UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

________________

 

Form 10-Q

 

(Mark One)

þ

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

For the quarterly period ended:    October 2, 2020

Or

For the quarterly period ended:    September 29, 2017
Or
o

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: 0-11634

________________

 

STAAR SURGICAL COMPANY

(Exact nameName of registrantRegistrant as specifiedSpecified in its charter)Charter)

 

Delaware

95-3797439

(State or other jurisdictionOther Jurisdiction of

incorporationIncorporation or organization)Organization)

(I.R.S. Employer

Identification No.)

25651 Atlantic Ocean Drive
Lake Forest, California

92630

(Address of Principal Executive Offices)

(Zip Code)

 

1911 Walker Avenue

Monrovia, California 91016

(Address of principal executive offices)

(626) 303-7902

(Registrant’s telephone number, including area code))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

STAA

NASDAQ

 

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 þ     No o

Indicate by check mark whether the Registrantregistrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 Registrantregistrant was required to submit and post such files).    Yes þ     No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

 

o

Large accelerated filer

þ

Accelerated filer

o

Non-accelerated filer

(Do not check if a smaller reporting company)

o

Smaller reporting company

oEmerging 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 o     No þ

The registrant has 41,164,23146,109,765 shares of common stock, par value $0.01 per share, issued and outstanding as of October 30, 2017.2020.

 


STAAR SURGICAL COMPANY

 

INDEX

 

PAGE

NUMBER

NUMBER

PART I – FINANCIAL INFORMATION

1

ITEM 1

Item 1.FINANCIAL STATEMENTS

Financial Statements.

1

ITEM 2.

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

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

15

19

ITEM 3.

Item 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Quantitative and Qualitative Disclosures About Market Risk.

20

24

ITEM 4.

Item 4.CONTROLS AND PROCEDURES

Controls and Procedures.

21

25

PART II – OTHER INFORMATION

25

ITEM 1.

Item 1.LEGAL PROCEEDINGS

Legal Proceedings.

21

25

ITEM 1A.

Item 1A.RISK FACTORS

Risk Factors.

21

26

ITEM 4.

Item 4.MINE SAFETY DISCLOSURES

Mine Safety Disclosures.

21

26

ITEM 5.

Item 5.OTHER INFORMATION

Other Information.

21

26

ITEM 6.

Item 6.EXHIBITS

Exhibits.

22

26

 


PART 1I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

ITEM 1.

FINANCIAL STATEMENTS

STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value amounts)

(Unaudited)

 

 

 

September 29,

2017

  December 30, 2016 

 

October 2, 2020

 

 

January 3, 2020

 

ASSETS        

 

 

 

 

 

 

 

 

        
Current assets:        

 

 

 

 

 

 

 

 

Cash and cash equivalents $16,133  $13,999 

 

$

128,338

 

 

$

119,968

 

Accounts receivable trade, net of allowance for doubtful accounts of $2,255 and $2,056, respectively  16,237   16,344 

Accounts receivable trade, net of allowance of doubtful accounts of

$131 and $88, respectively

 

 

42,063

 

 

 

30,996

 

Inventories, net  13,274   14,825 

 

 

18,234

 

 

 

17,142

 

Insurance receivable (Note 12)  7,000    
Prepayments, deposits and other current assets  4,936   4,349 

 

 

7,368

 

 

 

6,560

 

Total current assets  57,580   49,517 

 

 

196,003

 

 

 

174,666

 

Property, plant and equipment, net  10,999   11,790 

 

 

22,662

 

 

 

17,065

 

Finance lease right-of-use assets, net

 

 

640

 

 

 

1,867

 

Operating lease right-of-use assets, net

 

 

7,725

 

 

 

6,684

 

Intangible assets, net  326   473 

 

 

275

 

 

 

296

 

Goodwill  1,786   1,786 

 

 

1,786

 

 

 

1,786

 

Deferred income taxes  1,043   1,105 

 

 

5,007

 

 

 

3,750

 

Other assets  969   772 

 

 

600

 

 

 

751

 

Total assets $72,703  $65,443 

 

$

234,698

 

 

$

206,865

 

        
LIABILITIES AND STOCKHOLDERS’ EQUITY        

 

 

 

 

 

 

 

 

        
Current liabilities:        

 

 

 

 

 

 

 

 

Line of credit $4,442  $4,283 

 

$

1,353

 

 

$

1,827

 

Accounts payable  5,734   8,311 

 

 

7,830

 

 

 

8,050

 

Obligations under capital leases  1,269   1,198 
Litigation settlement obligation (Note 12)  7,000    

Obligations under finance leases

 

 

422

 

 

 

560

 

Obligations under operating leases

 

 

2,215

 

 

 

2,700

 

Allowance for sales returns

 

 

4,427

 

 

 

3,644

 

Other current liabilities  7,253   7,275 

 

 

17,612

 

 

 

17,697

 

Total current liabilities  25,698   21,067 

 

 

33,859

 

 

 

34,478

 

Obligations under capital leases  834   1,339 
Deferred income taxes  984   881 

Obligations under finance leases

 

 

73

 

 

 

366

 

Obligations under operating leases

 

 

5,571

 

 

 

4,086

 

Asset retirement obligations  203   195 

 

 

216

 

 

 

211

 

Deferred rent  184   59 
Pension liability  4,138   3,997 

 

 

8,587

 

 

 

7,840

 

Total liabilities  32,041   27,538 

 

 

48,306

 

 

 

46,981

 

        
Commitments and contingencies (Note 12)        
        

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders’ equity:        

 

 

 

 

 

 

 

 

Common stock, $0.01 par value; 60,000 shares authorized; 41,156 and 40,732 shares issued and outstanding at September 29, 2017 and December 30, 2016, respectively  412   407 

Common stock, $0.01 par value; 60,000 shares authorized: 46,072 and

44,822 shares issued and outstanding at October 3, 2020 and

January 3, 2020, respectively

 

 

461

 

 

 

448

 

Additional paid-in capital  202,148   197,657 

 

 

328,074

 

 

 

304,288

 

Accumulated other comprehensive loss  (788)  (1,050)

 

 

(2,925

)

 

 

(3,048

)

Accumulated deficit  (161,110)  (159,109)

 

 

(139,218

)

 

 

(141,804

)

Total stockholders’ equity  40,662   37,905 

 

 

186,392

 

 

 

159,884

 

Total liabilities and stockholders’ equity $72,703  $65,443 

 

$

234,698

 

 

$

206,865

 

See accompanying notes to the condensed consolidated financial statements.

 

1

1


STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSINCOME

(In thousands, except per share amounts)

(Unaudited)

  Three Months Ended  Nine Months Ended 
  

September 29,

2017

  

September 30,

2016

  

September 29,

2017

  

September 30,

2016

 
             
Net sales $23,473  $20,052  $65,759  $60,295 
Cost of sales  6,624   5,180   18,859   17,804 
                 
Gross profit  16,849   14,872   46,900   42,491 
                 
General and administrative  4,946   4,985   15,065   18,378 
Marketing and selling  6,431   7,149   20,282   22,006 
Research and development  4,429   4,453   13,924   16,018 
Total operating expenses  15,806   16,587   49,271   56,402 
                 
Operating income (loss)  1,043   (1,715)  (2,371)  (13,911)
                 
Other income (expense):                
Interest expense, net  (27)  (29)  (88)  (85)
Gain (loss) on foreign currency transactions  444   (29)  738   13 
Royalty income  141   134   400   507 
Other income (expense), net  (19)  (68)  17   (150)
Other income, net  539   8   1,067   285 
                 
Income (loss) before provision (benefit) for income taxes  1,582   (1,707)  (1,304)  (13,626)
Provision (benefit) for income taxes  409   71   697   (1,664)
Net income (loss) $1,173  $(1,778) $(2,001) $(11,962)
                 
Net income (loss) per share – basic $0.03  $(0.04) $(0.05) $(0.30)
Net income (loss) per share – diluted $0.03  $(0.04) $(0.05) $(0.30)
                 
Weighted average shares outstanding – basic  41,110   40,486   40,939   40,227 
Weighted average shares outstanding – diluted  42,104   40,486   40,939   40,227 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Net sales

 

$

47,081

 

 

$

39,055

 

 

$

117,462

 

 

$

111,302

 

Cost of sales

 

 

12,210

 

 

 

10,004

 

 

 

33,401

 

 

 

28,172

 

Gross profit

 

 

34,871

 

 

 

29,051

 

 

 

84,061

 

 

 

83,130

 

Selling, general and administrative expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

General and administrative

 

 

8,589

 

 

 

7,098

 

 

 

24,406

 

 

 

21,443

 

Selling and marketing

 

 

12,649

 

 

 

12,463

 

 

 

34,003

 

 

 

34,288

 

Research and development

 

 

8,751

 

 

 

6,156

 

 

 

22,960

 

 

 

17,889

 

Total selling, general and administrative expenses

 

 

29,989

 

 

 

25,717

 

 

 

81,369

 

 

 

73,620

 

Operating income

 

 

4,882

 

 

 

3,334

 

 

 

2,692

 

 

 

9,510

 

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

1

 

 

 

266

 

 

 

237

 

 

 

796

 

Gain (loss) on foreign currency transactions

 

 

468

 

 

 

(584

)

 

 

388

 

 

 

(821

)

Royalty income

 

 

93

 

 

 

106

 

 

 

239

 

 

 

440

 

Other income (expense), net

 

 

(63

)

 

 

26

 

 

 

(83

)

 

 

124

 

Total other income (expense), net

 

 

499

 

 

 

(186

)

 

 

781

 

 

 

539

 

Income before income taxes

 

 

5,381

 

 

 

3,148

 

 

 

3,473

 

 

 

10,049

 

Provision for income taxes

 

 

1,489

 

 

 

760

 

 

 

887

 

 

 

2,380

 

Net income

 

$

3,892

 

 

$

2,388

 

 

$

2,586

 

 

$

7,669

 

Net income per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.08

 

 

$

0.05

 

 

$

0.06

 

 

$

0.17

 

Diluted

 

$

0.08

 

 

$

0.05

 

 

$

0.05

 

 

$

0.16

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

45,903

 

 

 

44,563

 

 

 

45,394

 

 

 

44,426

 

Diluted

 

 

48,180

 

 

 

46,857

 

 

 

47,589

 

 

 

46,848

 

See accompanying notes to the condensed consolidated financial statements.

2

2


STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED STATEMENTS

OF COMPREHENSIVE INCOME (LOSS)

(In thousands)

(Unaudited)

 

  Three Months Ended  Nine Months Ended 
  September 29, 2017  September 30, 2016  September 29, 2017  September 30, 2016 
Net income (loss) $1,173  $(1,778) $(2,001) $(11,962)
Other comprehensive income (loss):                
Defined benefit pension plans:                
Net change in plan assets  (15)  (11)  (43)  (34)
Reclassification into earnings  20   27   60   80 
Foreign currency translation gain (loss)  (51)  232   360   2,000 
Tax effect  13   (67)  (110)  (611)
Other comprehensive income (loss), net of tax  (33)  181   267   1,435 
Comprehensive income (loss) $1,140  $(1,597) $(1,734) $(10,527)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Net income

 

$

3,892

 

 

$

2,388

 

 

$

2,586

 

 

$

7,669

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Defined benefit plans:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net change in plan assets

 

 

(334

)

 

 

(1,037

)

 

 

(387

)

 

 

(1,677

)

Reclassification into other income, net

 

 

70

 

 

 

26

 

 

 

212

 

 

 

80

 

Foreign currency translation loss

 

 

316

 

 

 

(22

)

 

 

402

 

 

 

317

 

Tax effect

 

 

(68

)

 

 

115

 

 

 

(104

)

 

 

80

 

Other comprehensive income (loss), net of tax

 

 

(16

)

 

 

(918

)

 

 

123

 

 

 

(1,200

)

Comprehensive income

 

$

3,876

 

 

$

1,470

 

 

$

2,709

 

 

$

6,469

 

 

See accompanying notes to the condensed consolidated financial statements.

3

 

3


STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands)

(Unaudited)

 

 

Three Months Ended

 

 

 

Common

Stock Shares

 

 

Common

Stock Par

Value

 

 

Additional

Paid-In

Capital

 

 

Accumulated

Other

Compre-

hensive

Income

(Loss)

 

 

Accumulated

Deficit

 

 

Total

 

Balance, at July 3, 2020

 

 

45,788

 

 

$

458

 

 

$

320,235

 

 

$

(2,909

)

 

$

(143,110

)

 

$

174,674

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,892

 

 

 

3,892

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(16

)

 

 

 

 

 

(16

)

Common stock issued upon exercise of options

 

 

269

 

 

 

3

 

 

 

4,426

 

 

 

 

 

 

 

 

 

4,429

 

Stock-based compensation

 

 

 

 

 

 

 

 

3,413

 

 

 

 

 

 

 

 

 

3,413

 

Unvested restricted stock

 

 

11

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vested restricted stock

 

 

4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, at October 2, 2020

 

 

46,072

 

 

$

461

 

 

$

328,074

 

 

$

(2,925

)

 

$

(139,218

)

 

$

186,392

 

Balance, at June 28, 2019

 

 

44,534

 

 

$

445

 

 

$

296,063

 

 

$

(1,602

)

 

$

(150,571

)

 

$

144,335

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,388

 

 

 

2,388

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(918

)

 

 

 

 

 

(918

)

Common stock issued upon exercise of options

 

 

64

 

 

 

1

 

 

 

718

 

 

 

 

 

 

 

 

 

719

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,816

 

 

 

 

 

 

 

 

 

2,816

 

Vested restricted stock

 

 

8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, at September 27, 2019

 

 

44,606

 

 

$

446

 

 

$

299,597

 

 

$

(2,520

)

 

$

(148,183

)

 

$

149,340

 

 

See accompanying notes to the condensed consolidated financial statements.


4


STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (CONTINUED)

(In thousands)

(Unaudited)

 

 

Nine Months Ended

 

 

 

Common

Stock Shares

 

 

Common

Stock Par

Value

 

 

Additional

Paid-In

Capital

 

 

Accumulated

Other

Compre-

hensive

Income

(Loss)

 

 

Accumulated

Deficit

 

 

Total

 

Balance, at January 3, 2020

 

 

44,822

 

 

$

448

 

 

$

304,288

 

 

$

(3,048

)

 

$

(141,804

)

 

$

159,884

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,586

 

 

 

2,586

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

123

 

 

 

 

 

 

123

 

Common stock issued upon exercise of options

 

 

1,146

 

 

 

12

 

 

 

13,974

 

 

 

 

 

 

 

 

 

13,986

 

Stock-based compensation

 

 

 

 

 

 

 

 

9,812

 

 

 

 

 

 

 

 

 

9,812

 

Unvested restricted stock

 

 

11

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vested restricted stock

 

 

93

 

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

1

 

Balance, at October 2, 2020

 

 

46,072

 

 

$

461

 

 

$

328,074

 

 

$

(2,925

)

 

$

(139,218

)

 

$

186,392

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, at December 28, 2018

 

 

44,195

 

 

$

442

 

 

$

289,584

 

 

$

(1,320

)

 

$

(156,280

)

 

$

132,426

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,669

 

 

 

7,669

 

Impact of the adoption of lease accounting standard

 

 

 

 

 

 

 

 

 

 

 

 

 

 

113

 

 

 

113

 

Impact of adoption of nonemployee share-based payment standard

 

 

 

 

 

 

 

 

(315

)

 

 

 

 

 

315

 

 

 

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(1,200

)

 

 

 

 

 

(1,200

)

Common stock issued upon exercise of options

 

 

190

 

 

 

2

 

 

 

1,827

 

 

 

 

 

 

 

 

 

1,829

 

Stock-based compensation

 

 

 

 

 

 

 

 

8,501

 

 

 

 

 

 

 

 

 

8,501

 

Unvested restricted stock

 

 

11

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vested restricted stock

 

 

210

 

 

 

2

 

 

 

 

 

 

 

 

 

 

 

 

2

 

Balance, at September 27, 2019

 

 

44,606

 

 

$

446

 

 

$

299,597

 

 

$

(2,520

)

 

$

(148,183

)

 

$

149,340

 

See accompanying notes to the condensed consolidated financial statements.

5


STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

  Nine Months Ended 
  September 29, 2017  September 30, 2016 
Cash flows from operating activities:        
Net loss $(2,001) $(11,962)
Adjustments to reconcile net loss to net cash provided by operating activities:        
Depreciation of property, plant and equipment  2,344   1,933 
Amortization of long-lived intangibles  166   171 
Deferred income taxes  164   (1,806)
Change in net pension liability  95   390 
Loss on disposal of property and equipment  22   65 
Stock-based compensation expense  2,185   8,143 
Provision for sales returns and bad debts  186   99 
Inventory provision  1,267   1,379 
Changes in working capital:        
Accounts receivable trade  41   1,707 
Inventories  725   222 
Prepayments, deposits and other current assets  (764)  (1,118)
Accounts payable  (2,751)  594 
Other current liabilities  62   1,104 
Net cash provided by operating activities  1,741   921 
         
Cash flows from investing activities:        
Acquisition of property and equipment  (969)  (2,709)
Net cash used in investing activities  (969)  (2,709)
         
Cash flows from financing activities:        
Repayment of capital lease obligations  (984)  (302)
Proceeds from sale leaseback transactions     1,154 
Repurchase of employee common stock for taxes withheld  (234)  (611)
Proceeds from vested restricted stock and exercise of stock options  2,276   1,652 
Net cash provided by financing activities  1,058   1,893 
         
Effect of exchange rate changes on cash, cash equivalents, and restricted cash  305   777 
         
Increase in cash, cash equivalents, and restricted cash  2,135   882 
Cash, cash equivalents, and restricted cash, at beginning of the period  14,118   13,521 
Cash, cash equivalents, and restricted cash, at end of the period $16,253  $14,403 
         
Supplemental Disclosure of Non-Cash Operating Activities        
Insurance Receivable $7,000  $ 
Settlement Liability $7,000  $ 

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net income

 

$

2,586

 

 

$

7,669

 

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

 

 

 

 

 

 

 

 

Depreciation of property, plant, and equipment

 

 

2,276

 

 

 

2,853

 

Amortization of intangibles

 

 

26

 

 

 

26

 

Deferred income taxes

 

 

(1,215

)

 

 

526

 

Change in net pension liability

 

 

522

 

 

 

264

 

Loss on disposal of property and equipment

 

 

3

 

 

 

14

 

Stock-based compensation expense

 

 

8,965

 

 

 

7,778

 

Provision for sales returns and bad debts

 

 

815

 

 

 

309

 

Inventory provision

 

 

1,195

 

 

 

1,222

 

Changes in working capital:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(10,975

)

 

 

(4,260

)

Inventories

 

 

(1,353

)

 

 

(179

)

Prepayments, deposits, and other current assets

 

 

(636

)

 

 

(230

)

Accounts payable

 

 

(657

)

 

 

546

 

Other current liabilities

 

 

(151

)

 

 

(536

)

Net cash provided by operating activities

 

 

1,401

 

 

 

16,002

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Acquisition of property and equipment

 

 

(6,259

)

 

 

(7,169

)

Acquisition of patents and licenses

 

 

 

 

 

(30

)

Net cash used in investing activities

 

 

(6,259

)

 

 

(7,199

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Repayment of finance lease obligations

 

 

(455

)

 

 

(998

)

Repayment on line of credit

 

 

(511

)

 

 

(1,512

)

Proceeds from the exercise of stock options

 

 

13,986

 

 

 

1,829

 

Proceeds from vested restricted stock

 

 

1

 

 

 

2

 

Net cash provided by (used in) financing activities

 

 

13,021

 

 

 

(679

)

Effect of exchange rate changes on cash, cash equivalents and restricted cash

 

 

207

 

 

 

204

 

Increase in cash, cash equivalents and restricted cash

 

 

8,370

 

 

 

8,328

 

Cash, cash equivalents and restricted cash, at beginning of the period

 

 

119,968

 

 

 

103,999

 

Cash, cash equivalents and restricted cash, at end of the period

 

$

128,338

 

 

$

112,327

 

 

See accompanying notes to the condensed consolidated financial statements.

4

 

6


STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

 

Note 1 — Basis of Presentation and Significant Accounting Policies

The condensed consolidated financial statementsCondensed Consolidated Financial Statements of the Company present the financial position, results of operations, and cash flows of STAAR Surgical Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Exchange Commission. In accordance with those rules and regulations certain information and footnote disclosures normally included in comprehensive financial statementsthe Comprehensive Financial Statements have been condensed or omitted pursuant to such rules and regulations. The consolidated balance sheetConsolidated Balance Sheet as of December 30, 2016January 3, 2020 was derived from the audited financial statements at that date, but does not include all the information and footnotes required by GAAP. These financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 30, 2016.

January 3, 2020.

The condensed consolidated financial statementsCondensed Consolidated Financial Statements for the three and nine months ended September 29, 2017October 2, 2020 and September 30, 2016,27, 2019, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the Company’s financial condition and results of operations. The results of operations for the three and nine months ended September 29, 2017October 2, 2020 and September 30, 2016,27, 2019, are not necessarily indicative of the results to be expected for any other interim period or for the entire year.

  

Each of the Company’s fiscal reporting periods ends on the Friday nearest to the quarter ending date and generally consists of 13 weeks.  Unless the context indicates otherwise “we,” “us,” the “Company,” and “STAAR” refer to STAAR Surgical Company and its consolidated subsidiaries.

Vendor Concentration

Recently Adopted Accounting PronouncementsThere were two vendors which accounted for over 29% of the Company’s consolidated accounts payable as of October 2, 2020.  There was one vendor which accounted for over 11% of the Company’s consolidated accounts payable as of January 3, 2020.  There was one vendor who accounted for over 10% of the Company’s consolidated purchases for the three months ended October 2, 2020.  There were no vendors who accounted for over 10% of the Company’s consolidated purchases for the nine months ended October 2, 2020.  

Use of Estimates

During the COVID-19 pandemic, the Company believes it has used reasonable estimates and assumptions in determining valuation allowances for uncollectible trade receivables, sales returns reserves, obsolete and excess inventory reserves, deferred income taxes, and tax reserves, including valuation allowances for deferred tax assets, pension liabilities, evaluation of asset impairment, in determining the useful life of depreciable and definite-lived intangible assets, and in the variables and assumptions used to calculate and record stock-based compensation.  Throughout the COVID-19 pandemic the Company offered extended payment terms to assist its surgeon customers and their clinics as they resumed business. During the quarter ended March 31, 2017,October 2, 2020, the Company adopted Financialhas experienced improvements in customer payments and is unaware of any material impairment of customer receivables.  The Company’s sales representatives throughout the world remain engaged with customers conducting online training and other educational courses which have been very well attended.  This activity has given the Company insight into COVID-19’s impact on customers and potential impairment of receivables.

Recently Adopted Accounting Standards Board (“FASB”)Pronouncements and Recent Accounting Pronouncements Not Yet Adopted

On January 4, 2020 (beginning of fiscal year 2020), the Company adopted Accounting Standards Update (“ASU”) 2015-11, “Simplifying the2016‑13, “Financial Instruments – Credit Losses (Topic 326):  Measurement of Inventory”. ASU 2015-11 requires a company to measure inventoryCredit Losses on Financial Instruments,” which (i) significantly changes the impairment model for most financial assets that are measured at the lower ofamortized cost and net realizable value. Net realizable value is defined ascertain other instruments from an incurred loss model to an expected loss model; and (ii) provides for recording credit losses on available-for-sale debt securities through an allowance account.  ASU 2016-13 also requires certain incremental disclosures.  Subsequently, the “estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposalFASB issued ASU 2018-19, ASU 2019-04, ASU 2019-05, ASU 2020-02 and transportation”. We adopted this standard as of December 31, 2016 (beginning of FY 2017).ASU 2020-03 to clarify and improve ASU 2016-13.  The adoption of ASU 2015-112016-13 did not have a material effectimpact on the consolidated financial statements.Condensed Consolidated Financial Statements.

7

During the quarter ended March 31, 2017, the Company adopted ASU 2016-09, “Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting”, which simplified several aspects of the accounting for share-based payment transactions, including the income tax consequences, forfeitures, classification of awards as either equity or liabilities, and classification of awards on the statement of cash flows. We adopted this standard as of December 31, 2016 (beginning of FY 2017). The adoption of ASU 2016-09 did not have a material effect on the consolidated financial statements and prior periods were not restated.

During the quarter ended March 31, 2017, the Company adopted ASU 2015-17, “Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes”, on a retrospective basis, which changes how deferred taxes are classified on the Company’s balance sheets. Accordingly, the Company adjusted the December 30, 2016 balance sheet for current and noncurrent deferred tax assets to conform to the presentation for the current quarter due to the adoption of ASU 2015-17. The ASU eliminates the requirement to present deferred tax liabilities and assets as current and noncurrent on the balance sheet. Instead, companies are required to classify all deferred tax assets and liabilities as noncurrent. We adopted this standard as of December 31, 2016 (beginning of FY 2017). The adoption of ASU 2015-17 did not have a material effect on the consolidated financial statements.

During the quarter ended March 31, 2017, the Company adopted ASU 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash”, that requires that the statement of cash flows explain the change during the period in the total of cash, cash equivalents, and restricted cash and that restricted cash be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. We early adopted this standard as of December 31, 2016 (beginning of FY 2017). The adoption of ASU 2016-18 did not have a material effect on the consolidated financial statements, however, prior period restricted cash was added to beginning and ending cash and cash equivalents in the statement of cash flows to conform to the current presentation.

5


STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

 

Note 1 — Basis of Presentation and Significant Accounting Policies (Continued)

The following table provides a reconciliation of cash, cash equivalents,Recently Adopted Accounting Pronouncements and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in 000’s):

  September 29,  December 30,  September 30,  January 1, 
  2017  2016  2016  2016 
Cash and cash equivalents $16,133  $13,999  $14,284  $13,402 
Restricted cash included in other long-term assets  120   119   119   119 
Total cash, cash equivalents, and restricted cash                
as shown in the statements of cash flows $16,253  $14,118  $14,403  $13,521 

The Company has restricted cash of approximately $120,000 set aside as collateral for a standby letter of credit required by the California Department of Public Health for unforeseen future regulatory costs related to the decommissioning of certain manufacturing equipment.

Recent Accounting Pronouncements Not Yet Adopted (Continued)

In May 2017,On January 4, 2020 (beginning of fiscal year 2020), the FASB issuedCompany adopted ASU 2017-09 “Scope of Modification Accounting,2018-13, “Fair Value Measurement (Topic 820):  Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement,” which amends the scope of modification accountingmodifies certain disclosures requirements for share-based payment arrangements, provides guidance on the types of changes to the terms or conditions of share-based payment awards to which an entity would be required to apply modification accounting under ASC 718. For all entities, the ASU is effective for annual reporting periods, including interim periods within those annual reporting periods, beginning after December 15, 2017, and thereafter. Early adoption is permitted, including adoption in any interim period. We will adopt this standard as of December 30, 2017 (beginning of FY 2018) and do not expect thefair value measurements.  The adoption of the standard willASU 2018-13 did not have a material impact on our consolidated financial statements.the Condensed Consolidated Financial Statements.

On January 4, 2020 (beginning of fiscal year 2020), the Company adopted ASU 2018-14, “Compensation – Retirement Benefits – Defined Benefit Plans – General (Subtopic 715-20); Disclosure Framework – Changes in the Disclosure Requirement for Defined Benefit Plans,” which modifies disclosure requirements for employers that sponsor defined benefit pension or other post retirement plans.  The adoption of ASU 2018-14 did not have a material impact on the Condensed Consolidated Financial Statements.

In March 2017,December 2019, the FASB issued ASU 2017-07, “Compensation-Retirement Benefits (Topic 715), Improving the Presentation of Net Periodic Pension Cost and Net Periodic Postretirement Benefit Cost.” The standard requires that an employer report the service cost component in the same line items as other compensation costs arising from services rendered by the pertinent employees during the period. The other components of net benefit cost are required to be presented in the income statement separately from the service cost component and outside of operating profit. The standard is effective for public companies for annual periods beginning after December 15, 2017, including interim periods within those annual periods. Prior periods are required to be recast. We will adopt this standard as of December 30, 2017 (beginning of FY 2018) and are currently evaluating the impact ASU 2017-07 may have on our consolidated financial statements.

In October 2016, the FASB issued ASU 2016-16,2019-12, “Income Taxes (Topic 740):  Intra-Entity Transfers of Assets Other Than Inventory”, whichSimplifying the Accounting for Income Taxes.” ASU 2019-12 removes the prohibitionfollowing exceptions:  exception to the incremental approach for intra period tax allocation; exception to accounting for basis differences when there are ownership changes in ASC 740 against the immediate recognition of the currentforeign investments; and deferred incomeexception to interim period tax effects of intra-entity transfers of assets other than inventory. Theaccounting for year to date losses that exceed anticipated losses.  ASU is effective2019-12 also improves financial reporting for public companies for fiscal years beginning after December 15, 2017, and interim periods within those annual periods. The ASU should be appliedfranchise taxes that are partially based on income; transactions with a modified retrospective basis, recognizing the effectsgovernment that result in retained earnings as of the beginning of the year of adoption. We will adopt this standard as of December 30, 2017 (beginning of FY 2018) and are currently evaluating the impact ASU 2016-16 may have on our consolidated financial statements.

In January 2017, the FASB issued ASU 2017-04, “Intangibles—Goodwill and Other (Topic 350)”, which simplifies the test for goodwill impairment. ASU 2017-04 is effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. The Company does not expect ASU 2017-04 to have a material effect on the consolidated financial statements.

In August 2016, the FASB issued ASU 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments” (“ASU 2016-15”), which clarifies how companies present and classify certain cash receipts and cash paymentsstep up in the statementtax basis of cash flows.goodwill; separate financial statements of legal entities that are not subject to tax; and enacted changes in tax laws in interim periods.  ASU 2016-152019-12 is effective for fiscal years beginning after December 15, 2017 (beginning of FY 2018)2020 and early adoption is permitted. The Company is currently evaluating the impact ASU 2016-15 may have on its consolidated financial statements.

In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842)”, which requires lessees to recognize assets and liabilities for leases with lease terms greater than twelve months in the statement of financial position. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02 also requires improved disclosures to help users of financial statements better understand the amount, timing and uncertainty of cash flows arising from leases. The update is effective for fiscal years beginning after December 15, 2018, including interim reporting periods within that reporting period.those fiscal years.  Early adoption is permitted.  The Company is gathering data to evaluate the impact the adoptionwill adopt this standard as of ASU 2016-02 may have on its consolidated financial statements and expects to complete the evaluation by the third quarterJanuary 2, 2021 (beginning of 2018.

6

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

In May 2014, the FASB issued ASU 2014-09, “Revenue from Contracts with Customers (Topic 606)”, which supersedes nearly all existing revenue recognition guidance under GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five-step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing GAAP. The revised revenue standard is effective for public entities for annual periods beginning after December 15, 2017, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients; or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures).

In August 2015, ASU 2014-09 was amended by ASU No. 2015-14, “Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date”, which defers the effective date of ASU 2014-09 by onefiscal year for all entities and permits early adoption on a limited basis. ASU 2014-09 was subsequently amended by four additional pronouncements: (i) ASU No. 2016-10, “Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing;” (ii) ASU No. 2016-11, “Revenue Recognition (Topic 605) and Derivatives and Hedging (Topic 815): Rescission of SEC Guidance Because of Accounting Standards Updates 2014-09 and 2014-16 Pursuant to Staff Announcements at the March 3, 2016 EITF Meeting”; (iii) ASU No. 2016-12, “Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients”; and (iv) ASU No. 2016-20, “Revenue from Contracts with Customers (Topic 606): Technical Corrections and Improvements to Topic 606”.

The Company is nearing completion of its assessment2021) and is performing a final review ofcurrently evaluating the disclosure requirements and its evaluation of the new standard, including a detailed review of its revenue streams and contracts.  The majority of the Company’s revenue relates to the sale of implantable lenses (ICLs and IOLs) for which revenue is recognized at a point in time (i.e., typically at shipping point, except for certain customers and for our STAAR Japan subsidiary, which is typically recognized when the customer receives the product). The Company does not believe the adoption of the new standard will materially impact these transactions.  The Company has also determined that it will make accounting policy elections to 1) treat shipping and handling activities that occur after the customer obtains control of the goods as fulfillment costs, and 2) exclude sales and other similar taxes from the measurement of the transaction price. Basedeffect on the work performed to date, the Company does not expect adoption of the new standard to have a material impact on its consolidated financial statements.  The Company is still evaluating the effect the standard will have on its financial statement disclosures.  The Company expects to apply the modified retrospective method to adopt the standard on December 30, 2017.

Condensed Consolidated Financial Statements.

Note 2 — Inventories

Inventories, net are stated at the lower of cost and net realizable value, determined on a first-in, first-out basis and consisted of the following (in thousands):

 

  September 29,  December 30, 
  2017  2016 
Raw materials and purchased parts $2,330  $2,264 
Work-in-process  2,363   1,924 
Finished goods  11,059   14,268 
   15,752   18,456 
Less: inventory reserves  2,478   3,631 
  $13,274  $14,825 

7

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

 

 

October 2, 2020

 

 

January 3, 2020

 

Raw materials and purchased parts

 

$

1,818

 

 

$

3,334

 

Work in process

 

 

4,693

 

 

 

1,870

 

Finished goods

 

 

13,018

 

 

 

12,976

 

Total inventories, gross

 

 

19,529

 

 

 

18,180

 

Less inventory reserves

 

 

1,295

 

 

 

1,038

 

Total inventories, net

 

$

18,234

 

 

$

17,142

 

 

Note 3 — Prepayments, Deposits, and Other Current Assets

Prepayments, deposits, and other current assets consisted of the following (in thousands):

 

 

October 2, 2020

 

 

January 3, 2020

 

Prepayments and deposits

 

$

3,534

 

 

$

3,031

 

Prepaid insurance

 

 

242

 

 

 

1,488

 

Consumption tax receivable

 

 

1,059

 

 

 

875

 

Value added tax (VAT) receivable

 

 

1,492

 

 

 

713

 

Other(1)

 

 

1,041

 

 

 

453

 

Total prepayments, deposits and other current assets

 

$

7,368

 

 

$

6,560

 

 

  September 29,  December 30, 
  2017  2016 
Prepayments and deposits $1,944  $1,003 
Prepaid insurance  607   935 
Income tax receivable  532   686 
Consumption tax receivable  325   573 
Value added tax (VAT) receivable  809   668 
Pension benefit prepayment  90    
Other current assets(1)  629   484 
  $4,936  $4,349 

(1)No individual item in “Other

(1)

No individual item in “other current assets” above exceeds 5% of the total prepayments, deposits and other current assets.

8


STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

 

Note 4 — Property, Plant and Equipment

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

  September 29,  December 30, 
  2017  2016 
Machinery and equipment $17,680  $19,807 
Furniture and fixtures  9,410   8,025 
Leasehold improvements  9,597   9,179 
   36,687   37,011 
Less: accumulated depreciation  25,688   25,221 
  $10,999  $11,790 

During the third quarter of 2017, the Company disposed of approximately $1.6 million of assets which were no longer in service and fully depreciated except for an asset disposal loss of approximately $21,000 which was included in the statement of operations.

 

 

October 2, 2020

 

 

January 3, 2020

 

Machinery and equipment

 

$

21,275

 

 

$

17,173

 

Computer equipment and software

 

 

6,686

 

 

 

6,244

 

Furniture and fixtures

 

 

4,614

 

 

 

4,169

 

Leasehold improvements

 

 

11,200

 

 

 

10,151

 

Construction in process

 

 

10,293

 

 

 

8,477

 

Total property, plant and equipment, gross

 

 

54,068

 

 

 

46,214

 

Less accumulated depreciation

 

 

31,406

 

 

 

29,149

 

Total property, plant and equipment, net

 

$

22,662

 

 

$

17,065

 

 

Note 5 — Intangible–Intangible Assets

Intangible assets, net consisted of the following (in thousands):

 

  September 29, 2017  December 30, 2016 
  

Gross

Carrying

Amount

  

Accumulated

Amortization

  Net  

Gross

Carrying

Amount

  

Accumulated

Amortization

  Net 
Long-lived intangible assets:                        
Patents and licenses $9,245  $(8,965) $280  $9,224  $(8,930) $294 
Customer relationships  1,393   (1,359)  34   1,343   (1,209)  134 
Developed technology  886   (874)  12   854   (809)  45 
Total $11,524  $(11,198) $326  $11,421  $(10,948) $473 

 

 

October 2, 2020

 

 

January 3, 2020

 

Long-lived amortized intangible assets

 

Gross

Carrying

Amount

 

 

Accumulated

Amortization

 

 

Net

 

 

Gross

Carrying

Amount

 

 

Accumulated

Amortization

 

 

Net

 

Patents and licenses

 

$

9,369

 

 

$

(9,094

)

 

$

275

 

 

$

9,353

 

 

$

(9,057

)

 

$

296

 

 

Note 6 Other Current Liabilities

Other current liabilities consisted of the following (in thousands):

 

 

September 29,

2017

  

December 30,

2016

 

 

October 2, 2020

 

 

January 3, 2020

 

Accrued salaries and wages $3,080  $2,334 

 

$

5,194

 

 

$

4,400

 

Accrued bonuses  1,680   1,414 

 

 

1,000

 

 

 

4,184

 

Accrued insurance

 

 

96

 

 

 

1,346

 

Income taxes payable

 

 

3,898

 

 

 

2,710

 

Accrued consumption tax  304   424 

 

 

1,228

 

 

 

1,164

 

Accrued insurance  197   501 
Accrued income taxes  371   1,095 

Accrued professional fees for clinical trials

 

 

1,554

 

 

 

567

 

Marketing obligations

 

 

1,197

 

 

 

633

 

Other(1)  1,621   1,507 

 

 

3,445

 

 

 

2,693

 

 $7,253  $7,275 

Total other current liabilities

 

$

17,612

 

 

$

17,697

 

(1)

No individual item in “Other” above exceeds 5% of the other current liabilities.

Note 7 – Lines of Credit

Since 1998, the Company’s wholly owned Japanese subsidiary, STAAR Japan, has had an agreement with Mizuho Bank which provides for borrowings of up to 500,000,000 Yen, at an interest rate equal to the uncollateralized overnight call rate (approximately 0.06% as of October 2, 2020) plus a 0.50% spread, and may be renewed quarterly (the current line expires on November 21, 2020).  The credit facility is not collateralized.  The Company had 142,500,000 Yen and 197,500,000 Yen outstanding on the line of credit as of October 2, 2020 and January 3, 2020, respectively (approximately $1,353,000 and $1,827,000 based on the foreign exchange rates on October 2, 2020 and January 3, 2020, respectively), which approximates fair value due to the short-term maturity and market interest rates of the total other current liabilitiesline of credit.  In case of default, the interest rate will be increased to 14% per annum.  There was 357,500,000 Yen and 302,500,000 Yen available for borrowing as of October 2, 2020 and January 3, 2020, respectively (approximately $3,393,000 and $2,798,000 based on the foreign exchange rate on October 2, 2020 and January 3, 2020, respectively).  At maturity on November 21, 2020, the Company expects to renew this line of credit for an additional three months, with similar terms.

9

8


STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

 

Note 7 – Lines of Credit (Continued)

In September 2013, the Company’s wholly owned Swiss subsidiary, STAAR Surgical AG, entered into a framework agreement for loans (“framework agreement”) with Credit Suisse (the “Bank”). The framework agreement provides for borrowings of up to 1,000,000 CHF (Swiss Francs) (approximately $1,100,000 and $1,000,000 at the rate of exchange on October 2, 2020 and January 3, 2020 respectively), to be used for working capital purposes. Accrued interest and 0.25% commissions on average outstanding borrowings is payable quarterly and the interest rate will be determined by the Bank based on the then prevailing market conditions at the time of borrowing. The framework agreement is automatically renewed on an annual basis based on the same terms assuming there is no default. The framework agreement may be terminated by either party at any time in accordance with its general terms and conditions. The framework agreement is not collateralized and contains certain conditions such as providing the Bank with audited financial statements annually and notice of significant events or conditions, as defined in the framework agreement. The Bank may also declare all amounts outstanding to be immediately due and payable upon a change of control or a “material qualification” in STAAR Surgical independent auditors’ report, as defined. There were 0 borrowings outstanding as of October 2, 2020 and January 3, 2020.

The Company is in compliance with covenants of its credit facilities and lines of credit as of October 2, 2020.

Note 8 – Leases

Finance Leases

The Company entered into finance leases primarily related to purchases of equipment used for manufacturing or computer-related equipment.  These finance leases are two to five years in length and have fixed payment amounts for the term of the contract and have options to purchase the assets at the end of the lease term.  Supplemental balance sheet information related to finance leases consisted of the following (dollars in thousands):

 

 

October 2, 2020

 

 

January 3, 2020

 

Machinery and equipment

 

$

569

 

 

$

1,885

 

Computer equipment and software

 

 

827

 

 

 

912

 

Furniture and fixtures

 

 

 

 

 

102

 

Leasehold improvements

 

 

 

 

 

27

 

Finance lease right-of-use assets, gross

 

 

1,396

 

 

 

2,926

 

Less accumulated depreciation

 

 

756

 

 

 

1,059

 

Finance lease right-of-use assets, net

 

$

640

 

 

$

1,867

 

 

 

 

 

 

 

 

 

 

Total finance lease liability

 

$

495

 

 

$

926

 

Weighted-average remaining lease term (in years)

 

 

1.0

 

 

 

1.1

 

Weighted-average discount rate

 

 

3.71

%

 

 

6.17

%

Supplemental cash flow information related to finance leases consisted of the following (dollars in thousands):

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Amortization of finance lease right-of-use asset

 

$

48

 

 

$

141

 

 

$

215

 

 

$

447

 

Interest on finance lease liabilities

 

 

7

 

 

 

17

 

 

 

25

 

 

 

58

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating cash flows

 

 

7

 

 

 

17

 

 

 

25

 

 

 

58

 

Financing cash flows

 

 

109

 

 

 

317

 

 

 

455

 

 

 

998

 

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

 

 

0

 

 

 

0

 

 

 

22

 

 

 

679

 

10


STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 8 – Leases (Continued)

Operating Leases

The Company entered into operating leases primarily related to real property (office, manufacturing and warehouse facilities), automobiles and copiers.  These operating leases are two to ten years in length with options to extend.  The Company did not include any lease extensions in the initial valuation unless the Company was reasonably certain to extend the lease.  Depending on the lease, there are those with fixed payment amounts for the entire length of the contract or payments which increase periodically as noted in the contract or increased at an inflation rate indicator.  For operating leases that increase using an inflation rate indicator, the Company used the inflation rate at the time the lease was entered into for the length of the lease term.  Supplemental balance sheet information related to operating leases consisted of the following (dollars in thousands):

 

 

October 2, 2020

 

 

January 3, 2020

 

Machinery and equipment

 

$

845

 

 

$

765

 

Computer equipment and software

 

 

462

 

 

 

462

 

Real property

 

 

14,115

 

 

 

11,116

 

Operating lease right-of-use assets, gross

 

 

15,422

 

 

 

12,343

 

Less accumulated depreciation

 

 

7,697

 

 

 

5,659

 

Operating lease right-of-use assets, net

 

$

7,725

 

 

$

6,684

 

 

 

 

 

 

 

 

 

 

Total operating lease liability

 

$

7,786

 

 

$

6,786

 

Weighted-average remaining lease term (in years)

 

 

5.5

 

 

 

2.3

 

Weighted-average discount rate

 

 

2.49

%

 

 

1.82

%

Supplemental cash flow information related to operating leases was as follows (dollars in thousands):

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Operating lease cost

 

$

752

 

 

$

726

 

 

$

2,238

 

 

$

2,020

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating cash flows

 

 

780

 

 

 

739

 

 

 

2,281

 

 

 

2,031

 

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

 

 

2,842

 

 

 

140

 

 

 

3,160

 

 

 

2,797

 

Future Minimum Lease Commitments

Estimated future minimum lease payments under operating and finance leases having initial or remaining non-cancelable lease terms more than one year as of October 2, 2020 is as follows (in thousands):

As of October 2, 2020

12 Months Ended

 

Operating Leases

 

 

Finance Leases

 

September 2021

 

$

2,374

 

 

$

433

 

September 2022

 

 

1,632

 

 

 

51

 

September 2023

 

 

1,404

 

 

 

15

 

September 2024

 

 

896

 

 

 

8

 

September 2025

 

 

637

 

 

 

 

Thereafter

 

 

1,228

 

 

 

 

Total minimum lease payments, including interest

 

$

8,171

 

 

$

507

 

Less amounts representing interest

 

 

385

 

 

 

12

 

Total minimum lease payments

 

$

7,786

 

 

$

495

 

11


STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 9 Income Taxes

The Company recorded an income tax provision as follows (in thousands):

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Provision for income taxes

 

$

1,489

 

 

$

760

 

 

$

887

 

 

$

2,380

 

The Company recorded income taxes of $1,489,000 for the three months ended October 2, 2020 due to pre-tax income generated in certain foreign jurisdictions, partially offset by a reversal of $154,000 of its U.S. valuation allowance, as a result of an increase in foreign income and changes in the usage and release of certain deferred tax assets.  The Company recorded income taxes of $760,000 for the three months ended September 27, 2019 due to pre-tax income generated in certain foreign jurisdictions and withholding taxes on foreign operations.  The Company recorded income taxes of $887,000 for the nine months ended October 2, 2020 due to income tax expense from profits generated from its foreign operations, partially offset by the release of its U.S. valuation allowance.  The Company recorded income taxes of $2,380,000 for the nine months ended September 27, 2019, primarily due to pre-tax income generated in certain foreign jurisdictions and withholding taxes on foreign operations.  The Company’s quarterly provision for income taxes is determined by estimating an annual effective tax rate.  This estimate may fluctuate throughout the year as new information becomes available affecting its underlying assumptions.  In the fourth quarter of fiscal year 2019, the Company reversed all previously recorded withholding taxes recorded for 2019, at which time the Company formed STAAR Surgical UK Limited as a holding company for its foreign operations.  Based on the current tax treaties between the U.S., United Kingdom and Switzerland, the Company will no longer accrue for Switzerland withholding taxes on foreign earnings after fiscal 2018 (see also Note 10 in its fiscal 2019 Form 10-K for more information). There are 0 unrecognized tax benefits related to uncertain tax positions taken by the Company.   All earnings from the Company’s subsidiaries are not considered to be permanently reinvested.

The 2017 Tax Act subjects a U.S. shareholder to tax on Global Intangible Low Tax Income (“GILTI”) earned by certain foreign subsidiaries.  In general, GILTI is the excess of a U.S. shareholder’s total net foreign income over a deemed return on tangible assets.  The provision further allows a deduction of 50 percent of GILTI, however this deduction is limited by the Company’s U.S. taxable income.  The Company has elected to account for GILTI as a current period expense when incurred.

On July 20, 2020 the U.S. Treasury issued final regulations for addressing the treatment of foreign income that is subject to a high rate of foreign tax (the GILTI high-tax exclusion). The final regulations allow companies to exclude certain high-taxed income from their GILTI calculation.  The GILTI high-tax exclusion applies if the effective foreign tax rate is 90% or more of the rate that would apply if the income were subject to the maximum US rate of tax specified in section 11 (currently 18.9%, based on a maximum rate of 21%).  The final regulations also provide that the GILTI high-tax exclusion is an annual election made each year and is retroactive to years beginning after December 31, 2017.  The Company has made the election to exclude certain high-taxed income from its GILTI calculation for 2019 and the three and nine months ended October 2, 2020.

The ultimate realization of deferred tax assets is dependent upon future generation of income during the periods in which temporary differences representing net future deductible amounts become deductible. Management considers the projected future income and tax planning strategies in making this assessment. As of fiscal year end 2019, the Company had three years of accumulated profits for federal and various state income tax purposes as a result of GILTI.  However, the three-year income position is not solely determinative and, accordingly, management considers all other available positive and negative evidence in its analysis. This includes existing profits in foreign jurisdiction as well as projected future profits. As further described in Notes 1 and 10 of the Company’s fiscal 2019 Form 10-K, under the “incremental cash tax savings approach,” the Company recorded a valuation allowance release of $3,003,000 and $373,000 against the federal and certain states deferred tax assets, respectively.  During the nine months ended October 2, 2020, the Company revised its global forecasts as a result of COVID‑19, and due to changes in the usage and release of certain deferred tax assets, the Company released an additional $1,215,000 of valuation allowance.  As of October 2, 2020, the Company released approximately $4,591,000 of valuation allowance on its deferred tax assets in the U.S. jurisdiction utilizing the incremental cash tax savings approach.

12


STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 9 Income Taxes (Continued)

Under the incremental cash tax savings approach, the U.S. valuation allowances of $35,745,000, will remain as the usage of the remaining net operating losses and deferred tax assets will not result in cash tax savings and therefore provide no additional benefit.  As of October 2, 2020, the Company had net deferred tax assets in the U.S. of $4,727,000, which consisted of the federal and state valuation allowance release of $4,307,000 and $284,000, respectively, and the refundable alternative minimum tax credit of $136,000.  

On March 27, 2020, the Coronavirus Aid, Relief and Economic Security (“CARES”) Act was enacted and signed into law.  The Company reviewed the provisions of the CARES Act, but does not expect it to have a material impact to its tax provision (also see note 15). 

Note 10 – Defined Benefit Pension Plans

 

The Company has defined benefit plans covering employees of its Switzerland and Japan operations.

The following table summarizes the components of net periodic pension cost recorded for the Company’s defined benefit pension plans (in thousands):

 

 Three Months Ended  Nine Months Ended 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 29,

2017

  

September 30,

2016

  

September 29,

2017

  

September 30,

2016

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Service cost(1) $126  $155  $380  $466 

 

$

320

 

 

$

240

 

 

$

959

 

 

$

720

 

Interest cost(2)  15   19   43   54 

 

 

12

 

 

 

20

 

 

 

34

 

 

 

60

 

Expected return on plan assets(2)  (25)  (24)  (71)  (69)

 

 

(47

)

 

 

(36

)

 

 

(136

)

 

 

(103

)

Net amortization of transitional obligation (a)  3   3   9   10 
Actuarial loss recognized in current period (a)  17   24   51   70 
Total $136  $177  $412  $531 

Prior service credit(2),(3)

 

 

(9

)

 

 

(6

)

 

 

(26

)

 

 

(17

)

Actuarial loss recognized in current period(2),(3)

 

 

79

 

 

 

32

 

 

 

238

 

 

 

97

 

Net periodic pension cost

 

$

355

 

 

$

250

 

 

$

1,069

 

 

$

757

 

(1)

Recognized in selling general and administrative expenses on the Condensed Consolidated Statements of Income.

(2)

Recognized in other income (expense), net on the Condensed Consolidated Statements of Income.

(3)

Amounts reclassified from accumulated other comprehensive income (loss).

 

(a) Amounts reclassified from accumulated other comprehensive loss.

During the nine months ended September 29, 2017 and September 30, 2016, the Company made cash contributions of approximately $518,000 and $419,000, respectively, to its Swiss pension plan and the Company is not required to make additional cash contributions during the remainder of 2017. The Company currently is not required to and does not make contributions to its Japan pension plan.

Note 8 — Basic and Diluted Net Income (Loss) Per Share

The following table sets forth the computation of basic and diluted net income (loss) per shareCompany’s contributions to its Swiss pension plan are as follows (in thousands except per share amounts)thousands):

 

  Three Months Ended  Nine Months Ended 
  

September 29,

2017

  

September 30,

2016

  

September 29,

2017

  

September 30,

2016

 
Numerator:                
Net income (loss) $1,173  $(1,778) $(2,001) $(11,962)
Denominator:                
Weighted average common shares outstanding  41,131   40,501   40,960   40,242 
Less: Unvested restricted stock  21   15   21   15 
Denominator for basic and diluted calculation  41,110   40,486   40,939   40,227 
Effect of dilutive shares:                
Options  837          
Restricted stock and units  157          
Denominator for diluted calculation  42,104   40,486   40,939   40,227 
Net income (loss) per share – basic $0.03  $(0.04) $(0.05) $(0.30)
Net income (loss) per share – diluted $0.03  $(0.04) $(0.05) $(0.30)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Employer contribution

 

$

189

 

 

$

141

 

 

$

519

 

 

$

404

 

 

The following table sets forth the weighted average number of options to purchase shares of common stock and restricted stock and units, which were not included in the calculation of diluted per share amounts because the effects would be anti-dilutive (in thousands).13

  Three Months Ended  Nine Months Ended 
  

September 29,

2017

  

September 30,

2016

  

September 29,

2017

  

September 30,

2016

 
Options  1,545   2,134   2,497   2,937 
Restricted stock and units     60   159   48 
Total  1,545   2,194   2,656   2,985 

9


STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 9 — Geographic and Product Data

The Company markets and sells its products in over 60 countries and conducts its manufacturing in the United States. Other than China, Japan, and the United States, the Company does not conduct business in any country in which its sales exceed 10% of worldwide consolidated sales. Sales are generally attributed to countries based on location of customers. The composition of the Company’s net sales to unaffiliated customers is set forth below (in thousands):

  Three Months Ended  Nine Months Ended 
  September 29,  September 30,  September 29,  September 30, 
  2017  2016  2017  2016 
China $7,164  $4,254  $17,489  $11,749 
Japan  4,633   4,029   12,849   12,258 
United States  1,896   2,419   5,946   7,355 
Other  9,780   9,350   29,475   28,933 
Total $23,473  $20,052  $65,759  $60,295 

100% of the Company’s sales are generated from the ophthalmic surgical product segment and the chief operating decision maker makes operating decisions and allocates resources based upon the consolidated operating results, and therefore the Company operates as one operating segment for financial reporting purposes. The Company’s principal products are implantable Collamer lenses (“ICLs”) used in refractive surgery and intraocular lenses (“IOLs”) used in cataract surgery. The composition of the Company’s net sales by product line is as follows (in thousands):

  Three Months Ended  Nine Months Ended 
  September 29,  September 30,  September 29,  September 30, 
  2017  2016  2017  2016 
ICLs $18,110  $14,801  $49,698  $43,389 
IOLs  3,892   4,649   12,875   14,783 
Other surgical products  1,471   602   3,186   2,123 
Total $23,473  $20,052  $65,759  $60,295 

One customer, our distributor in China, accounted for 31% and 27% of net sales for the three and nine months ended September 29, 2017, respectively, and the same customer accounted for 21% and 19% of net sales for the three and nine months ended September 30, 2016, respectively. As of September 29, 2017 and December 30, 2016, respectively, one customer, our distributor in China, accounted for 26% and 22% of consolidated trade receivables.

 

Note 10 11 Stockholders’ Equity

Stock-Based Compensation

The cost that has been charged against income for stock-based compensation is set forth below (in thousands):

 

 Three Months Ended  Nine Months Ended 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 29,

2017

  

September 30,

2016

  

September 29,

2017

  

September 30,

2016

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Employee stock options $443  $208  $1,204  $5,257 

 

$

2,469

 

 

$

2,178

 

 

$

7,206

 

 

$

5,770

 

Restricted stock  50   32   136   259 

 

 

119

 

 

 

77

 

 

 

273

 

 

 

236

 

Restricted stock units  314   146   845   2,569 

 

 

415

 

 

 

246

 

 

 

1,238

 

 

 

1,661

 

Performance stock units

 

 

54

 

 

 

 

 

 

54

 

 

 

 

Nonemployee stock options           58 

 

 

69

 

 

 

57

 

 

 

194

 

 

 

111

 

Total $807  $386  $2,185  $8,143 

Total stock-based compensation expense

 

$

3,126

 

 

$

2,558

 

 

$

8,965

 

 

$

7,778

 

 

The Company recorded stock-based compensation costs in the following categories on the accompanying condensed consolidated statements of operations (in thousands):

 

  Three Months Ended  Nine Months Ended 
  

September 29,

2017

  

September 30,

2016

  

September 29,

2017

  

September 30,

2016

 
Cost of sales $2  $  $6  $560 
General and administrative  377   248   1,035   3,936 
Marketing and selling  214   72   558   1,544 
Research and development  214   66   586   2,103 
Total stock compensation expense  807   386   2,185   8,143 
Amounts capitalized as part of inventory  107   39   269   227 
Total $914  $425  $2,454  $8,370 

10

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Cost of sales

 

$

30

 

 

$

7

 

 

$

82

 

 

$

43

 

General and administrative

 

 

1,307

 

 

 

1,082

 

 

 

3,601

 

 

 

2,878

 

Marketing and selling

 

 

807

 

 

 

692

 

 

 

2,674

 

 

 

2,553

 

Research and development

 

 

982

 

 

 

777

 

 

 

2,608

 

 

 

2,304

 

Total stock-based compensation expense, net

 

 

3,126

 

 

 

2,558

 

 

 

8,965

 

 

 

7,778

 

Amounts capitalized as part of inventory

 

 

287

 

 

 

258

 

 

 

847

 

 

 

723

 

Total stock-based compensation expense, gross

 

$

3,413

 

 

$

2,816

 

 

$

9,812

 

 

$

8,501

 

 

Stock OptionIncentive Plan

OurThe Amended and Restated Omnibus Equity Incentive Plan (“the Plan”) provides for various forms of stock-based incentives. To date, of the available forms of awards under the Plan, the Company has granted only stock options, restricted stock, unrestricted share grants, restricted stock units (“RSUs”), and performance contingent stock units.units (“PSUs”). Options under the planPlan are granted at fair market value on the date of grant, become exercisable generally over a three-year period, or as determined by ourthe Board of Directors, and expire over periods not exceeding 10 years from the date of grant. Certain option and share awards provide for accelerated vesting under certain circumstances in the event ofif there is a change in control and pre-established financial metrics are met (as defined in the Plan). Pursuant to the Plan, options for 3,826,956 shares wereGrants of restricted stock outstanding at September 29, 2017 with exercise prices ranging between $0.95 and $17.62 per share. Restricted stock grants under the Plan generally vest over a period betweenperiods of one to fourthree years. There were 20,833Grants of RSUs and PSUs outstanding under the Plan generally vest based on service, performance, or a combination of both.  On July 30, 2020, stockholders approved a proposal to increase the number of shares under the plan by 2,650,000 shares, for a total of restricted stock and 438,039 RSUs outstanding at September 29, 2017.18,035,000 shares. As of September 29, 2017,October 2, 2020, there were 1,273,4203,376,152 shares authorized and available for grantsgrant under the Plan.

Assumptions

The fair value of each option award is estimated on the date of grant using a Black-Scholes option valuation model applying the weighted-average assumptions noted in the following table.  Expected volatilities are based on historical volatility of the Company’s stock. The expected term of options granted is derived from the historical exercises and post-vesting cancellations and represents the period of time that options granted are expected to be outstanding.  The Company has calculated an 11.3%6% estimated forfeiture rate based on historical forfeiture experience.  The risk-free rate is based on the U.S. Treasury yield curve corresponding to the expected term at the time of the grant.

14

  Three Months Ended  Nine Months Ended 
  

September 29,

2017

  

September 30,

2016

  

September 29,

2017

  

September 30,

2016

 
Expected dividend yield  0%  0%  0%  0%
Expected volatility  57%  57%  57%  57%
Risk-free interest rate  1.83%  1.19%  1.95%  1.34%
Expected term (in years)  5.67   5.57   5.67   5.57 

A summary of option activity under the Plan for the nine-month period ended September 29, 2017 is presented below:

Options

Shares

(000’s)

Outstanding at December 30, 20163,502
Granted829
Exercised(334)
Forfeited or expired(170)
Outstanding at September 29, 20173,827
Exercisable at September 29, 20172,752

A summary of restricted stock and RSU activity under the Plan for the nine-month period ended September 29, 2017 is presented below:

  

Restricted

Shares

(000’s)

  

 

RSUs

(000’s)

 
Outstanding at December 30, 2016  23   274 
Granted  21   291 
Vested  (23)  (93)
Forfeited     (34)
Outstanding at September 29, 2017  21   438 

11


STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

 

Note 11 — Stockholders’ Equity (Continued)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Expected dividend yield

 

 

0

%

 

 

0

%

 

 

0

%

 

 

0

%

Expected volatility

 

 

53

%

 

 

53

%

 

 

53

%

 

 

53

%

Risk-free interest rate

 

 

0.31

%

 

 

1.55

%

 

 

0.53

%

 

 

2.40

%

Expected term (in years)

 

 

5.72

 

 

 

5.67

 

 

 

5.72

 

 

 

5.67

 

 

Note 11 — Income TaxesStock Options

As discussed in Note 1A summary of stock option activity under the notes to the condensed consolidated financial statements, the Company adopted an accounting standards update regarding the recognition of excess tax benefits through the income statement upon settlement of share-based compensation awards. As the Company has a full valuation allowance, any realized benefits would be offset by the valuation allowance with no impact to the tax provision. Accordingly, there is no benefit reflected in the current tax provision and no restatement of the prior period.

The Company’s quarterly provision for income taxes is determined by estimating an annual effective tax rate.  This estimate may fluctuate throughout the year as new information becomes available affecting its underlying assumptions.

The Company recorded an income tax provision of $0.4 million and $0.7 million for the three and nine months ended September 29, 2017 primarily due to pre-tax income generated in certain foreign jurisdictions.  There are no unrecognized tax benefits related to uncertain tax positions taken by the Company.   

The income tax benefit of $1.7 millionPlan for the nine months ended September 30, 2016 was primarily due to net operating losses from our foreign operations, primarily due to the acceleration of stock compensation and tax benefits related to the dissolution of one of our foreign subsidiaries. October 2, 2020 is presented below:

 

 

 

Stock

Options

(in 000’s)

 

 

Minimum

Exercise

Price

 

 

Maximum

Exercise

Price

 

Outstanding at January 3, 2020

 

 

4,326

 

 

 

 

 

 

 

 

 

Granted

 

 

616

 

 

 

 

 

 

 

 

 

Exercised

 

 

(1,146

)

 

 

 

 

 

 

 

 

Forfeited or expired

 

 

(14

)

 

 

 

 

 

 

 

 

Outstanding at October 2, 2020

 

 

3,782

 

 

$

5.05

 

 

$

51.42

 

Exercisable at October 2, 2020

 

 

2,594

 

 

 

 

 

 

 

 

 

All earnings from

Restricted Stock, Restricted Stock Units and Performance Stock Units

A summary of restricted stock, RSUs and PSUs activity under the Company’s subsidiaries are not considered to be permanently reinvested.  Accordingly,Plan for the Company provides withholding and U.S. taxes on all unremitted foreign earnings. The Company reduced its deferred tax liability in 2016 related to withholding taxes from unremitted foreign earnings by the accumulated deficit of one of its foreign subsidiaries dissolved as of April 1, 2016.nine months ended October 2, 2020 is presented below:

 

 

Restricted

Stock

(in 000’s)

 

 

Restricted

Stock

Units

(in 000’s)

 

 

Performance

Stock

Units

(in 000’s)

 

Unvested at January 3, 2020

 

 

11

 

 

 

104

 

 

 

 

Granted

 

 

11

 

 

 

127

 

 

 

15

 

Vested

 

 

(11

)

 

 

(93

)

 

 

 

Forfeited or expired

 

 

 

 

 

(1

)

 

 

 

Unvested at October 2, 2020

 

 

11

 

 

 

137

 

 

 

15

 

 

Note 12 - Commitments and Contingencies

Lines of Credit

Since 1988, the Company’s wholly owned Japanese subsidiary, STAAR Japan, has had an agreement, as amended on or about November 21, 2016, with Mizuho Bank which provides for borrowings of up to 500,000,000 Yen, at an interest rate equal to the uncollateralized overnight call rate (approximately 0.12% as of September 29, 2017) plus a 0.50% spread, and may be renewed annually (the current line expires on November 21, 2017).  The credit facility is not collateralized.  The Company had 500,000,000 Yen outstanding on the line of credit as of September 29, 2017 and December 30, 2016 (approximately $4.4 million and $4.3 million based on the foreign exchange rates on September 29, 2017 and December 30, 2016, respectively), which approximates fair value due to the short-term maturity and market interest rates of the line of credit.  In case of default, the interest rate will be increased to 14% per annum. As of September 29, 2017, there were no available borrowings under the line.

In August 2010, the Company’s wholly owned Swiss subsidiary, STAAR Surgical AG, entered into a credit agreement with Credit Suisse (the Bank). The credit agreement provides for borrowings of up to 1,000,000 CHF (Swiss Francs) ($1.0 million at the rate of exchange on September 29, 2017), to be used for working capital purposes. Accrued interest and 0.25% commissions on average outstanding borrowings is payable quarterly and the interest rate will be determined by the Bank based on the then prevailing market conditions at the time of borrowing. The credit agreement is automatically renewed on an annual basis based on the same terms assuming there is no default. The credit agreement may be terminated by either party at any time in accordance with its general terms and conditions. The credit facility is not collateralized and contains certain conditions such as providing the Bank with audited financial statements annually and notice of significant events or conditions as defined in the credit agreement. The Bank may also declare all amounts outstanding to be immediately due and payable upon a change of control or a “material qualification” in STAAR Surgical independent auditors’ report, as defined. There were no borrowings outstanding as of September 29, 2017 and December 30, 2016.

Covenant Compliance

The Company is in compliance with the covenants of its credit facilities as of the date of this filing. 

12

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

Lease Line of Credit (Capital Leases)

On January 30, 2017, the Company entered into lease schedule 010 with Farnam Street Financial, Inc (“Farnam”). The line of credit provides for borrowings of up to $2.0 million at a lease rate factor of 3.94% per $1 for hardware equipment and 4.75% per $1 for non-hardware equipment. Interim rent is paid until the full amount of the line is used at which time the lease commences. As of September 29, 2017, approximately $737,456 of the line was available for borrowing.

On January 31, 2017, the Company entered into lease schedule 009R with Farnam. Under 009R, equipment with a cost of $1,957,000 was financed over a period of 24 months at a lease rate factor of 3.94% per $1 for hardware equipment and 4.75% per $1 for non-hardware equipment. At the end of the lease the Company can opt to continue to rent the equipment, return the equipment, or exercise a fair market value purchase option. As of September 29, 2017, approximately $1,310,609 was outstanding.

On June 12, 2014, the Company entered into lease schedule 008R with Farnam. Under the agreement, hardware and non-hardware with a cost of $964,612 was financed over a period of 36 months at a lease rate factor of 2.81% per $1 for hardware equipment and 3.12% per $1 for non-hardware equipment. At the end of the lease the Company could opt to continue to rent the equipment, return the equipment, or exercise a fair market value purchase option. The lease schedule was paid off in May 2017 and the Company is renting the equipment on a month to month basis temporarily until it decides to either return the equipment or exercise the fair market value purchase option.

Litigation and Claims

From time to time the Company may be subject to various claims and legal proceedings arising out of the normal course of our business. These claims and legal proceedings may relate to contractual rights and obligations, employment matters, and claims of product liability. The most significant of these actions, proceedings and investigations are described below. STAAR maintains insurance coverage for product liability and certain securities claims. Legal proceedings can extend for several years, and most of the matters concerning the Company are at early stages of the legal and administrative process. As a result, these matters have not yet progressed sufficiently through discovery and/or development of important factual information and legal issues to enable the Company to determine whether the proceedings are material to the Company or to estimate a range of possible loss, if any. Unless otherwise disclosed, the Company is unable to estimate the possible loss or range of loss for the legal proceedings described below. While it is not possible to accurately predict or determine outcomes of these items, an adverse determination in one or more of these items currently pending could have a material adverse effect on the Company’s consolidated results of operations, financial position, or cash flows.

Stockholder Securities Litigation: Todd Action

On July 8, 2014, August 19, 2020, a putative federal securities class action, lawsuitAlwazaan v. STAAR Surgical Co., et al., was filed by Edward Todd against STAARthe Company and three officerscertain of its executives in the U.S. District Court for the Central District of California. The plaintiff claims that STAAR made misleading statements to and omitted material information from our investors between February 27, 2013 andOn September 29, 2014 about alleged regulatory violations at STAAR’s Monrovia manufacturing facility. On October 20, 2014, plaintiff amended its complaint, dismissed two Company officers, added one other officer, reduced the alleged Class Period to November 1, 2013 through September 29, 2014, and demanded compensatory damages and attorneys’ fees. On January 5, 2017, the court granted plaintiff’s Motion for Class Certification. On June 20, 2017, plaintiff sought preliminary approval of2020, a proposedsubstantially similar federal securities class action, settlement inZhang v. STAAR Surgical Co., et al., was filed against the amount of $7,000,000. The settlement documents filed by the plaintiff included a “Stipulation and Agreement of Settlement” that provided, among other things, that the $7,000,000 settlement amount “shall be wired on behalf of all Defendants and Released Persons out of insurance proceeds from STAAR’s Insurance Policies into the Settlement Escrow Account.” The Company determined it was probable the insurance carriers would satisfy their obligation. On July 10, 2017, the court granted the plaintiff’s application for preliminary approval of the class action settlement. On or about July 28, 2017, the Company’s insurance carriers directly funded the entire settlement amount to the court-authorized escrow account. On October 23, 2017, the court granted plaintiff’s application for final approval of the class action settlement in the amount of $7,000,000. A third-party claims administrator will administer and oversee distribution of the settlement funds to qualified class members, pursuant to the process approved by the court. The Company recorded the liability associated with the settlement and the corresponding insurance receivable of $7,000,000 as of September 29, 2017. These entries did not have any impact on the statement of operations or cash flows for the nine months ended September 29, 2017. As of October 23, 2017, the Company, upon the Court’s final approval, relieved both the payable and the receivable off of its consolidated balance sheet.

Stockholder Derivative Litigation: Forestal Action

On June 21, 2016, Kevin Forestal filed a stockholder derivative complaint against our then-current Board of Directors, which included Caren Mason, Mark B. Logan, Stephen C. Farrell, Richard A. Meier, John C. Moore, J. Steven Roush, Louis E. Silverman, and William P. Wall, and STAAR as well as Barry G. Caldwell and John S. Santossame executives in the U.S. District Court for the Central District of California. On September 11, 2020, the court consolidated the two actions under the caption In re STAAR Surgical Co. Securities Litigation. The plaintiff alleges breaches of fiduciary duties by, among other things, allowing STAAR to disseminate misleading statements to investors regardingplaintiffs in the condition of the Company’s Quality System, failing to properly overseelawsuit allege that the Company made material misstatements regarding its sales in China, its marketing spend, and unjust enrichment. The complaint seeksits R&D expenses. Plaintiffs seek compensatory and punitive damages restitution and governance reforms,as well as attorneys’ fees, and costs. On January 31, 2017, the court granted the Company’s Motion to Dismiss. On February 6, 2017, plaintiff filed a Notice of Appeal, and on July 17, 2017 plaintiff filed his appellate brief. On September 14, 2017, the Company filed its appellate answering brief.fees.  Although the ultimate outcome of this action cannot be determined with certainty, the Company believes that the allegations in the Complaint are without merit. The Company has not recordeddenies any loss or accrual in the accompanying condensed consolidated financial statements at September 29, 2017wrongdoing and December 30, 2016 for this matter as the likelihood and amount of loss, if any, has not been determined and is not currently estimable.will vigorously defend itself against these claims.

13

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

Employment Agreements

The Company’s Chief Executive Officer entered into an employment agreement with the Company, effective March 1, 2015. She and certain officers have as provisions of their agreements certain rights, including continuance of cash compensation and benefits, upon a “change in control,” which may include an acquisition of substantially all of its assets, or termination “without cause or for good reason” as defined in the employment agreements.

15


STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

 

Note 13 — ReclassificationsBasic and Diluted Net Income Per Share

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

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

3,892

 

 

$

2,388

 

 

$

2,586

 

 

$

7,669

 

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common shares outstanding

 

 

45,914

 

 

 

44,573

 

 

 

45,405

 

 

 

44,436

 

Less:  Unvested restricted stock

 

 

(11

)

 

 

(10

)

 

 

(11

)

 

 

(10

)

Denominator for basic calculation

 

 

45,903

 

 

 

44,563

 

 

 

45,394

 

 

 

44,426

 

Weighted average effects of potentially diluted common stock:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options

 

 

2,208

 

 

 

2,194

 

 

 

2,124

 

 

 

2,260

 

Unvested restricted stock

 

 

 

 

 

2

 

 

 

5

 

 

 

6

 

Restricted stock units

 

 

68

 

 

 

98

 

 

 

66

 

 

 

156

 

Performance stock units

 

 

1

 

 

 

 

 

 

 

 

 

 

Denominator for diluted calculation

 

 

48,180

 

 

 

46,857

 

 

 

47,589

 

 

 

46,848

 

Net income per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.08

 

 

$

0.05

 

 

$

0.06

 

 

$

0.17

 

Diluted

 

$

0.08

 

 

$

0.05

 

 

$

0.05

 

 

$

0.16

 

The following table sets forth (in thousands) the weighted average number of options to purchase shares of common stock, restricted stock, RSUs and PSUs with either exercise prices or unrecognized compensation cost per share greater than the average market price per share of the Company’s common stock, which were not included in the calculation of diluted per share amounts because the effects would be anti-dilutive.

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Stock options

 

 

12

 

 

 

1,836

 

 

 

896

 

 

 

1,446

 

Restricted stock, restricted stock units and performance stock units

 

 

8

 

 

 

 

 

 

13

 

 

 

 

Total

 

 

20

 

 

 

1,836

 

 

 

909

 

 

 

1,446

 

16


STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

 

Note 14 — Disaggregation of Sales, Geographic Sales and Product Sales

In the following tables, sales are disaggregated by category, sales by geographic market and sales by product data.  The following breaks down sales into the following categories (in thousands):

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Non-consignment sales

 

$

42,535

 

 

$

34,696

 

 

$

96,381

 

 

$

98,518

 

Consignment sales

 

 

4,546

 

 

 

4,359

 

 

 

21,081

 

 

 

12,784

 

Total net sales

 

$

47,081

 

 

$

39,055

 

 

$

117,462

 

 

$

111,302

 

The Company reclassified inventory reserves from Changesmarkets and sells its products in Working Capital - Inventoryover 75 countries and conducts its manufacturing in the StatementUnited States.  Other than China and Japan, the Company does not conduct business in any country in which its sales exceed 10% of Cash Flowsworldwide consolidated net sales. Sales are attributed to the non-cash sectioncountries based on location of customers. The composition of the StatementCompany’s net sales to unaffiliated customers was as follows (in thousands):

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Domestic

 

$

1,477

 

 

$

1,783

 

 

$

4,098

 

 

$

5,849

 

Foreign:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

China

 

 

23,301

 

 

 

18,361

 

 

 

53,619

 

 

 

49,526

 

Japan

 

 

9,208

 

 

 

7,345

 

 

 

24,973

 

 

 

19,139

 

Other(1)

 

 

13,095

 

 

 

11,566

 

 

 

34,772

 

 

 

36,788

 

Total foreign sales

 

 

45,604

 

 

 

37,272

 

 

 

113,364

 

 

 

105,453

 

Total net sales

 

$

47,081

 

 

$

39,055

 

 

$

117,462

 

 

$

111,302

 

(1)

No other location individually exceeds 10% of the total sales.

100% of the Company’s sales are generated from the ophthalmic surgical product segment and the chief operating decision maker makes operating decisions and allocates resources based upon the consolidated operating results, and therefore the Company operates as 1 operating segment for bothfinancial reporting purposes. The Company’s principal products are implantable Collamer lenses (“ICLs”) used in refractive surgery and intraocular lenses (“IOLs”) used in cataract surgery.  The composition of the Company’s net sales by product line was as follows (in thousands):

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

ICLs

 

$

41,493

 

 

$

33,815

 

 

$

101,561

 

 

$

96,033

 

Other product sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

IOLs

 

 

3,325

 

 

 

4,093

 

 

 

9,880

 

 

 

11,984

 

Other surgical products

 

 

2,263

 

 

 

1,147

 

 

 

6,021

 

 

 

3,285

 

Total other product sales

 

 

5,588

 

 

 

5,240

 

 

 

15,901

 

 

 

15,269

 

Total net sales

 

$

47,081

 

 

$

39,055

 

 

$

117,462

 

 

$

111,302

 

One customer, the Company’s distributor in China, accounted for 49% and 46% of net sales for the three and nine months ended October 2, 2020, respectively, and the same customer, accounted for 47% and 44% of net sales for the three and nine months ended September 29, 201727, 2019, respectively.  As of October 2, 2020 and September 30, 2016.January 3, 2020, respectively, one customer, the Company’s distributor in China, accounted for 59% and 43% of consolidated trade receivables.

17


STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 15 — COVID-19 and CARES Act Developments

In December 2019, COVID-19 surfaced and in March 2020, the World Health Organization declared a pandemic related to the rapid spread of COVID-19 around the world.  The impact of the COVID-19 outbreak on the businesses and the economy in the U.S. and the rest of the world is, and is expected to continue to be, uncertain and may be significant. Accordingly, the Company cannot predict the extent to which its financial condition and results of operation will be affected. On March 17, 2020, the Company suspended most of its production and non-essential business locations where employees can work from home.  A very limited number of manufacturing personnel remained at work for critical late staged processes, until the end of March 2020.  Manufacturing resumed on April 27, 2020.  The Company’s revenues have been adversely impacted, as customers in China were not able to carry out procedures during the month of February and the Company experienced a substantial slowdown in sales beginning March 20, 2020 in global geographies characterized as “hot spots” for the COVID-19 virus, including parts of Europe, North America, the Middle East and India.  In certain of these markets, sales have paused as elective surgeries are discouraged to support COVID-19 related needs.  The Company also reclassified $65,000 from Cash Proceeds from Saleexpects decreases in sales in certain geographies to continue through the remainder of Property2020 and Equipmentinto 2021 as different geographies resume business activities on differing timelines.  

The CARES Act, among other things, includes provisions relating to Lossrefundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations, increased limitations on Disposalqualified charitable contributions, and technical corrections to tax depreciation methods for qualified improvement property.  The Company did not apply for or require financing available under the CARES Act and does not expect to do so given the strength of Property and Equipment forour balance sheet.  The Company will continue to monitor the nine months ended September 30, 2016.impact that the CARES Act may have on its business, financial condition, results of operations, or liquidity.

 


14

ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The matters addressed in this Item 2 that are not historical information constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Readers can recognize forward-looking statements by the use of words like “anticipate,” “estimate,” “expect,” “intend,” “plan,” “believe,” “will,” “should,” “forecast” and similar expressions in connection with any discussion of future operating or financial performance. In particular, these include statements about any of the following: any projections of or guidance as to earnings, revenue, sales, profit margins, expense rate, cash, effective tax rate, capital expense or any other financial items; the expected impact of the COVID-19 pandemic and related public health measures (including but not limited to their impact on sales, operations or clinical trials globally),the plans, strategies, and objectives of management for future operations or prospects for achieving such plans; statements regarding new, existing, or improved products, including but not limited to, expectations for success of new, existing, and improved products in the U.S. or international markets or government approval of a new or improved products (including the Toric ICLEVO family of lenses in the U.S. and the EVO Viva family of lenses for presbyopia internationally); commercialization of new or improved products; the nature, timing and likelihood of resolving issues cited in the FDA’s 2014 Warning Letter or 2015 FDA-483; future economic conditions or size of market opportunities; expected costs of quality system and completion of FDA remediation efforts;operations; statements of belief, including as to achieving 20172020 business plans; expected regulatory activities and approvals, product launches, and any statements of assumptions underlying any of the foregoing.

Although we believe that the expectations reflected in these forward-looking statements are reasonable, such statements are inherently subject to risks and we can give no assurance that our expectations will prove to be correct. Actual results could differ from those described in this report because of numerous factors, many of which are beyond our control. These factors include, without limitation, risks and uncertainties related to the COVID-19 pandemic and related public health measures,and those described in in our Annual Report on Form 10-K in “Item 1A. Risk Factors” filed on March 2, 2017.February 26, 2020, as well as the updated risk factor disclosed in our Quarterly Report on Form 10-Q in “Item 1A. Risk Factors” filed on May 16, 2020.  We undertake no obligation to update these forward-looking statements after the date of this report to reflect future events or circumstances or to reflect actual outcomes.

The following discussion should be read in conjunction with the unauditedaudited consolidated financial statements of STAAR, including the related notes, provided in this report.

Overview

STAAR Surgical Company designs, develops, manufactures, and sells implantable lenses for the eye and companion delivery systems used to deliver the lenses into the eye. We believe we are the world’s leading manufacturer of intraocular lenses for patients seeking refractive vision correction, and we also make lenses for use in surgery to treat cataracts. All the lenses we make are foldable, which allows the surgeon to insert them into the eye through a small incision during minimally invasive surgery. Refractive surgery is performed to treat the type of visual disorders that have traditionally been corrected using eyeglasses or contact lenses. We refer to our lenses used in refractive surgery as “implantable Collamer® lenses” or “ICLs,“ICLs. which includes the EVO Visian ICL™ product line. The field of refractive surgery includes both lens-based procedures, using products like our ICL family of products, and laser-based procedures like LASIK. Successful refractive surgery can correct common vision disorders such as myopia, hyperopia, and astigmatism. Cataract surgery is a common outpatient procedure where the eye’s natural lens that has become cloudy with age is removed and replaced with an artificial lens called an intraocular lens (IOL) to restore the patient’s vision. STAAR employs a commercialization strategy that strives for sustainable profitable growth. Our goal is to position our refractive lenses throughout the world as primary and premium solutions for patients seeking visual freedom from wearing glasseseyeglasses or contact lenses while achieving excellent visual acuity through refractive vision correction. We position our IOL lenses used in cataract surgery in standardthat treats cataracts based on quality and premium value segments.value.

 

STAAR has significant operations globally. Activities outsideRecent Developments

For the United States (“U.S.”) accountedthird quarter of 2020 STAAR’s net sales increased 21% over the prior year driven by 25% global ICL unit growth as markets more fully reopened following COVID-19 related shutdowns. Notable markets for 92% of our total salesICL unit growth in the third quarter of 2017, primarily due to the pacing of product approvals and commercialization that tend to occur first outside the U.S. STAAR sells its products in more than 60 countries, with direct distribution in2020 included China, Japan, North America,South Korea, Spain, Germany, Singapore,European distributor markets, and rest of APAC. India and the U.K., and independent distribution inMiddle East were the remainder of the world. STAAR maintains operational and administrative facilities in the U.S., Switzerland and Japan.

Recent Developments and Strategic Priorities for 2017

Intwo markets that remained most challenged by COVID-19 during the third quarter of 2017, quarterly net sales increased 17% from prior year quarter to $23.5 million. Worldwide ICL sales increased 22% and units increased 18% from prior year quarter. In the quarter, ICL sales grew 256% in Canada, 32% in Japan and 69% in China. In regional markets, compared to the prior year quarter, ICL sales increased 10% in North America, 6% in Europe, Middle East and Africa, and 35% in Asia Pacific, in spite of planned challenges in Korea. Global Toric ICL shipments continue to account for a growing percentage of the ICL product mix. For the third quarter of 2017, injector part sales were significantly higher than prior year third quarter. We continue to recover from challenges with one of the materials used in our silicone IOL preloaded injectors. During the third quarter of 2017, we continued to enter into new strategic business agreements with customers, and renew or extend existing agreements.

15

With the discontinuation ofcompleted patient enrollment in our U.S. silicone IOLEVO clinical trial and by October 30, 2020 all primary patients in the trial were implanted with the lens. Primary study analysis will be conducted when 300 primary eyes complete six months of follow-up, which is anticipated early in the second quarter of 2021 with submission of the study results to the FDA shortly thereafter. Considering the subsequent six-month patient follow-up and time to prepare our data submission to the FDA, we believe we are on track for potential marketing approval and commercialization of EVO in the U.S. in the second half of 2021. Also, on November 4, 2020, we announced the first EVO Viva lens patient who was implanted in Belgium. We are embarking upon the phased rollout of that presbyopia-correcting lens in Europe.


While COVID-19 hotspots and government public health mandates may reoccur moving forward, we anticipate less business interruption and sales impacted by the materials challengecontinued interest in our silicone IOL preloaded injectors, we expect that IOL sales will decreaseEVO ICL lens-based refractive solutions in the fourth quarter of 2017 compared2020. We also continue to believe that we will achieve a 20% share of the refractive procedure market in China by the end of the year. Assuming significant COVID-19 hotspots and government public health mandates do not reoccur and global economic improvement progresses, our outlook for the fourth quarter of 2016. We expect sales of injector parts to continue to increase compared to prior year2020 currently anticipates revenue in the fourth quarterrange of 2017. In September, our Notified Body in the European Union, DEKRA, approved an expanded age range for our EVO Visian ICL for myopia from adults aged 21$42 to 45 years old to adults aged 21 to 60 years old. Our first-in-man clinical trial for the next generation ICL with EDOF continued in the third quarter and the results continue to be positive.

For 2017, our strategic priorities remain as follows:

1.                     Complete Remediation Plan and Quality Systems Overhaul: We expect to complete our internal remediation and quality system rebuild commitments while also maintaining our global quality certifications;

2.                     Continue to Build theVisual Freedom Market for Implantable Lenses: We will continue our activities to position the ICL as a primary and premium refractive procedure with clinical validation, new digital and social media marketing, product branding launched in 2016, and enhanced surgeon training and practice development programs;

3.                     Build Go-to-Market Strategy to Expand Market Share Globally: We are planning for double digit ICL growth through a refreshed sales strategy and by entering into additional strategic business relationships with growth-oriented refractive surgical providers operating eye hospitals and clinics;

4.                     Deliver Global Clinical Validation & Clinical Utility Excellence: The expanded Global Clinical and Medical Affairs teams will continue to assist in supporting submissions to and responding to queries from regulatory agencies and will monitor clinical data, conduct and monitor clinical studies and patient registries established in 2016 and enhance our medical communications protocol; and

5.                     Innovate, Develop and Release to Market Premium Collamer Lenses and Delivery Systems: We plan to complete research and development efforts relating to EVO (spherical) with EDOF lens design and meet internal commitments regarding other research and development priorities.

We continue to expect double-digit ICL unit growth in 2017 driven primarily by increasing market acceptance of the EVO Visian ICL in established markets$44 million with the exceptioncaveat of the U.S. and Korea. We continueincreased spending to anticipate gross profit assupport a percentage of salesdeveloping strong outlook for full year 2017 to be higher than 2016. We continue to expect operating expenses for 2017 will be below operating expenses in 2016. Finally, we will continue to evaluate opportunities to acquire new product lines, technologies, and companies.

2021.

Critical Accounting Policies

This Management’s Discussion and Analysis of Financial Condition and Results of Operations discusses and analyzes data in our unaudited Condensed Consolidated Financial Statements provided in this report, which we have prepared in accordance with U.S. generally accepted accounting principles. Preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. Management bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Senior management has discussed the development, selection and disclosure of these estimates with the Audit Committee of our Board of Directors. Actual conditions may differ from our assumptions and actual results may differ from our estimates.

An accounting policy is deemed critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, if different estimates reasonably could have been used, or if changes in the estimate that are reasonably likely to occur could materially impact the financial statements. Management believes that there have been no significant changes during the nine months ended September 29, 2017 October 2, 2020 to the items that we disclosed as our critical accounting policies and estimates in Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the fiscal year ended December 30, 2016.

16

January 3, 2020.

Results of Operations

The following table shows the percentage of our total sales represented by the specificcertain items listed reflected in our condensed consolidated statementsCondensed Consolidated Statements of operationsOperations for the periods indicated, and the percentage by which these items increased or decreased over the prior period.indicated.

 

  Percentage of Net Sales
for Three Months
  Percentage of Net Sales
for Nine Months
 
  September 29,
2017
  September 30,
2016
  September 29,
2017
  September 30,
2016
 
Net sales  100.0%  100.0%  100.0%  100.0%
Cost of sales  28.2   25.8   28.7   29.5 
Gross profit  71.8   74.2   71.3   70.5 
                 
General and administrative  21.1   24.9   22.9   30.5 
Marketing and selling  27.4   35.7   30.8   36.5 
Research and development  18.9   22.2   21.2   26.6 
   67.4   82.8   74.9   93.6 
Operating income (loss)  4.4   (8.6)  (3.6)  (23.1)
Other income (expense), net  2.3   0.2   1.6   0.5 
Income (loss) before provision for income taxes  6.7   (8.4)  (2.0)  (22.6)
Provision (benefit) for income taxes  1.7   0.4   1.1   (2.8)
Net income (loss)  5.0%  (8.8)%  (3.1)%  (19.8)%

 

 

Percentage of Net Sales

for Three Months

 

 

Percentage of Net Sales

for Nine Months

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

Net sales

 

 

100.0

%

 

 

100.0

%

 

 

100.0

%

 

 

100.0

%

Cost of sales

 

 

25.9

%

 

 

25.6

%

 

 

28.4

%

 

 

25.3

%

Gross profit

 

 

74.1

%

 

 

74.4

%

 

 

71.6

%

 

 

74.7

%

General and administrative

 

 

18.2

%

 

 

18.2

%

 

 

20.8

%

 

 

19.3

%

Selling and marketing

 

 

26.9

%

 

 

31.9

%

 

 

29.0

%

 

 

30.8

%

Research and development

 

 

18.6

%

 

 

15.8

%

 

 

19.5

%

 

 

16.1

%

Total selling, general and administrative

 

 

63.7

%

 

 

65.9

%

 

 

69.3

%

 

 

66.2

%

Operating income

 

 

10.4

%

 

 

8.5

%

 

 

2.3

%

 

 

8.5

%

Total other income (expense), net

 

 

1.1

%

 

 

(0.5

)%

 

 

0.7

%

 

 

0.5

%

Income before income taxes

 

 

11.5

%

 

 

8.0

%

 

 

3.0

%

 

 

9.0

%

Provision for income taxes

 

 

3.2

%

 

 

1.9

%

 

 

0.8

%

 

 

2.1

%

Net income

 

 

8.3

%

 

 

6.1

%

 

 

2.2

%

 

 

6.9

%


Net Sales

  Three Months Ended  Percentage Change  Nine Months Ended  Percentage Change 
  

September 29,

2017

  

September 30,

2016

  

2017

vs. 2016

  September 29, 2017  September 30, 2016  

2017

vs. 2016

 
Net sales $23,473  $20,052   17.1% $65,759  $60,295   9.1%
                         
ICL  18,110   14,801   22.4   49,698   43,389   14.5 
IOL  3,892   4,649   (16.3)  12,875   14,783   (12.9)
Other  1,471   602   144.4   3,186   2,123   50.1 

 

 

Three Months Ended

 

 

Percentage

Change

 

 

Nine Months Ended

 

 

Percentage

Change

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

ICLs

 

$

41,493

 

 

$

33,815

 

 

 

22.7

%

 

$

101,561

 

 

$

96,033

 

 

 

5.8

%

Other product sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

IOLs

 

 

3,325

 

 

 

4,093

 

 

 

(18.8

)%

 

 

9,880

 

 

 

11,984

 

 

 

(17.6

)%

Other surgical products

 

 

2,263

 

 

 

1,147

 

 

 

97.3

%

 

 

6,021

 

 

 

3,285

 

 

 

83.3

%

Total other product sales

 

 

5,588

 

 

 

5,240

 

 

 

6.6

%

 

 

15,901

 

 

 

15,269

 

 

 

4.1

%

Net sales

 

$

47,081

 

 

$

39,055

 

 

 

20.6

%

 

$

117,462

 

 

$

111,302

 

 

 

5.5

%

 

Net sales for the three months ended September 29, 2017October 2, 2020 were $23.5$47.1 million, an increase of 17% compared with $20.121% from $39.1 million reported during the same period of 2016. Total2019.  The increase in net sales was due to increased ICL sales of $7.7 million and other product sales of $0.3 million.  Changes in foreign currency favorably impacted net sales by $0.4 million.

Net sales for the nine months ended September 29, 2017October 2, 2020 were $65.8$117.5 million, an increase of 9.1% compared with $60.36% from $111.3 million reported during the same period of 2016.2019.  The effect of exchange rate changes had an unfavorable impact onincrease in net sales was due to increased ICL sales of $0.3$5.5 million and $0.4 million, respectively, during the three and nine months ended September 29, 2017.

other product sales of $0.6 million.  Changes in foreign currency favorably impacted net sales by $0.5 million.

Total ICL sales for the three months ended September 29, 2017October 2, 2020 were $18.1$41.5 million, an increase of 22% compared with $14.823% from $33.8 million reported duringfor the same period of 2016. North America ICL sales were $1.6 million during the third quarter, an2019, with unit increase of 10% in both25%. The APAC region sales and units comparedincreased by 29%, with unit growth up 31% due to the prior year period. The increase in North America ICL sales was driven by a 256% increase in Canada sales as a result of the successful commercialization of the EVO Toric ICL which was introduced late in the third quarter of 2016. APAC ICL sales were $11.0 million during the third quarter of 2017, an increase of 35% compared to the prior year period, which was comprised of a 34% increase in units and a 1% increase in average selling prices, driven by strong double-digitunit growth in Japan up 67%, other APAC Distributors up 67%, China Japan,up 33%, and APAC distributor markets. EMEA ICLKorea up 21%.  The Europe, Middle East, Africa and Latin America region sales were $5.4 million during the third quarter, an increaseincreased 7% with unit decrease of 6% compared2% due to the prior year period, which was comprised of an 8%a decrease in units in the Middle East and Africa of 54%, offset by unit growth in the UK up 44%, Spain up 24%, Distributor Operations up 17%, Germany up 13% and Latin America up 12%.  The North America region sales decreased 3%, with unit decrease of 1%, due to a 15% increasedecrease in average selling prices.

units of 8% in the U.S., offset by unit growth in Canada of 31%.  ICL sales represented 88.1% and 86.6% of our total sales for the three months ended October 2, 2020 and September 27, 2019, respectively.

Total ICL sales for the nine months ended September 29, 2017October 2, 2020 were $49.7$101.6 million, a 15%6% increase compared with $43.4from $96.0 million reported duringfor the same period of 2016. Total ICL units2019, with unit growth up 10%. The APAC region sales increased by 13%, with unit growth up 17% due to unit growth in Japan up 62%, Korea up 17%, China up 16% and average selling pricesother APAC Distributors up 30%.  The Europe, Middle East, Africa and Latin America region sales decreased 1%9% and units decreased 12%.  EMEAThe North America region sales and units decreased 22%.  The decrease in both these regions were impacted by the COVID-19 pandemic in the first half of 2020; most markets started to reopen in mid-May/early June.  ICL sales represented 86.5% and 86.3% of our total sales for the nine months ended October 2, 2020 and September 27, 2019, respectively.

Other product sales, including IOLs were $16.3$5.6 million for the three months ended October 2, 2020, an increase of 7% from $5.2 million reported for the same period of 2019.  Other product sales were $15.9 million for the nine months ended September 29, 2017, a 5%October 2, 2020, an increase compared to $15.5of 4% from $15.3 million reported in the same period in 2016 which was comprised of a 2% increase in units and a 3% increase in average selling prices. APAC ICL sales were $28.2 million for the nine months ended September 29, 2017, a 21% increase compared to $23.2 million reported during the same period of 2016.2019.  The increase in both periods was comprised of 25% increase in units anddue to increased preloaded injector part sales to a 3% decrease in average selling prices. The increase was driven by a 49% increase in China sales, partiallythird-party manufacturer for product they sell to their customers, offset by lowerdecreased IOL sales.  Other product sales in Indiarepresented 11.9% and Korea. North America ICL sales were $5.1 million during the nine months ended September 29, 2017, an 11% increase in sales and units compared to the same period in 2016.

17

Total IOL13.4% of our total sales for the three months ended October 2, 2020 and September 29, 2017 were $3.9 million, a decrease27, 2019, respectively, and represented 13.5% and 13.7% of 16% compared with $4.6 million reported during the same period of 2016. Total IOLour total sales for the nine months ended October 2, 2020 and September 29, 2017 were $12.9 million, a 13% decrease compared with $14.8 million reported during the same period in 2016. The decline for both the three and nine-month periods was due to the discontinuance of the silicone IOL product line in the U.S. during 2016 and due to production issues with one of the materials used in our silicone IOL preloaded injectors which has resulted in lower than planned IOL sales in Japan.27, 2019, respectively.

Gross Profit

 

Other product sales for the three months ended September 29, 2017, were $1.5 million, an increase of 144% compared with the $0.6 million reported during the same period of 2016. Total other product sales for the nine months ended September 29, 2017 were $3.2 million, a 50% increase compared with $2.1 million reported during the same period in 2016. The increase in other product sales is due to an increase in injector part sales as expected.

Gross Profit

  Three Months Ended  Percentage
Change
  Nine Months Ended  Percentage Change 
  September 29,
2017
  September 30,
2016
  

2017

vs. 2016

  September 29,
2017
  September 30,
2016
  

2017

vs. 2016

 
Gross Profit $16,849  $14,872   13.3% $46,900  $42,491   10.4%
Gross Profit Margin  71.8%  74.2%      71.3%  70.5%    

 

 

Three Months Ended

 

 

Percentage

Change

 

 

Nine Months Ended

 

 

Percentage

Change

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

Gross profit

 

$

34,871

 

 

$

29,051

 

 

 

20.0

%

 

$

84,061

 

 

$

83,130

 

 

 

1.1

%

Gross margin

 

 

74.1

%

 

 

74.4

%

 

 

 

 

 

 

71.6

%

 

 

74.7

%

 

 

 

 

 

Gross profit for the three months ended September 29, 2017October 2, 2020 was $16.8$34.9 million, or 71.8%a 20.0% increase compared to the $29.1 million reported for the same period of 2019.  Gross profit margin decreased to 74.1% of revenue for the three months ended October 2, 2020 compared with $14.9 million, or 74.2%to 74.4% of revenue in the prior year period. The decrease in gross margin for the quarter isthree months ended September 27, 2019, due to unfavorable product mix due to increased sales of low margin injector parts, increased inventory provisions due to timing, and an increase in ICL unit costs, partially offset by an increasedgeographic sales mix, period costs associated with the manufacturing expansion projects, and increased mix of Toric ICLs.injector part sales which carry a lower margin.  


Gross profit for the nine months ended September 29, 2017October 2, 2020 was $46.9$84.1 million, or 71.3%a 1.1% increase compared to the $83.1 million reported for the same period of 2019.  Gross profit margin decreased to 71.6% of revenue for the nine months ended October 2, 2020 compared with $42.5 million, or 70.5%to 74.7% of revenue in the prior year period. The increase in gross margin for the first ninethree months of 2017 isended September 27, 2019, due primarily to an increasedgeographic sales mix, of Toric ICLs, the cost of sales$1.2 million in expenses related to the $0.6COVID-19 manufacturing pause from March 17 through April 27, 2020, period costs associated with the manufacturing expansion projects and increased mix of injector part sales which carry a lower margin.  

General and Administrative Expense

 

 

Three Months Ended

 

 

Percentage

Change

 

 

Nine Months Ended

 

 

Percentage

Change

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

General and administrative expense

 

$

8,589

 

 

$

7,098

 

 

 

21.0

%

 

$

24,406

 

 

$

21,443

 

 

 

13.8

%

Percentage of sales

 

 

18.2

%

 

 

18.2

%

 

 

 

 

 

 

20.8

%

 

 

19.3

%

 

 

 

 

General and administrative expenses for the three months ended October 2, 2020 were $8.6 million, non-cash charge relateda 21.0% increase compared to the immediate vesting$7.1 million reported for the same period of all unvested equity awards as a result of the triggering of the “Change of Control” provision of the Company’s equity incentive plan recorded in the first nine months of 2016 which was not repeated in 2017, and lower inventory provisions, partially offset by unfavorable product mix2019, due to increased sales of low margin injector parts,salary-related expenses, variable compensation and lower average selling prices.

General and Administrative

  Three Months Ended  Percentage Change  Nine Months Ended  Percentage Change 
  September 29,
2017
  September 30,
2016
  

2017

vs. 2016

  September 29,
2017
  September 30,
2016
  

2017

vs. 2016

 
General and Administrative $4,946  $4,985   (0.8)% $15,065  $18,378   (18.0)%
Percentage of Net Sales  21.1%  24.9%      22.9%  30.5%    

facility costs.  General and administrative expenses for the nine months ended September 29, 2017October 2, 2020 were $15.1$24.4 million, a decrease of 18% when13.8% increase compared with $18.4to the $21.4 million reported for the same period last year. The decrease was primarilyof 2019, due to lower stock basedincreased salary-related expenses, variable compensation, expenses due to the $2.9 million non-cash charge related to the immediate vesting of all unvested equity awards as a result of the triggering of the “Change of Control” provision of the Company’s equity incentive plan recorded during the first nine months of 2016 which were not repeated in the first nine months of 2017. Generaltax consulting, facility costs and administrative expenses for the first nine months of 2017 were also lower due tocorporate insurance, partially offset by decreased compensationtravel expenses.

Selling and Marketing Expense

 

 

 

Three Months Ended

 

 

Percentage

Change

 

 

Nine Months Ended

 

 

Percentage

Change

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

Selling and marketing expense

 

$

12,649

 

 

$

12,463

 

 

 

1.5

%

 

$

34,003

 

 

$

34,288

 

 

 

(0.8

)%

Percentage of sales

 

 

26.9

%

 

 

31.9

%

 

 

 

 

 

 

29.0

%

 

 

30.8

%

 

 

 

 

MarketingSelling and Selling

  Three Months Ended  Percentage Change  Nine Months Ended  Percentage Change 
  September 29,
2017
  September 30,
2016
  

2017

vs. 2016

  September 29,
2017
  September 30,
2016
  

2017

vs. 2016

 
Marketing and Selling $6,431  $7,149   (10.0)% $20,282  $22,006   (7.8)%
Percentage of Net Sales  27.4%  35.7%      30.8%  36.5%    

Marketing and sellingmarketing expenses for the three months ended September 29, 2017October 2, 2020 were $6.4$12.6 million, a decrease of 10% when1.5% increase compared with $7.1to the $12.5 million reported for the same period last year. The decrease wasof 2019, due to the timing of the ESCRS which was held in the third quarter of 2016increased salary-related expenses, advertising and will be held in the fourth quarter of 2017, partiallypromotional activities and variable compensation, offset by increased sales rep expenses in China. The Company expects fourth quarter 2017 expenses will be higher for this reason.

decreased trade show and travel expenses.  Marketing and selling expenses for the nine months ended September 29, 2017October 2, 2020 were $20.3$34.0 million, aan 0.8% decrease of 8% when compared with $22.0to the $34.3 million reported for the same period last year. The decrease isof 2019, due to decreased trade show and travel expenses, offset by increased advertising and promotional activities, salary-related expenses and variable compensation.

Research and Development Expense

 

 

Three Months Ended

 

 

Percentage

Change

 

 

Nine Months Ended

 

 

Percentage

Change

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

Research and development expense

 

$

8,751

 

 

$

6,156

 

 

 

42.2

%

 

$

22,960

 

 

$

17,889

 

 

 

28.3

%

Percentage of sales

 

 

18.6

%

 

 

15.8

%

 

 

 

 

 

 

19.5

%

 

 

16.1

%

 

 

 

 

Research and development expenses for the three months ended October 2, 2020 were $8.8 million, a 42.2% increase compared to the $6.2 million reported for the same period of 2019, primarily due to lower stock based compensationincreased clinical expenses due to the $1.5 million non-cash charge related to the immediate vesting of all unvested equity awards as a result of the triggering of the “Change of Control” provision of the Company’s equity incentive plan recorded during the first nine months of 2016 which was not repeatedassociated with our EVO clinical trial in the first nine months of 2017U.S., variable compensation and due to lower overall headcount and promotional costs in Japan.

18

Research and Development

  Three Months Ended  Percentage Change  Nine Months Ended  Percentage Change 
  September 29,
2017
  September 30,
2016
  

2017

vs. 2016

  September 29,
2017
  September 30,
2016
  

2017

vs. 2016

 
Research and Development $4,429  $4,453   (0.5)% $13,924  $16,018   (13.1)%
Percentage of Net Sales  18.9%  22.2%      21.2%  26.6%    

salary-related expenses. Research and development expenses for the nine months ended September 29, 2017October 2, 2020 were $13.9$23.0 million, a 13.1% decrease28.3% increase compared to $16.0the $17.9 million reported for the same prior year period. The decrease isperiod of 2019, primarily due to lower stock based compensationincreased clinical expenses associated with our EVO clinical trial in the U.S., and increased salary-related expenses, partially offset by travel expense.  


Other Income (Expense), Net

 

 

Three Months Ended

 

 

Percentage

Change

 

 

Nine Months Ended

 

 

Percentage

Change

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

Other income (expense), net

 

$

499

 

 

$

(186

)

 

 

—*

 

 

$

781

 

 

$

539

 

 

 

44.9

%

Percentage of sales

 

 

1.1

%

 

 

(0.5

)%

 

 

 

 

 

 

0.7

%

 

 

0.5

%

 

 

 

 

*

Denotes change is greater than +100%.

Other income, net for the three months ended October 2, 2020 was $0.5 million, compared to other expense, net of $0.2 million reported for the same period of 2019.  The change in other income (expense), net for the three months was due to the $1.9 million non-cash charge related to the immediate vesting of all unvested equity awardsincreased foreign exchange gains (primarily euro), partially offset by a decrease interest income, net, as a result of lower interest rates.  Other income, net for the triggering of the “Change of Control” provision of the Company’s equity incentive plan recorded during the first nine months of 2016 whichended October 2, 2020 was not repeated in the first nine months of 2017.

Research and development expense consists primarily of compensation and related costs for personnel responsible$0.8 million, a 44.9% increase compared to $0.5 million reported for the research and developmentsame period of new and existing products and the regulatory and clinical activities required to acquire and maintain product approvals globally. These costs are expensed as incurred.

Other Income, Net

  Three Months Ended  Percentage Change  Nine Months Ended  Percentage Change 
  September 29,
2017
  September 30,
2016
  

2017

vs. 2016

  September 29,
2017
  September 30,
2016
  

2017

vs. 2016

 
Other income, net $539  $8   * $1,067  $285   *

* Denotes change is greater than+100%

2019.  The changeincrease in other income, net for the three and nine months ended September 29, 2017 is primarilywas due to increased foreign currency transaction gains.exchange gains (primarily the euro), offset by decreases in interest income, as a result of lower interest rates, and royalty income, which was impacted by COVID-19 pandemic.  

Income Taxes

 

 

 

Three Months Ended

 

 

Percentage

Change

 

 

Nine Months Ended

 

 

Percentage

Change

 

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

 

October 2, 2020

 

 

September 27, 2019

 

 

2020 vs. 2019

 

Income tax provision (benefit)

 

$

1,489

 

 

$

760

 

 

 

95.9

%

 

$

887

 

 

$

2,380

 

 

 

(62.7

)%

Income Taxes

  Three Months Ended  Percentage Change  Nine Months Ended  Percentage Change 
  September 29,
2017
  September 30,
2016
  

2017

vs. 2016

  September 29,
2017
  September 30,
2016
  

2017

vs. 2016

 
Provision (benefit) for income taxes $409  $71   * $697  $(1,664)  *

* Denotes change is greater than+100%

The provision for We recorded income taxes is determined using an estimated annual effective tax rate.  We recorded an income tax provision of $0.4$1.5 million and $0.7 million, respectively, for the three and nine months ended September 29, 2017.  The income tax provision for the three and nine months ended September 29, 2017 isOctober 2, 2020 due primarily to pre-tax income generated in certain higher rate foreign jurisdictions. Thejurisdictions, partially offset by a reversal of $0.2 million of our U.S. valuation allowance, as a result of an increase in foreign income and changes in the usage and release of our deferred tax assets. We recorded income taxes of $0.8 million for the three months ended September 27, 2019 due to pre-tax income generated in certain foreign jurisdictions and withholding taxes on foreign operations.  We recorded income taxes of $0.9 million for the nine months ended October 2, 2020 due to income tax benefitexpense from profits generated by our foreign operations, partially offset by the release of our U.S. valuation allowances.  We recorded income taxes of $2.4 million for the nine months ended September 30, 2016 was27, 2019 primarily due to net operating losses frompre-tax income generated in certain foreign jurisdictions and withholding taxes on foreign operations.  In the fourth quarter of fiscal year 2019, we reversed all previously recorded withholding taxes recorded for 2019, at which time we formed STAAR Surgical UK Limited as a holding company for our foreign operations, primarily due tooperations.  Based on the acceleration of stock compensation,current tax treaties between the U.S., United Kingdom and tax benefits related to the dissolution of one ofSwitzerland, we will no longer accrue for Switzerland withholding taxes on foreign earnings after fiscal 2018 (see also Note 10 in our foreign subsidiaries.fiscal 2019 Form 10-K for more information).  We have no unrecognized tax benefits pertaining to any uncertain tax positions as of any period presented.   

ASC 740 requires that a valuation allowance be established when it is more likely than not that all or a portion of a deferred tax asset may not be realizable.  As further described in Notes 1 and 10 of our fiscal 2019 Form 10-K, under the “incremental cash tax savings approach,” we recorded a valuation release of $3.0 million and $0.4 million against federal and certain states deferred tax assets, respectively.  During the nine months ended October 2, 2020, we revised our global forecasts as a result of COVID-19, and due to changes in the usage and release of certain deferred tax assets, we released an additional $1.2 million of valuation allowance.  As of October 2, 2020, we released approximately $4.6 million of valuation allowance on our deferred tax assets in the U.S. jurisdiction utilizing the incremental cash tax savings approach.  The ultimate realization of deferred tax assets is dependent upon future generation of income during the periods in which temporary differences representing net future deductible amounts become deductible. We considered the projected future income, tax planning strategies and all other available evidence both positive and negative, as well as results of recent operations in making this assessment. In applying the incremental cash tax savings approach, we will continue to maintain a valuation allowance on the balance of the Company’s net U.S. deferred tax assets of $35.7 million.

Liquidity and Capital Resources

We have historically financed our operations primarily through operating cash flows, the issuance of common stock and proceeds from stock option exercises, borrowings under lines of credit and by relying on equipment and other commercial financing. During 2017, and for the foreseeable future, we will be highly dependent on our operating cash flows to supplement our current liquidity and funding of our operations. We may in the future supplement our working capital.

With continued expanding ICL sales and gross margins, the Company has been able to invest in its operations while maintaining its cash balances. Since 2014, we have maintained an average cash balance of approximately $13.5 million through the second quarter of 2017, increasing to $16.3 million at the end of the third quarter of 2017 and went from using approximately $8.0 million in cash for operating activities in 2014 to generating $1.8 million from operating activities during the first nine months of 2017. As we shift from remediation to commercialization, we expect to invest more in sales and marketing while maintaining quality. We believe these investments will accelerate high margin sales which should result in a significantly improved cash position and profitability.

19

 We believe ourthat current cash, balances coupled withcash equivalents and future cash flow from operating activities will be sufficient to meet our anticipated cash needs, including working capital requirementsneeds, capital expenditures and contractual obligations for at least 12 months from the foreseeable future. Our needissuance date of the financial statements included in this quarterly report. Although we have experienced some delays in payments on accounts receivable as a result of the COVID-19 pandemic in the first half of 2020, this has improved during the third quarter of 2020 as our customers resume elective refractive surgery.  However, at this time we are


unaware of any impairment of assets resulting from the COVID-19 pandemic.  The Company did not apply for working capital, and the terms on whichor require financing may be available will depend in part on our degree of success in maintaining positive cash flow through the strategies described above under the caption “Recent DevelopmentsCoronavirus Aid, Relief, and Strategic Priorities for 2017.”Economic Security “CARES” Act and does not expect to do so given the strength of our balance sheet.  Our financial condition at October 2, 2020 and January 3, 2020 included the following (in millions):

 

Overview of Changes in Cash and Cash Equivalents and Other Working Capital Accounts.

 

 

October 2, 2020

 

 

January 3, 2020

 

 

2020 vs. 2019

 

Cash and cash equivalents

 

$

128.3

 

 

$

120.0

 

 

$

8.3

 

Current assets

 

$

196.0

 

 

$

174.7

 

 

$

21.3

 

Current liabilities

 

 

33.9

 

 

 

34.5

 

 

 

(0.6

)

Working capital

 

$

162.1

 

 

$

140.2

 

 

$

21.9

 

 

AsWe invest the net proceeds in short-term interest-bearing obligations, investment-grade instruments, certificates of September 29, 2017 and December 30, 2016, respectively, STAAR had $16.3deposit or direct or guaranteed obligations of the U.S. government.  Additionally, at October 2, 2020, we have a line of credit with a Japanese lender, in the amount of $1.3 million, and $14.1with $3.4 million of cash, cash equivalentsavailability and restricted cash.

a line of credit with a Swiss lender, in the amount of $1.1 million, which is fully available for borrowing.

Net cash provided by operating activities was $1.8$1.4 million and $0.9for the nine months ended October 2, 2020 compared to net cash provided by operating activities of $16.0 million for the nine months ended September 29, 2017 and September 30, 2016, respectively. The net27, 2019.  Net cash provided by operating activities for the nine months ended September 29, 2017, resulted from a net lossOctober 2, 2020, consisted of $2.0 million, offset by $6.4 million$12.6 in non-cash items and decreased$2.6 million in net income, offset by a $2.7$13.8 million increasein working-capital changes.  The decrease in net cash provided by operating activities during the nine months ended October 2, 2020 was due to decreases in net working capital.

capital of $9.1 million, net income of $5.1 million and non-cash items of $0.4 million.

Net cash used in investing activities was $1.0$6.3 million and $7.2 million for the nine months ended October 2, 2020 and September 29, 2017, compared to $2.7 million in net cash used in investing activities for the nine months ended September 30, 2016. Net cash used in investing activities for both periods was due27, 2019, respectively, and relate primarily to the acquisition of property, plant, and equipment.

  

Net cash provided by financing activities was $1.1$13.0 million and $1.9for the nine months ended October 2, 2020 compared to net cash used in financing activities of $0.7 million for the nine months ended September 29, 2017 and September 30, 2016, respectively.27, 2019.  Net cash provided by financing activities duringfor the first nine months ended October 2, 2020 consisted of 2017 resulted primarily$14.0 million of proceeds from the proceeds from vested restricted stock and exercisesexercise of stock options, and proceeds from sale-leaseback transactions, partially offset by purchase$0.5 million repayment on the Japan line of employee common stock for taxes withheldcredit and the$0.5 million repayment of capitalfinance lease obligations.

Credit Facilities and Commitments

Lines of Credit and Lease Line of Credit (Capital Leases)

Leases

See Note 12Notes 7 and 8 of the accompanying Condensed Consolidated Financial Statements.

Covenant Compliance

The Company is in compliance with the covenants of its credit facilities as of September 29, 2017.October 2, 2020.

Employment Agreements

The Company’s Chief Executive Officer entered into an employment agreement with the Company, effective March 1, 2015.  She and certain officers have as provisions of their agreements certain rights, including continuance of cash compensation and benefits, upon a “change in control,” which may include an acquisition of substantially all of its assets, or termination “without cause or for good reason” as defined in the employment agreements.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements, as that term is defined in the rules of the SEC, that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

During the nine months ended September 29, 2017,October 2, 2020, there have been no material changes in the Company’s qualitative and quantitative market risk since the disclosure in the Company’s Annual Report on Form 10-K for the year ended December 30, 2016.January 3, 2020.


ITEM 4.

20

ITEM 4 .

CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our management, including our CEO and CFO, of the effectiveness of the design and operation of the disclosure controls and procedures of the Company.  Based on that evaluation, our CEO and CFO concluded, as of the end of the period covered by this quarterly report on Form 10-Q, that our disclosure controls and procedures were effective.  For purposes of this statement, the term “disclosure controls and procedures” means controls and other procedures of the Company that are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act (15 U.S.C. 78a et seq.) is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

Our management, including the CEO and the CFO, do not expect that our disclosure controls and procedures or our internal control over financial reporting will necessarily prevent all fraud or material errors. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations on all internal control systems, our internal control system can provide only reasonable assurance of achieving its objectives and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of internal control is also based in part upon certain assumptions about the likelihood of future events, and can provide only reasonable, not absolute, assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in circumstances, or the degree of compliance with the policies and procedures may deteriorate.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the quarter ended September 29, 2017October 2, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

ITEM 1.

From time to time,On August 19, 2020, a putative federal securities class action, Alwazaan v. STAAR Surgical Co., et al., was filed against the Company is involved in various legal proceedings and other matters arisingcertain of its executives in the normal courseU.S. District Court for the Central District of business. Certain legal proceedingsCalifornia. On September 1, 2020, a substantially similar federal securities class action, Zhang v. STAAR Surgical Co., et al., was filed against the Company and the same executives in which we are currently involved are discussedthe U.S. District Court for the Central District of California. On September 11, 2020, the court consolidated the two actions under “Litigationthe caption In re STAAR Surgical Co. Securities Litigation. The plaintiffs in the lawsuit allege that the Company made material misstatements regarding its sales in China, its marketing spend, and Claims” in Note 12, “Commitmentsits R&D expenses. Plaintiffs seek compensatory and Contingencies,” to our Condensed Consolidated Financial Statements provided inpunitive damages as well as attorneys’ fees.  Although the ultimate outcome of this report,action cannot be determined with certainty, the Company denies any wrongdoing and such discussions are hereby incorporated by reference.will vigorously defend itself against these claims.


ITEM 1A.

RISK FACTORS

Our short and long-term success is subject to many factors that are beyond our control. Investors and prospective investors should consider carefully information contained in this report and the risks and uncertainties described in “Part I—Item 1A—Risk Factors” of the Company’s Form 10-K for the fiscal year ended December 30, 2016.January 3, 2020 and in “Part II—Item 1A—Risk Factors” of the Company’s Form 10-Q for the three months ended April 3, 2020. Such risks and uncertainties could materially adversely affect our business, financial condition or operating results.

ITEM 4.

MINE SAFETY DISCLOSURES

Not Applicable.

ITEM 5.

OTHER INFORMATION

Effective August 10, 2017, weOn or about October 30, 2020, STAAR Surgical Company entered into a standard commercial lease extending toamendment (the “Lease Amendment”) with 2000 Gold L.P. (its Landlord), exercising its renewal option of a total of approximately 45,000 square feet of leased, industrial use real property located at 1911 Walker Avenue and 1900 Myrtle Avenue, Monrovia, California (“Premises”). The Lease Amendment expires October 31, 20202023. The Company has conducted office and manufacturing related operations at the term of our lease regarding a portion of our corporate headquarters located in Monrovia, California.

Premises since 2012.

ITEM 6.

21

EXHIBITS

 

   3.1

ITEM 6.

EXHIBITS

3.1Amended and Restated Certificate of Incorporation.(1)

3.2

Amended and Restated Bylaws.(4)(2)

4.4

   4.1

Form of Certificate for Common Stock, par value $0.01 per share.(3)

†4.5

 †4.2

Amended and Restated Omnibus Equity Incentive Plan, effective February 25, 2016.(2)Plan.(4)

 10.39

Lease agreement entered into on September 14, 2020 between STAAR Surgical Company and Calderari & Schwab.(5)

 

 

10.45

 10.40

Letter of theFirst Amendment to Lease Agreement dated October 1, 2020 between STAAR Surgical Company dated September 27, 2017 to Deborah Andrews, Vice President of Finance, Chief Financial Officer, regarding compensation.(5)and Pacific Equity Partners, LLC.(6)

 

 

10.46

 10.41

First Amendment to Lease Agreement dated August 10, 2017 by andOctober 30, 2020 between theSTAAR Surgical Company and 2000 Gold L.P.*

31.1

Certifications Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*

31.2

Certifications Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*

32.1

Certification Pursuant to 18 U.S.C. Section 1350, Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. **

101

Financial statements from the quarterly report on Form 10-Q of STAAR Surgical Company for the quarter ended September 29, 2017,October 2, 2020 formatted in Inline Extensible Business Reporting Language (XBRL)(iXBRL), are filed herewith and include: (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Operations,Income, (iii) the Condensed Consolidated Statements of Comprehensive Loss,Income, (iv) the Condensed Consolidated Statements of Stockholders’ Equity, (v) the Condensed Consolidated Statements of Cash Flows, and (v)(vi) the Notes to Condensed Consolidated Financial Statements tagged as blocks of text.*

(1)

Incorporated by reference to

 104

The cover page from the Company’s CurrentQuarterly Report on Form 8-K as filed10-Q for the quarter ended October 2, 2020, has been formatted in Inline XBRL with the Commission on June 11, 2014.applicable taxonomy extension information contained in Exhibit 101.

(2)

(1)

Incorporated by reference to Appendix 12 of the Company’s Proxy Statement on Form DEF 14A as filed with the Commission on May 2, 2016.April 13, 2018

(3)

(2)

Incorporated by reference to Appendix 3 of the Company’s Proxy Statement on Form DEF 14A as filed with the Commission on April 13, 2018.


(3)

Incorporated by reference to Exhibit 4.1 to Amendment No. 1 to the Company’s Registration Statement on Form 8-A/8‑A/A as filed with the Commission on April 18, 2003.

(4)

Incorporated by reference to Exhibit 4.2 to the Company’s Quarterly Report on Form 10-Q, for the period ended June 30, 2017,July 3, 2020, as filed with the Commission on August 2, 2017.5, 2020.

(5)

Incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on September 28, 2017.14, 2020.

(6)

Incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on October 8, 2020.

*

Filed herewith.

**

Furnished herewith.

Management contract or compensatory plan.

22


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

STAAR SURGICAL COMPANY

Date:

Dated:

November 8, 20174, 2020

By: /s/ DEBORAH J. ANDREWS

/s/ PATRICK F. WILLIAMS

Deborah J. Andrews

Patrick F. Williams

Chief Financial Officer

(on behalf of the Registrant and as it’s

its principal financial officer)

23

 

28