. For delivery of promised products, control transfers and revenue is recognized upon shipment, unless the contractual arrangement requires transfer of control when products reach their destination, for which revenue is recognized once the product arrives at its destination. Revenue for extended service agreementswarranties are recognized ratably over the term of the agreements.


For Breast Products, with the exceptionagreements, and revenue related to marketing program deliverables are recognized upon delivery of the Company’s BIOCORNEUM scar management products, the Company allows for the return of products from customers within six months after the original sale, which is accounted for as variable consideration. Reserves are established for anticipated sales returns based on the expected amount calculated with historical experience, recent gross sales and any notification of pending returns. The estimated sales return is recorded as a reduction of revenue and as a sales return liability in the same period revenue is recognized. Actual sales returns in any future period are inherently uncertain and thus may differ from the estimates. If actual sales returns differ significantly from the estimates, an adjustment to revenue in the currentmarketing product or subsequent period would be recorded. The Company has established an allowance for sales returns of $7.6 million and $6.0 million as of September 30, 2019 and December 31, 2018 respectively, recorded as “sales return liability” on the condensed consolidated balance sheets.

The following table provides a rollforwardperformance of the sales return liability (in thousands):service.

 

 

Sales return liability

 

Balance as of December 31, 2018

 

$

6,048

 

Addition to reserve for sales activity

 

 

74,621

 

Actual returns

 

 

(73,815

)

Change in estimate of sales returns

 

 

709

 

Balance as of September 30, 2019

 

$

7,563

 

For Breast Products, a portion of the Company’s revenue is generated from the sale of consigned inventory of breast implants maintained at doctor, hospital, and clinic locations. For these products, revenue is recognized at the time the Company is notified by the customer that the product has been implanted, not when the consigned products are delivered to the customer’s location.

For miraDry, in addition to domestic and international direct sales, the Company leverages a distributor network for selling the miraDry System internationally. The Company recognizes revenue when control of the goods or services is transferred to the distributors. Standard terms in both direct sales agreements (domestic and international), and international distributor agreements do not allow for trial periods, right of return, refunds, payment contingent on obtaining financing or other terms that could impact the customer’s payment obligation.

Arrangements with Multiple Performance Obligations

The Company has determined that the delivery of each unit of product in the Company’s revenue contracts with customers is a separate performance obligation. The Company’s revenue contracts may include multiple products or services, each of which is considered a separate performance obligation. For such arrangements, the Company allocates revenue to each performance obligation based on its relative standalone selling price. The Company generally determines standalone selling prices based on observable prices or using an expected cost plus margin approach when an observable price is not available. The Company invoices customers once products are shipped or delivered to customers depending on the negotiated shipping terms.

The Company introduced its Platinum20 Limited Warranty Program, or Platinum20, in May 2018 on all OPUS breast implants implanted in the United States or Puerto Rico on or after May 1, 2018.  Platinum20 provides for financial assistance for revision surgeries and no-charge contralateral replacement implants upon the occurrence of certain qualifying events. The Company considers Platinum20 to have an assurance warranty component and a service warranty component. The assurance component is recorded as a warranty liability at the time of sale (as discussed in Note 6). The Company considers the service warranty component as an additional performance obligation and defers revenue at the time of sale based on the relative estimated selling price, by estimating a standalone selling price using the expected cost plus margin approach for the performance obligation. Inputs into the expected cost plus margin approach include historical incidence rates, estimated replacement costs, estimated financial assistance payouts and an estimated margin. The liability for unsatisfied performance obligations under the service warranty and deliverables under certain marketing programs as of September 30, 2019 and December 31, 2018 was $0.9 million and $0.4 million respectively. The short-term obligation related to the service warranty was $0.4 million and $0.2 million2020 were as of September 30, 2019 and December 31, 2018, respectively, and is included in “accrued and other current liabilities” on the condensed consolidated balance sheets. The long-term obligation related to the service warranty was $0.5 million and $0.3 million as of September 30, 2019 and December 31, 2018, respectively, and is included in “warranty reserve and other long-term liabilities” on the condensed consolidated balance sheets. The performance obligation is satisfied at the time that Platinum20 benefits are provided and are expected to be satisfied over the following 6 to 24 month period for financial assistance and 20 years for product replacement. Revenue recognized for the service warranty performance obligations for the three and nine months ended September 30, 2019 was immaterial.follows:


 

 

Nine Months Ended September 30,

 

 

 

2020

 

Balance as of December 31, 2019

 

$

2,089

 

Additions and adjustments

 

 

2,077

 

Revenue recognized

 

 

(1,389

)

Balance as of September 30, 2020

 

$

2,777

 

Practical Expedients and Policy Election

The Company generally expenses sales commissions when incurred because the amortization period would have been one year or less. These costs are recorded within sales and marketing expenses.

The Company does not adjust accounts receivable for the effects of any significant financing components as customer payment terms are shorter than one year.

The Company has elected to account for shipping and handling activities performed after a customer obtains control of the products as activities to fulfill the promise to transfer the products to the customer. Shipping and handling activities are largely provided to customers free of charge for the Breast Products segment. The associated costs were $1.4 million and $0.9 million for the nine months ended September 30, 2019 and 2018 respectively. The associated costs were $0.5 million and $0.3 million for the three months ended September 30, 2019 and 2018 respectively. These costs are viewed as part of the Company’s sales and marketing programs and are recorded as a component of sales and marketing expense in the condensed consolidated statement of operations as an accounting policy election. For the miraDry segment, shipping and handling charges are typically billed to customers and recorded as revenue. The shipping and handling costs incurred are recorded as a component of cost of goods sold in the condensed consolidated statement of operations. The associated costs were $0.6 million and $0.2 million for the nine months ended September 30, 2019 and 2018 respectively. The associated costs were $0.3 million and $0.1 million for the three months ended September 30, 2019 and 2018 respectively.

4.

Fair Value of Financial Instruments

The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, customer deposits and sales return liability are reasonable estimates of their fair value because of the short maturity of these items. The fair value of the common stock warrant liability, and contingent consideration, and the convertible feature related to the convertible note are discussed in Note 5. The fair value of the debt is based on the amount of future cash flows associated with the instrument discounted using the Company’s estimated market rate. As of September 30, 2019,2020, the carrying value of the long-term debt and convertible note was not materially different from the fair value.

5.

Fair Value Measurements

Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.

Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

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

Level 2 — Observable inputs (other than Level 1 quoted prices) such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

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


Level 2 — Observable inputs (other than Level 1 quoted prices) such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

Common Stock Warrants

The Company’s common stock warrant liabilities are carried at fair value determined according to the fair value hierarchy described above. The Company has utilized an option pricing valuation model to determine the fair value of its outstanding common stock warrant liabilities. The inputs to the model include fair value of the common stock related to the warrant, exercise price of the warrant, expected term, expected volatility, risk-free interest rate and dividend yield. The warrants are valued using the fair value of common stock as of the measurement date. The Company estimates its expected stock volatility based on company-specific historical and implied volatility information of its stock. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company has estimated a 0% dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared dividends. As several significant inputs are not observable,of September 30, 2020, the overall fair value measurement of the warrants is classifiedwas immaterial as Level 3.a result of the decline in the Company’s stock price.

Contingent Consideration

The Company assessed the fair value of the contingent consideration for future royalty payments related to the acquisition of BIOCORNEUM and the contingent consideration for the future milestone payments related to the acquisition of miraDry using a Monte-Carlo simulation model. Significant assumptions used inThe contingent consideration related to the measurement includeacquisition of BIOCORNEUM consist of royalty obligations based on future net sales for a defined term, andbeginning in 2024. The significant assumption utilized in the risk-adjustedfair value measurement was the revenue discount rate, associated withwhich was 20.0%. The contingent consideration for future milestone payments related to the business.acquisition of miraDry is based on the timing of achievement of target net sales, which is estimated based on an internal management forecast. The significant assumption utilized in the fair value measurement was the miraDry company discount rate, which was 11.2%. As thethese inputs are not observable, the overall fair value measurement of the contingent consideration is classified as Level 3. During the nine months ended September 30, 2020, the total change in the fair value of contingent consideration was $0.1 million and 0 settlements were recorded.

Convertible note conversion feature

The Company assesses on a quarterly basis the fair value of the conversion feature related to the convertible note due in 2025. The conversion feature was bifurcated and recorded as a derivative liability on the condensed consolidated balance sheet with a corresponding discount at the date of issuance that is netted against the principal amount of the note. The Company utilizes a binomial lattice method to determine the fair value of the conversion feature, which utilizes inputs including the common stock price, volatility of common stock, the risk-free interest rate and the probability of conversion to common shares at the Base Conversion Rate in the event of a major transaction (e.g. a change in control). As the probability of conversion is a significant unobservable input, the overall fair value measurement of the conversion feature is classified as Level 3. During the three months ended September 30, 2020, the change in the fair value of the derivative liability was a decrease of $10.1 million. During the nine months ended September 30, 2020, the change in the fair value of the derivative liability was an increase of $8.4 million. NaN settlements were recorded.


The following tables present information about the Company’s liabilities that are measured at fair value on a recurring basis as of September 30, 20192020 and December 31, 20182019 and indicate the level of the fair value hierarchy utilized to determine such fair value (in thousands):

 

 

Fair Value Measurements as of

 

 

Fair Value Measurements as of

 

 

September 30, 2019 Using:

 

 

September 30, 2020 Using:

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liability for common stock warrants

 

$

 

 

 

 

 

 

3

 

 

 

3

 

Liability for contingent consideration

 

 

 

 

 

 

 

 

6,437

 

 

 

6,437

 

 

$

 

 

 

 

 

 

6,959

 

 

 

6,959

 

Liability for convertible note conversion feature

 

 

 

 

 

 

 

 

24,520

 

 

 

24,520

 

 

$

 

 

 

 

 

 

6,440

 

 

 

6,440

 

 

$

 

 

 

 

 

 

31,479

 

 

 

31,479

 

 

 

Fair Value Measurements as of

 

 

Fair Value Measurements as of

 

 

December 31, 2018 Using:

 

 

December 31, 2019 Using:

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liability for common stock warrants

 

$

 

 

 

 

 

 

113

 

 

 

113

 

 

$

 

 

 

 

 

 

38

 

 

 

38

 

Liability for contingent consideration

 

 

 

 

 

 

 

 

13,847

 

 

 

13,847

 

 

 

 

 

 

 

 

 

6,891

 

 

 

6,891

 

 

$

 

 

 

 

 

 

13,960

 

 

 

13,960

 

 

$

 

 

 

 

 

 

6,929

 

 

 

6,929

 

 

The liability for common stock warrants and the current portion of contingent consideration is included in “accrued and other current liabilities” and the long-term liabilities for the contingent consideration areportion is included in “deferred and contingent consideration” in the condensed consolidated balance sheet. The following table provides a rollforward ofliability for the aggregate fair values ofconversion feature related to the Company’s common stock warrants and contingent consideration for which fair valueconvertible note is determined by Level 3 inputs (in thousands):  included in “derivative liability” in the condensed consolidated balance sheet.

Warrant Liability

 

 

 

 

Balance, December 31, 2018

 

$

113

 

Change in fair value of warrant liability

 

 

(110

)

Balance, September 30, 2019

 

$

3

 

Contingent Consideration Liability

 

 

 

 

Balance, December 31, 2018

 

$

13,847

 

Settlements of contingent consideration

 

 

(8,000

)

Change in fair value of contingent consideration

 

 

590

 

Balance, September 30, 2019

 

$

6,437

 


The Company recognizes changes in the fair value of the warrantsderivative liability in “other income (expense), net”“change in fair value of derivative liability” in the condensed consolidated statement of operations and changes in the contingent consideration are recognized in “general and administrative” expense in the condensed consolidated statement of operations.

 

6.

Product Warranties

The Company offers a product replacement and limited warranty program for the Company’s silicone gel breast implants, and a product warranty for the Company’s miraDry Systems and consumable bioTips. For silicone gel breast implant surgeries occurring prior to May 1, 2018, the Company provides lifetime replacement implants and up to $3,600 in financial assistance for revision surgeries, for covered rupture events that occur within ten years of the surgery date. The Company introduced its Platinum20 Limited Warranty Program in May 2018, covering OPUS silicone gel breast implants implanted in the United States or Puerto Rico on or after May 1, 2018. The Company considers the program to have an assurance warranty component and a service warranty component. The service warranty component is discussed in Note 3 above. The assurance component is primarily related to the lifetime no-charge contralateral replacement implants and up to $5,000 in financial assistance for revision surgeries, for covered rupture events that occur within twenty years of the surgery date.  Under the miraDry warranty, the Company provides a standard product warranty for the miraDry System and bioTips, which the Company considers an assurance-type warranty.

The following table provides a rollforward of the accrued warranties (in thousands):

 

 

Nine Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

Balance as of January 1

 

$

1,395

 

 

$

1,642

 

 

$

1,562

 

 

$

1,395

 

Warranty costs incurred during the period

 

 

(492

)

 

 

(395

)

 

 

(501

)

 

 

(492

)

Changes in accrual related to warranties issued during the period

 

 

820

 

 

 

639

 

 

 

717

 

 

 

820

 

Changes in accrual related to pre-existing warranties

 

 

23

 

 

 

(637

)

 

 

(6

)

 

 

23

 

Balance as of September 30

 

$

1,746

 

 

$

1,249

 

 

$

1,772

 

 

$

1,746

 

 

 


7.

Net Loss Per Share

Basic net loss per share attributable to common stockholders is computed by dividing net loss by the weighted average number of common shares outstanding during each period. Diluted net loss per common share is computed by dividing net loss available to common stockholders by the weighted average number of common shares and dilutive potential common share equivalents then outstanding, to the extent they are dilutive. Potential common shares consist of shares issuable upon the exercise of stock options and warrants (using the treasury stock method). Dilutive net loss per share is the same as basic net loss per share for all periods presented because the effects of potentially dilutive items were anti-dilutive.

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2020

 

2019

 

 

2020

 

 

2019

 

Net loss (in thousands)

 

$

 

(22,433

)

 

$

 

(20,545

)

 

$

(86,571

)

 

$

(57,996

)

 

$

(5,821

)

 

$

(22,433

)

 

$

(68,710

)

 

$

(86,571

)

Weighted average common shares outstanding, basic

and diluted

 

 

 

49,401,094

 

 

 

 

28,462,975

 

 

 

37,671,215

 

 

 

24,312,300

 

 

 

50,394,858

 

 

 

49,401,094

 

 

 

50,155,623

 

 

 

37,671,215

 

Net loss per share attributable to common stockholders

 

$

 

(0.45

)

 

$

 

(0.72

)

 

$

(2.30

)

 

$

(2.39

)

 

$

(0.12

)

 

$

(0.45

)

 

$

(1.37

)

 

$

(2.30

)

 

The Company excluded the following potentially dilutive securities, outstanding as of September 30, 20192020 and 2018,2019, from the computation of diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 20192020 and 20182019 because they had an anti-dilutive impact due to the net loss attributable to common stockholders incurred for the periods.

 

 

September 30,

 

 

September 30,

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

Stock options to purchase common stock

 

 

924,097

 

 

 

1,926,835

 

 

 

1,571,375

 

 

 

2,036,027

 

Warrants for the purchase of common stock

 

 

47,710

 

 

 

47,710

 

 

 

27,264

 

 

 

47,710

 

Equity contingent consideration

 

 

607,442

 

 

 

 

Stock issuable upon conversion of convertible note

 

 

19,733,352

 

 

 

 

 

 

971,807

 

 

 

1,974,545

 

 

 

21,939,433

 

 

 

2,083,737

 

 


The Company uses the if-converted method for calculating any potential dilutive effects of the convertible note. The Company did not adjust the net loss for the three and nine months ended September 30, 2020 to eliminate any interest expense or gain/loss for the derivative liability related to the note in the computation of diluted loss per share, as the effects would be anti-dilutive.

8.

Balance Sheet Components

 

a.

Allowance for Doubtful Accounts

The Company has established an allowance for doubtful accounts of $3.3 million and $2.4 million as of September 30, 2019 and December 31, 2018, respectively, recorded net against accounts receivable in the balance sheet.

b.

Inventories

Inventories, net consist of the following (in thousands):

 

 

September 30,

 

 

December 31,

 

 

September 30,

 

 

December 31,

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

Raw materials

 

$

3,777

 

 

$

2,147

 

 

$

6,767

 

 

$

8,095

 

Work in progress

 

 

1,837

 

 

 

2,110

 

 

 

9,356

 

 

 

5,543

 

Finished goods

 

 

22,869

 

 

 

18,335

 

 

 

28,809

 

 

 

23,893

 

Finished goods - right of return

 

 

1,891

 

 

 

1,493

 

 

 

3,535

 

 

 

2,081

 

 

$

30,374

 

 

$

24,085

 

 

$

48,467

 

 

$

39,612

 

 


 

c.b.

Property and Equipment

Property and equipment, net consist of the following (in thousands): 

 

 

September 30,

 

 

December 31,

 

 

September 30,

 

 

December 31,

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

Leasehold improvements

 

$

408

 

 

$

402

 

 

$

2,857

 

 

$

2,841

 

Manufacturing equipment and toolings

 

 

3,384

 

 

 

1,928

 

 

 

9,037

 

 

 

8,175

 

Computer equipment

 

 

908

 

 

 

682

 

 

 

2,375

 

 

 

1,250

 

Software

 

 

1,441

 

 

 

1,039

 

 

 

3,056

 

 

 

2,602

 

Office equipment

 

 

111

 

 

 

156

 

 

 

167

 

 

 

111

 

Furniture and fixtures

 

 

1,031

 

 

 

826

 

 

 

1,192

 

 

 

1,144

 

 

 

7,283

 

 

 

5,033

 

 

 

18,684

 

 

 

16,123

 

Less accumulated depreciation

 

 

(3,303

)

 

 

(2,497

)

 

 

(5,942

)

 

 

(3,809

)

 

$

3,980

 

 

$

2,536

 

 

$

12,742

 

 

$

12,314

 

 

Depreciation expense for the three months ended September 30, 2020 and 2019 and 2018 was $0.3$1.0 million and $0.2$0.3 million, respectively. Depreciation expense for both the nine months ended September 30, 2020 and 2019 was $1.8 million and 2018 was $0.9 million.million, respectively.

 

Under the terms of the manufacturing agreement with Vesta, upon the commencement of Contract Year One (as defined in the agreement) which occurred following FDA-approval of all submissions related to the site-change PMA supplement for the Vesta manufacturing facility, Vesta was obligated to purchase the manufacturing equipment and tooling that Sientra had originally purchased for the manufacture of Sientra’s breast implant inventory at Vesta’s manufacturing facility. Vesta repurchased the equipment with a net book value of $2.7 million in the third quarter of 2018 through a reduction in the Company’s accounts payable balance owed to Vesta.

 

d.c.

Goodwill and Other Intangible Assets, net

The Company has determined that it has two reporting units, Breast Products and miraDry, and evaluates goodwill for impairment at least annually on October 1st and whenever circumstances suggest that goodwill may be impaired. As of September 30, 2019 and December 31, 2018 the miraDry reporting unit had a negative carrying value.


The changes in the carrying amount of goodwill during the nine months ended September 30, 2020 and the year ended December 31, 2019 were as follows (in thousands):

 

 

Breast Products

 

 

miraDry

 

 

Total

 

 

Breast Products

 

 

miraDry

 

 

Total

 

Balances as of December 31, 2018

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of December 31, 2019

 

 

 

 

 

 

 

 

 

 

 

 

Goodwill

 

$

19,156

 

 

$

7,629

 

 

$

26,785

 

 

 

23,480

 

 

 

7,629

 

 

 

31,109

 

Accumulated impairment losses

 

 

(14,278

)

 

 

 

 

 

(14,278

)

 

 

(14,278

)

 

 

(7,629

)

 

 

(21,907

)

Goodwill, net

 

$

4,878

 

 

$

7,629

 

 

$

12,507

 

 

$

9,202

 

 

$

 

 

$

9,202

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of September 30, 2019

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of September 30, 2020

 

 

 

 

 

 

 

 

 

 

 

 

Goodwill

 

$

19,156

 

 

$

7,629

 

 

$

26,785

 

 

 

23,480

 

 

 

7,629

 

 

 

31,109

 

Accumulated impairment losses

 

 

(14,278

)

 

 

(7,629

)

 

 

(21,907

)

 

 

(14,278

)

 

 

(7,629

)

 

 

(21,907

)

Goodwill, net

 

$

4,878

 

 

$

 

 

$

4,878

 

 

$

9,202

 

 

$

 

 

$

9,202

 

 

In the secondfirst quarter of 2019,2020, the Company noted a decline in actual and forecasted earnings for the miraDry reporting unit in comparisondue to forecasted earnings determined in prior periods. Based on this evaluation, the Company determined thatimpacts and uncertainty surrounding the carrying value of the miraDry reporting unit more likely than not exceeded its estimated fair value.COVID-19 pandemic. As a result, the Company performed a quantitative analysis to comparetest of recoverability by comparing the faircarrying value of the reporting unit to its carrying amount.

The Company’s fair value analysis of goodwill utilizes the income approach, which requires the use of estimates about a reporting unit’s future revenues and free cash flows, discount rates, terminal value and enterprise value to determine the estimated fair value. The Company’s future revenues and free cash flow assumptions are determined based upon actual results giving effect to management’s expected changes in operating results in future years. The enterprise value, discount rates and terminal value are based upon market participant assumptions using a defined peer group.

After performing the impairment test as of June 30, 2019 the Company determined that the carrying value of its miraDry reporting unit exceeded its estimated fair value using the income approach, as described above, by an amount that indicated a full impairment of the carrying value of goodwill. Consequently, the Company recorded a non-cash goodwill impairment charge of $7.6 million during the second quarter ended June 30, 2019, which is reflected in the accompanying condensed consolidated statement of operations for the nine months ended September 30, 2019.

The components of the Company’s other intangible assets consist of the following (in thousands):

 

 

Average

 

 

 

 

 

 

Amortization

 

 

September 30, 2019

 

 

 

Period

 

 

Gross Carrying

 

 

Accumulated

 

 

Intangible

 

 

 

(in years)

 

 

Amount

 

 

Amortization

 

 

Assets, net

 

Intangibles with definite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer relationships

 

 

11

 

 

$

9,540

 

 

$

(3,412

)

 

$

6,128

 

Trade names - finite life

 

 

14

 

 

 

2,000

 

 

 

(257

)

 

 

1,743

 

Developed technology

 

 

13

 

 

 

1,500

 

 

 

(42

)

 

 

1,458

 

Non-compete agreement

 

 

2

 

 

 

80

 

 

 

(80

)

 

 

 

Regulatory approvals

 

 

1

 

 

 

670

 

 

 

(670

)

 

 

 

Acquired FDA non-gel product approval

 

 

11

 

 

 

1,713

 

 

 

(1,713

)

 

 

 

Total definite-lived intangible assets

 

 

 

 

 

$

15,503

 

 

$

(6,174

)

 

$

9,329

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangibles with indefinite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trade names - indefinite life

 

 

 

 

450

 

 

 

 

 

 

450

 

Total indefinite-lived intangible assets

 

 

 

 

 

$

450

 

 

$

 

 

$

450

 


 

 

Average

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization

 

 

December 31, 2018

 

 

 

Period

 

 

Gross Carrying

 

 

Accumulated

 

 

Intangible

 

 

 

(in years)

 

 

Amount

 

 

Amortization

 

 

Assets, net

 

Intangibles with definite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer relationships

 

 

11

 

 

$

11,240

 

 

$

(3,486

)

 

$

7,754

 

Trade names - finite life

 

 

14

 

 

 

5,800

 

 

 

(541

)

 

 

5,259

 

Developed technology

 

 

15

 

 

 

3,000

 

 

 

(338

)

 

 

2,662

 

Distributor relationships

 

 

9

 

 

 

500

 

 

 

(130

)

 

 

370

 

Non-compete agreement

 

 

2

 

 

 

80

 

 

 

(80

)

 

 

 

Regulatory approvals

 

 

1

 

 

 

670

 

 

 

(670

)

 

 

 

Acquired FDA non-gel product approval

 

 

11

 

 

 

1,713

 

 

 

(1,713

)

 

 

 

Total definite-lived intangible assets

 

 

 

 

 

$

23,003

 

 

$

(6,958

)

 

$

16,045

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangibles with indefinite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trade names - indefinite life

 

 

 

 

450

 

 

 

 

 

 

450

 

Total indefinite-lived intangible assets

 

 

 

 

 

$

450

 

 

$

 

 

$

450

 

In connection with the circumstances leading to the impairment of goodwill for the miraDry reporting unit, in the second quarter of 2019 the Company performed a test of recoverability of the intangible assets in the miraDry reporting unit by comparing the carrying amount of the intangible assets to the future undiscounted cash flows the assets arereporting unit is expected to generate. As the future undiscounted cash flows attributable to the intangible assetsasset group were less than the carrying value, the Company performed a quantitative analysis to compare the fair value of the intangible assets in the reporting unit to their carrying amount.

 


The Company’s fair value analysis of intangible assets utilizes methods under various income approaches. The Company values its customer relationships using an excess earnings method, which assumes the value of the asset is the discounted cash flow using estimates of future cash flowflows derived from existing customers. Similarly, distributor relationshipscustomersand requires the use of customer attrition rates and discount rates to determine the estimated fair value. The future revenues and free cash flow from existing customers are valueddetermined based upon actual results giving effect to management’s expected changes in operating results in future years. The attrition rate is based on average historical levels of customer attrition and the discount rate is based upon market participant assumptions using a distributor method, which assumes the value of the asset is the discounted cash flow using estimates of future cash flow derived from existing distributors.defined peer group. Tradenames and developed technology are valued using a relief from royalty method, which assumes the value of the asset is the discounted cash flows of the amount that would be paid by a hypothetical market participant had they not owned the asset and instead licensed the asset from another company.

This method requires the use of royalty rates which are determined based on comparable third-party license agreements involving similar assets and discount rates similar to the above to determine the estimated fair value.

After performing the impairment testanalysis as of June 30, 2019,March 31, 2020, the Company determined that the carrying values of all of the intangible assets in the miraDry reporting unit exceeded their estimated fair values. Consequently, the Company recorded total non-cash impairment charges of $0.4$1.1 million for trade names, $1.4 million for developed technology, and $3.9 million for customer relationships $0.3 million for distributor relationships, $3.3 million for tradenames, and $1.0 million for developed technology within goodwill and other intangible impairment during the second quarter ended June 30, 2019, which is reflected in the accompanying condensed consolidated statement of operations for the nine months ended September 30, 2019.

2020. As of September 30, 20192020, the Company assessed qualitative factors in order to determine whether any events or circumstances existed which indicated that it was more likely than not that the fairremaining carrying value of the intangible assets did not exceed their carrying values and concluded no such events or circumstances existed which would require a quantitative impairment analysis to be performed. As such,are entirely associated with the Company did not record impairment charges forBreast Products segment.

The components of the three months ended September 30, 2019.Company’s other intangible assets consist of the following (in thousands):

 

 

 

Average

 

 

 

 

 

 

Amortization

 

 

September 30, 2020

 

 

 

Period

 

 

Gross Carrying

 

 

Accumulated

 

 

Intangible

 

 

 

(in years)

 

 

Amount

 

 

Amortization

 

 

Assets, net

 

Intangibles with definite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer relationships

 

 

10

 

 

$

4,940

 

 

$

(3,727

)

 

$

1,213

 

Trade names - finite life

 

 

12

 

 

 

800

 

 

 

(306

)

 

 

494

 

Non-compete agreement

 

 

2

 

 

 

80

 

 

 

(80

)

 

 

 

Regulatory approvals

 

 

1

 

 

 

670

 

 

 

(670

)

 

 

 

Acquired FDA non-gel product approval

 

 

11

 

 

 

1,713

 

 

 

(1,713

)

 

 

 

Manufacturing know-how

 

 

19

 

 

 

8,240

 

 

 

(678

)

 

 

7,562

 

Total definite-lived intangible assets

 

 

 

 

 

$

16,443

 

 

$

(7,174

)

 

$

9,269

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangibles with indefinite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trade names - indefinite life

 

 

 

 

450

 

 

 

 

 

 

450

 

Total indefinite-lived intangible assets

 

 

 

 

 

$

450

 

 

$

 

 

$

450

 


Intangibles amortization

 

 

Average

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization

 

 

December 31, 2019

 

 

 

Period

 

 

Gross Carrying

 

 

Accumulated

 

 

Intangible

 

 

 

(in years)

 

 

Amount

 

 

Amortization

 

 

Assets, net

 

Intangibles with definite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer relationships

 

 

11

 

 

$

9,540

 

 

$

(3,846

)

 

$

5,694

 

Trade names - finite life

 

 

14

 

 

 

2,000

 

 

 

(292

)

 

 

1,708

 

Developed technology

 

 

13

 

 

 

1,500

 

 

 

(84

)

 

 

1,416

 

Non-compete agreement

 

 

2

 

 

 

80

 

 

 

(80

)

 

 

 

Regulatory approvals

 

 

1

 

 

 

670

 

 

 

(670

)

 

 

 

Acquired FDA non-gel product approval

 

 

11

 

 

 

1,713

 

 

 

(1,713

)

 

 

 

Manufacturing know-how

 

 

19

 

 

 

8,240

 

 

 

(118

)

 

 

8,122

 

Total definite-lived intangible assets

 

 

 

 

 

$

23,743

 

 

$

(6,803

)

 

$

16,940

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangibles with indefinite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trade names - indefinite life

 

 

 

 

450

 

 

 

 

 

 

450

 

Total indefinite-lived intangible assets

 

 

 

 

 

$

450

 

 

$

 

 

$

450

 

Amortization expense for the three months ended September 30, 2020 and 2019 was $0.3 million and 2018 were $0.5 million, and $0.6 million, respectively. Intangibles amortizationAmortization expense for both the nine months ended September 30, 2020 and 2019 was $1.2 million and 2018 was $1.7 million.million, respectively. The following table summarizes the estimated amortization expense relating to the Company's definite-lived intangible assets as of September 30, 20192020 (in thousands):

 

 

Amortization

 

 

Amortization

 

Period

 

Expense

 

 

Expense

 

Remainder of 2019

 

$

511

 

2020

 

 

1,554

 

 

$

332

 

2021

 

 

1,305

 

 

 

1,221

 

2022

 

 

1,122

 

 

 

1,163

 

2023

 

 

975

 

 

 

1,092

 

2024

 

 

948

 

Thereafter

 

 

3,862

 

 

 

4,513

 

 

$

9,329

 

 

$

9,269

 

 

 

e.d.

Accrued and Other Current Liabilities

Accrued and other current liabilities consist of the following (in thousands):

 

 

September 30,

 

 

December 31,

 

 

September 30,

 

 

December 31,

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

Payroll and related expenses

 

$

5,729

 

 

$

6,466

 

 

$

2,574

 

 

$

6,789

 

Accrued severance

 

 

980

 

 

 

894

 

Accrued commissions

 

 

3,750

 

 

 

5,321

 

 

 

5,335

 

 

 

4,984

 

Accrued equipment

 

 

1,107

 

 

 

18

 

Accrued manufacturing

 

 

835

 

 

 

2,616

 

Deferred and contingent consideration, current portion

 

 

6,361

 

 

 

7,645

 

 

 

6,931

 

 

 

6,830

 

Audit, consulting and legal fees

 

 

585

 

 

 

703

 

 

 

304

 

 

 

630

 

Accrued sales and marketing expenses

 

 

1,314

 

 

 

1,374

 

 

 

861

 

 

 

1,109

 

Operating lease liabilities

 

 

5,008

 

 

 

 

Finance lease liabilities

 

 

41

 

 

 

 

Lease liabilities

 

 

1,556

 

 

 

1,299

 

Other

 

 

4,846

 

 

 

6,170

 

 

 

7,303

 

 

 

7,400

 

 

$

28,741

 

 

$

27,697

 

 

$

26,679

 

 

$

32,551

 

 


9.

Leases

 

The Company leases certain office space, warehouses, distribution facilities and office equipment. The Company also has embedded leases of manufacturing facilities and equipment associated with the Company’s manufacturing contracts. The Company determines if an arrangement contains a lease at inception by evaluating whether the arrangement conveys the right to use an identified asset and whether the Company obtains substantially all of the economic benefits from and has the ability to direct the use of the asset.

 

Operating and finance lease right-of-use, or ROU, assets and lease liabilities are recognized based on the present value of the future lease payments over the lease term at the commencement date. The Company determines its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities as the Company’s leases generally do not provide an implicit rate. The ROU assets also include any initial direct costs incurred and any lease payments made at or before the lease commencement date, less lease incentives received. Lease terms may include options to extend or terminate when the Company is reasonably certain that the option will be exercised. During the second quarter of 2019, the Company included a five-year renewal option in the lease term for one operating lease as it was concluded that it is reasonably certain that the Company will exercise the option. The Company elected to apply the short-term lease measurement and recognition exemption in which ROU assets and lease liabilities are not recognized for short-term leases. The Company’s lease agreements generally do not contain material residual value guarantees or material restrictive covenants.

 


The Company’s leases of office space, warehouses and distribution facilities are treated as operating leases and often contain lease and non-lease components. The Company has elected to account for these lease and non-lease components separately. Non-lease components for these assets are primarily comprised of common-area maintenance, utilities, and real estate taxes that are passed on from the lessor in proportion to the space leased by the Company, and are recognized in operating expenses in the period in which the obligation for those payments was incurred. Lease cost for these operating leases is recognized on a straight-line basis over the lease term in operating expenses.

The Company’s embedded leases of manufacturing facilities and equipment are treated as operating leases and often contain lease and non-lease components. The Company has elected to account for these lease and non-lease components as a single lease component. There may be variability in future lease payments as the amount of the non-lease components is based on the costs of manufacturing and is dependent on the amount and types of units produced. The Company reduces the operating lease liability when the inventory is purchased.

 

The Company’s leases of office equipment are accounted for as finance leases as they meet one or more of the five finance lease classification criteria. Lease cost for these finance leases is comprised of amortization of the ROU asset and interest expense which are recognized in operating expenses and other income (expense), net.

 

Components of lease expense were as follows:

 

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

 

September 30,

 

 

September 30,

 

Lease Cost

 

Classification

 

2019

 

 

2019

 

 

Classification

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating lease cost

 

Operating expenses

 

$

389

 

 

$

1,155

 

 

Operating expenses

 

$

428

 

 

$

389

 

 

$

1,270

 

 

$

1,155

 

Operating lease cost

 

Inventory

 

 

1,248

 

 

 

3,743

 

 

Inventory

 

 

131

 

 

 

1,248

 

 

 

364

 

 

 

3,743

 

Total operating lease cost

 

 

 

 

 

$

1,637

 

 

$

4,898

 

 

 

 

$

559

 

 

$

1,637

 

 

$

1,634

 

 

$

4,898

 

Finance lease cost

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of right-of-use assets

 

Operating expenses

 

 

10

 

 

 

30

 

 

Operating expenses

 

 

10

 

 

 

10

 

 

 

31

 

 

 

30

 

Amortization of right-of-use assets

 

Inventory

 

 

12

 

 

 

 

 

 

24

 

 

 

 

Interest on lease liabilities

 

Other income (expense), net

 

 

1

 

 

 

3

 

 

Other income (expense), net

 

 

3

 

 

 

1

 

 

 

7

 

 

 

3

 

Total finance lease cost

 

 

 

 

 

$

11

 

 

$

33

 

 

 

 

$

25

 

 

$

11

 

 

$

62

 

 

$

33

 

Variable lease cost

 

Inventory

 

 

3,291

 

 

 

7,886

 

 

Inventory

 

 

 

 

 

3,291

 

 

 

 

 

 

7,886

 

Total lease cost

 

 

 

 

 

$

4,939

 

 

$

12,817

 

 

 

 

$

584

 

 

$

4,939

 

 

$

1,696

 

 

$

12,817

 

 

Short-term lease expense for both the three and nine months ended September 30, 2020 and 2019 was immaterial.not material.

 


Supplemental cash flow information related to operating and finance leases for the nine months ended September 30, 20192020 was as follows (in thousands):

 

 

Nine Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2019

 

 

2020

 

 

2019

 

Cash paid for amounts included in the measurement of lease liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Operating cash outflows from operating leases

 

$

4,605

 

 

$

1,337

 

 

$

4,605

 

Operating cash outflows from finance leases

 

 

33

 

 

 

61

 

 

 

33

 

Right-of-use assets obtained in exchange for lease obligations:

 

 

 

 

 

 

 

 

 

 

 

 

Operating leases

 

$

24,779

 

 

$

1,242

 

 

$

24,779

 

Finance leases

 

 

117

 

 

 

157

 

 

 

117

 

 


Supplemental balance sheet information, as of September 30, 2019,2020, related to operating and finance leases was as follows (in thousands, except lease term and discount rate):

 

 

September 30,

 

 

September 30,

 

 

December 31,

 

 

2019

 

 

2020

 

 

2019

 

Reported as:

 

 

 

 

 

 

 

 

 

 

 

 

Other assets

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease right-of-use assets

 

$

21,263

 

 

$

7,581

 

 

$

7,494

 

Finance lease right-of-use assets

 

 

88

 

 

 

180

 

 

 

78

 

Total right-of use assets

 

$

21,351

 

 

$

7,761

 

 

$

7,572

 

Accrued and other current liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease liabilities

 

$

5,008

 

 

$

1,472

 

 

$

1,259

 

Finance lease liabilities

 

 

41

 

 

 

84

 

 

 

40

 

Warranty reserve and other long-term liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease liabilities

 

 

16,752

 

 

 

6,358

 

 

 

6,434

 

Finance lease liabilities

 

 

45

 

 

 

97

 

 

 

35

 

Total lease liabilities

 

$

21,846

 

 

$

8,011

 

 

$

7,768

 

Weighted average remaining lease term (years)

 

 

 

 

 

 

 

 

 

 

 

 

Operating leases

 

 

4

 

 

 

5

 

 

 

5

 

Finance leases

 

 

2

 

 

 

2

 

 

 

2

 

Weighted average discount rate

 

 

 

 

 

 

 

 

 

 

 

 

Operating leases

 

 

8.08

%

 

 

7.73

%

 

 

7.45

%

Finance leases

 

 

4.12

%

 

 

6.18

%

 

 

4.06

%

 

As of September 30, 2019,2020, maturities of the Company’s operating and finance lease liabilities are as follows (in thousands):

 

Period

 

Operating leases

 

 

Finance leases

 

 

Total

 

Remainder of 2019

 

$

1,652

 

 

$

11

 

 

$

1,663

 

2020

 

 

6,640

 

 

 

43

 

 

 

6,683

 

2021

 

 

6,672

 

 

 

36

 

 

 

6,708

 

2022

 

 

6,405

 

 

 

 

 

 

6,405

 

2023

 

 

3,083

 

 

 

 

 

 

3,083

 

2024 and thereafter

 

 

964

 

 

 

 

 

 

964

 

Total lease payments

 

$

25,416

 

 

$

90

 

 

$

25,506

 

Less imputed interest

 

 

3,656

 

 

 

4

 

 

 

3,660

 

Total operating lease liabilities

 

$

21,760

 

 

$

86

 

 

$

21,846

 

As previously reported in our Annual Report on Form 10-K for the year ended December 31, 2018 and under legacy lease accounting (ASC 840), future minimum lease payments under non-cancellable leases as of December 31, 2018 was as follows (in thousands):

Year Ended December 31:

 

 

 

 

2019

 

$

1,325

 

2020

 

 

1,134

 

2021

 

 

1,060

 

2022

 

 

947

 

2023 and thereafter

 

 

1,557

 

 

 

$

6,023

 

Period

 

Operating leases

 

 

Finance leases

 

 

Total

 

Remainder of 2020

 

$

527

 

 

$

24

 

 

$

551

 

2021

 

 

2,095

 

 

 

89

 

 

 

2,184

 

2022

 

 

1,920

 

 

 

53

 

 

 

1,973

 

2023

 

 

1,968

 

 

 

29

 

 

 

1,997

 

2024

 

 

1,507

 

 

 

1

 

 

 

1,508

 

2025 and thereafter

 

 

1,534

 

 

 

 

 

 

1,534

 

Total lease payments

 

$

9,551

 

 

$

196

 

 

$

9,747

 

Less imputed interest

 

 

1,721

 

 

 

15

 

 

 

1,736

 

Total operating lease liabilities

 

$

7,830

 

 

$

181

 

 

$

8,011

 

 


The table above does not include the minimum purchase obligations of approximately $21.6 million over the five years following December 31, 2018 under the Company’s contracts with its manufacturers which upon adoption of ASU 2016-02 on January 1, 2019 were accounted for as operating lease ROU assets and lease liabilities.

10.

Long-Term Debt

Term Loan and Revolving Loan

 

On July 25, 2017, the Company entered into a Term Loan Credit and Security Agreement or the Existing Termand a Revolving Loan Credit Agreement, and a Credit and Security Agreement, or the Existing Revolving Credit Agreement with MidCap Financial Trust (“MidCap”), which replaced the Company’s prior Silicon Valley Bank Loan Agreement, or the SVB Loan Agreement. On July 1, 2019 the Company entered into a Restated Term Loan Credit Agreement with MidCap Financial Trust as the agentBoth agreements were amended and lender, and additional lenders thereto from time to time, or the Restated Term Loan Agreement, which restated the Existing Term Loan Agreement. Also on July 1, 2019 and further amended on November 7, 2019 (as so amended, the Company entered into an Amended“Restated Term Loan Agreement” and Restated Credit and Security Agreement (Revolving Loan), by and among the Company, the lenders party thereto from time to time, and MidCap Financial Trust, or the Restated“Restated Revolving Credit AgreementAgreement” and, together, with the Restated Term Loan Agreement, the Credit Agreements, which restated the Existing Revolving Credit Agreement.“Credit Agreements”).

 

The Restated Term Loan Agreement providedprovides for the following tranches: (i) a $35 million term loan facility drawn at signing, (ii) a $5 million term loan facility drawn at signing, (iii) at any time after September 30, 2020 to December 31, 2020, a $10.0 million term loan facility (subject to the satisfaction of certain conditions, including evidence that the Company’s Net Revenuenet revenue for the past 12 months was greater than or equal to $100.0 million), and (iv) until December 31, 2020 and upon the consent of Agentthe agent and the lenders following a request from the Company, an additional $15.0 million term loan facility, or altogether, the Restated Term Loan.facility. The Restated Term Loanloan matures on July 1, 2024 and carries an interest rate of LIBOR plus 7.50%. The Company will make monthly payments of accrued interest under the Restated Term Loan from the funding date of the Restated Term Loan, until July 31, 2021, to be followed by monthly installments of principal and interest through the Maturity Date of July 1, 2024.maturity date. The Company may prepay some or all of the Restated Term Loanprincipal prior to its maturity date provided the Company pays MidCap a prepayment fee. Net proceeds fromThe loan provides that the Restated Term Loan were usedCompany shall pay an exit fee equal to repay5.0% of the $35 million outstanding balance relatedaggregate amount of all term loans funded to the Company.

On May 11, 2020, the Company entered in to the Second Amendment to Amended and Restated Credit and Security Agreement (Term Loan), by and among the Company, certain of the Company’s subsidiaries, the lenders party thereto and MidCap Financial Trust as agent (the “Term Amendment”). The Term Loans. Amendment provides for, among other things, the prepayment by the Company of $25.0 million of outstanding principal, $0.1 million of accrued interest, and $1.25 million in prepaid exit fees with the parties agreeing to waive the prepayment fee with respect to these amounts. The Term Amendment increases the tranche 3 commitment amount from $10.0 million to $15.0 million, extends the tranche 3 termination date from December 31, 2020 to June 30, 2021, and amended certain conditions upon which the tranche 3 commitment can be withdrawn, including evidence that the Company’s Net Revenue for the past six months was greater than or equal to $30.0 million. In addition, the Term Amendment amends certain financial requirements including reducing the Company’s minimum unrestricted cash amount from $20.0 million to $5.0 million and amends certain minimum net revenue requirements. Further, the monthly minimum net revenue requirements were revised to be calculated on a trailing three-month basis.

As of September 30, 2019,2020, there was $40.0$15.0 million of outstanding principal and $0.8 million of exit fee payable related to the Restated Term Loans. As of September 30, 2019, the long-term portion of theterm loans, reduced by unamortized debt issuance costs on the Restated Term Loans was approximately $1.9of $1.1 million included in “Long-term debt” and are$0.7 million included as a reduction to debtin “Current portion of long-term debt” on the condensed consolidated balance sheet. As of September 30, 2019, there was no current portion of unamortized debt issuance costs.sheets.

 

The Restated Revolving Credit Agreement provides for, among other things, a revolving loan of up to $10.0 million (the “Restated Revolving Loan”).million. The amount of loans available to be drawn under the Revolving Credit Agreement is based on a borrowing base equal to 85% of the net collectible value of eligible accounts receivable plus 40% of eligible finished goods inventory, or the Borrowing Base, provided that availability from eligible finished goods inventory does not exceed 20% of the Borrowing Base. The Restated Revolving Loanrevolving loan carries an interest rate of LIBOR plus 4.50%. The BorrowersCompany may make (subject to the applicable borrowing base at the time) and repay borrowings from time to time under the Restated Revolving Credit Agreement until the maturity of the facility on July 1, 2024. Immediately prior

On May 11, 2020, the Company entered in to the effectivenessSecond Amendment to Amended and Restated Credit and Security Agreement (Revolving Loan), by and among the Company, certain of the RestatedCompany’s subsidiaries, the lenders party thereto and MidCap Financial Trust as agent (the “Revolving Amendment”).  The Revolving Credit Agreement,Amendment includes conforming changes to reflect the Company convertedchanges in the $4.3 million outstanding borrowings underTerm Amendment. In addition, the Revolving Loan intoAmendment reduces the Restated Revolving Loan. borrowing base by the portion of the eligible inventory previously included in the calculation.


As of September 30, 2019,2020, there were $7.4 million0 borrowings outstanding under the Revolving Loan. As of September 30, 2019,2020, the unamortized debt issuance costs related to the Revolving Loanrevolving loan was approximately $0.1 million and was included in other long-term assets“Other assets” on the condensed consolidated balance sheet.sheets.

 

The amortization of debt issuance costs on the term loan and the revolving loan for the three months ended September 30, 2020 and 2019 were $0.2 million and 2018 was $0.1 million, and $47,000, respectively. The amortization of debt issuance costs on the term loan and revolving loan for the nine months ended September 30, 2020 and 2019 and 2018 was $0.2$0.7 million and $0.1$0.2 million, respectively, and was included in interest expense in the condensed consolidated statements of operations.

The Credit Agreements include customary affirmative and restrictive covenants and representations and warranties, including a financial covenant for minimum revenues, a financial covenant for minimum cash requirements, a covenant against the occurrence of a “change in control,” financial reporting obligations, and certain limitations on indebtedness, liens, investments, distributions, collateral, mergers or acquisitions, taxes, and deposit accounts. Upon the occurrence of an event of default, a default interest rate of an additional 5.0% may be applied to any outstanding principal balances, and MidCap may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the Credit Agreements. The Company’s obligations under the Credit Agreements are secured by a security interest in substantially all of Thethe Company’s assets.

Convertible Note

On March 11, 2020, the Company issued $60.0 million of unsecured and subordinated convertible notes with an interest rate of 4.00% (“Note”) to Deerfield Partners, L.P. (“Holder”) in order to fund ongoing operations. The Note matures on March 11, 2025, subject to earlier conversion by the option of the Holder at any time in whole or in part into common shares of the Company, for a period up to five years. Upon conversion by the Holder, the Company shall deliver, shares of the Company’s common stock at a conversion rate of 14,634 per $1,000 principal amount of the Note (which represents an initial conversion rate price of $4.10), or the Base Conversion Rate, in each case subject to customary anti-dilution adjustments. In addition to the typical anti-dilution adjustment, the Note also provides the Holder with additional consideration (“Make-Whole Provision”) beyond the settlement of the conversion obligation, in the event of a major transaction prior to maturity (e.g. a change in control). Upon conversion by the Holder in the event of a major transaction, the Company shall deliver, either cash, shares of the Company’s common stock or a combination of cash and common stock at the Base Conversion rate plus the additional consideration from the Make-Whole Provision. The $60.0 million principal amount of the Note is not payable until the maturity date of March 11, 2025, unless converted to equity earlier. The Company will pay interest in cash on the Note at 4.00% per annum, quarterly from July 1, 2020.

The conversion features in the outstanding convertible debt instrument are accounted for as a free-standing embedded derivative bifurcated from the principal balance of the Note, as (1) the conversion features are not clearly and closely related to the debt instrument and are not considered to be indexed to the Company’s equity, (2) the conversion features standing alone meet the definition of a derivative, and (3) the Note is not remeasured at fair value each reporting period with changes in fair value recorded in the condensed consolidated statement of operations.

The initial embedded derivative liability of $16.1 million was recorded as a non-current liability on the condensed consolidated balance sheet and is remeasured to fair value at each balance sheet date with a resulting non-cash gain or loss related to the change in the fair value being charged to earnings (loss). As of September 30, 2020, the fair value of the derivative liability was $24.5 million. A corresponding debt discount to the initial embedded derivative liability of $16.1 million and issuance costs of $1.5 million were recorded on the issuance date and is netted against the principal amount of the Note. As of September 30, 2020, the unamortized debt discount and issuance costs were $16.3 million. The Company will amortize the debt discount and debt issuance costs to interest expense under the effective interest method over the term of the Note, at a resulting effective interest rate of approximately 12%. For the three and nine months ended September 30, 2020, the amortization of the convertible debt discount and issuance costs were $0.7 million and $1.5 million, respectively, and were included in interest expense in the condensed consolidated statements of operations.


CARES Act

On April 20, 2020, the Company was granted a loan of $6.7 million under the Paycheck Protection Program of the CARES Act, or the PPP Loan, from Silicon Valley Bank, or the Lender. The PPP Loan matures on April 20, 2022, or the Maturity Date, and bears interest at a rate of 1.0% per annum. Under the terms of the PPP Loan, the Company will make no payments until the date which forgiveness of the PPP Loan is determined, which can be up to 10 months following the end of the covered period (which is defined as 24 weeks from the date of the loan), or the Deferral Period. Commencing one month after the expiration of the Deferral Period, and continuing on the same day of each month until the Maturity Date, the Company will pay to Lender monthly payments of principal and interest, in an amount required to fully amortize the principal amount outstanding on the PPP Loan on the last day of the Deferral Period by the Maturity Date. As of September 30, 2020, $5.8 million is recorded in “Long-term debt” and $0.8 million is recorded in “Current portion of long-term debt” on the Company’s condensed consolidated balance sheets.

All or a portion of the PPP Loan may be forgiven upon submission of documentation of expenditures in accordance with certain specified requirements. Under the CARES Act, loan forgiveness is available for the sum of documented payroll costs, covered rent payments, covered mortgage interest and covered utilities during the 24-week period beginning on the date of loan approval. Not more than 40% of the forgiven amount may be for non-payroll costs. The amount of the PPP Loan eligible to be forgiven will be reduced if the Company’s full-time headcount declines, or if salaries and wages for employees with salaries of $100,000 or less annually are reduced by more than 25%. The Company will be required to repay any portion of the outstanding principal that is not forgiven, along with accrued interest, in accordance with the amortization schedule described above. The Company has elected to account for the PPP loan in accordance with ASC 470 – Debt, and any forgiveness of the loan will be treated as a gain on extinguishment within the condensed consolidated statement of operations.  

 

Future Principal and Exit Fee Payments of Debt

 

The future schedule of principal and exit fee payments for theall outstanding Term Loansdebt as of September 30, 20192020 was as follows (in thousands):

 

Fiscal Year

 

 

 

 

 

 

 

 

Remainder of 2019

 

$

 

2020

 

 

 

Remainder of 2020

 

$

 

2021

 

 

5,556

 

 

 

5,409

 

2022

 

 

13,333

 

 

 

8,326

 

2023

 

 

13,333

 

 

 

5,000

 

2024

 

 

3,667

 

Thereafter

 

 

7,778

 

 

 

60,000

 

Total

 

$

40,000

 

 

$

82,402

 

 

11.

Stockholders’ Equity

 

a.

Authorized Stock

The Company’s Amended and Restated Certificate of Incorporation authorizes the Company to issue 210,000,000 shares of common and preferred stock, consisting of 200,000,000 shares of common stock with $0.01 par value and 10,000,000 shares of preferred stock with $0.01 par value. As of September 30, 20192020 and December 31, 2018,2019, the Company had no0 preferred stock issued or outstanding.

 

b.

Common Stock Warrants

On January 17, 2013, the Company entered into a Loan and Security Agreement, or the Original Term Loan Agreement, with Oxford Finance, LLC, or Oxford. On June 30, 2014, the Company entered into an Amended and Restated Loan and Security Agreement, or the Amended Term Loan Agreement, with Oxford. In connection with the Original Term Loan Agreement and the Amended Term Loan Agreement, the Company issued to Oxford


(i) seven-year warrants in January 2013 to purchase shares of the Company’s common stock with a value equal to 3.0% of the tranche A, B and C term loans amounts, or the Original Warrants, and (ii) seven-year warrants in June 2014 to purchase shares of the Company’s common stock with a value equal to 2.5% of the tranche D term loan amount. The warrants have an exercise price per share of $14.671. The warrants within Tranche A expired on January 17, 2020 and the warrants within Tranche B expired on August 1, 2020. As of September 30, 2019,2020, there were warrants to purchase an aggregate of 47,71027,264 shares of common stock outstanding.

 

c.

Stock Option Plans

In April 2007, the Company adopted the 2007 Equity Incentive Plan, or the 2007 Plan. The 2007 Plan provides for the granting of stock options to employees, directors and consultants of the Company. Options granted under the 2007 Plan may either be incentive stock options or nonstatutory stock options. Incentive stock options, or ISOs, may be granted only to Company employees. Nonstatutory stock options, or NSOs, may be granted to all eligible recipients. A total of 1,690,448 shares of the Company’s common stock were initially reserved for issuance under the 2007 Plan.

The Company’s board of directors adopted the 2014 Equity Incentive Plan, or 2014 Plan, in July 2014, and the stockholders approved the 2014 Plan in October 2014. The 2014 Plan became effective upon completion of the IPO on November 3, 2014, at which time the Company ceased granting awards under the 2007 Plan. Under the 2014 Plan, the Company may issue ISOs, NSOs, stock appreciation rights, restricted stock awards, restricted stock unit awards and other forms of stock awards, or collectively, stock awards, all of which may be granted to employees, including officers, non-employee directors and consultants of the Company and their affiliates. ISOs may be granted only to employees.  A total of 1,027,500 shares of common stock were initially reserved for issuance under the 2014 Plan, subject to certain annual increases. As of September 30, 2019,2020, a total of 541,2442,544,816 shares of the Company’s common stock were available for issuance under the 2014 Plan.


Pursuant to a board-approved Inducement Plan, the Company may issue NSOs and restricted stock unit awards, or collectively, stock awards, all of which may only be granted to new employees of the Company and their affiliates in accordance with NASDAQ Stock Market Rule 5635(c)(4) as an inducement material to such individuals entering into employment with the Company.  As of September 30, 2019,2020, inducement grants for 1,201,7281,412,083 shares of common stock have been awarded, and 266,652923,342 shares of common stock were available for future issuance under the Inducement Plan.

Options under the 2007 Plan and the 2014 Plan may be granted for periods of up to ten years as determined by the Company’s board of directors, provided, however, that (i) the exercise price of an ISO shall not be less than 100% of the estimated fair value of the shares on the date of grant, and (ii) the exercise price of an ISO granted to a more than 10% shareholder shall not be less than 110% of the estimated fair value of the shares on the date of grant. An NSO has no such exercise price limitations. NSOs under the Inducement Plan may be granted for periods of up to ten years as determined by the board of directors, provided, the exercise price will not be less than 100% of the estimated fair value of the shares on the date of grant.  Options generally vest with 25% of the grant vesting on the first anniversary and the balance vesting monthly on a straight-lined basis over the requisite service period of three additional years for the award. Additionally, options have been granted to certain key executives that vest upon achievement of performance conditions based on performance targets as defined by the board of directors, which have included net sales targets and defined corporate objectives over the performance period with possible payout ranging from 0% to 100% of the target award. Compensation expense is recognized on a straight-lined basis over the vesting term of one year based upon the probable performance target that will be met. The vesting provisions of individual options may vary but provide for vesting of at least 25% per year.


The following summarizes all option activity under the 2007 Plan, 2014 Plan and Inducement Plan:

 

 

 

 

 

 

Weighted

 

 

Weighted

average

 

 

 

 

 

 

Weighted

 

 

Weighted

average

 

 

 

 

 

 

average

 

 

remaining

 

 

 

 

 

 

average

 

 

remaining

 

 

Option

 

 

exercise

 

 

contractual

 

 

Option

 

 

exercise

 

 

contractual

 

 

Shares

 

 

price

 

 

term (years)

 

 

Shares

 

 

price

 

 

term (year)

 

Balances at December 31, 2018

 

 

1,953,334

 

 

$

7.42

 

 

 

6.30

 

Balances at December 31, 2019

 

 

1,880,846

 

 

$

7.42

 

 

 

5.48

 

Exercised

 

 

(48,724

)

 

 

2.37

 

 

 

 

 

 

 

(6,181

)

 

 

2.48

 

 

 

 

 

Forfeited

 

 

(10,500

)

 

 

16.24

 

 

 

 

 

 

 

(313,347

)

 

 

7.92

 

 

 

 

 

Balances at September 30, 2019

 

 

1,894,110

 

 

$

7.50

 

 

 

5.72

 

Balances at September 30, 2020

 

 

1,561,318

 

 

$

7.34

 

 

 

4.49

 

 

 

For stock-based awards the Company recognizes compensation expense based on the grant date fair value using the Black-Scholes option valuation model. There was 0 stock-based compensation expense related to stock options for the three and nine months ended September 30, 2020. Stock-based compensation expense related to stock options was $0.1 million and $0.5$0.4 million for the three months ended September 30, 2019 and 2018, respectively. Stock-based compensation expense related to stock options was $0.4 million and $1.3 million for the nine months ended September 30, 2019 and 2018, respectively.2019. As of September 30, 2019,2020, there was $0.1 million ofwere also 0 unrecognized compensation costs related to stock options. The expense is recorded within the operating expense components in the condensed consolidated statement of operations based on the recipients receiving the awards. These costs are expected to be recognized over a weighted average period of less than 1 year.

 

d.

Restricted Stock Units

The Company has issued restricted stock unit awards, or RSUs, under the 2014 Plan and the Inducement Plan. The RSUs issued to employees generally vest on a straight-line basis annually over a 3-year requisite service period. RSUs issued to non-employees generally vest either monthly or annually over the service term.  

Activity related to RSUs is set forth below:

 

 

 

 

 

 

Weighted

average

 

 

 

 

 

 

Weighted

average

 

 

Number

 

 

grant date

 

 

Number

 

 

grant date

 

 

of shares

 

 

fair value

 

 

of shares

 

 

fair value

 

Balances at December 31, 2018

 

 

2,141,350

 

 

$

13.27

 

Balances at December 31, 2019

 

 

2,232,956

 

 

$

11.99

 

Granted

 

 

1,314,547

 

 

 

8.01

 

 

 

934,965

 

 

 

5.63

 

Vested

 

 

(852,375

)

 

 

12.13

 

 

 

(921,964

)

 

 

10.45

 

Forfeited

 

 

(280,399

)

 

 

14.14

 

 

 

(701,907

)

 

 

9.07

 

Balances at September 30, 2019

 

 

2,323,123

 

 

$

10.60

 

Balances at September 30, 2020

 

 

1,544,050

 

 

$

10.38

 

 


Stock-based compensation expense for RSUs for the three months ended September 30, 2020 and 2019 and 2018 was $2.8$1.5 million and $3.7$2.8 million, respectively. Stock-based compensation expense for RSUs for the nine months ended September 30, 2020 and 2019 and 2018 was $8.9$4.9 million and $8.3$8.9 million, respectively. As of September 30, 2019,2020, there was $16.5$7.1 million of total unrecognized compensation costs related to non-vested RSU awards. The cost is expected to be recognized over a weighted average period of approximately 21.43 years.

 

e.

Employee Stock Purchase Plan

The Company’s board of directors adopted the 2014 Employee Stock Purchase Plan, or ESPP, in July 2014, and the stockholders approved the ESPP in October 2014. The ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation, subject to any plan limitations. The ESPP provides for offering periods not to exceed 27 months, and each offering period will include purchase periods, which will be the approximately six-month period commencing with one exercise date and ending with the next exercise date. Employees are able to purchase shares at 85% of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the purchase date.  A total of 255,500 shares of common stock were initially reserved for issuance under the ESPP, subject to certain annual increases.     


During the nine months ended September 30, 2019,2020, employees purchased 175,624203,728 shares of common stock at a weighted average price of $6.93$4.11 per share. As of September 30, 2019,2020, the number of shares of common stock available for future issuance was 654,619.946,292.

The Company estimated the fair value of employee stock purchase rights using the Black-Scholes model. Stock-based compensation expense related to the ESPP was $0.1 million and $0.2 million for both the three months ended September 30, 2020 and 2019, and 2018.respectively. Stock-based compensation expense related to the ESPP was $0.5$0.4 million and $0.4$0.5 million for the nine months ended September 30, 20192020 and 2018,2019, respectively.

 

f.

Significant Modifications

During the nine months ended September 30, 2019 the Company entered into two consulting agreements with former employees that resulted in2020, there were 0 material modifications of their existing equity awards. During the nine months ended September 30, 2019, the Company recognized $0.6 million in incremental compensation cost resulting from these modifications.entering into a consulting agreement with two former employees that resulted in the modification of their existing equity awards.

12.

Income Taxes

The Company operates in several tax jurisdictions and is subject to taxes in each jurisdiction in which it conducts business. To date, the Company has incurred cumulative net losses and maintains a full valuation allowance on its net deferred tax assets due to the uncertainty surrounding realization of such assets. The Company had no0 tax expense for both the three and nine months ended September 30, 20192020 and 2018.2019.

13.

Segment Information

 

Reportable Segments

 

The Company has two2 reportable segments: Breast Products and miraDry. The Breast Products segment focuses on sales of silicone gel breast implants, tissue expanders and scar management products under the brands Opus,OPUS, Luxe, Curve, AlloX2, Dermaspan, Softspan and BIOCORNEUM. The miraDry segment, acquired on July 25, 2017, focuses on sales of the miraDry System, consisting of a console and a handheld device which uses consumable single-use bioTips. These segments align with the Company’s principal target markets. miraDry has been included in the condensed consolidated results of operations as of the acquisition date and financial performance of the acquired business is reported in the miraDry segment. The Vesta Acquisition, completed on November 7, 2019, has been included in the condensed consolidated results of operations as of the acquisition date and financial performance of the acquired business is reported in the Breast Products segment.

 

The Company’s Chief Operating Decision Maker, or CODM, assesses the performance of each segment and allocates resources to those segments based on net sales and operating income (loss). Operating income (loss) by segment includes items that are directly attributable to each segment, including sales and marketing functions, as well as finance, information technology, human resources, legal and related corporate infrastructure costs, along with certain benefit-related expenses.  There are no0 unallocated expenses for the two segments.


 

The following tables present the net sales, net operating loss and net assets by reportable segment for the periods presented (in thousands):

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

September 30,

 

 

September 30,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Breast Products

 

$

12,626

 

 

$

8,613

 

 

$

33,570

 

 

$

26,566

 

 

$

15,330

 

 

$

12,626

 

 

$

37,109

 

 

$

33,570

 

miraDry

 

 

9,786

 

 

 

8,262

 

 

 

26,919

 

 

 

22,538

 

 

 

3,887

 

 

 

9,786

 

 

 

11,488

 

 

 

26,919

 

Total net sales

 

$

22,412

 

 

$

16,875

 

 

$

60,489

 

 

$

49,104

 

 

$

19,217

 

 

$

22,412

 

 

$

48,597

 

 

$

60,489

 


 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

September 30,

 

 

September 30,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Loss from operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Breast Products

 

$

(12,319

)

 

$

(13,873

)

 

$

(38,555

)

 

$

(39,111

)

 

$

(9,304

)

 

$

(12,319

)

 

$

(30,683

)

 

$

(38,555

)

miraDry

 

 

(9,141

)

 

 

(5,689

)

 

 

(45,722

)

 

 

(16,278

)

 

 

(4,654

)

 

 

(9,141

)

 

 

(22,595

)

 

 

(45,722

)

Total loss from operations

 

$

(21,460

)

 

$

(19,562

)

 

$

(84,277

)

 

$

(55,389

)

 

$

(13,958

)

 

$

(21,460

)

 

$

(53,278

)

 

$

(84,277

)

 

 

 

 

 

 

 

September 30,

 

 

December 31,

 

 

September 30,

 

 

December 31,

 

 

 

 

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Breast Products

 

 

 

 

 

$

186,298

 

 

$

130,149

 

 

$

156,538

 

 

$

169,613

 

miraDry

 

 

 

 

 

 

33,584

 

 

 

38,210

 

 

 

21,266

 

 

 

34,791

 

Total assets

 

 

 

 

 

$

219,882

 

 

$

168,359

 

 

$

177,804

 

 

$

204,404

 

 

14.

Commitments and Contingencies

The Company is subject to claims and assessment from time to time in the ordinary course of business. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.

miraDry Class Action Litigation

On August 3, 2017, a lawsuit styled as a verified class action on the part of the former stockholders of miraDry was filed in the Court of Chancery for the State of Delaware against the former board of directors of miraDry, or the Defendants, alleging breach of their fiduciary duties in connection with the Company’s acquisition of miraDry.  On August 30, 2017, the Defendants moved to dismiss the verified class action complaint for failure to state a claim upon which relief can be granted.  On November 11, 2017 the parties notified the Court that they had reached an agreement to settle the matter pending completion of confirmatory discovery regarding the fairness of the settlement and obtaining approval from the court.  Following a hearing, the Delaware Chancery Court approved the proposed settlement terms on January 15, 2019, with a modification to the amount of attorneys’ fees awarded to the plaintiffs’ attorneys. Under the terms of the settlement, in exchange for a full and final settlement and release of all claims, the Defendants (and/or their indemnitors and/or insurers) paid a settlement consideration of $0.4 million. The miraDry Merger Agreement contained a holdback amount expected to be used for the settlement and associated costs of the miraDry Class Action litigation. The holdback amount has been used to offset $0.6 million of legal fees and $0.4 million was included in “legal settlement payable” on the consolidated balance sheet as of December 31, 2018. The legal settlement of $0.4 million was paid during the first quarter of 2019.


15.

Subsequent Events

Vesta Asset Acquisition

On November 7, 2019 (the “Closing Date”), the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Vesta Intermediate Fundings, Inc. (“Vesta”), pursuant to which the Company purchased certain assets and assumed certain liabilities and obtained a non-exclusive, royalty-free, perpetual, irrevocable, assignable, sublicensable, and worldwide license to certain intellectual property owned by Vesta (the “Vesta Acquisition”). In consideration of the Vesta Acquisition, the Company paid $14.0 million in cash on the Closing Date and will pay an additional $3.2 million and $3.0 million in cash (the “Post-Closing Amounts”) on November 7, 2021 and November 7, 2023, respectively. In addition, in the event the closing price of the Company’s common stock equals or exceeds a certain agreed upon price target (the “First Milestone Price Target”) on any date through November 7, 2023, the Company will issue Vesta 303,721 shares of common stock (the “First Milestone Shares”) within five business days of such date and in the event the closing price of the Company’s common stock equals or exceeds a certain agreed upon price target (the “Second Milestone Price Target”) on any date through November 7, 2023, the Company will issue Vesta 303,721 shares of common stock (the “Second Milestone Shares”) within five business days of such date. The Company will use its commercially reasonable efforts to file and maintain a resale registrations statement registering the resale of the First Milestone Shares and the Second Milestone Shares. The Purchase Agreement contains customary representations and warranties and indemnification provisions. The Purchase Agreement also includes a two-year, mutual non-solicitation agreement.

In connection with, and as a condition to the closing of, the Purchase Agreement, on November 7, 2019, the Company entered into a Lease with Vesta (the “Lease”) whereby the Company will lease approximately 24,000 square feet in the building where the manufacturing operations acquired in the Vesta Acquisition are located (the “Facility”). The Lease has an initial term of four years (the “Initial Term”). The Company will pay annual rent of $200,000 for each of the first two years and $320,000 for each of the third and fourth years of the Lease payable in equal monthly installments. The Lease includes an option for the Company to extend the term of the Lease one time for an additional four years (the “Extended Term”). The annual rent payable during the Extended Term shall be the annual rent payable during the Initial Term increased by the percentage increase in the Consumer Price Index, as specified in the Lease. The Lease contains customary events of default and, additionally, any failure by the Company to pay the Post-Closing Amounts when due or issue the First Milestone Shares or Second Milestone Shares when required shall be considered an event of default. The Lease also provides that, in the event of a sale of the Facility, the Company will have a right of first offer to purchase the Facility from Vesta.

Sientra is currently evaluating the purchase price allocation following the consummation of the Vesta Acquisition. It is not practicable to disclose the preliminary purchase price allocation, given the short period of time between the acquisition date and the issuance of these consolidated financial statements.

Tissue Expander Manufacturing Agreement

On November 7, 2019, the Company entered into an Amended and Restated Manufacturing and Supply Agreement (the “Manufacturing Agreement”) with Vesta Intermediate Funding, Inc. (“Vesta”), providing for the manufacture and supply of the Company’s tissue expanders and accessories (the “Expander Products”). The Manufacturing Agreement has a six-year term, which may be extended by written agreement of the parties, and may only be terminated for cause by the non-defaulting party following written notice of default with a reasonable period to cure.  The Manufacturing Agreement provides that the Company will purchase fixed percentages of its requirements for Expander Products intended for global distribution from Vesta, with such percentages decreasing over time.  In the event that Vesta fails to timely deliver a minimum threshold of the Expander Product orders for a specified period, the purchase requirements shall be adjusted downwards as provided in the Manufacturing Agreement. The Manufacturing Agreement contains customary representations and warranties.

Supply Agreement

On November 7, 2019, the Company entered into a Master Supply Agreement (the “Supply Agreement”) with NuSil Technology LLC (“NuSil”) which provides that NuSil will serve as the exclusive supplier of the Company’s silicone materials for short and long-term implantable products (the “Silicone Products”). The Supply Agreement provides for Set Pricing and Discount Pricing that the Company is able to obtain upon reaching certain minimum purchase requirements in a calendar year. The Supply Agreement has an initial term through December 31, 2026 (the “Initial


Term”) which automatically renews for subsequent one year terms (each, a “Renewal Term”), unless a party provides written notice of intent to terminate the Supply Agreement no later than six (6) months prior to expiration of the Initial Term or the then current Renewal Term. The Supply Agreement may be terminated in the event of breach following a 45 day period to cure or in the event of insolvency of a party.

Organizational Efficiency Initiative

On November 6, 2019, the Board of Directors of the Company approved an organizational efficiency initiative (the “Plan”) designed to reduce spending and simplify operations, effective immediately. Under the Plan, the Company will implement numerous initiatives to reduce spending, including closing the Santa Clara offices of miraDry, Inc. (“miraDry”), outsourcing miraDry product assembly to a third party, and consolidating a number of business support services via a shared services organization at the Company’s Santa Barbara headquarters. Under the Plan, the Company intends to reduce its workforce by terminating approximately 70 employees, which the Company expects to be completed over the next 10 months. As a result, the Company expects to incur charges between $2.7 million and $3.0 million in connection with one-time employee termination costs, retention costs and other benefits. These charges are expected to be incurred over the next 10 months. In addition, the Company expects to incur estimated charges between $1.0 million and $1.5 million related to contract termination, outsourcing miraDry product assembly and duplicate operating costs over the next 10 months. In total, the Plan is estimated to cost between $3.7 million and $4.5 million over the next 10 months, excluding non-cash charges, with related cash payments expected to be substantially paid out by September 30, 2020.

The estimates of costs that the Company expects to incur and the timing thereof are subject to a number of assumptions and actual results may differ.

Huiner Settlement and Consulting Agreement

As previously disclosed, on September 30, 2019 (the “Separation Date”), Charles Huiner, the Company’s Chief Operating Officer and Senior Vice President of Corporate Development and Strategy, stepped down from his role to pursue other opportunities. On November 1, 2019, the Company entered into a Confidential Settlement, Release and Consulting Agreement with Mr. Huiner (the “Huiner Agreement”). Pursuant to the Huiner Agreement, in exchange for a general release of all claims, the Company will (1) pay Mr. Huiner, in accordance with the Company’s regular payroll cycle, an amount equal to twelve months of his base salary in effect on the Separation Date, or $393,225, (2) make a lump sum payment equal to Mr. Huiner’s bonus for 2019 prorated through the Separation Date and based upon the achievement of objectives and the determination of the Board of Directors of the final 2019 corporate bonus payout, payable by check in a lump sum no later than April 1, 2020 and (3) reimburse Mr. Huiner for COBRA premiums until the earlier of (1) thirteen months following the Separation Date (2) the date Mr. Huiner is eligible for group health insurance coverage through a new employer or (3) the date Mr. Huiner ceases to be eligible for COBRA continuation coverage for any reason. In addition, the Huiner Agreement provides that Mr. Huiner will continue to provide consulting services (the “Services”) for eight months following the Separation Date. As consideration for the Services, the Company will pay Mr. Huiner a one-time lump sum consulting fee of $32,768.76, continue the vesting of all unvested restricted stock units and performance stock units granted in April 2019 and accelerated the vesting of 33,333 restricted stock units granted in January 2018. In addition, the Huiner Agreement extends the exercise period for any vested stock options until thirteen months from the Separation Date.

Product Liability Litigation

On October 7, 2019, a lawsuit was filed in the Superior Court of the State of California against the Company and Silimed Industria de Implantes Ltda. (the Company’s former contract manufacturer). The lawsuit alleges that the Company’s textured breast implants caused certain of the plaintiffs to develop a condition known as breast implant associated anaplastic large cell lymphoma (“BIA-ALCL”), and that the Company is liable to the Plaintiffsplaintiffs based on claims for strict liability (failure to warn), strict liability (defective manufacture), negligence and loss of consortium. On January 21, 2020, the Company filed a demurrer to the plaintiff’s complaint, which demurrer is still pending before the Court. The Company intends to vigorously defend itself in this lawsuit. Given the nature of this case, the Company is unable to estimate the reasonably possible loss or range of loss, if any, arising from this matter.

On September 23, 2020, a lawsuit was filed in the Eastern District of Tennessee against the Company. The lawsuit alleges that the Company’s textured breast implants caused certain of the plaintiffs to develop a condition known as breast implant associated anaplastic large cell lymphoma (“BIA-ALCL”), and that the Company is liable to the plaintiffs based on claims for negligence, strict liability (manufacturing defects), strict liability (failure to warn), breach of express and implied warranties, and punitive damages. No response has been filed to the complaint at presented. The Company intends to vigorously defend itself in this lawsuit. Given the nature of this case, the Company is unable to estimate the reasonably possible loss or range of loss, if any, arising from this matter.


ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q and the audited financial statements and notes thereto as of and for the year ended December 31, 20182019 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations are contained in our Annual Report on Form 10-K for the year ended December 31, 2018,2019, filed with the Securities and Exchange Commission on March 14, 2019,16, 2020, or the Annual Report. Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Sientra,” “the Company,” “we,” “us” and “our” refer to Sientra, Inc.

Forward-Looking Statements

The information in this discussion contains forward-looking statements and information within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning our strategy, future operations, future financial position, future revenues, projected costs, prospects and plans and objectives of management. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the risks set forth in Part II, Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements.

Overview

We are a medical aesthetics company committed to making a difference in patients’ lives by enhancing their body image, growing their self self‑esteem and restoring their confidence. We were founded to provide greater choices to board board‑certified plastic surgeons and patients in need of medical aesthetics products. We have developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. We sell our breast implants and tissue expandersfor augmentation procedures exclusively to board board‑certified and board board‑admissible plastic surgeons and tailor our customer service offerings to their specific needs, which we believe helps secure their loyalty and confidence. We sell our breast tissue expanders for reconstruction procedures predominantly to hospitals and surgery centers, and our BIOCORNEUM scar management products to plastic surgeons, dermatologists and other specialties.

On June 11, 2017, we entered into a Merger Agreement with miraDry (formerly Miramar Labs) pursuant to which we commenced a tender offer to purchase all of the outstanding shares of miraDry’s common stock. Pursuant to the transaction, which closed on July 25, 2017 we added the miraDry System, the only FDA clearedFDA-cleared device to reduce underarm sweat, odor and hair of all colors to our aesthetics portfolio. Following our acquisition of miraDry in July 2017, we began selling the miraDry System, consisting of a console and a handheld device, and consumable single-use bioTips.  As a result of the miraDry acquisition, we determined that we will conduct our business in two operating segments: Breast Products and miraDry. The Breast Products segment focuses on sales of our breast implants, tissue expanders and scar management products under the brands OPUS,Sientra, AlloX2, Dermaspan, Softspan and BIOCORNEUM. The miraDry segment focuses on sales of the miraDry System, consisting of a console and a handheld device which uses consumable single-use bioTips.

We sell both our Breast Products and miraDry products in the U.S. through a direct sales organization, which as of September 30, 2019,2020, consisted of 10165 employees, including 8654 sales representatives and 1511 sales managers. Additionally, we also sell our miraDry System in several international markets where we leverage a combination of distributor relationships and direct sales efforts. As of September 30, 20192020, our international operations were supported by 73 sales representatives and 42 sales managers, as well as a number of consultants supporting both direct sales efforts and distributerdistributor relationships.


Recent developments

COVID-19 Pandemic

The rapid, global spread of COVID-19 has resulted in significant economic uncertainty, significant declines in business and consumer confidence and global demand in the non-essential healthcare industry (among others), a global economic slowdown, and could lead to a global recession. We are subject to risks and uncertainties as a result of the COVID-19 pandemic. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, and employee-related amounts, will depend on future developments that are highly uncertain. We continue to monitor and assess new information related to the COVID-19 pandemic, the actions taken to contain or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets.

As an aesthetics company, surgical procedures involving our breast and miraDry products are susceptible to local and national government restrictions, such as social distancing, “shelter in place” orders and business closures, due to the economic and logistical impacts these measures have on consumer demand as well as the practitioners’ ability to administer such procedures. The inability or limited ability to perform such non-emergency procedures significantly harmed our revenues during the three months ended June 30, 2020 and continued to harm our revenues during the three months ended September 30, 2020. While some states have lifted certain restrictions on non-emergency procedures during the three months ended September 30, 2020, we will likely continue to experience future harm to our revenues while existing or new restrictions remain in place.

Further, the spread of COVID-19 has caused us to modify our workforce practices, and we may take further actions that we determine are in the best interests of our employees or as required by governments. In addition, capital markets and economies worldwide have also been negatively impacted by the COVID-19 pandemic, and it is possible that this can lead to a local and/or global economic recession, which may result in further harm to the aesthetics market. Such economic disruption could adversely affect our business. The continued spread of COVID-19, or another infectious disease, could also result in delays or disruptions in our supply chain or adversely affect our manufacturing facilities and personnel. Further, trade and/or national security protection policies may be adjusted as a result of the COVID-19 pandemic, such as actions by governments that limit, restrict or prevent the movement of certain goods into a country and/or region, and current U.S./China trade relations may be further exacerbated by the pandemic.

The estimates used for, but not limited to, determining the collectability of accounts receivable, fair value of long-lived assets and goodwill, and sales returns liability required could be impacted by the pandemic. While the full impact of COVID-19 is unknown at this time, we have made appropriate estimates based on the facts and circumstances available as of the reporting date. These estimates may change as new events occur and additional information is obtained.

Change in miraDry business strategy

In April 2020, in part as a result of the impact of COVID-19, we re-focused our miraDry business to drive high margin, bioTip utilization to our existing installed base. We expect that the net sales we generate from our bioTips will represent high margin sales (on a gross margin basis) and account for a substantial amount of our net sales for the next several years, with high margin consumables comprising a sizable percentage of our miraDry segment’s net sales.

Restructuring

On November 7, 2019, we announced an organizational efficiency initiative, or the Plan, designed to reduce spending and simplify operations. Under the Plan, we are implementing numerous initiatives to reduce spending, including closing the Santa Clara offices of miraDry, Inc. and consolidating a number of business support services via a shared services organization at our Santa Barbara headquarters.

Under the Plan, we intend to reduce our workforce by terminating approximately 70 employees. As a result, we expect to incur total charges of approximately $2.5 million in connection with one-time employee termination costs,


retention costs and other benefits. In addition, we expect to incur estimated charges of approximately $0.5 million related to duplicate operating costs and other associated costs. In total, the Plan is estimated to cost approximately $3.0 million, excluding non-cash charges, with related cash payments expected to be substantially paid out with cash on hand by the end of 2020.

The following table details the amount of the liabilities related to the Plan included in "Accrued and other current liabilities" in the condensed consolidated balance sheet as of September 30, 2020 (amounts in thousands):

 

 

Severance costs

 

 

Other associated costs

 

 

Duplicate operating costs

 

Balance at December 31, 2019

 

$

894

 

 

$

 

 

$

 

Costs charged to expense

 

 

1,467

 

 

 

208

 

 

 

174

 

Costs paid or otherwise settled

 

 

(1,995

)

 

 

(208

)

 

 

(174

)

Balance at September 30, 2020

 

$

365

 

 

$

 

 

$

 

The following table details the charges by reportable segment, recorded in "Restructuring" under operating expenses in the condensed consolidated statements of operations for the nine months ended September 30, 2020 (amounts in thousands):

 

 

Year Ended

 

 

Nine Months Ended

 

 

Cumulative Restructuring

 

 

 

December 31, 2019

 

 

September 30, 2020

 

 

Charges

 

Breast Products

 

$

499

 

 

$

389

 

 

$

888

 

miraDry

 

 

584

 

 

 

1,460

 

 

 

2,044

 

Total

 

$

1,083

 

 

$

1,849

 

 

$

2,932

 

It is anticipated that we will incur approximately $0.1 million of additional restructuring costs during 2020 attributable to the miraDry segment. We expect to realize cost savings of approximately $10.0 million in 2020 and approximately $5.0 million in 2021. All of the 2020 cost savings are expected to be realized in operating expenses, and the 2021 cost savings are expected to be realized approximately 20% in operating expenses and 80% in cost of goods sold. Savings in operating expenses are expected to result from the reduction of headcount through a shared services organization. Savings in cost of goods sold are expected to result from the elimination of manufacturing roles at miraDry. As the development of the Plan is completed, we will update the costs and cost savings as needed.

Components of Operating Results

 

Net Sales

Our Breast Products segment net sales include sales of silicone gel breast implants, tissue expanders and BIOCORNEUM. We recognize revenue on breast implants and tissue expanders, net of sales discounts and estimated returns, as the customer has a standard six-month window to return purchased breast implants and tissue expanders. We defer the value of our service warranty revenue and deliverables under certain marketing programs and recognize it once all performance obligations have been met.

Our miraDry segment net sales include sales of the miraDry System and consumable bioTips along with service warranties and deliverables under certain marketing programs. We recognize revenue on miraDry Systems and bioTips on delivery to the customer. We defer the value of our service warranty and deliverables under certain marketing programs and recognize it over the term of the service warranty contract for service warranties and once all performance obligations have been met for deliverables under certain marketing programs.

We expect that, in the future, our net sales will fluctuate on a quarterly basis due to a variety of factors, including seasonality of breast augmentation procedures, the impact of the pandemic, and purchase of miraDry procedures. We believe that aesthetic procedures are subject to seasonal fluctuation due to patients planning their procedures leading up to the summer season and in the period around the winter holiday season.


Cost of Goods Sold and Gross Margin

Cost of goods sold consists primarily of raw material, labor, overhead, and variable manufacturing costs, of finished products purchased from our third‑party manufacturers, reserve for product assurance warranties, royalty costs, excess and obsolete inventory reserves, and warehouse and other related costs. For miraDry, cost of goods sold also consists of raw material, labor, overhead, and variable manufacturing costs associated with the manufacturing of the miraDry Systems and bioTips.

With respect to our supplier contracts, all our products and raw materials are manufactured under contracts with fixed unit costs.costs which can increase over time at specified amounts.

Under our Breast Products segment, we provide an assurance and service warranty on our silicone gel breast implants. Under our miraDry segment, we provide an assurance and service warranty on our miraDry Systems, and an assurance warranty on our handpieces and bioTips. The estimated warranty costs are recorded at the time of sale. Costs related to our service warranty are recorded when expense is incurred related to meeting our performance obligations. In addition, the inventory fair market value associated with purchase accounting adjustments and royalty costs related to both the SSP and miraDry acquisitions wereare recorded at the time of sale.

We expect our overall gross margin, which is calculated as net sales less cost of goods sold for a given period divided by net sales, to fluctuate in future periods primarily as a result of quantity of units sold, manufacturing price increases, the changing mix of products sold with different gross margins, warranty costs, overhead costs and targeted pricing programs. Specific to the Breast Products segment, we expect our gross margin to decline as a result of increased unit cost of our gel implants following the Vesta Acquisition.

Sales and Marketing Expenses

Our sales and marketing expenses primarily consist of salaries, bonuses, benefits, incentive compensation, stock-based compensation, consumer marketing, and travel for our sales, marketing and customer support personnel. Our sales and marketing expenses also include expenses for trade shows, our no‑charge customer shipping program for the Breast Products segment and no-charge product evaluation units for the Breast Products segment, as well as educational and promotional and marketing activities, including direct and online marketing.activities. We expect our sales and marketing expenses related to our Breast Products segment to fluctuate in future periods as a result of headcount and timing of our marketing programs.  However,programs, and we generally expect these costs will increaseour sales and marketing expense related to our miraDry segment to decrease as a result of the organizational efficiency initiative and the change in absolute dollars.the miraDry business strategy.


Research and Development Expenses

Our research and development, or R&D, expenses primarily consist of clinical expenses, product development costs, regulatory expenses, consulting services, outside research activities, quality control and other costs associated with the development of our products and compliance with Good Clinical Practices, or cGCP, requirements. R&D expenses also include related personnel and consultant compensation and stock‑based compensation expense. We expense R&D costs as they are incurred.

We expect our R&D expenses to vary as different development projects are initiated, including improvements to our existing products, expansions of our existing product lines, new product acquisitions and our clinical studies. However, we generally expect these costs will increase in absolute terms over time as we continue to expand our product portfolio and add related personnel.

General and Administrative Expenses

Our general and administrative, or G&A, expenses primarily consist of salaries, bonuses, benefits, incentive compensation and stock-based compensation for our executive, financial, legal, business development and administrative functions. Other G&A expenses include contingent consideration fair market value adjustments, bad debt expense, outside legal counsel and litigation expenses, independent auditors and other outside consultants, corporate insurance, facilities and information technologies expenses.

We expect future G&A expenses to increasedecrease as we continue to build our finance, legal, information technology, human resources and other general administration resources to continue to advanceimplement the commercialization of our products. In addition,organizational efficiency initiative, but we also expect to continue to incur G&A expenses in connection with operating as a public company.


Other Income (Expense), net

Other income (expense), net primarily consists of interest income, interest expense, changes in the fair value of the embedded derivative liability and common stock warrants, and amortization of issuance costs associated with our Credit Agreements.

Income Taxes

 

Income tax expense consists of an estimate for income taxes based on the projected income tax expense for the period. We operate in several tax jurisdictions and are subject to taxes in each jurisdiction in which we conduct business. To date, we have incurred cumulative net losses and maintain a full valuation allowance on our net deferred tax assets due to the uncertainty surrounding realization of such assets.

 

Critical Accounting Policies and Significant Judgments and Estimates

The preparation of our unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and the revenues and expenses incurred during the reported periods. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We discussed accounting policies and assumptions that involve a higher degree of judgment and complexity in Note 21 of the “Notes to Financial Statements” in our audited financial statements included in the Annual Report. There have been no material changes to our critical accounting policies and estimates from those disclosed in the Annual Report, other than the implementation of ASU 2016-02 (Topic 842) Leases, as discussed in Note 2 of the unaudited condensed consolidated financial statements included in this Form 10-Q.Report.


Recent Accounting Pronouncements

Please refer to Note 21 - Summary of Significant Accounting Policies in the notes to the unaudited condensed consolidated financial statements included in this Form 10-Q for information on recent accounting pronouncements and the expected impact on our unaudited condensed consolidated financial statements.


Results of Operations

Comparison of the Three Months Ended September 30, 20192020 and 20182019

The following table sets forth our results of operations for the three months ended September 30, 20192020 and 2018:2019:

 

 

Three Months Ended

 

 

Three Months Ended

 

 

September 30,

 

 

September 30,

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

(In thousands)

 

 

(In thousands)

 

Statement of operations data

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

22,412

 

 

$

16,875

 

 

$

19,217

 

 

$

22,412

 

Cost of goods sold

 

 

9,754

 

 

 

6,398

 

 

 

8,391

 

 

 

9,754

 

Gross profit

 

 

12,658

 

 

 

10,477

 

 

 

10,826

 

 

 

12,658

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

18,668

 

 

 

15,254

 

 

 

12,872

 

 

 

18,668

 

Research and development

 

 

3,201

 

 

 

2,881

 

 

 

2,060

 

 

 

3,201

 

General and administrative

 

 

12,249

 

 

 

11,904

 

 

 

10,238

 

 

 

12,249

 

Restructuring

 

 

(386

)

 

 

 

Total operating expenses

 

 

34,118

 

 

 

30,039

 

 

 

24,784

 

 

 

34,118

 

Loss from operations

 

 

(21,460

)

 

 

(19,562

)

 

 

(13,958

)

 

 

(21,460

)

Other income (expense), net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

510

 

 

 

133

 

 

 

5

 

 

 

510

 

Interest expense

 

 

(1,344

)

 

 

(953

)

 

 

(2,059

)

 

 

(1,344

)

Change in fair value of derivative liability

 

 

10,090

 

 

 

 

Other income (expense), net

 

 

(139

)

 

 

(163

)

 

 

101

 

 

 

(139

)

Total other income (expense), net

 

 

(973

)

 

 

(983

)

 

 

8,137

 

 

 

(973

)

Loss before income taxes

 

 

(22,433

)

 

 

(20,545

)

 

 

(5,821

)

 

 

(22,433

)

Income tax (benefit) expense

 

 

 

 

 

 

Income tax

 

 

 

 

 

 

Net loss

 

$

(22,433

)

 

$

(20,545

)

 

$

(5,821

)

 

$

(22,433

)

Net Sales

Net sales increased $5.5decreased $3.2 million, or 32.8%14.3%, to $19.2 million for the three months ended September 30, 2020 as compared to $22.4 million for the three months ended September 30, 2019 as compared to $16.92019. Net sales of our Breast Products segment was $15.3 million, an increase of $2.7 million for the three months ended September 30, 2018. Net sales of our Breast Products segment was2020, as compared to $12.6 million, an increase of $4.0 million for the three months ended September 30, 2019, as comparedprimarily due to $8.6 million for the three months ended September 30, 2018, driven primarily by an increase in the volume of domestic and international sales of silicone gel breast implants andas well as an increase in the sales volume of BioCorneum, partially offset by a decrease in the sales volume of Allox2 and Dermaspan breast tissue expanders. Net sales of our miraDry segment was $9.8$3.9 million, an increasea decrease of $1.5$5.9 million, as compared to $8.3 million for the three months ended September 30, 2018, driven primarily by an increase in the volume of sales of miraDry consoles in the US.

As of September 30, 2019, our U.S. sales organization included 86 sales representatives as compared to 80 sales representatives as of September 30, 2018. The increase is attributed to headcount increases of both miraDry and Sientra sales representatives.


Cost of Goods Sold and Gross Margin

Cost of goods sold increased $3.4 million, or 52.5%, to $9.8 million for the three months ended September 30, 2019 resulting from an overall decrease in the volume of sales of miraDry systems and consumable bioTips due to the effects of the COVID-19 pandemic and the change in miraDry business strategy.

As of September 30, 2020, our U.S. sales organization included 54 sales representatives as compared to $6.486 sales representatives as of September 30, 2019. The decrease is primarily attributed to an overall decrease in sales headcount implemented under the organizational efficiency initiative and the change in miraDry business strategy.

Cost of Goods Sold and Gross Margin

Cost of goods sold decreased $1.4 million, or 14.0%, to $8.4 million for the three months ended September 30, 2018. The increase was primarily due2020 as compared to an adjustment in the warranty reserve in Q3 2018 in the Breast Products segment resulting in a reduction of cost of goods sold$9.8 million for the three months ended September 30, 2018 that did not re-occur2019. The decrease was primarily due to a decrease in 2019, coupled with a generalsales in the miraDry segment, offset by an increase in net sales.the sales volume and unit costs of breast implants in the Breast Products segment.


The gross margins for the three months ended September 30, 2020 and 2019 were 56.3% and 2018 were 56.5% and 62.1%, respectively. The decrease was primarily due to an adjustment in the warranty reserve in Q3 2018increased unit cost of gel implants in the Breast Products segment resulting infollowing the Vesta Acquisition, offset by a reductionhigher sales mix of cost of goods sold for the three months ended September 30, 2018 that did not re-occur in 2019, and the impact of increased miraDry console salesconsumables which carry lower margins.a higher margin.

Sales and Marketing Expenses

Sales and marketing expenses increased $3.4decreased $5.8 million, or 22.4%31.0%, to $12.9 million for the three months ended September 30, 2020 as compared to $18.7 million for the three months ended September 30, 2019, as compared2019. The decrease was primarily due to $15.3decreases in employee payroll and incentive compensation related expenses, and a reduction in marketing events and initiatives associated with the organizational efficiency initiative, the change in the miraDry business strategy and other cost saving measures implemented in response to COVID-19.

Research and Development Expenses

R&D expenses decreased $1.1 million, or 35.6%, to $2.1 million for the three months ended September 30, 2018. The increase was primarily due to higher employee-related costs2020 as a result of increased sales headcount, and an increase in marketing expenses and initiatives.

Research and Development Expenses

R&D expenses increased $0.3 million, or 11.1%,compared to $3.2 million for the three months ended September 30, 2019, as compared to $2.9 million for the three months ended September 30, 2018.2019. The increasedecrease was primarily due to higher employee-related costs as a result of additional headcountdecreases in employee payroll and an increaseincentive compensation related expenses associated with the organizational efficiency initiative, the change in the miraDry business strategy and other cost saving measures implemented in response to COVID-19, coupled with decreases in costs related to clinical and regulatory activities.

 

General and Administrative Expenses

G&A expenses increased $0.3decreased $2.0 million, or 2.9%16.4%, to $10.2 million for the three months ended September 30, 2020 as compared to $12.2 million for the three months ended September 30, 2019, as compared2019. The decrease is primarily related to $11.9 milliondecreases in employee payroll and incentive compensation related expenses, and consulting expenses associated with the organizational efficiency initiative, the change in the miraDry business strategy and other cost saving measures implemented in response to COVID-19. In addition, there were decreases in legal expenses, severance expenses, and fair value adjustments, offset by an increase in bad debt expense, insurance, and freight expense.

Restructuring Expenses

Restructuring expenses for the three months ended September 30, 2018. The increase is primarily related2020 were ($0.4) million, resulting from a change in estimated severance costs to an increase in consulting expense, payroll related expenses and bad debt expense, offset by a decrease in incentive compensation expense and stock-based compensation expense.be incurred under the organizational efficiency initiative.  

Other Income (Expense), net

Other income (expense), net for the three months ended September 30, 2020 changed $9.1 million as compared to the three months ended September 30, 2019 and 2018 was primarily associated with expenses relateddue to the decrease in the fair value of the derivative liability, offset by an increase in interest expense and amortization of debt issuance costs and debt discounts associated with our Credit Agreements the change in fair value of warrants, interest income on cash held in a money market account, and foreign exchange gains and losses.Convertible Note.

Income Tax Expense

For the three months ended September 30, 20192020 and 20182019 there was no income tax expense.


Comparison of the Nine Months Ended September 30, 20192020 and 20182019

The following table sets forth our results of operations for the nine months ended September 30, 20192020 and 2018:2019:

 

 

Nine Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

(In thousands)

 

 

(In thousands)

 

Statement of operations data

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

60,489

 

 

$

49,104

 

 

$

48,597

 

 

$

60,489

 

Cost of goods sold

 

 

24,041

 

 

 

19,154

 

 

 

20,733

 

 

 

24,041

 

Gross profit

 

 

36,448

 

 

 

29,950

 

 

 

27,864

 

 

 

36,448

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

60,987

 

 

 

45,990

 

 

 

37,614

 

 

 

60,987

 

Research and development

 

 

9,526

 

 

 

7,930

 

 

 

7,747

 

 

 

9,526

 

General and administrative

 

 

37,538

 

 

 

31,419

 

 

 

27,500

 

 

 

37,538

 

Goodwill and other intangible impairment

 

 

12,674

 

 

 

 

Restructuring

 

 

1,849

 

 

 

 

Impairment

 

 

6,432

 

 

 

12,674

 

Total operating expenses

 

 

120,725

 

 

 

85,339

 

 

 

81,142

 

 

 

120,725

 

Loss from operations

 

 

(84,277

)

 

 

(55,389

)

 

 

(53,278

)

 

 

(84,277

)

Other income (expense), net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

1,083

 

 

 

214

 

 

 

203

 

 

 

1,083

 

Interest expense

 

 

(3,276

)

 

 

(2,474

)

 

 

(7,289

)

 

 

(3,276

)

Change in fair value of derivative liability

 

 

(8,420

)

 

 

 

Other income (expense), net

 

 

(101

)

 

 

(347

)

 

 

74

 

 

 

(101

)

Total other income (expense), net

 

 

(2,294

)

 

 

(2,607

)

 

 

(15,432

)

 

 

(2,294

)

Loss before income taxes

 

 

(86,571

)

 

 

(57,996

)

 

 

(68,710

)

 

 

(86,571

)

Income tax benefit (expense)

 

 

 

 

 

 

Income tax

 

 

 

 

 

 

Net loss

 

$

(86,571

)

 

$

(57,996

)

 

$

(68,710

)

 

$

(86,571

)

Net Sales

Net sales increased $11.4decreased $11.9 million, or 23.2%19.7%, to $48.6 million for the nine months ended September 30, 2020 as compared to $60.5 million for the nine months ended September 30, 2019 as compared to $49.12019. Net sales of our Breast Products segment was $37.1 million, an increase of $3.5 million for the nine months ended September 30, 2018. Net sales of our Breast Products segment was2020, as compared to $33.6 million, an increase of $7.0 million for the nine months ended September 30, 2019, as compared to $26.6 million for the nine months ended September 30, 2018, driven primarily by an increase in the volume of sales of silicone gel breast implants and Allox2 and Dermaspan breast tissue expanders.implants. Net sales of our miraDry segment was $26.9$11.5 million, an increasea decrease of $4.4$15.4 million, as compared to $22.5$26.9 million for the nine months ended September 30, 2018 driven primarily by2019 resulting from an increaseoverall decrease in the volume of sales of miraDry systems and consumable bioTips due to the effects of the COVID-19 pandemic and the change in the US and internationally.miraDry business strategy.

Cost of Goods Sold and Gross Margin

Cost of goods sold increased $4.9decreased $3.3 million, or 25.5%13.8%, to $20.7 million for the nine months ended September 30, 2020 as compared to $24.0 million for the nine months ended September 30, 2019, as compared to $19.2 million for the nine months ended September 30, 2018.2019. The increasedecrease was primarily due to an adjustmenta decrease in sales in the warranty reservemiraDry segment, offset by an increase in Q3 2018the sales volume and unit costs of breast implants in the Breast Products segment resulting in a reduction of cost of goods sold for the nine months ended September 30, 2018 that did not re-occur in 2019.segment.

The gross margins for the nine months ended September 30, 2020 and 2019 were 57.3% and 2018 were 60.3% and 61.0%, respectively. The slight decrease was primarily due to an adjustment in the warranty reserve in Q3 2018increased unit cost of gel implants in the Breast Products segment resulting in a reduction of cost of goods soldfollowing the Vesta Acquisition.


Sales and Marketing Expenses

Sales and marketing expenses decreased $23.4 million, or 38.3%, to $37.6 million for the nine months ended September 30, 2018 that did not re-occur in 2019, offset by increased sales of consumable bioTips in the miraDry reporting unit which carry higher margins.


Sales and Marketing Expenses

Sales and marketing expenses increased $15.0 million, or 32.6%,2020 as compared to $61.0 million for the nine months ended September 30, 2019, as compared2019. The decrease was primarily due to $46.0decreases in employee payroll and incentive compensation related expenses, and a reduction in consulting fees and marketing events and initiatives associated with the organizational efficiency initiative, the change in the miraDry business strategy and other cost saving measures implemented in response to COVID-19.

Research and Development Expenses

R&D expenses decreased $1.8 million, or 18.7%, to $7.7 million for the nine months ended September 30, 2018. The increase was primarily due to higher employee-related costs2020 as a result of increased sales headcount, and an increase in marketing expenses and initiatives.

Research and Development Expenses

R&D expenses increased $1.6 million, or 20.1%,compared to $9.5 million for the nine months ended September 30, 2019, as compared to $7.9 million for the nine months ended September 30, 2018.2019. The increasedecrease was primarily due to an increasedecreases in employee payroll and incentive compensation related expenses associated with the organizational efficiency initiative, the change in the miraDry business strategy and other cost saving measures implemented in response to COVID-19, coupled with decreases in costs related to clinical and regulatory activities.

 

General and Administrative Expenses

G&A expenses increased $6.1decreased $10.0 million, or 19.5%26.7%, to $27.5 million for the nine months ended September 30, 2020 as compared to $37.5 million for the nine months ended September 30, 2019, as compared2019. The decrease is primarily related to $31.4 milliondecreases in employee payroll and incentive compensation related expenses, and consulting and legal expenses associated with the organizational efficiency initiative, the change in the miraDry business strategy and other cost saving measures implemented in response to COVID-19. In addition, there were decreases in intangibles amortization expense, fair value adjustments, offset by an increase in bad debt expense, insurance expense, and accounting fees.

Restructuring Expenses

Restructuring expenses for the nine months ended September 30, 2018. The increase is2020 were $1.8 million, consisting primarily relatedof severance expenses of employees affected by the organizational efficiency initiative.  

Impairment Expenses

Impairment expenses for the nine months ended September 30, 2020 were $6.4 million, due to an increasefull impairments of intangible assets in consultingthe miraDry reporting unit. Impairment expenses payroll related expenses, legal expenses and bad debt expense, offset by a decrease in contingent consideration fair value adjustments, stock-based compensation, and incentive compensation.

Goodwill and Other Intangible Impairment

Goodwill and other intangible impairment expenses were $12.7 million for the nine months ended September 30, 2019 were $12.7 million, due to impairmentsa full impairment of goodwill and partial impairment of intangible assets in the miraDry reporting unit.

Other Income (Expense), net

Other income (expense), net for the nine months ended September 30, 2020 increased $13.1 million as compared to the nine months ended September 30, 2019 and 2018 was primarily associated with expenses relateddue to the increase in the fair value of the derivative liability, interest expense and amortization of debt issuance costs and debt discounts associated with our Credit Agreements the change in fair value of warrants and interest income on cash held in a money market account.Convertible Note.

Income Tax Expense

For the nine months ended September 30, 20192020 and 20182019 there was no income tax expense.

Liquidity and Capital Resources

Since our inception, we have incurred significant net operating losses and anticipate that our losses will continue in the near term.  We expect our operating expenses will continue to grow as we expand our operations.  We will need to generate significant net sales to achieve profitability. To date, we have funded our operations primarily with


proceeds from the sales of preferred stock, borrowings under our term loans and convertible note, sales of our products since 2012, and the proceeds from the sale of our common stock in public offerings.

On July 25, 2017,

As of September 30, 2020, we entered intohad $63.5 million in cash and cash equivalents. Our historical cash outflows have primarily been associated with activities relating to commercialization and increases in working capital, including the Existing Credit Agreements with Midcap. On July 1, 2019,expansion of our sales force and marketing programs. In addition, we entered into certain credit agreements with Midcap Financial Trust pursuanthave used cash to which we repaidfund the acquisitions of miraDry, BIOCORNEUM, our existing indebtedness under our Existing Credit Agreementstissue expander portfolio, and the outstanding commitment fee was cancelled.

See Note 10 to the condensed consolidated financial statements for a full description of our long-term debt and revolving line of credit.Vesta Acquisition.

 

In February 2018, we entered into an At-The-Market Equity Offering Sales Agreement with Stifel, Nicolaus & Company, Incorporated, or Stifel, as sales agent pursuant to which we may sell, from time to time, through Stifel shares of our common stock having an aggregate gross offering price of up to $50 million. As of September 30, 20192020, we have notthe Company has sold any37,000 shares of its common stock pursuant to the sales agreement.  agreement, resulting in net proceeds after commissions of approximately $0.3 million.

On July 1, 2019, we entered into certain credit agreements with Midcap Financial Trust pursuant to which we repaid our existing indebtedness under our existing credit agreements and the outstanding commitment fee was cancelled. Further on March 11, 2020, we entered into a facility agreement with Deerfield Partners, L.P., issuing $60.0 million in principal amount of 4.0% unsecured and subordinated convertible notes.See Note 10 – Debt to the condensed consolidated financial statements for a full description of our long-term debt, revolving line of credit, and convertible note.

 

On May 7, 2018,In April 2020, we completed an underwritten follow-on public offeringwere granted a loan of $6.7 million under the Paycheck Protection Program of the CARES Act, or the PPP Loan, all or a portion of which may be forgiven dependent on our use of proceeds. The PPP Loan matures on April 20, 2022 and bears interest at a rate of 1.0% per annum. All or a portion of the PPP Loan may be forgiven upon submission of documentation of expenditures in which we sold 7,407,408 shares of common stock at $13.50 per share, as well as 1,111,111 additional shares of common stock pursuantaccordance with certain specified requirements. See Note 10 – Debt to the condensed consolidated financial statements for a full exercisedescription of the over-allotment option grantedPPP Loan. We sought and obtained the PPP Loan due to the underwriters. Net proceeds were approximately $107.6 million after deducting underwriting discountsimmediate and commissions of $6.9 million and offering expenses of approximately $0.5 million.


Further, on June 7, 2019, we completed an underwritten follow-on public offering of 17,391,305 shares of common stock at $5.75 per share, as well as 2,608,695 additional shares of common stock pursuant to the full exercisecontinued impact of the over-allotment option grantedCOVID-19 pandemic on our revenues and prospects. The PPP Loan has allowed us to satisfy our payroll obligations without a material reduction in pay for our employees or a material headcount reduction, other than the underwriters. Net proceeds were approximately $107.7 million after deducting underwriting discounts and commissions of $6.9 million and offering expenses of approximately $0.4 million.reductions in the previously announced organizational efficiency initiative.

 

As of September 30, 2019, we had $120.9 million in cash and cash equivalents. Our historical cash outflows have primarily been associated with activitiesDue to the continued uncertainty relating to commercialization and increasesthe COVID-19 pandemic, our revenues may continue to be adversely impacted. If we are unable to achieve certain revenue targets, we may breach certain financial covenants set forth in working capital, includingour Credit Agreement with MidCap Financial Trust.  If we breach these covenants, MidCap will have the expansionright to accelerate repayment of the outstanding amounts. In addition, a breach of a financial covenant in the Credit Agreement would result in a cross default under our Note with Deerfield, which would allow Deerfield to accelerate repayment of the amounts owed, subject to certain restrictions. In the event that any of MidCap or Deerfield accelerates the repayment of our sales force and marketing programs. In addition,indebtedness, there can be no assurance that we will have usedsufficient cash on hand to fund the acquisitions of miraDry, BIOCORNEUMsatisfy such obligations and our tissue expander portfolio.

business operations may be materially harmed.

To fund our ongoing operating and capital needs, we may need to raise additional equity or debt capital. We believe we have sufficient capital resources to continue as a going concern through the next twelve months.

Cash Flows

The following table shows a summary of our cash flows (used in) provided by operating, investing and financing activities for the periods indicated:

 

 

Nine Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

Net cash (used in) provided by:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating activities

 

$

(73,503

)

 

$

(41,418

)

 

$

(52,739

)

 

$

(73,503

)

Investing activities

 

 

(3,180

)

 

 

(414

)

 

 

(3,192

)

 

 

(3,180

)

Financing activities

 

 

110,699

 

 

 

118,252

 

 

 

31,806

 

 

 

110,699

 

Net change in cash, cash equivalents and restricted cash

 

$

34,016

 

 

$

76,420

 

 

$

(24,125

)

 

$

34,016

 


 

Cash used in operating activities

Net cash used in operating activities was $52.7 million during the nine months ended September 30, 2020 as compared to $73.5 million during the nine months ended September 30, 2019, as compared to $41.4 million during the nine months ended September 30, 2018.2019. The increasedecrease in cash used in operating activities between the nine months ended September 30, 20192020 and 20182019 was primarily associated with highera lower net loss of $68.7 million for the nine months ended September 30, 2020 as compared to $86.6 million for the nine months ended September 30, 2019, as compared to $58.0 million for the nine months ended September 30, 2018, an increase in fair value adjustments to the derivative liability and the provision for doubtful accounts, and decreases in accounts receivable offset by a lower impairment, stock-based compensation expense, and inventory, and decreases in customer deposits, accounts payable, and accrued liabilities, partially offset by a smaller decrease in accounts receivable due to the timing of sales and collections, an increase in amortization of right-of-use assets expense, and an increase in goodwill and other intangible impairment.liabilities, and prepaid expenses, other current assets and other assets.

Cash used in investing activities

Net cash used in investing activities was $3.2 million during the nine months ended September 30, 2019 as compared to $0.4 million during the nine months ended September 30, 2018.2020 and 2019. The slight increase in cash used in investing activities between the nine months ended September 30, 20192020 and 20182019 was due to an increase in property and equipment purchases.

Cash provided by financing activities

Net cash provided by financing activities was $31.8 million during the nine months ended September 30, 2020 as compared to $110.7 million during the nine months ended September 30, 2019 as compared to $118.3 million during the nine months ended September 30, 2018.2019. The decrease in cash provided by financing activities was primarily the result of a decrease in proceeds from borrowings under the Term Loan, an increase in tax payments related to shares withheld for vested RSUs, and payment of contingent consideration, offset by an increase in the proceeds from issuance of common stock, repayments of the term loan, and decrease in borrowings under ESPP for the nine months ended September 30, 2019.revolving loan, offset by an increase in proceeds from issuance of the convertible note and the PPP loan.


Our liquidity position and capital requirements are subject to a number of factors. For example, our cash inflow and outflow may be impacted by the following:

 

the ability of the Vestaour implant manufacturing facility in Franklin Wisconsin to meet capacity to meet customer requirements;requirements and maintain unit costs that will drive gross margin;

net sales generated by our Breast Products and miraDry segments, and any other future products that we may develop and commercialize;

the ability of our third-party tissue expander manufacturing facility operated by SiMatrix to meet capacity to meet customer requirements;

costs associated with expanding our sales force and marketing programs;

net sales generated by our Breast Products and miraDry segments, and any other future products that we may develop and commercialize;

cost associated with developing and commercializing our proposed products or technologies;

the scope and duration of the COVID-19 pandemic and its effect on our operations;

expenses we incur in connection with potential litigation or governmental investigations;

costs associated with expanding our sales force and marketing programs;

cost of obtaining and maintaining regulatory clearance or approval for our current or future products;

cost associated with developing and commercializing our proposed products or technologies;

cost of ongoing compliance with regulatory requirements, including compliance with Sarbanes-Oxley;

expenses we incur in connection with potential litigation or governmental investigations;

anticipated or unanticipated capital expenditures; and

cost of obtaining and maintaining regulatory clearance or approval for our current or future products;

cost of ongoing compliance with regulatory requirements, including compliance with Sarbanes-Oxley;

unanticipated G&A expenses.

anticipated or unanticipated capital expenditures; and

unanticipated G&A expenses.


Our primary short-term capital needs, which are subject to change, include expenditures related to:

support of our sales and marketing efforts related to our current and future products;

support of our sales and marketing efforts related to our current and future products;

new product acquisition and development efforts;

new product acquisition and development efforts;

facilities expansion needs; and

facilities expansion needs; and

investment in inventory required to meet customer demands.

investment in inventory required to meet customer demands.

Although we believe the foregoing items reflect our most likely uses of cash in the short-term, we cannot predict with certainty all of our particular short-term cash uses or the timing or amount of cash used.  If cash generated from operations is insufficient to satisfy our working capital and capital expenditure requirements, we may be required to sell additional equity or debt securities or obtain credit facilities.  Additional capital, if needed, may not be available on satisfactory terms, if at all.  Furthermore, any additional equity financing may be dilutive to stockholders, and debt financing, if available, may include restrictive covenants.  For a discussion of other factors that may impact our future liquidity and capital funding requirements, see “Risk Factors — Risks Related to Our Financial Results” in our Annual Report on Form 10-K.

Off-Balance Sheet Arrangements

During the periods presented we did not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.

ITEM 3: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As of September 30, 2019,2020, we had $120.9$63.5 million in cash and cash equivalents. We generally hold our cash in checking accounts and interest-bearing money market accounts. Our exposure to market risk related to interest rate sensitivity is affected by changes in the general level of U.S. interest rates. Due to the short-term maturities of our cash equivalents and the low risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash equivalents. We have established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity.


ITEM 4: CONTROLS AND PROCEDURESPROCEDURES

Evaluation of Disclosure Controls and Procedures

 

Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with U.S. GAAP. We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our chief executive officerChief Executive Officer, or CEO, and chief financial officer,Chief Financial Officer, or CFO, as appropriate, to allow timely decisions regarding required disclosure. Our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting for our Annual Report on Form 10-K for the first year we are no longer an “emerging growth company” under the JOBS Act.

 

As of September 30, 20192020, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer, or CEO and Chief Financial Officer, or CFO, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on that evaluation, the CEO and CFO concluded that the Company’s disclosure controls and procedures were not effective as of September 30, 2020 as a result of the material weakness described in our Annual Report on Form 10-K and below.


The control environment was ineffective in holding individuals accountable for the operation of their internal control responsibilities. This control failure prevented the effective operation of controls over goodwill and intangible asset impairment, including the underlying financial data, calculations and assumptions supporting the forecasted financial information utilized to measure the fair value of the reporting unit, intangible assets, and the associated impairment charges. This deficiency did not result in an adjustment but still represented a material weakness in our internal control over financial reporting as of December 31, 2019 because there is a reasonable possibility that material misstatements to our consolidated financial statements would not be prevented or detected on a timely basis.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such date.that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected on a timely basis.

Remediation

As disclosed in our Annual Report, we have identified and begun to implement several actions designed to remediate the material weakness. Our remediation process includes, but is not limited to communicating expectations over performance of controls, monitoring for compliance with those expectations, and holding individuals accountable for their roles related to internal control over financial reporting.

Changes in Internal Control over Financial Reporting

 

There wasExcept as discussed above, there have been no changechanges in our internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.


PART II. OTHER INFORMATIONINFORMATION

ITEM 1. LEGAL PROCEEDINGS

From time to time, we are involved in legal proceedings and regulatory proceedings arising out of our operations. We establish reserves for specific liabilities in connection with legal actions that we deem to be probable and estimable. The ability to predict the ultimate outcome of such matters involves judgments, estimates, and inherent uncertainties. The actual outcome of such matters could differ materially from management’s estimates. Information regarding certain legal proceedings is provided in this Quarterly Report in Note 14 and Note 15 of the Condensed Consolidated Financial Statements.condensed consolidated financial statements.

Item 1A. RISK FACTORS

Except as set forth below, there have been no material changes from the risk factors disclosed in Part I, Item 1A, of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018,2019, which are incorporated herein by reference.

We rely on sole suppliersThe COVID-19 pandemic has adversely affected, and continues to manufacture someadversely affect, our business, our operations and our financial results. Future pandemics, epidemics or outbreaks of an infectious disease may similarly affect our business, our operations and our financial results.

The rapid, global spread of COVID-19 has resulted in significant economic uncertainty, significant declines in business and consumer confidence and global demand in the non-essential healthcare industry (among others), a global economic slowdown, and could lead to a global recession. The COVID-19 pandemic has drastically impacted healthcare systems in the United States and globally and resulted in travel restrictions which impact medical tourism and our sales professionals’ ability to travel. In addition, hospitals have limited access for non-patients, including our sales professionals, which could negatively impact our access to physicians. As an aesthetics company, a significant percentage of our products are utilized in elective surgeries or procedures, which may be deferred or avoided altogether due to the COVID-19 outbreak, materially impacting our financial results. Future pandemics or other outbreaks of infectious disease may result in a similar period of business disruption, including reduced sales as patients might cancel or defer elective procedures or otherwise avoid medical facilities, resulting in reduced patient volumes and operating revenues. Governmental agencies and hospital administrators may also instruct hospitals to postpone some elective procedures in preparation for COVID-19-related hospitalizations. Further, the spread of COVID-19 has caused us to modify our workforce practices, and we may take further actions that we determine are in the best interests of our employees or as required by governments. The continued spread of COVID-19, or another infectious disease, could also result in delays or disruptions in our supply chain or adversely affect our manufacturing facilities and personnel. Further, trade and/or national security protection policies may be adjusted as a result of the COVID-19 pandemic, such as actions by governments that limit, restrict or prevent the movement of certain goods into a country and/or region, and current U.S./China trade relations may be further exacerbated by the pandemic. The COVID-19 outbreak has materially impacted our operations and financial results and continues to be fluid and uncertain, making it difficult to forecast the final impact it could have on our future operations or financial results.

Our debt obligations could impair our financial condition and limit our operating flexibility.

Our indebtedness under our credit agreements with MidCap Financial Trust, or the Credit Agreements, our Convertible Note with Deerfield and our other financial obligations could:

impair our ability to obtain financing or additional debt in the future for working capital, capital expenditures, acquisitions or general corporate purposes;

impair our ability to access capital and credit markets on terms that are favorable to us;


have a material adverse effect on us if we fail to comply with financial and affirmative and restrictive covenants in our Credit Agreements and an event of default occurs as a result of a failure that is not cured or waived;

require us to dedicate a portion of our cash flow for interest payments on our indebtedness and other financial obligations, thereby reducing the availability of our cash flow to fund working capital and capital expenditures; and

limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate.

Our financial covenants in the Credit Agreements require us to achieve certain levels of net revenue calculated on a rolling monthly basis.  Due to the continued uncertainty relating to the COVID-19 pandemic, our revenues may continue to be adversely impacted. If we are unable to achieve certain revenue targets, we may breach certain financial covenants set forth in our Credit Agreements.  If we breach these covenants, MidCap will have the right to accelerate repayment of the outstanding amounts. In addition, a breach of a financial covenant in the Credit Agreement would result in a cross default under our Convertible Note with Deerfield, which would allow Deerfield to accelerate repayment of the amounts owed, subject to certain restrictions. In the event that any of MidCap or Deerfield accelerates the repayment of our indebtedness, there can be no assurance that we will have sufficient cash on hand to satisfy such obligations and our business operations may be materially harmed.

Furthermore, there is no guarantee that we will be able to pay the principal and interest under the Credit Agreements or the Convertible Note or that future working capital, borrowings or equity financing will be available to repay or refinance any amounts outstanding under the Credit Agreements or Convertible Note. Our obligations under the Credit Agreements are secured by a perfected security interest in all of our tangible and intangible assets (including our intellectual property assets), except for certain customary excluded property and all of our and our subsidiaries capital stock, with certain limited exceptions. In addition, we may enter into debt agreements in the future that may contain similar or more burdensome terms and covenants, including financial covenants.

We may not successfully integrate newly acquired businesses into our business operations or realize the benefits of partnerships with other companies, acquisitions of complementary products or technologies or other strategic alternatives.

We have completed a series of business and product acquisitions including our scaracquisition of our manufacturing operations from Vesta, our acquisition of miraDry, our product acquisitions, including BIOCORNEUM and our tissue expanders portfolio. As a result of these acquisitions, we have undergone substantial changes to our business and product offerings in a short period of time. In addition, in the future, we may consider other opportunities to partner with or acquire other businesses, products or technologies that may enhance our product platform or technology, expand the breadth of our markets or customer base or advance our business strategies.

Integrating the business practice and operations of a new business with that of our own is a complex, costly and time-consuming process, which requires significant management tissue expanderattention and bioTips products,resources. The integration process may disrupt our existing operations and, any production problems or inabilityif implemented ineffectively, would preclude realization of the full benefits expected by us. Our failure to meet the challenges involved in successfully integrating our demandacquisitions in order to realize the anticipated benefits may cause an interruption of, or a loss of momentum in, our operating activities and could adversely affect our business prospects.

We rely on sole suppliers to manufacture certain of our products or the components used therein, and the loss of any such supplier or any disruption in operations, production problems or inability to meet our supply demands of any such supplier could have a material adverse and severe effect on our business, financial condition and results of operations. Additionally, thereFor example, we recently determined to refocus our miraDry reporting unit to driving sales of consumable bioTips to our existing installed base. There can be no guaranteesassurances that we wouldwill achieve significant sales of the miraDry system under this refocused plan or, if we do, that we will be able to replacedo so in a profitable manner. Potential difficulties, costs and delays we may encounter as part of the integration process may include:

distracting management from day‑to‑day operations;

potential incompatibility of corporate cultures;


an inability to achieve synergies as planned;

risks associated with the assumption of contingent or other liabilities of acquisition targets;

adverse effects on existing business relationships with suppliers or customers;

inheriting and uncovering previously unknown issues, problems and costs from the acquired company;

uncertainties associated with entering new markets in which we have limited or no experience;

increased legal and accounting costs relating to the partnership or acquisition or compliance with regulatory matters;

delays between our expenditures to acquire new products, technologies or businesses and the generation of net sales from those acquired products, technologies or businesses;

realization of assets and settlement of liabilities at amounts equal to estimated fair value as of the acquisition date of any acquisition or disposition;

costs and delays in implementing common systems and procedures (including technology, compliance programs, financial systems, distribution and general business operations, among others); and

increased difficulties in managing our business due to the addition of international locations.

Any one or transition to alternative suppliers on a timely basisall of these factors may increase operating costs or at all, if needed. If welower anticipated financial performance. Many of these factors are required to replace anyalso outside of our sole suppliers, or transition to alternative suppliers, it may adversely impact our operations.

For example, we have entered into a definitive manufacturing agreement with NuSil Technology LLC (“NuSil”), who serves as the sole supplier of our silicone materials for short and long-term implantable products (the “Silicone Products”). If NuSil is unable to scale its manufacturingcontrol. In addition, even if new business operations to meet our requirements in any future period, or if there are any delays or disruptions in manufacturing or delivering the implants,integrated successfully, we may not realize the full benefits of the acquisition, including the synergies, cost savings or sales or growth opportunities that we expect or within the anticipated time frame. Additional unanticipated costs may be able to achieve our anticipated sales levels and our net sales and business prospects could suffer significantly. In addition, if NuSil were to terminate or otherwise fail to perform under the definitive manufacturing agreement, we would need to identify and qualify another alternate manufacturer, which would require a significant amount of time and resources and result in a supply interruption.

There are numerous risks in relying on sole suppliers to manufacture our products, which, individually orincurred in the aggregate,integration of the businesses. All of these factors could have a material adversedecrease or delay the expected accretive effect of the transaction, and severe effect on our business, financial condition and results of operations.

Disruption in our manufacturing operations may prevent us from meeting customer demand, and our sales and profitability may suffer as a result.

Withnegatively impact the Vesta Acquisition, we are now responsible for the manufacturingprice of our breast implants.  A serious disruption, such as an earthquake, flood, fire,common stock. The failure to manufacturing facility could damage our inventory levels and manufacturingintegrate the business operations and could materially impair our ability to distribute our breast implant products to customers in a timely mannerof miraDry or at a reasonable cost. We could also incur significantly higher costs and experience longer lead times during the time required to reopen or replace our primary distribution center or manufacturing facility.  As a result, any serious disruption couldacquired business successfully would have a material adverse effect on our business, financial condition and results of operations.


Any disruption at As noted above, we determined to refocus efforts on driving sales of bioTips to our facilities could adversely affectexisting installed base. There can be no assurance that this shift in focus will allow us to realize the expected benefits from this acquisition.

If we are unable to drive sales of our bioTips to our existing installed base of miraDry systems, our business and operating results.future prospects will be harmed.

Our principal offices are located in Santa Barbara, California. Substantially allIn April 2020, we determined to focus on driving high margin, bioTip utilization to our existing installed base combined with a controlled placement of consoles. We expect that the net sales we generate from our bioTips will represent high margin sales (on a gross margin basis) and account for a substantial amount of our operations are conducted at this location, including customer service, development and management and administrative functions. Substantially allnet sales for the next several years, with high margin consumables comprising a sizable percentage of our inventorymiraDry segment’s net sales. Accordingly, our success depends on the acceptance among physicians and patients of Breast Productsthe miraDry procedure as a preferred treatment for being sweat-bothered. Although we have received FDA clearance to market the miraDry procedure for the treatment of primary axillary hyperhidrosis, odor and permanent hair reduction in the United States and are approved or are otherwise free to market the miraDry procedure for the treatment of primary ancillary hyperhidrosis in adults in over 40 international markets, the degree of market acceptance of the miraDry procedure by physicians and patients is heldunproven. We believe that market acceptance of the miraDry procedure will depend on many factors, including:

the perceived advantages or disadvantages of the miraDry System compared to other products and procedures;

the safety and efficacy of the miraDry System relative to other products and alternative procedures;


the price of the miraDry System relative to other products and alternative procedures;

the effectiveness of our marketing, advertising, and commercialization initiatives;

the development and publication of long-term clinical data in peer-reviewed journals supporting the long term efficacy of the miraDry procedure;

our ability to obtain regulatory clearance to market miraDry for additional treatment indications in the United States and other international markets;

education of physicians, especially general practitioners and dermatologists, regarding alternative procedures for sweat-bothered patients through key opinion leaders and product demonstrations at conferences, physician offices and webinars; and

the success of patient education through direct-to-consumer marketing campaigns that utilize social media outlets and testimonials.

In addition, the COVID-19 pandemic has limited our ability to educate physicians and drive market acceptance of the procedure. We cannot guarantee that the miraDry procedure will achieve broad market acceptance among physicians and patients. We expect to derive a second locationsubstantial portion of sales from the sale of our consumable bioTip products, which represent higher margin products within our product portfolio. As a result, any failure of this product to achieve meaningful market acceptance will harm our business, sales, profitability and future prospects.

If changes in Santa Barbara, California, we manufacture, distribute,the economy and serviceconsumer spending reduce consumer demand for our products, our sales and profitability would suffer.

We are subject to the risks arising from adverse changes in general economic and market conditions, pandemics or political actions including new or increased trade protection policies such as tariffs, particularly in China, where certain components of our miraDry Systems at a third locationproducts are manufactured. Certain elective procedures, such as breast augmentation and the miraDry procedure, are typically not covered by insurance. Adverse changes in Santa Clara, California, and, with the Vesta Acquisition, we manufacture our breast implants at a fourth location in Minnesota. Despite our efforts to safeguard our facilities, including acquiring insurance, adopting health and safety protocols and utilizing off-site storage of computer data, vandalism, terrorismeconomy or a natural or“trade war” may cause consumers to reassess their spending choices and reduce the demand for these surgeries and other disaster, such asprocedures and could have an earthquake, fire or flood,adverse effect on consumer spending. This shift could damage or destroy our inventory of finished goods, cause substantial delays in our operations, result in the loss of key information and cause us to incur additional expenses. Our insurance may not cover our losses in any particular case. In addition, regardless of the level of insurance coverage, damage to our facilities may have a materialan adverse effect on our business, financial conditionnet sales and operating results.

Product liabilityprofitability. Furthermore, consumer preferences and warranty claims or other litigationtrends may shift due to a variety of factors, including changes in demographic and related negative publicitysocial trends, public health initiatives and product innovations, which may adversely affectreduce consumer demand for our business, sales, financial condition and operating results.

As a supplier of medical devices, we are and may be subject to warranty or product liability claims alleging that the use of our products has resulted in adverse health effects or other litigation in the ordinary course of business that may require us to make significant expenditures to defend these claims or pay damage awards. The breast implant industry has a particularly significant history of product liability litigation. The risks of litigation exist even with respect to products that have received or in the future may receive regulatory approval for commercial sale, such as our Breast Products.products. For example, on October 7, 2019,as a lawsuit was filed in the Superior Courtresult of the State of California against us and Silimed Industria de Implantes Ltda. (our former contract manufacturer). The lawsuit alleges thatCOVID-19 outbreak in China, our textured breast implants caused certain of the plaintiffsbioTip manufacturer in China was required to develop a condition known as breast implant associated anaplastic large cell lymphoma (“BIA-ALCL”), and that we are liable to the Plaintiffs based on claims for strict liability (failure to warn), strict liability (defective manufacture), negligence and loss of consortium. We intend to vigorously defend ourselves in this lawsuit. Given the recent publicity surrounding BIA-ALCL and the FDA recommendationclose for a “boxed warning” on labeling materials for breast implants,week. In addition, as the outbreak spread through the United States and globally, we may face additional litigation and negative publicity surroundinghave experienced a significant reduction in demand as non-emergency medical procedures are deferred. There can be no assurances that once healthcare systems resume normal activity that these deferred procedures will be rescheduled. The outbreak has adversely affected our breast implants in the future. An increase in product liability claims and the related negative publicity could significantly harm our business, sales, financial condition and results of operations.

In addition, historically our silicone gel breast implants were sold with a warranty providing for no-charge replacement implants in the event of certain ruptures that occur any time during the life of the patient and this warranty also includes cash payments to offset surgical fees if the rupture occurs within ten years of implantation. In April 2018, we announced our Platinum20 product replacement and limited warranty program, which we believe provides an industry-leading program of no-charge replacement implants for covered rupture events that occur during the lifetime of the patient, and no-charge replacement implants for other covered events that occur within twenty years of the implant procedure, as well as financial assistance for certain qualifying events that occur within twenty years of the implant procedure. If we experience an increase in warranty claims following the launch of our Platinum20 warranty in excess of our expectations, or if our replacement costs associated with warranty claims increase significantly, we will incur liabilities for potential warranty claims that may be greater than we expect. An increase in the frequency of warranty claims or amount of warranty costs may harm our reputation and could have a material adverse effect on our business, results of operations and financial condition.

We maintain product liability insurance, but this insurance is limited in amount and subject to significant deductibles. There is no guarantee that insurance will be available or adequate to protect against all claims. Our insurance policies are subject to annual renewal and we may not be able to obtain liability insurance in the future on acceptable terms or at all. In addition, our insurance premiums could be subject to increases in the future, which may be material. If the coverage limits are inadequate to cover our liabilities or our insurance costslikely continue to increase as a result of warranty or product liability claims or other litigation, thenadversely impact our business, financial condition and operating results may be adversely affected.


Failure to comply with the regulatory requirements for the PMA post-approval studies for our Breast Products may result in the suspension or withdrawal of our PMA.

We received pre-market approval, or PMA, for our silicone gel breast implants from the FDA in 2012. As a condition of PMA approval, the FDA imposes certain requirements in order to maintain the PMA. Failure to comply with the applicable regulatory requirements can result in, among other things, warning letters, administrative or judicially imposed sanctions such as injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, the suspension or withdrawal of our PMA, or criminal prosecution. For example, in March 2019, we received a warning letter from the FDA stating that we failed to meet the expected patient follow-up rate in one of our post-approval studies for our silicone gel breast implants. The warning letter stated that failure to promptly correct this deficiency may result in the withdrawal of our PMA. We provided a comprehensive response to the FDA and are working collaboratively with the agency to quickly and fully resolve this matter. If we are unable to timely correct the deficiency included in the warning letter to the satisfaction of the FDA, or if we fail to meet any of the other requirements of our PMA, our PMA may be suspended or withdrawn by the FDA. Any such suspension or withdrawal would have a significant negative impact on our results of operations or financial condition.

The long-term safety of our Breast Products has not fully been established and our breast implants are currently under study in our PMA post-approval studies, which could reveal unanticipated complications.

We have been marketing our silicone gel breast implants in the United States with pre-market approval from the FDA since 2012. However, there could still be unanticipated complications or unforeseen health consequences of being implanted with our silicone gel breast implants over the long-term (defined as 10 years or more). Additionally, we rely on our clinical data to make favorable comparisons of our product to our competitive products, and our longer-term data may change over time. Further, future studies or clinical experience may indicate that treatment with our products is not differentiated to treatment with competitive products. Such results could slow the adoption of our products and significantly reduce our sales, which could prevent us from achieving our forecasted sales targets or achieving or sustaining profitability. Moreover, if long-term results and experience indicate that our products cause unexpected or serious complications, we could be subject to required product labeling revisions, mandatory product recalls, suspension or withdrawal of clearance or approval by the FDA or other applicable regulatory bodies and significant legal liability.

We received a Warning Letter from FDA, dated March 19, 2019, relating to the Company’s failure to meet the FDA-approved minimum retention rate for a post-approval study.  We responded to this Warning Letter and are in continued dialogue with FDA to fully address our study’s participant retention, including patient questionnaire completion and additional follow-up office visits.

On March 25-26, 2019, the FDA convened a meeting of the General and Plastic Surgery Devices Panel at the FDA’s Headquarters in Silver Spring, Maryland, to discuss a range of topics concerning the benefit-risk profile of breast implants. In addition to a presentation of data and information about our products and those of other breast implant manufacturers, this two-day public meeting included presentations, recommendations, and discussion on breast implant associated anaplastic large cell lymphoma (BIA-ALCL); systemic symptoms reported in patients receiving breast implants; the use of registries for breast implant surveillance; revision of magnetic resonance imaging (MRI) screening recommendations for silent rupture of silicone gel filled breast implants; the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy; the use of real-world data and patient perspectives in regulatory decision making; product labeling revisions; and recommendations for best practices (including a standardized checklist) for informed consent discussions between patients and clinicians.

We cannot predict future changes that may occur to the regulatory landscape regarding our products based on this Panel Meeting and subsequent developments regarding long-term data.  For example, FDA recently issued draft guidance informed by the Panel’s recommendations to require a boxed warning and a standardized patient decision checklist as part of the informed consent process, along with other recommendations to update and provide additional labeling information.


Among the long-term health risks of breast implants which are being studied and followed, health regulators believe there is an association between breast implants and a rare form of lymphoma called anaplastic large-cell lymphoma.

In January 2011, the FDA issued a Safety Communication indicating that there was a possible association between saline and silicone gel breast implants and anaplastic large-cell lymphoma, or BIA-ALCL. Since our FDA approval in 2012, Sientra’s breast-implant product labeling, which is approved by the FDA, has been required to contain a description of BIA-ALCL as a possible outcome. Since its report in January 2011, the FDA has continued to gather information about BIA-ALCL in women with breast implants through the review of medical device reports, review of medical literature, and collaboration with international regulators, scientific experts, ASPS, ASAPS, ISAPS, and other organizations.

As of August 23, 2017, the FDA updated its recommendations on BIA-ALCL and subsequently requested all breast implant manufacturers to revise their physician and patient labeling with the most up-to-date information. The FDA has continued to monitor these matters, and on February 6, 2019 issued a “Letter to Health Care Providers” and a public statement detailing updated medical device report (MDR) data involving BIA-ALCL, and stating that the data and published information reviewed to date suggest that patients with breast implants have an increased risk of BIA-ALCL. The FDA states: “Over time, we have strengthened our understanding of this condition. In 2016, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.until heathcare systems resume normal activity. At this time, most data suggest that BIA-ALCL occurs more frequently following implantationpoint, the duration and extent of breast implants with textured surfaces rather than those with smooth surfaces.” The FDA noted it does not recommend prophylactic breast implant removal in a patient without symptoms or other abnormality.

On March 25-26, 2019, the FDA convened a meeting of the General and Plastic Surgery Devices Panel which covered a range of topics concerning the benefit-risk profile of breast implants, including BIA-ALCL. More recently, on October 24, 2019, FDA issued a draft guidance document providing recommendations to breast implant manufacturers regarding the content and format of revised labeling information for saline and silicone gel-filled breast implants.  The recommendations included a recommendation for a boxed warning that, among other things, states: “Breast implants have been associated with the risk of developing BIA-ALCL and may be associated with systemic symptoms.”

Further studies or clinical experience may indicate that breast implants, including our products, expose individuals to a more substantial risk of developing BIA-ALCL or other unexpected complications than currently anticipated. As a result, we may be exposed to increased regulatory scrutiny, negative publicity and lawsuits from any individual who may develop BIA-ALCL after using our products, any of which could have a significant negativesuch impact on our results of operations or financial condition. Moreover, if long-term results and clinical experience indicate that our products cause unexpected or serious complications, we could be subject to mandatory product recalls, suspension or withdrawal of regulatory clearances and approvals and significant legal liability.is uncertain.

If we are unsuccessful in executing our cost plan, our business and results of operations may be adversely affected.

In November 2019, we announced an organizational efficiency initiative (the “Plan”) designed to reduce spending and simplify operations to better align our cost structure to our long-term margin targets. Under the Plan, we will implement numerous initiatives to reduce spending, including closing the Santa Clara offices of miraDry, Inc. (“miraDry”), outsourcing miraDry product assembly to a third party, and consolidating a number of business support services via a shared services organization at our Santa Barbara headquarters. Under the Plan, we also intend to reduce our workforce in a series of targeted reductions, which we expect to be completed by the end of the third quarter of 2020. In total, the Plan is estimated to cost between $3.7 million and $4.5 million through September 30, 2020, excluding non-cash charges.


We cannot provide assurance that our Plan will be successful, that anticipated cost savings will be realized, that our operations, business and financial results will improve and/or that these efforts will not disrupt our operations (beyond what is intended).


In April 2020, we implemented additional workforce reductions as cost savings measures. Our ability to achieve the anticipated cost savings and other benefits within the expected time frames is subject to many estimates and assumptions, which are subject to significant economic, competitive and other uncertainties, some of which are beyond our control. Further, we may experience delays in the timing of these efforts and/or higher than expected or unanticipated costs in implementing them. Moreover, changes in the size, alignment or organization of our workforce could adversely affect employee morale and retention, relations with customers and business partners, our ability to develop and deliver products and services as anticipated and/or impair our ability to realize our current or future business and financial objectives. If we do not succeed in these efforts, if these efforts are more costly or time-consuming than expected, if our estimates and assumptions are not correct, if we experience delays or if other unforeseen events occur, our business and results of operations may be adversely affected.

Any disruption at our facilities could adversely affect our business and operating results.

Our principal offices are located in Santa Barbara, California. Substantially all of our operations are conducted at this location, including customer service, development and management and administrative functions. Substantially all of our inventory of Breast Products is held at a second location in Santa Barbara, California, and, with the Vesta Acquisition, we manufacture our breast implants at a third location in Wisconsin. Despite our efforts to safeguard our facilities, including acquiring insurance, adopting health and safety protocols and utilizing off-site storage of computer data, vandalism, terrorism, public health crisis (such as the recent COVID-19 outbreak) or a natural or other disaster, such as an earthquake, tornado, fire or flood, could damage or destroy our inventory of finished goods, cause substantial delays in our operations, result in the loss of key information and cause us to incur additional expenses. Our insurance may not cover our losses in any particular case. In addition, regardless of the level of insurance coverage, damage to our facilities may have a material adverse effect on our business, financial condition and operating results.

We accepted a loan under the CARES Act pursuant to the Paycheck Protection Program, or the PPP, which loan may not be forgiven or may subject us to challenges and investigations regarding qualification for the loan. In addition, we may be subject to audit in connection with the loan and should we request that the loan be forgiven, the United States Small Business Administration, or SBA, will conduct a full audit in connection with the loan. If there is any adverse finding from the audit or if we are subject to any other investigation or challenge in connection with the loan, we could be required to return the full amount of the PPP loan plus interest, which could reduce our liquidity, and could be subject to significant fines, damages and penalties and our business could otherwise be adversely affected, whether or not there is an adverse finding. Such events could have a material adverse effect on our business, financial condition and results of operations.

In April 2020, we were granted a loan of $6.7 million under the PPP of the CARES Act, or the PPP Loan, all or a portion of which may be forgiven dependent on our use of proceeds. The PPP Loan matures on April 20, 2022 and bears interest at a rate of 1.0% per annum. All or a portion of the PPP Loan may be forgiven by the SBA upon submission of documentation of expenditures in accordance with the SBA’s requirements. Under the CARES Act, loan forgiveness is available for the sum of documented payroll costs, covered rent payments, covered mortgage interest and covered utilities during the 24-week period beginning on the date of loan approval. Not more than 40% of the forgiven amount may be for non-payroll costs. The amount of the PPP Loan eligible to be forgiven will be reduced if our full-time headcount declines, or if salaries and wages for employees with salaries of $100,000 or less annually are reduced by more than 25%. We will be required to repay any portion of the outstanding principal that is not forgiven, along with accrued interest, in accordance with the amortization schedule described above, and we cannot provide any assurance that we will be eligible for loan forgiveness, that we will ultimately apply for forgiveness, or that any amount of the PPP Loan will ultimately be forgiven by the SBA. Furthermore, on April 28, 2020, the Secretary of the U.S. Department of the Treasury stated that the SBA will perform a full review of any PPP loan over $2.0 million before forgiving the loan.

The PPP Loan application required us to certify, among other things, that the current economic uncertainty made the PPP Loan request necessary to support our ongoing operations. While we made this certification in good faith after analyzing, among other things, our financial situation and access to alternative forms of capital, and believe that we satisfied all eligibility criteria for the PPP Loan and that our receipt of the PPP Loan is consistent with the broad objectives of the PPP of the CARES Act, the certification described above does not contain any objective criteria and is subject to interpretation. In addition, the SBA has stated that it is unlikely that a public company with


substantial market value and access to capital markets will be able to make the required certification in good faith. The lack of clarity regarding loan eligibility under the Paycheck Protection Program has resulted in significant media coverage and controversy with respect to public companies applying for and receiving loans. If, despite our good faith belief that we satisfied all eligibility requirements for the PPP Loan, we are found to have been ineligible to receive the PPP Loan or in violation of any of the laws or governmental regulations that apply to us in connection with the PPP Loan, including the False Claims Act, we may be subject to penalties, including significant civil, criminal and administrative penalties and could be required to repay the PPP Loan. In the event that we seek forgiveness of all or a portion of the PPP Loan, we will also be required to make certain certifications which will be subject to audit and review by governmental entities and could subject us to significant penalties and liabilities if found to be inaccurate, including under the False Claims Act. In addition, our receipt of the PPP Loan may result in adverse publicity and damage to our reputation, and a review or audit by the SBA or other government entity or claims under the False Claims Act could consume significant financial and management resources. Any of these events could harm our business, results of operations and financial condition.

Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

Huiner Settlement and Consulting Agreement

As previously disclosed, on September 30, 2019 (the “Separation Date”), Charles Huiner, the Company’s Chief Operating Officer and Senior Vice President of Corporate Development and Strategy, stepped down from his role to pursue other opportunities. On November 1, 2019, the Company entered into a Confidential Settlement, Release and Consulting Agreement with Mr. Huiner (the “Huiner Agreement”). Pursuant to the Huiner Agreement, in exchange for a general release of all claims, the Company will (1) pay Mr. Huiner, in accordance with the Company’s regular payroll cycle, an amount equal to twelve months of his base salary in effect on the Separation Date, or $393,225, (2) make a lump sum payment equal to Mr. Huiner’s bonus for 2019 prorated through the Separation Date and based upon the achievement of objectives and the determination of the Board of Directors of the final 2019 corporate bonus payout, payable by check in a lump sum no later than April 1, 2020 and (3) reimburse Mr. Huiner for COBRA premiums until the earlier of (1) thirteen months following the Separation Date (2) the date Mr. Huiner is eligible for group health insurance coverage through a new employer or (3) the date Mr. Huiner ceases to be eligible for COBRA continuation coverage for any reason. In addition, the Huiner Agreement provides that Mr. Huiner will continue to provide consulting services (the “Services”) for eight months following the Separation Date. As consideration for the Services, the Company will pay Mr. Huiner a one-time lump sum consulting fee of $32,768.76, continue the vesting of all unvested restricted stock units and performance stock units granted in April 2019 and accelerated the vesting of 33,333 restricted stock units granted in January 2018. In addition, the Huiner Agreement extends the exercise period for any vested stock options until thirteen months from the Separation Date.None.


Tissue Expander Manufacturing Agreement

On November 7, 2019, the Company entered into an Amended and Restated Manufacturing and Supply Agreement (the “Manufacturing Agreement”) with Vesta Intermediate Funding, Inc. (“Vesta”), providing for the manufacture and supply of the Company’s tissue expanders and accessories (the “Expander Products”). The Manufacturing Agreement has a six-year term, which may be extended by written agreement of the parties, and may only be terminated for cause by the non-defaulting party following written notice of default with a reasonable period to cure.  The Manufacturing Agreement provides that the Company will purchase fixed percentages of its requirements for Expander Products intended for global distribution from Vesta, with such percentages decreasing over time.  In the event that Vesta fails to timely deliver a minimum threshold of the Expander Product orders for a specified period, the purchase requirements shall be adjusted downwards as provided in the Manufacturing Agreement. The Manufacturing Agreement contains customary representations and warranties.

Supply Agreement

On November 7, 2019, the Company entered into a Master Supply Agreement (the “Supply Agreement”) with NuSil Technology LLC (“NuSil”) which provides that NuSil will serve as the exclusive supplier of the Company’s silicone materials for short and long-term implantable products (the “Silicone Products”). The Supply Agreement provides for Set Pricing and Discount Pricing that the Company is able to obtain upon reaching certain minimum purchase requirements in a calendar year. The Supply Agreement has an initial term through December 31, 2026 (the “Initial Term”) which automatically renews for subsequent one year terms (each, a “Renewal Term”), unless a party provides written notice of intent to terminate the Supply Agreement no later than six (6) months prior to expiration of the Initial Term or the then current Renewal Term. The Supply Agreement may be terminated in the event of breach following a 45 day period to cure or in the event of insolvency of a party.


ITEM 6. EXHIBITSEXHIBITS

The following exhibits are filed or furnished as part of this report:

 

Number

 

Description

 

 

 

  10.1#

Confidential Settlement, Release and Consulting Agreement, dated November 4, 2019, by and between Sientra, Inc. and Charles Huiner.

  10.2

Amended and Restated Manufacturing and Supply Agreement, dated November 7, 2019, by and between Sientra, Inc. and Vesta Intermediate Funding, Inc.

  10.3

Master Supply Agreement, dated November 7, 2019, by and between Sientra, Inc. and NuSil Technology LLC.

31.1*

 

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

 

 

 

  31.2*

 

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

 

 

 

  32.1*

 

Certification of Principal Executive Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

  32.2*

 

Certification of Principal Financial Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

101.INS

 

Instance Document - the instance document does not appear in the interactive Data File because its XBRL Instance Document.tags are embedded within the Inline XBRL document.

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document.

 

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

 

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document.

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document.

 

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

104

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

 

#*

Indicates management contract or compensatory plan, contract, or agreement.

Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(10).

*

This certification is deemed not filed for purpose of section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.Filed herewith.


SIGNATURESSIGNATURES

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.

 

 

SIENTRA, INC.

 

 

November 7, 20199, 2020

By:

/s/ Jeffrey Nugent

 

 

Jeffrey Nugent

 

 

Chairman and Chief Executive Officer

��

 

 

November 7, 20199, 2020

By:

/s/ Paul Little

 

 

Paul Little

 

 

Chief Financial Officer and Treasurer

 

4245