UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

________________

 

Form 10-Q

 

(Mark One)

þQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 For the quarterly period ended:  September 29, 201728, 2018
 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 name of registrant as specified in its charter)

 

Delaware95-3797439

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

1911 Walker Avenue

Monrovia, California 91016

(Address of principal executive offices)

(626) 303-7902

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

 

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 filerþ Accelerated filer

o Non-accelerated filer

(Do not check if a smaller reporting company)

o Smaller reporting company
o Emerging growth company

o Emerging growth company

 

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

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes o¨     No þ

 

The registrant has 41,164,23144,131,509 shares of common stock, par value $0.01 per share, issued and outstanding as of October 30, 2017.26, 2018.

 

 

 

 

 

STAAR SURGICAL COMPANY

 

INDEX

 PAGE
NUMBER
  NUMBER
PART I – FINANCIAL INFORMATION
Item 1.Financial Statements.1
   
Item 2.ITEM 1.Management’s Discussion and Analysis of Financial Condition and Results of OperationsFINANCIAL STATEMENTS151
   
Item 3.ITEM 2.Quantitative and Qualitative Disclosures About Market Risk.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS2018
   
Item 4.ITEM 3.Controls and Procedures.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK2123
   
PART II – OTHER INFORMATION
Item 1.ITEM 4.Legal Proceedings.CONTROLS AND PROCEDURES2123
   
Item 1A.PART II – OTHER INFORMATIONRisk Factors.2124
   
Item 4.ITEM 1.Mine Safety Disclosures.LEGAL PROCEEDINGS2124
   
Item 5.ITEM 1A.Other Information.RISK FACTORS2124
   
ITEM 4.MINE SAFETY DISCLOSURES24
 
ItemITEM 5.OTHER INFORMATION24
ITEM 6.Exhibits.EXHIBITS2225

 

 

 

 

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  September 28,
2018
  December 29,
2017
 
ASSETS             
        
Current assets:                
Cash and cash equivalents $16,133  $13,999  $102,195  $18,520 
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 for doubtful accounts of $616 and $350, respectively  23,732   20,035 
Inventories, net  13,274   14,825   16,180   13,674 
Insurance receivable (Note 12)  7,000    
Prepayments, deposits and other current assets  4,936   4,349 
Prepayments, deposits, and other current assets  5,190   4,207 
Total current assets  57,580   49,517   147,297   56,436 
Property, plant and equipment, net  10,999   11,790   11,462   9,776 
Intangible assets, net  326   473   244   271 
Goodwill  1,786   1,786   1,786   1,786 
Deferred income taxes  1,043   1,105   1,201   1,242 
Other assets  969   772   998   967 
Total assets $72,703  $65,443  $162,988  $70,478 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
        
Current liabilities:                
Line of credit $4,442  $4,283  $4,162  $4,438 
Accounts payable  5,734   8,311   8,282   6,033 
Obligations under capital leases  1,269   1,198   1,359   1,278 
Litigation settlement obligation (Note 12)  7,000    
Allowance for sales returns  2,802   2,546 
Other current liabilities  7,253   7,275   10,935   7,339 
Total current liabilities  25,698   21,067   27,540   21,634 
Obligations under capital leases  834   1,339   662   531 
Deferred income taxes  984   881   679   350 
Asset retirement obligations  203   195   201   202 
Deferred rent  184   59   203   172 
Pension liability  4,138   3,997   4,839   4,653 
Total liabilities  32,041   27,538   34,124   27,542 
        
Commitments and contingencies (Note 12)                
        
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: 44,104 and 41,383 shares issued and outstanding at September 28, 2018 and December 29, 2017, respectively  441   414 
Additional paid-in capital  202,148   197,657   287,000   204,920 
Accumulated other comprehensive loss  (788)  (1,050)  (1,201)  (1,150)
Accumulated deficit  (161,110)  (159,109)  (157,376)  (161,248)
Total stockholders’ equity  40,662   37,905   128,864   42,936 
Total liabilities and stockholders’ equity $72,703  $65,443  $162,988  $70,478 

 

See accompanying notes to the condensed consolidated financial statements.

 1 

 

STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 Three Months Ended  Nine Months Ended  Three Months Ended  Nine Months Ended 
 

September 29,

2017

  

September 30,

2016

  

September 29,

2017

  

September 30,

2016

  September 28,
2018
  September 29
2017
  September 28,
2018
  September 29,
2017
 
                  
Net sales $23,473  $20,052  $65,759  $60,295  $31,770  $23,473  $92,768  $65,759 
Cost of sales  6,624   5,180   18,859   17,804   7,910   6,624   24,250   18,859 
                
Gross profit  16,849   14,872   46,900   42,491   23,860   16,849   68,518   46,900 
                                
Selling, general and administrative expenses:                
General and administrative  4,946   4,985   15,065   18,378   6,087   4,716   18,054   14,380 
Marketing and selling  6,431   7,149   20,282   22,006   10,620   6,495   28,733   20,473 
Research and development  4,429   4,453   13,924   16,018   5,570   4,594   16,323   14,418 
Total operating expenses  15,806   16,587   49,271   56,402 
Total selling, general and administrative expenses  22,277   15,805   63,110   49,271 
                                
Operating income (loss)  1,043   (1,715)  (2,371)  (13,911)  1,583   1,044   5,408   (2,371)
                                
Other income (expense):                                
Interest expense, net  (27)  (29)  (88)  (85)  (29)  (27)  (65)  (88)
Gain (loss) on foreign currency transactions  444   (29)  738   13   52   444   (545)  738 
Royalty income  141   134   400   507   159   141   465   400 
Other income (expense), net  (19)  (68)  17   (150)  40   (19)  61   17 
Other income, net  539   8   1,067   285 
Other income (expense), net  222   539   (84)  1,067 
                                
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)
Income (loss) before income taxes  1,805   1,583   5,324   (1,304)
Income tax provision  346   410   1,452   697 
Net income (loss) $1,173  $(1,778) $(2,001) $(11,962) $1,459  $1,173  $3,872  $(2,001)
                                
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)
Net income (loss) per share:                
Basic $0.03  $0.03  $0.09  $(0.05)
Diluted $0.03  $0.03  $0.09  $(0.05)
                                
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 
Weighted average shares outstanding:                
Basic  43,054   41,110   42,065   40,939 
Diluted  46,025   42,104   44,618   40,939 

See accompanying notes to the condensed consolidated financial statements.

 

 2 

 

 

STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED STATEMENTS

OF COMPREHENSIVE INCOME (LOSS)

(In thousands)

(Unaudited)

 

 Three Months Ended  Nine Months Ended 
 Three Months Ended  Nine Months Ended  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
 September 29, 2017  September 30, 2016  September 29, 2017  September 30, 2016          
Net income (loss) $1,173  $(1,778) $(2,001) $(11,962) $1,459  $1,173  $3,872  $(2,001)
Other comprehensive income (loss):                
Defined benefit pension plans:                
Other comprehensive income (loss)                
Defined benefit plans:                
Net change in plan assets  (15)  (11)  (43)  (34)  (21)  (17)  (51)  (54)
Reclassification into earnings  20   27   60   80 
Foreign currency translation gain (loss)  (51)  232   360   2,000 
Reclassification into other income (expense), net  25   18   76   55 
Foreign currency translation gains (losses)  (321)  (46)  (114)  360 
Tax effect  13   (67)  (110)  (611)  105   13   38   (99)
Other comprehensive income (loss), net of tax  (33)  181   267   1,435   (212)  (32)  (51)  262 
Comprehensive income (loss) $1,140  $(1,597) $(1,734) $(10,527) $1,247  $1,141  $3,821  $(1,739)

 

See accompanying notes to the condensed consolidated financial statements.

 

 3 

 

STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 Nine Months Ended  Nine Months Ended 
 September 29, 2017  September 30, 2016  September 28,
2018
  September 29,
2017
 
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 
Net income (loss) $3,872  $(2,001)
Adjustments to reconcile net income (loss) to net cash provided by operating activities:        
Depreciation of property, plant, and equipment  1,792   2,344 
Amortization of intangibles  26   166 
Deferred income taxes  164   (1,806)  363   164 
Change in net pension liability  95   390   233   95 
Loss on disposal of property and equipment  22   65   8   22 
Stock-based compensation expense  2,185   8,143   4,926   2,185 
Provision for sales returns and bad debts  186   99   892   186 
Inventory provision  1,267   1,379   1,181   1,267 
Changes in working capital:                
Accounts receivable trade  41   1,707 
Accounts receivable  (3,989)  41 
Inventories  725   222   (3,625)  725 
Prepayments, deposits and other current assets  (764)  (1,118)
Prepayments, deposits, and other current assets  (1,021)  (764)
Accounts payable  (2,751)  594   2,121   (2,751)
Other current liabilities  62   1,104   3,643   62 
Net cash provided by operating activities  1,741   921   10,422   1,741 
                
Cash flows from investing activities:                
Acquisition of property and equipment  (969)  (2,709)  (1,721)  (969)
Net cash used in investing activities  (969)  (2,709)  (1,721)  (969)
                
Cash flows from financing activities:                
Proceeds from public offering of stock  72,150    
Repayment of capital lease obligations  (984)  (302)  (1,396)  (984)
Proceeds from sale leaseback transactions     1,154 
Repayment on line of credit  (251)   
Repurchase of employee common stock for taxes withheld  (234)  (611)     (234)
Proceeds from vested restricted stock and exercise of stock options  2,276   1,652   4,582   2,276 
Net cash provided by financing activities  1,058   1,893   75,085   1,058 
                
Effect of exchange rate changes on cash, cash equivalents, and restricted cash  305   777 
Effect of exchange rate changes on cash, cash equivalents and restricted cash  (111)  305 
Increase in cash, cash equivalents and restricted cash  83,675   2,135 
Cash, cash equivalents and restricted cash, at beginning of the period  18,641   14,118 
Cash, cash equivalents and restricted cash, at end of the period $102,316  $16,253 
                
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  $ 
Supplemental disclosure of non-cash operating activities        
Insurance receivable    $7,000 
Settlement liability    $7,000 

 

See accompanying notes to the condensed consolidated financial statements.

 

 4 

 

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

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 statementsComprehensive Financial Statements have been condensed or omitted pursuant to such rules and regulations. The consolidated balance sheetConsolidated Balance Sheet as of December 30, 201629, 2017 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, 2016.29, 2017.

 

The condensed consolidated financial statementsCondensed Consolidated Financial Statements for the three and nine months ended September 29, 201728, 2018 and September 30, 2016,29, 2017, 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, 201728, 2018 and September 30, 2016,29, 2017, 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.

 

Recently Adopted Accounting PronouncementsCash, Cash Equivalents and Restricted Cash

During the quarter ended March 31, 2017, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2015-11, “Simplifying the Measurement of Inventory”. ASU 2015-11 requires a company to measure inventory at the lower of cost and net realizable value. Net realizable value is defined as the “estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation”. We adopted this standard as of December 31, 2016 (beginning of FY 2017). The adoption of ASU 2015-11 did not have a material effect on the consolidated financial statements.

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 (CONTINUED)

 

The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheetsConsolidated Balance Sheets that sum to the total of the same such amounts shown in the condensed consolidated statementsCondensed Consolidated Statements of cash flowsCash Flows (in 000’s):

 

 September 29, December 30, September 30, January 1, 
 2017  2016  2016  2016  September 28,
2018
  December 29,
2017
  September 29,
2017
 
Cash and cash equivalents $16,133  $13,999  $14,284  $13,402  $102,195  $18,520  $16,133 
Restricted cash included in other long-term assets  120   119   119   119   121   121   120 
Total cash, cash equivalents, and restricted cash                
as shown in the statements of cash flows $16,253  $14,118  $14,403  $13,521 
Total cash, cash equivalents and restricted cash as shown in the Consolidated Statements of Cash Flows $102,316  $18,641  $16,253 

 

The Company has restricted cash of approximately $120,000$121,000 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.

 

RecentRevenue

On December 30, 2017 (beginning of FY 2018), the Company adopted Financial Accounting Pronouncements Not Yet AdoptedStandards Board (“FASB”) Accounting Standards Update (“ASU”) 2014-09, “Revenue from Contracts with Customers (Topic 606)” and its subsequent amendments: (i) ASU No. 2015-14, “Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date”; (ii) ASU No. 2016-10, “Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing;” (iii) 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”; (iv) ASU No. 2016-12, “Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients”; and (v) ASU No. 2016-20, “Revenue from Contracts with Customers (Topic 606): Technical Corrections and Improvements to Topic 606”, using the modified retrospective method, and determined that there was no cumulative effect adjustment on the Consolidated Financial Statements. The Company determined that the adoption of the new standard did not materially impact the revenue recognition on its Consolidated Financial Statements.

5

STAAR SURGICAL COMPANY

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

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

Revenue (Continued)

The Company recognizes revenue when its contractual performance obligations with customers are satisfied. The Company’s performance obligations are generally limited to single sales orders with product shipping to the customer within a month of receipt of the sales order. Substantially all of the Company’s revenues are recognized at a point-in-time when control of its products transfers to the customer, which is typically upon shipment (as discussed below). The Company presents sales tax and similar taxes it collects from its customers on a net basis (excluded from revenues).

The Company sells certain injector parts to an unrelated customer and supplier (collectively referred to as “supplier”) whereby these injector part sales are either made as a final sale to the supplier or, are sold to be combined with an acrylic IOL by the supplier into finished goods inventory (a preloaded acrylic IOL). These finished goods are then sold back to the Company at an agreed upon, contractual price. The Company makes a profit margin on either type of sale with the supplier and each type of sale is made under separate purchase and sales orders between the two parties resulting in cash settlement for the orders sold or repurchased. For parts that are sold as a final sale, the Company recognizes a sale and those sales are classified as other product sales in total net sales. For the injector parts that are sold to be combined with an acrylic IOL into finished goods, the Company records the transaction at its carrying value deferring any profit margin as contra-inventory, until the finished goods inventory is sold to an end-customer (not the supplier) at which point the Company recognizes revenues.

For all sales, the Company is considered the principal in the transaction as the Company is the party providing specified goods it has control over prior to when control is transferred to the customer. Cost of sales includes cost of production, freight and distribution, and inventory provisions, net of any purchase discounts. Shipping and handling activities that occur after the customer obtains control of the goods are recognized as fulfillment costs.

The Company generally permits returns of product if the product is returned within the time allowed by its return policies and records an allowance for estimated returns at the time revenue is recognized. The Company’s allowance for estimated returns considers historical trends and experience, the impact of new product launches, the entry of a competitor, availability of timely and pertinent information and the various terms and arrangements offered, including sales with extended credit terms. For estimated returns, sales are reported net of estimated returns and cost of sales are reported net of estimated returns that can be resold. On the Condensed Consolidated Balance Sheets, the balances associated for estimated sales returns are as follows:

  September 28,
2018
  December 29,
2017
 
Estimated returns - inventory(1) $678  $534 
Allowance for sales returns  2,802   2,546 

(1)Recognized in inventories, net on the Condensed Consolidated Balance Sheets

The Company performs ongoing credit evaluations of its customers and adjusts credit limits based on customer payment history and credit worthiness, as determined by the Company’s review of its customers’ current credit information. The Company continuously monitors collections and payments from customers and maintains a provision for estimated credit losses and uncollectible accounts based upon its historical experience and any specific customer collection issues that have been identified. Amounts determined to be uncollectible are written off against the allowance for doubtful accounts.

The Company disaggregates its revenue into the following categories: non-consignment sales, consignment sales and royalty income.

Non-consignment Sales

The Company recognizes revenue from non-consignment product sales at a point-in-time when control has been transferred, which is typically at shipping point, except for certain customers and for the STAAR Japan subsidiary, which is typically recognized when the customer receives the product. The Company does not have significant deferred revenues as of September 28, 2018 or September 29, 2017, as delivery to the customer is generally made within the same or the next day of shipment.

6

STAAR SURGICAL COMPANY

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

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

Revenue (Continued)

In May

The Company also enters into certain strategic cooperation agreements with customers in which, as consideration for certain commitments made by the customer, including minimum purchase commitments, the Company agrees, among other things, to pay for marketing, educational training and general support of the Company’s products. The provisions in these arrangements allow for these payments to be made directly to the customer or payments can be made directly to a third party for distinct marketing, educational training and general support services provided to or on behalf of the customer by the third party. For payments the Company makes to another party, or reimburses the customer for distinct marketing and support services, the Company recognizes these payments as sales and marketing expense as incurred. These strategic cooperation agreements are generally for periods of 12 months or more with quarterly minimum purchase commitments. The Company recognizes sales and marketing expenses in the period in which it expects the customer will achieve its minimum purchase commitment, generally quarterly, and any unpaid amounts are recorded in Other Current Liabilities in “Other” on the Condensed Consolidated Statements of Operations, see Note 6. Reimbursements made directly to the customer for general marketing incentives are treated as a reduction in revenues. The Company’s performance obligations generally occur in the same quarter as the shipment of product.

Since the payments for distinct or non-distinct services occur within the quarter corresponding with the purchases made by the customer and the shipments made by the Company to that customer, there is no remaining performance obligation by the Company to the customer. Accordingly, there are no deferred revenues associated with these types of arrangements as of September 28, 2018 or September 29, 2017.

Consignment Sales

The Company’s products are marketed to ophthalmic surgeons, hospitals, ambulatory surgery centers or vision centers, and distributors. IOLs and ICLs may be offered to surgeons and hospitals on a consignment basis. The Company maintains title and risk of loss on consigned inventory and recognizes revenue for consignment inventory at a point-in-time when the Company is notified that the lenses have been implanted, thus completing the performance obligation.

Royalty Income

From time to time, the Company licenses its patents to third parties in connection with the manufacture of product. One type of licensing contract requires that the licensee pay the Company a quarterly royalty based on a percentage of the licensee’s quarterly sales. The Company recognizes the revenue at a point-in-time, typically quarterly based on various factors including information from the licensee, historical performance and contract minimums; royalty income was as follows (in thousands):

  Three Months Ended  Nine Months Ended 
  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
Royalty income(1) $159  $141  $465  $400 
                 

(1)Shown as a separate line item in other income, net on the Condensed Consolidated Statements of Operations.

Another type of licensing contract requires that the licensee pay the Company a lump sum royalty once certain milestones are achieved, such as upon the first commercial sale of a product incorporating a licensed patent or technology (performance obligation occurs over a period of time); no such income was recognized for the three and nine months ended September 28, 2018 or September 29, 2017, respectively.

See Note 9 for additional information on disaggregation of revenues, geographic sales information and product sales.

7

STAAR SURGICAL COMPANY

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

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

Revenue (Continued)

The following table summarizes the FASB issuedimpact of adopting Topic 606 on the Company’s Condensed Consolidated Balance Sheets for September 28, 2018 (in 000’s) (see also Note 14):

  As Reported  Adjustments  Balances
without the
adoption of
606
 
Accounts receivable trade, net $23,732  $(2,802) $20,930 
Total current assets  147,297   (2,802)  144,495 
Total assets  162,988   (2,802)  160,186 
Allowance for sales returns  2,802   (2,802)   
Total current liabilities  27,540   (2,802)  24,738 
Total liabilities  34,124   (2,802)  31,322 
Total liabilities and stockholders’ equity  162,988   (2,802)  160,186 

Recently Adopted Accounting Pronouncements

On December 30, 2017 (beginning of FY 2018), the Company adopted ASU 2017-09 “Scope“Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting,” which amends the scope of modification accounting 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 adoption of ASU 2017-09 did not have a material impact on 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 ofCondensed Consolidated Financial Statements.

On December 30, 2017 (beginning of FY 2018) and do not expect, the adoption of the standard will have a material impact on our consolidated financial statements.

In March 2017, the FASB issuedCompany adopted 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 effectiveadoption of ASU 2017-09 did not have a material impact on the Condensed Consolidated Financial Statements, see Note 7 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 ofadditional information.

On 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 issuedCompany adopted ASU 2016-16, “Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory”, which removes the prohibition in ASC 740 against the immediate recognition of the current and deferred income tax effects of intra-entity transfers of assets other than inventory. The ASU is effective for public companies for fiscal years beginning after December 15, 2017, and interim periods within those annual periods. The ASU should be applied on ainventory, using the modified retrospective basis, recognizingmethod, and determined that there was no cumulative effect adjustment on the effects in retained earnings asConsolidated Financial Statements. The adoption of ASU 2016-16 did not have a material impact on the beginning of the year of adoption. We will adopt this standard as ofCondensed Consolidated Financial Statements.

On 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 issuedadopted 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 payments in the statement of cash flows. The adoption of ASU 2016-15 is effective for fiscal years beginning after December 15, 2017 (beginning of FY 2018) and early adoption is permitted. The Company is currently evaluatingdid not have a material impact on the impact ASU 2016-15 may have on its consolidated financial statements.Condensed Consolidated Financial Statements.

Recent Accounting Pronouncements Not Yet Adopted

 

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. Early adoption is permitted. The Company is gathering data to evaluate the impact the adoption of ASU 2016-02 may have on its consolidated financial statements and expects to complete the evaluation by the third quarter of 2018.

 

 68 

STAAR SURGICAL COMPANY

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

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

 

Recent Accounting Pronouncements Not Yet Adopted (Continued)

 

In May 2014,July 2018, 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 one 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 and2018-10, “Codification Improvements to Topic 606”842, Leases,” which narrows aspects of the guidance issued in ASU 2016-02 including those regarding residual value guarantees, rate implicit in the lease, lessee reassessment of lease classification, lessor reassessment of lease term and purchase option, variable lease payments that depend on an index or a rate, investment tax credits, lease term and purchase option, transition guidance for amounts previously recognized in business combinations, certain transition adjustments, transition guidance for leases previously classified as capital leases under Topic 840, transition guidance for modifications to leases previously classified as direct financing or sales-type leases under Topic 840, transition guidance for sale and leaseback transactions, impairment of net investment in the lease, unguaranteed residual asset, effect of initial direct costs on rate implicit in the lease, and failed sale and leaseback transactions.

Also, in July 2018, the FASB issued ASU 2018-11, “Leases (Topic 842): Targeted improvements,” which provide an additional and optional transition method to adopt the new leases standard. Under this new transition method, an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Consequently, an entity’s reporting for the comparative periods presented in the financial statements in which it adopts the new leases standard will continue to be in accordance with current GAAP (Topic 840, Leases).

 

The Company is nearing the completion of its assessment and is performing a final review of its evaluation of the new standard. The Company elected to use the practical expedients of not assessing expired contracts, using current lease classification and not assessing any initial direct costs. The Company has also elected not to capitalize leases that have terms less than 12 months. The Company will initially apply the new standard includingon December 29, 2018 (beginning of Fiscal Year 2019) and recognize a detailed review of its revenue streams and contracts.  The majority of the Company’s revenue relatescumulative-effect adjustment to the saleopening balance 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).retained earnings. 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. Based on the work performed to date, the Company does not expect adoption of the new standard to haveresult in a material impact on its consolidated financial statements.adjustment to beginning retained earnings. The Company is still evaluating the effects on its financial statement disclosures.

In February 2018, the FASB issued ASU 2018-02, “Income Statement – Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income,” provides an option to reclassify stranded tax effects within Accumulated Other Comprehensive Income to retained earnings in each period in which the effect of the change in the U.S. federal corporate income tax rate in the Tax Cuts and Jobs Act is recorded. This is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted. The Company will adopt this standard as of December 29, 2018 (beginning of Fiscal Year 2019) and is currently evaluating the impact on ASU 2018-02 will have on its financial statement disclosures.Condensed Consolidated Financial Statements.

In June 2018, the FASB issued ASU 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting,” aligns the accounting for share-based payments to nonemployees similar to employees. This is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted. The Company expectswill adopt this standard as of December 29, 2018 (beginning of Fiscal Year 2019) and is currently evaluating the impact on ASU 2018-07 will have on its Condensed Consolidated Financial Statements.

In August 2018, the FASB issued ASU 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework – Changes to apply the modified retrospective method toDisclosure Requirements for Fair Value Measurement,” which modifies certain disclosures requirements for reporting fair value measurements. This is effective for fiscal years ending after December 15, 2019. Early adoption is permitted. The Company will adopt this standard as of January 4, 2020 (beginning of Fiscal Year 2020) and is currently evaluating the disclosure requirements and its effect on the Condensed Consolidated Financial Statements.

In August 2018, the FASB issued 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. This is effective for fiscal years ending after December 15, 2020. Early adoption is permitted. The Company will adopt this standard as of January 2, 2021 (beginning of Fiscal Year 2021) and is currently evaluating the disclosure requirements and its effect on December 30, 2017.the Condensed Consolidated Financial Statements.

9

STAAR SURGICAL COMPANY

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

 

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)

  September 28,
2018
  December 29,
2017
 
Raw materials and purchased parts $2,586  $2,506 
Work in process  2,755   1,996 
Finished goods  12,247   11,533 
   17,588   16,035 
Less inventory reserves  1,408   2,361 
Total $16,180  $13,674 

 

Note 3 — Prepayments, Deposits, and Other Current Assets

 

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

 

 September 29, December 30, 
 2017  2016  September 28,
2018
  December 29,
2017
 
Prepayments and deposits $1,944  $1,003  $2,039  $1,435 
Prepaid insurance  607   935   529   943 
Income tax receivable  532   686 
Consumption tax receivable  325   573   764   541 
Value added tax (VAT) receivable  809   668   1,198   910 
Pension benefit prepayment  90    
Other current assets(1)  629   484   660   378 
 $4,936  $4,349 
Total $5,190  $4,207 

 

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

 

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.

  September 28,
2018
  December 29,
2017
 
Machinery and equipment $18,607  $16,562 
Furniture and fixtures  9,853   9,201 
Leasehold improvements  9,883   9,631 
   38,343   35,394 
Less accumulated depreciation  26,881   25,618 
Total $11,462  $9,776 

 

Note 5 — Intangible–Intangible Assets

 

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

 

 September 29, 2017  December 30, 2016  September 28, 2018  December 29, 2017 
 

Gross

Carrying

Amount

  

Accumulated

Amortization

  Net  

Gross

Carrying

Amount

  

Accumulated

Amortization

  Net  Gross
Carrying
Amount
  Accumulated
Amortization
  Net  Gross
Carrying
Amount
  Accumulated
Amortization
  Net 
Long-lived intangible assets:                        
Long-lived amortized intangible assets:                        
Patents and licenses $9,245  $(8,965) $280  $9,224  $(8,930) $294  $9,240  $(8,996) $244  $9,244  $(8,973) $271 
Customer relationships  1,393   (1,359)  34   1,343   (1,209)  134   1,381   (1,381)     1,392   (1,392)   
Developed technology  886   (874)  12   854   (809)  45   878   (878)     885   (885)   
Total $11,524  $(11,198) $326  $11,421  $(10,948) $473  $11,499  $(11,255) $244  $11,521  $(11,250) $271 

10

STAAR SURGICAL COMPANY

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

 

Note 6 Other Current Liabilities

 

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

 

  

September 29,

2017

  

December 30,

2016

 
Accrued salaries and wages $3,080  $2,334 
Accrued bonuses  1,680   1,414 
Accrued consumption tax  304   424 
Accrued insurance  197   501 
Accrued income taxes  371   1,095 
Other(1)  1,621   1,507 
  $7,253  $7,275 

(1)No individual item in “Other” above exceeds 5% of the total other current liabilities

  September 28,
2018
  December 29,
2017
 
Accrued salaries and wages $3,792  $2,407 
Accrued insurance  33   565 
Accrued consumption tax  820   446 
Accrued income taxes  1,121   210 
Accrued bonuses  3,408   2,026 
Other(1))  1,761   1,685 
Total $10,935  $7,339 

 

(1)8No individual item in “Other” exceeds 5% of the other current liabilities.

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

 

Note 7 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

  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
Service cost(1) $126  $155  $380  $466  $137  $128  $414  $386 
Interest cost(2)  15   19   43   54   15   14   44   42 
Expected return on plan assets(2)  (25)  (24)  (71)  (69)  (28)  (24)  (82)  (71)
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 
Net amortization of transitional obligation(2),(3)  3   3   8   9 
Prior service credit(2),(3)  (6)  (2)  (17)  (6)
Actuarial loss recognized in current period(2),(3)  28   17   85   52 
Net periodic pension cost $149  $136  $452  $412 

 

(a) Amounts reclassified from accumulated other comprehensive loss.

(1)Recognized in selling general and administrative expenses on the Condensed Consolidated Statements of Operations.
(2)For 2018, recognized in other income (expense), net, and for 2017, recognized in selling, general and administrative on the Condensed Consolidated Statements of Operations.
(3)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. The Company’s contributions to its Swiss pension plan are as follows (in thousands):

  Three Months Ended  Nine Months Ended 
  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
Employer contribution $80  $66  $225  $197 

11

STAAR SURGICAL COMPANY

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

 

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 share (in thousands except per share amounts):

  Three Months Ended  Nine Months Ended 
  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
Numerator:                
Net income (loss) $1,459  $1,173  $3,872  $(2,001)
Denominator:                
Weighted average common shares:                
Common shares outstanding  43,065   41,131   42,076   40,960 
Less:  Unrestricted stock  (11)  (21)  (11)  (21)
Denominator for basic calculation  43,054   41,110   42,065   40,939 
Weighted average effects of potentially dilutive common stock:                
Stock options  2,686   837   2,245    
Unvested restricted stock  4      12    
Restricted stock units  281   157   296    
Warrants            
Denominator for diluted calculation  46,025   42,104   44,618   40,939 
                 
Net income (loss) per share:                
Basic $0.03  $0.03  $0.09  $(0.05)
Diluted $0.03  $0.03  $0.09  $(0.05)

 

  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)

Because the Company had a net loss for the nine months ended September 29, 2017, the number of diluted shares is equal to the number of basic shares. Outstanding options and warrants to purchase common stock, restricted stock and restricted stock units would have had an anti-dilutive effect on diluted per share amounts.

 

The following table sets forth (in thousands) the weighted average number of options and warrants to purchase shares of common stock, restricted stock, and restricted stock and units 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-dilutiveanti-dilutive.

  Three Months Ended  Nine Months Ended 
  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
Options  389   1,545   278   2,497 
Restricted stock and restricted stock units        1   159 
Total  389   1,545   279   2,656 

Note 9 — Disaggregation of Revenues, Geographic Sales and Product Sales

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

 

  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 
  Three Months Ended  Nine Months Ended
  September 28,
2018
  September 29,
2017
  September 28, 2018  September 29,
2017
Non-consignment sales $27,503  $19,590  $79,345  $53,432 
Consignment sales  4,267   3,883   13,423   12,327 
Total net sales  31,770   23,473   92,768   65,759 
Royalty income(1)  159   141   465   400 
Total revenues $31,929  $23,614  $93,233  $66,159 

(1)Shown as a separate line item in other income, net on the Condensed Consolidated Statements of Operations.

 

 912 

STAAR SURGICAL COMPANY

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

 

Note 9 — Disaggregation of Revenues, Geographic Sales and Product DataSales (Continued)

 

The Company markets and sells its products in over 6075 countries and conducts its manufacturing in the United States. Other than China Japan, and the United States,Japan, the Company does not conduct business in any country in which its sales exceed 10% of worldwide consolidated net 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 
  Three Months Ended  Nine Months Ended 
  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
China $13,349  $7,397  $35,224  $18,069 
Japan  6,006   4,633   17,781   12,849 
Other(1)  12,415   11,443   39,763   34,841 
Total revenues $31,770  $23,473  $92,768  $65,759 

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

In addition, domestic and foreign sales are as follows (in thousands):

  Three Months Ended  Nine Months Ended 
  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
Domestic $1,676  $1,896  $5,327  $5,946 
Foreign  30,094   21,577   87,441   59,813 
Total revenues $31,770  $23,473  $92,768  $65,759 

 

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,  Three Months Ended  Nine Months Ended 
 2017  2016  2017  2016  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
ICLs $18,110  $14,801  $49,698  $43,389  $26,418  $18,110  $74,868  $49,698 
Other product sales                
IOLs  3,892   4,649   12,875   14,783   3,824   3,892   12,068   12,875 
Other surgical products  1,471   602   3,186   2,123   1,528   1,471   5,832   3,186 
Total $23,473  $20,052  $65,759  $60,295 
Total other product sales  5,352   5,363   17,900   16,061 
Total net sales $31,770  $23,473  $92,768  $65,759 

 

One customer, our distributor in China, accounted for 31%42% and 38% of net sales for the three and nine months ended September 28, 2018, respectively, and the same customer accounted for 32% 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, 201728, 2018 and December 30, 2016,29, 2017, respectively, one customer, our distributor in China, accounted for 26%36% and 22%24% of consolidated trade receivables.

13

STAAR SURGICAL COMPANY

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

 

Note 10 — 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

  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
Employee stock options $443  $208  $1,204  $5,257  $1,197  $443  $2,713  $1,204 
Restricted stock  50   32   136   259   82   50   192   136 
Restricted stock units  314   146   845   2,569   501   314   1,593   845 
Nonemployee stock options           58   247      428    
Total $807  $386  $2,185  $8,143  $2,027  $807  $4,926  $2,185 

 

The Company recorded stock-based compensation costs in the following categories on the accompanying condensed consolidated statementsCondensed Consolidated Statements of operationsOperations (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 
  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
Cost of sales $4  $2  $11  $6 
General and administrative  701   377   1,875   1,035 
Marketing and selling  471   214   1,297   558 
Research and development  851   214   1,743   586 
Total stock-based compensation expense  2,027   807   4,926   2,185 
Amounts capitalized as part of inventory  182   107   449   269 
Total stock-based compensation $2,209  $914  $5,375  $2,454 

 

Stock Option Plan

 

Our 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. Options under the plan are granted at fair market value on the date of grant, become exercisable over a three-year period, or as determined by our 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 of a change in control (as defined in the Plan). Pursuant to the Plan, options for 3,826,956 shares were 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 between one to fourthree years. There were 20,833 shares of restricted stock and 438,039 RSUs outstanding at September 29, 2017. As of September 29, 2017,28, 2018, there were 1,273,4202,488,237 shares authorized and available for grants 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 cancellationsand represents the period of time that options granted are expected to be outstanding. The Company has calculated an 11.3% 11%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.

 

 Three Months Ended  Nine Months Ended  Three Months Ended  Nine Months Ended 
 

September 29,

2017

  

September 30,

2016

  

September 29,

2017

  

September 30,

2016

  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
Expected dividend yield  0%  0%  0%  0%  0%  0%  0%  0%
Expected volatility  57%  57%  57%  57%  53%  57%  53%  57%
Risk-free interest rate  1.83%  1.19%  1.95%  1.34%  2.84%  1.83%  2.71%  1.95%
Expected term (in years)  5.67   5.57   5.67   5.57   5.72   5.67   5.72   5.67 

14

STAAR SURGICAL COMPANY

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

Note 10 — Stock-Based Compensation (Continued)

 

A summary of option activity under the Plan for the nine-month periodquarter ended September 29, 201728, 2018 is presented below:

 

  

Options

Option
Shares


(000’s)

 
Outstanding at December 30, 201629, 2017  3,5023,725 
Granted  829805 
Exercised  (334524)
Forfeited or expired  (17027)
Outstanding at September 29, 201728, 2018  3,8273,979 
Exercisable at September 29, 201728, 2018  2,7522,584 

As of September 28, 2018, exercise prices of outstanding stock options ranged between $0.95 and $39.90 per share.

 

A summary of restricted stock and RSU activity under the Plan for the nine-month periodquarter ended September 29, 201728, 2018 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 (CONTINUED)

  Restricted
Shares
(000’s)
  Restricted
Units
(000’s)
 
Outstanding at December 29, 2017  21   488 
Granted  11   49 
Vested  (21)  (185)
Forfeited or expired     (8)
Outstanding at September 28, 2018  11   344 

 

Note 11 — Income Taxes

As discussed in Note 1 of 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$346,000 and $0.7 million$1,452,000 for the three and nine months ended September 28, 2018, respectively, and $410,000 and $697,000 for the three and nine months ended September 29, 2017, respectively, 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.   

 

TheFor the fiscal year-ended December 29, 2017 and prior years, the Company provided foreign withholding and U.S. income tax benefit of $1.7 million fortaxes on all unremitted foreign earnings, as 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. 

All earnings from the Company’s foreign subsidiaries arewere not considered to be permanently reinvested. Accordingly,Effective for the current year, the Company no longer provides withholding and U.S. income taxes on all unremitted foreign earnings. Theearnings (see discussion below). Although foreign earnings are no longer subject to U.S. taxation, the Company reduced its deferred tax liability in 2016continues to provide withholding taxes related to withholding taxessuch unremitted earnings.

U.S. Federal Income Tax Reform

On December 22, 2017, the United States enacted major tax reform legislation. Most of the changes from unremittedthe new law are effective for years beginning after December 31, 2017 with the noted exemption of the deemed repatriation of offshore earnings. Public Law No. 115-97, commonly referred to as the 2017 Tax Cuts and Jobs Act (“2017 Tax Act”) put into effect a number of changes impacting operations outside the United States including, but not limited to, the imposition of a one-time tax “deemed repatriation” on accumulated offshore earnings not previously subject to U.S. tax, and shifts the U.S taxation of multinational corporations from a worldwide system of taxation to a territorial system. As such, the 2017 Tax Act provides an exemption against U.S. federal taxation on foreign earnings bygenerated after December 31, 2017 and repatriated back to the accumulated deficit of one of its foreign subsidiaries dissolved as of April 1, 2016.U.S.

 

15

STAAR SURGICAL COMPANY

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

Note 12 - Commitments and Contingencies

 

Lines of Credit

 

Since 1988,1998, 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%0.06% as of September 29, 2017)28, 2018) plus a 0.50% spread, and may be renewed annuallyquarterly (the current line expires on November 21, 2017)2018).  The credit facility is not collateralized.  The Company had 472,500,000 Yen and 500,000,000 Yen outstanding on the line of credit as of September 28, 2018 and December 29, 2017, respectively (approximately $4,162,000 and December 30, 2016 (approximately $4.4 million and $4.3 million$4,438,000 based on the foreign exchange rates on September 29, 201728, 2018 and December 30, 2016,29, 2017, 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 28, 2018 there was 27,500,000 Yen (approximately $242,000) available for borrowing and as of December 29, 2017 there were no available borrowings under the line. At maturity on November 21, 2018, the Company expects to renew this line of credit for an additional three months, with similar terms.

 

In August 2010,September 2013, the Company’s wholly owned Swiss subsidiary, STAAR Surgical AG, entered into a creditframework agreement for loans (“framework agreement”) with Credit Suisse (the Bank)“Bank”). The creditframework agreement provides for borrowings of up to 1,000,000 CHF (Swiss Francs) ($1.0 million(approximately $1,000,000 at the rate of exchange on September 28, 2018 and December 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 creditframework agreement is automatically renewed on an annual basis based on the same terms assuming there is no default. The creditframework agreement may be terminated by either party at any time in accordance with its general terms and conditions. The credit facilityframework 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 creditframework 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, 201728, 2018 and December 30, 2016.29, 2017.

 

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,March 8, 2018, the Company entered into lease schedule 010011 with Farnam Street Financial, IncInc. (“Farnam”). The line of credit provides for borrowings of up to $2.0 million$500,000 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, 2017,28, 2018, approximately $737,456$392,000 of the line was available for borrowing.

On March 8, 2018, the Company entered into lease schedule 010R with Farnam. Under 010R, equipment with a cost of $1,560,000 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 28, 2018, approximately $1,044,000 was outstanding on this capital lease.

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 28, 2018 and December 29, 2017, approximately $1,310,609$330,000 and $1,067,000, respectively, 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 equipmentoutstanding 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 Actionthis capital lease.

 

On July 8, 2014, a putative securities class action lawsuit was filed by Edward Todd against STAAR and three officers 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 and 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 of a proposed class action settlement in 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. Santos in the U.S. District Court for the Central District of California. The plaintiff alleges breaches of fiduciary duties by, among other things, allowing STAAR to disseminate misleading statements to investors regarding the condition of the Company’s Quality System, failing to properly oversee the Company, and unjust enrichment. The complaint seeks damages, restitution and governance reforms, 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. 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 recorded any loss or accrual in the accompanying condensed consolidated financial statements at September 29, 2017 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.

 1316 

STAAR SURGICAL COMPANY

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

 

Note 12 - Commitments and Contingencies (Continued)

Litigation and Claims

From time to time, the Company is involved in various legal proceedings and other matters arising in the normal course of business. These legal proceedings and other matters may relate to, among other things, contractual rights and obligations, employment matters, or claims of product liability. STAAR maintains insurance coverage for various matters, including product liability and certain securities claims. While the Company does not believe that any of the claims known is likely to have a material adverse effect on the Company’s financial condition or results of operations, new claims or unexpected results of existing claims could lead to significant financial harm.

 

Employment Agreements

 

The Company’s Chief Executive Officer 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.

 

Note 13 – Stockholders’ Equity

On August 10, 2018, the Company closed an offering of its common stock. As part of this transaction, the Company issued 1,999,850 shares of its common stock at a price of $36.309 per share. Net proceeds, after deducting expenses, received from this offering were $72,150,000. The Company intends to use the net proceeds of this offering to fund operations, which may include advancing and broadening commercialization of its ICL family of products, funding pipeline research and development activities and clinical trials, funding incremental investments in automation and precision manufacturing, and capital expenditures, such as information systems, and for general corporate purposes, including working capital. The Company has not yet determined the amounts on any of the areas listed above or the timing of these expenditures. The Company invests the net proceeds in short-term interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.

Note 14 — Reclassifications

 

TheIn accordance with ASU 2014-09, in order to disclose contract assets and contract liabilities, the Company reclassified the estimated amount of inventory reservesexpected to be returned from Changesthe allowance for sales returns to inventories, net on the Condensed Consolidated Balance Sheets. In addition, the Company reclassified the allowance for sales returns from accounts receivable, net to a separate line item in Working Capital - Inventory incurrent liabilities on the StatementCondensed Consolidated Balance Sheets, see Note 1.

Certain compensation related expenses were reclassified from General and Administrative to Marketing and Selling and Research and Development line items on the Condensed Consolidated Statements of Cash Flows toOperations for the non-cash section of the Statement for both thethree and nine months ended September 29, 2017 and September 30, 2016. The Company also reclassified $65,000 from Cash Proceeds from Sale of Property and Equipment to Loss on Disposal of Property and Equipment for the nine months ended September 30, 2016.conform with 2018 presentation.

 

 1417 

 

 

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 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 new or improved products (including the Toric ICLEVO family of lenses in the U.S.); 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; and expected costs of quality system and completion of FDA remediation efforts;systems or operations; statements of belief, including as to achieving 20172018 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, those described in our Annual Report on Form 10-K in “Item 1A. Risk Factors” filed on March 2, 2017.February 28, 2018. 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 unaudited 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 glasses 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 outside the United States (“U.S.”) accounted for 92% of ourRecent Developments

We achieved a 35% increase in net total sales and a 46% increase in ICL sales in the third quarter of 2017, primarily due2018 as compared to the pacingthird quarter of product approvals and commercialization that tend to occur first outside2017. ICL unit growth of 56% for the U.S. STAAR sells its productsthird quarter of 2018 arose in more than 60 countries, with direct distributionpart from EVO Visian ICL unit growth of 100% in China, 95% growth in Japan, North America, Spain, Germany, Singapore, the U.K.,27% growth in India and independent distribution20% growth in Germany. Sales of “Other” products, representing approximately 17% of overall sales in the remainderthird quarter of the world. STAAR maintains operational and administrative facilities in the U.S., Switzerland and Japan.

Recent Developments and Strategic Priorities for 2017

In2018, were essentially flat from the third quarter of 2017 quarterly netat $5.4 million in sales.

We believe our sales increased 17% from priormomentum can continue for the remainder of the year. Therefore, we believe our full year quarterfiscal 2018 sales growth percentage target should exceed 30% over 2017 based on current market conditions.

Furthermore, we continue 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,believe gross margins will increase as compared to 2017.We expect operating expenses in the prior yearfourth 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 percentage2018 will exceed that of the ICL product mix. For the thirdfourth quarter of 2017 injector part sales were significantly higher than prior year third quarter. as we continue to invest in the business.

We continue to recoverexpect profitability improvement as compared to 2017 and expect to achieve positive GAAP net income for the full year of 2018. We continue to expect to increase cash from challenges with one ofoperations for 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.full year.

 

 1518 

 

 

WithOn September 13, 2018, we announced that the discontinuationFDA granted approval of our U.S. silicone IOL business and sales impacted byPMA Supplement for the materials challenge in our silicone IOL preloaded injectors, we expect that IOL sales will decrease in the fourth quarter of 2017 compared to the fourth quarter of 2016. We expect sales of injector parts to continue to increase compared to prior year in the fourth quarter of 2017. In September, our Notified Body in the European Union, DEKRA, approved an expanded age range for our EVO Visian Toric ICL for the correction of myopia from adults aged 21 to 45 years old to adults aged 21 to 60 years old.with astigmatism. Our first-in-manstaged rollout of that product is in process. Our European multi-site EVO with EDOF presbyopia clinical trial forremains ongoing. While 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 with the exception of the U.S. and Korea. We continue to anticipate gross profit as a percentage of sales 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,trial continues, we cannot predict when, or if, we will continue to evaluate opportunities to acquire new product lines, technologies, and companies.succeed in meeting our end-points.

 

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. ManagementOn December 30, 2017 (beginning of fiscal year 2018), the Company adopted Accounting Standards Update 2014-09, “Revenue from Contract with Customers (Topic 606)”and its subsequent amendments. The Company determined that the adoption of this new standard did not materially impact revenue recognition, see Note 1 of the Condensed Consolidated Financial Statements. Other than the adoption of Topic 606, management believes that there have been no significant changes during the nine months ended September 29, 201728, 2018 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, 2016.29, 2017.

16

 

Results of Operations

 

The following table shows the percentage of our total sales represented by the specific items listed in our condensed consolidated statements of operations for the periods indicated, and the percentage by which these items increased or decreased over the prior period.

 

 Percentage of Net Sales
for Three Months
  Percentage of Net Sales
for Nine Months
  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
  September 28,
2018
  September 29,
2017
  September 28,
2018
  September 29,
2017
 
Net sales  100.0%  100.0%  100.0%  100.0%  100.0%  100.0%  100.0%  100.0%
Cost of sales  28.2   25.8   28.7   29.5   24.9   28.2   26.1   28.7 
Gross profit  71.8   74.2   71.3   70.5   75.1   71.8   73.9   71.3 
                                
General and administrative  21.1   24.9   22.9   30.5   19.2   20.1   19.5   21.9 
Marketing and selling  27.4   35.7   30.8   36.5   33.4   27.7   31.0   31.1 
Research and development  18.9   22.2   21.2   26.6   17.5   19.6   17.6   21.9 
  67.4   82.8   74.9   93.6 
Total selling, general and administrative expenses  70.1   67.4   68.1   74.9 
Operating income (loss)  4.4   (8.6)  (3.6)  (23.1)  5.0   4.4   5.8   (3.6)
Other income (expense), net  2.3   0.2   1.6   0.5   0.7   2.3   (0.1)  1.7 
Income (loss) before provision for income taxes  6.7   (8.4)  (2.0)  (22.6)  5.7   6.7   5.7   (1.9)
Provision (benefit) for income taxes  1.7   0.4   1.1   (2.8)
Provision for income taxes  1.1   1.7   1.6   1.1 
Net income (loss)  5.0%  (8.8)%  (3.1)%  (19.8)%  4.6%  5.0%  4.1%  (3.0)%

19

 

Net Sales

 

 Three Months Ended  Percentage Change  Nine Months Ended  Percentage Change  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

  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

 
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  $26,418  $18,110   45.9% $74,868  $49,698   50.6%
Other product sales:                        
IOL  3,892   4,649   (16.3)  12,875   14,783   (12.9)  3,824   3,892   (1.7)  12,068   12,875   (6.3)
Other  1,471   602   144.4   3,186   2,123   50.1   1,528   1,471   3.9   5,832   3,186   83.1 
Total other product sales  5,352   5,363   (0.2)  17,900   16,061   11.5 
Net sales  31,770   23,473   35.3%  92,768   65,759   41.1%

 

Net sales for the three months ended September 29, 201728, 2018 were $23.5$31.8 million, an increase of 17% compared with $20.135% from $23.5 million reported during the same period of 2016. Total2017. Net sales for the nine months ended September 29, 201728, 2018 were $65.8$92.8 million, an increase of 9.1% compared with $60.341% from $65.8 million reported during the same period of 2016. The effect of exchange rate changes had an unfavorable impact on net sales of $0.3 million and $0.4 million, respectively, during the three and nine months ended September 29, 2017.

 

Total ICL sales for the three months ended September 29, 201728, 2018 were $18.1$26.4 million, an increase of 22% compared with $14.846% from $18.1 million reportedreporting during the same period of 2016. North America ICL2017, with unit growth of 56%. The sales were $1.6 million during the third quarter, an increase of 10% in both sales and units compared to the prior year period. The increase in North America ICL sales was driven by a 256% increasethe APAC region, which grew 68% with unit growth of 79%, primarily due to sales growth in Japan up 90%, China up 83%, Korea up 16% and India up 20%. The Europe region grew 18% with unit growth of 17% primarily due to increased sales in Germany, Spain and Distributor Operations. In addition, the Middle East and Latin America region grew 6% with unit growth of 4%. Within North America, Canada sales as a result of the successful commercialization of the EVO Toric ICL which was introduced late in the third quarter of 2016. APACincreased 11%. ICL sales were $11.0 million duringrepresented 83.2% and 77.2% of total sales for the third quarter ofthree months ended September 28, 2018 and September 29, 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-digit growth in China, Japan, and APAC distributor markets. EMEA ICL sales were $5.4 million during the third quarter, an increase of 6% compared to the prior year period, which was comprised of an 8% decrease in units and a 15% increase in average selling prices.respectively.

 

Total ICL sales for the nine months ended September 29, 201728, 2018 were $49.7$74.9 million, a 15%an increase compared with $43.4of 51% from $49.7 million reported during the same period of 2016. Total ICL units2017, with unit growth of 55%. The sales increase was driven by the APAC region, which grew 76% with unit growth of 81%, primarily due to sales growth in China up 98%, Japan up 90%, and Korea up 28%. The Europe region grew 24% with unit growth of 13% primarily due to increased 16%sales in Germany, Distributor Operations and average selling prices decreased 1%Spain. ASPs in Europe were favorably impacted by the strength of the Euro compared to the U.S. dollar. In addition, the Middle East and Latin America region grew 20% with unit growth of 11%. EMEAWithin North America, Canada sales increased 23%. ICL sales were $16.3 millionrepresented 80.7% and 75.6% of total sales for the nine months ended September 28, 2018 and September 29, 2017, a 5% increase compared to $15.5 million reported inrespectively.

Other product sales, including IOLs, for the same period in 2016 which was comprised of a 2% increase in unitsthree months ended September 28, 2018 and a 3% increase in average selling prices. APAC ICLSeptember 29, 2017, were $5.4 million. Other product sales, were $28.2 millionincluding IOLs, for the nine months ended September 29, 2017, a 21% increase28, 2018 were $17.9 million, compared to $23.2$16.1 million reported during the same period of 2016.2017. The increase was comprised of 25% increase in units and a 3% decrease in average selling prices. The increase was driven by a 49% increase in China sales, partially offset by lower sales in India 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 IOL sales for the three months ended September 29, 2017 were $3.9 million, a decrease of 16% compared with $4.6 million reported during the same period of 2016. Total IOL sales for the nine months ended 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.

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.partially offset by a decrease in IOL sales.

 

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
 
  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

 
Gross Profit $23,860  $16,849   41.6% $68,518  $46,900   46.1%
Gross Profit Margin  75.1%  71.8%      73.9%  71.3%    

 

Gross profit for the three months ended September 29, 201728, 2018 was $23.9 million or 75.1% of sales, an increase of 42% from $16.8 million, or 71.8% of revenue, compared with $14.9 million, or 74.2%sales, reported during the same period of revenue, in the prior year period. The decrease in gross margin for the quarter is 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 increased sales mix of Toric ICLs.

2017. Gross profit for the nine months ended September 29, 201728, 2018 was $68.5 million or 73.9% of sales, an increase of 46% from $46.9 million, or 71.3% of revenue, compared with $42.5 million, or 70.5%sales, reported during the same period of revenue, in the prior year period.2017. The increaseimprovement in gross margin for the first nine months of 2017 is due to an increased sales mix of Toric ICLs, the cost of sales related to the $0.6 million non-cash charge related to the immediate vesting of all unvested equity awardsboth periods resulted primarily from lower unit costs as a result of the triggering of the “Change of Control” provision of the Company’s equity incentive plan recordedsignificantly increased production volumes resulting in the first nine months of 2016 which was not repeated in 2017,better overhead absorption, favorable product and country mix, and due to lower freight and inventory provisions, partially offset by unfavorable product mix due to increased salesthe effect of low margin injector parts, and lower average selling prices.

 

20

General and Administrative

 Three Months Ended  Percentage Change  Nine Months Ended  Percentage Change  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

  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

 
General and Administrative $4,946  $4,985   (0.8)% $15,065  $18,378   (18.0)% $6,087  $4,716   29.1% $18,054  $14,380   25.5%
Percentage of Net Sales  21.1%  24.9%      22.9%  30.5%    
Percentage of Sales  19.2%  20.1%      19.5%  21.9%    

 

General and administrative expenses for the three months ended September 28, 2018 was $6.1 million, an increase of 29% from $4.7 million reported for the same period of 2017. General and administrative expenses for the nine months ended September 29, 2017 were $15.128, 2018 was $18.1 million, a decreasean increase of 18% when compared with $18.426% from $14.4 million reported for the same period last year. The decrease was primarily due to lower stock based 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. GeneralThe increase in general and administrative expenses for the first nine months of 2017 were also lowerboth periods was due to decreasedan increase in salary-related expenses including stock-based compensation, expenses.facility costs, legal fees, travel, and investments in enhanced cybersecurity systems.

 

Marketing and Selling

 Three Months Ended  Percentage Change  Nine Months Ended  Percentage Change  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

  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

 
Marketing and Selling $6,431  $7,149   (10.0)% $20,282  $22,006   (7.8)% $10,620  $6,495   63.5% $28,733  $20,473   40.3%
Percentage of Net Sales  27.4%  35.7%      30.8%  36.5%    
Percentage of Sales  33.4%  27.7%      31.0%  31.1%    

 

Marketing and selling expenses for the three months ended September 29, 2017 were $6.428, 2018 was $10.6 million, a decreasean increase of 10% when compared with $7.164% from $6.5 million reported for the same period last year. The decrease was due to the timing of the ESCRS which was held in the third quarter of 2016 and will be held in the fourth quarter of 2017, partially offset by increased sales rep expenses in China. The Company expects fourth quarter 2017 expenses will be higher for this reason.

2017. Marketing and selling expenses for the nine months ended September 29, 2017 were $20.32018 was $28.7 million, a decreasean increase of 8% when compared with $22.040% from $20.5 million reported for the same period last year.of 2017. The decrease is primarilyincrease for both periods was due to lower stock based compensation 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 repeatedinvestments in the first nine months of 2017digital, consumer, and strategic marketing and commercial infrastructure and due to lower overall headcount and promotional costsa calendar shift in Japan.ESCRS from the prior year’s fourth quarter to the third quarter of 2018.

18

 

Research and Development

 Three Months Ended  Percentage Change  Nine Months Ended  Percentage Change  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

  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

 
Research and Development $4,429  $4,453   (0.5)% $13,924  $16,018   (13.1)% $5,570  $4,594   21.2% $16,323  $14,418   13.2%
Percentage of Net Sales  18.9%  22.2%      21.2%  26.6%    
Percentage of Sales  17.5%  19.6%      17.6%  21.9%    

 

Research and development expenses for the three months ended September 28, 2018 was $5.6 million, an increase of 21% from $4.6 million reported for the same period of 2017. Research and development expenses for the nine months ended September 29, 2017 were $13.92018 was $16.3 million, a 13.1% decrease compared to $16.0an increase of 13% from $14.4 million reported for the same prior year period.period of 2017. The decrease isincrease for both periods was primarily due to lower stock based compensationan increase in clinical expenses due toassociated with our clinical trial for the $1.9 million non-cash charge related tonext generation ICL with an EDOF optic, an increase in medical affairs expenses and for 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 repeated in the first nine months of 2017.three-month period, increased regulatory costs.

 

Research and development expense consists primarily of compensation and related costs for personnel responsible for the research and development 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.

21

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   *
  Three Months Ended  Percentage
Change
  Nine Months Ended  Percentage
Change
 
  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

 
Other Income (Expense), Net $222  $539   (58.8)% $(84) $1,067   *
Percentage of Sales  0.7%  2.3%      (0.1)%  1.7%    

________________

*Denotes change is greater than+100%.

 

* Denotes change is greater than+100%

The change in otherOther income, net for the three andmonths ended September 28, 2018 was $0.2 million, a decrease from $0.5 million reported for the same period of 2017. The decrease was a result of lower foreign exchange gains (primarily the euro). Other expense, net for the nine months ended September 29, 2017 is primarily due28, 2018 was $0.1 million compared to other income, net of $1.1 million reported for the same period of 2017. This change was a result of foreign exchange losses during the nine months ended September 28, 2018 compared to foreign currency transaction gains.exchange gains during the same period of 2017, due primarily to fluctuations in the euro rates.

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)  *
  Three Months Ended  Percentage
Change
  Nine Months Ended  Percentage
Change
 
  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

  September 28,
2018
  September 29,
2017
  

2018

vs. 2017

 
Income tax provision $346  $410   (15.6)% $1,452  $697   *
Percentage of Sales  1.1%  1.7%      1.6%  1.1%    

________________

* Denotes change is greater than+100%

*Denotes change is greater than+100%.

 

The provision for income taxes is determined using an estimated annual effective tax rate. We recorded an income tax provisiontaxes of $0.3 million and $1.5 million for the three and nine months ended September 28, 2018, respectively and $0.4 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 iswas due primarily to pre-tax income generated in certain higher rate foreign jurisdictions. The income tax benefit 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. We have no unrecognized tax benefits pertaining to any uncertain tax positions as of any period presented. 

Liquidity and Capital Resources

 

We have historically financedOn August 10, 2018, we closed an offering of our operations primarily through operating cash flows, the issuancecommon stock. As part of this transaction, we issued 1,999,850 shares of common stock at a price of $36.309 per share. Net proceeds, after deducting expenses, received from this offering were $72,150,000. We intend to use the net proceeds of this offering to fund operations, which may include advancing and proceeds from stock option exercises, borrowings under linesbroadening commercialization of creditits ICL family of products, funding pipeline research and by relying on equipmentdevelopment activities and other commercial financing. During 2017,clinical trials, funding incremental investments in automation and precision manufacturing, and capital expenditures, such as information systems, 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 ourgeneral corporate purposes, including working capital.

With continued expanding ICL sales and gross margins, We have not yet determined 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 endamounts on any of the third quarterareas listed above or the timing of 2017 and went from using approximately $8.0 millionthese expenditures. We invest the net proceeds in cash for operating activities in 2014 to generating $1.8 million from operating activities duringshort-term interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of 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 our current cash balances coupled with cash flow from operating activities will be sufficient to meet our working capital requirements for the foreseeable future. Our need for working capital, and the terms on which 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 Developments and Strategic Priorities for 2017.”

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

 

As of September 29, 2017 and December 30, 2016, respectively, STAAR28, 2018, we had $16.3 million and $14.1 million, of cash, cash equivalents and restricted cash.cash of $102.3 million. Additionally, we have a line of credit with a Japanese lender, in the amount of $4.4 million, with $0.2 million of availability and a line of credit with a Swiss lender, in the amount of $1.0 million, which is fully available for borrowing. Cash provided by operations and financing activities is expected to be adequate to cover our operational and business needs through at least the next 12 months.

 

Net cash provided by operating activities was $1.8$10.4 million for the nine months ended September 28, 2018 and $0.9$1.7 million for the nine months ended September 29, 2017 and September 30, 2016, respectively.2017. The net cash provided by operating activities for the nine months ended September 29, 2017,28, 2018, resulted from net income of $3.9 million and $9.4 million in non-cash items offset by a $2.9 million decrease in net working capital. The increase in net cash provided by operating activities during the nine months ended September 28, 2018 was due to recognition of net income of $3.9 million for the nine months ended September 28, 2018 compared to a net loss of $2.0 million offset by $6.4for the nine months ended September 29, 2017 and an increase of $3.0 million in non-cash items and decreased by a $2.7 million increase in net working capital.items.

22

  

Net cash used in investing activities was $1.7 million and $1.0 million for the nine months ended September 28, 2018 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 wasrespectively, due to the acquisition of property, plant and equipment.

 

Net cash provided by financing activities was $1.1$75.1 million and $1.9$1.1 million for the nine months ended September 29, 201728, 2018 and September 30, 2016,29, 2017, respectively. Net cash provided by financing activities during the first nine months of 20172018 resulted primarily from the proceeds from the equity offering, as discussed above. In addition, the increase is due to vested restricted stock and exercises of stock options, and proceeds from sale-leaseback transactions, partially offset by purchase of employee common stock for taxes withheld and the repayment of capital lease obligations.obligations and repayment on the line of credit.

Credit Facilities and Commitments

 

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

 

See Note 12 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, 2017.28, 2018.

 

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, 2017,28, 2018, 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, 2016.29, 2017.

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ITEM 4 .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.

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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, 201728, 2018 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II – OTHER INFORMATION

 

ITEM 1.LEGAL PROCEEDINGS

 

From time to time, the Company is involved in various legal proceedings and other matters arising in the normal course of business. CertainThese legal proceedings in whichand other matters may relate to, among other things, contractual rights and obligations, employment matters, or claims of product liability.  STAAR maintains insurance coverage for various matters, including product liability and certain securities claims.  While we are currently involved are discussed under “Litigation and Claims” in Note 12, “Commitments and Contingencies,”do not believe that any of the claims known is likely to have a material adverse effect on our Condensed Consolidated Financial Statements provided in this report, and such discussions are hereby incorporated by reference.financial condition or results of operations, new claims or unexpected results of existing claims could lead to significant financial harm.

 

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, 2016.29, 2017. 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, we entered into a standard commercial lease extending to October 31, 2020 the term of our lease regarding a portion of our corporate headquarters located in Monrovia, California.Not Applicable.

 

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ITEM 6.EXHIBITS

 

3.1Amended Restated Certificate of Incorporation.(1)
3.2Amended and Restated Bylaws.(4)(2)

4.44.1Form of Certificate for Common Stock, par value $0.01 per share.(3)
4.54.2Amended and Restated Omnibus Equity Incentive Plan, effective February 25, 2016.(2)Plan.(4)
10.45Letter of the Company dated September 27, 2017 to Deborah Andrews, Vice President of Finance, Chief Financial Officer, regarding compensation.(5)
10.46Lease dated August 10, 2017 by and between the Company and 2000 Gold L.P.*
31.1Certifications 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.*
31.2Certifications 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.*
32.1Certification Pursuant to 18 U.S.C. Section 1350, Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. **
101Financial statements from the quarterly report on Form 10-Q of STAAR Surgical Company for the quarter ended September 29, 2017,28, 2018, formatted in Extensible Business Reporting Language (XBRL), are filed herewith and include: (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Operations, (iii) the Condensed Consolidated Statements of Comprehensive Loss, (iv) the Condensed Consolidated Statements of Cash Flows, and (v) the Notes to Condensed Consolidated Financial Statements tagged as blocks of text.*

 

(1)Incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on June 11, 2014.
(2)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.
(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/A as filed with the Commission on April 18, 2003.
(4)Incorporated by reference to Appendix 1 of the Company’s Quarterly ReportProxy Statement on Form 10-Q for period ended June 30, 2017,DEF 14A as filed with the Commission on August 2, 2017.
(5)Incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on September 28, 2017.
April 13, 2018.
*Filed herewith.
**Furnished herewith.
Management contract or compensatory plan.

 

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SIGNATURES

 

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

 

 STAAR SURGICAL COMPANY
  
Date: November 8, 2017Dated: October 31, 2018By: /s//s/ DEBORAH J. ANDREWS
Deborah J. Andrews
  
Chief Financial OfficerDeborah J. Andrews
 Chief Financial Officer
(on behalf of the Registrant and as it’s
its principal financial officer)

 

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