STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, today reported financial results for the second quarter ended July 3, 2020.

Second Quarter 2020 Overview

  • Net Sales of $35.2 Million Down 11% from the Prior Year Quarter
  • ICL Sales of $30.7 Million Down 11% and Units Down 3% from the Prior Year Quarter
  • Gross Margin at 69.4% vs. 75.4% in the Prior Year Quarter
  • Net Loss of ($0.03) per Share vs. Prior Year Quarter Net Income of $0.08 per Share
  • Cash and Cash Equivalents Ended the Quarter at $116.3 Million.

“The outlook we provided in May accurately assessed the market dynamics and STAAR’s ability to perform well in the midst of a prolonged shutdown of elective surgeries in most of the global markets we serve. While refractive procedures were down significantly or came to a halt in April and May in much of North America, Europe, Latin America, India and the Middle East, continuing recovery and growth were recorded in Japan, Korea and China. In June, ICL implant procedures recorded strong year-over-year growth with units up 65% in Japan, 24% in Rest of Asia Pacific, 17% in Germany, 15% in Distributor Markets in Europe and 11% in Korea. The positive trending continued in July with China experiencing stronger than anticipated demand as the peak season began in earnest. While COVID-19 hotspots and government public health mandates may reoccur moving forward, we anticipate less business interruption and continued increased interest in our EVO ICL lens-based refractive solutions in Q3 and Q4. Our team is squarely focused on generating significant growth by supporting our surgeon partners as they restart their practices with patient recruiting programs, training and digital marketing,” said Caren Mason, President and CEO of STAAR Surgical.

“During Q3, we plan to launch the European commercialization of our innovative EVO Viva™ presbyopia-correcting lens. We will begin our phased rollout of the EVO Viva lens to select surgeons in early September. We are also anticipating completing enrollment in our U.S. EVO clinical trial in the September timeframe,” concluded Ms. Mason.

Financial Overview – Q2 2020

Net sales were $35.2 million for the second quarter of 2020, down 11% compared to $39.7 million reported in the prior year quarter. The sales decrease was driven by ICL revenue and unit growth declines of 11% and 3%, respectively, as compared to the prior year period. Other Product Sales decreased 15% compared to the prior year quarter. ICL revenue was 87% of total Net sales for the second quarter of 2020.

Gross profit margin for the second quarter of 2020, was 69.4% compared to the prior year period of 75.4%. The decrease in gross margin is primarily attributable to geographic sales mix and a voluntary six-week COVID-19 related manufacturing pause that ended on April 27, 2020. Excluding the manufacturing pause related expenses from the second quarter of 2020 gross profit margin would have been 72.2%.

Operating expenses for the second quarter were $25.5 million compared to the prior year quarter of $25.3 million. General and administrative expenses were $7.8 million compared to the prior year quarter of $7.5 million. The increase in general and administrative expenses was due to increased headcount and salary-related expenses, partially offset by a decrease in variable compensation and travel expenses. Marketing and selling expenses were $10.3 million compared to the prior year quarter of $11.7 million. The decrease in marketing and selling expenses is due to decreased trade show expenses and travel expenses, partially offset by increased advertising and promotional activities. Research and development expenses were $7.3 million compared to the prior year quarter of $6.1 million. The increase in research and development expenses was due to increased clinical expenses associated with our EVO clinical trial in the U.S., and increased headcount and salary-related expenses, partially offset by variable compensation and travel expense.

Net loss for the second quarter of 2020 was ($1.2) million or approximately ($0.03) per diluted share compared with net income of $3.9 million or $0.08 per diluted share for the prior year quarter. Adjusted Net Income for the second quarter of 2020 was $1.4 million or $0.03 per diluted share compared to $6.5 million or $0.14 per diluted share for the prior year quarter. The reconciliation between GAAP and non-GAAP financial information is provided in the financial tables included with this release.

Cash and cash equivalents at July 3, 2020 totaled $116.3 million, compared to $120.0 million at the end of fiscal 2019. The Company had $1.3 million drawn on its line of credit in Japan and no other debt at July 3, 2020. During the second quarter of 2020, the Company achieved breakeven cash from operations and invested $2.0 million in property and equipment.

Conference Call

The Company will host a conference call and webcast today, Wednesday, August 5, at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and operational progress. To access the conference call (Conference ID 9428649), please dial 833-350-1429 for domestic participants and 647-689-6661 for international participants. The live webcast can be accessed from the investor relations section of the STAAR website at www.staar.com.

A taped replay of the conference call (Conference ID 9428649) will be available beginning approximately one hour after the call’s conclusion for seven days. This replay can be accessed by dialing 800-585-8367 for domestic callers and 416-621-4642 for international callers. An archived webcast will also be available at www.staar.com.

Use of Non-GAAP Financial Measures

This press release includes supplemental non-GAAP financial information, which STAAR believes investors will find helpful in understanding its operating performance. “Adjusted Net Income” and “Adjusted Net Income Per Share” exclude the following items that are included in “Net Income” as calculated in accordance with U.S. generally accepted accounting principles (“GAAP”): gain or loss on foreign currency transactions, stock-based compensation expenses, and valuation allowance adjustments. Management believes that “Adjusted Net Income” and “Adjusted Net Income per share” are useful to investors in gauging the outcome of the key drivers of the business performance: the ability to increase sales revenue and our ability to increase profit margin by improving the mix of high value products while reducing the costs over which management has control.

Management has also excluded gains and losses on foreign currency transactions because of the significant fluctuations that can result from period to period as a result of market driven factors. Stock-based compensation expenses consist of expenses for stock options and restricted stock under the Financial Accounting Standards Board’s Accounting Standards Codification (ASC) 718. Valuation allowance adjustments can occur from time to time based on forecasted changes in operating results until all net operating loss carryforwards are fully utilized. In calculating Adjusted Net Income and Adjusted Net Income Per Share, STAAR excludes these expenses because they are non-cash expenses and because of the considerable judgment involved in calculating their values. In addition, these expenses tend to be driven by fluctuations in the price of our stock and not by the same factors that generally affect our other business expenses.

The Company also uses Constant Currency as a Non-GAAP financial measure to exclude the effects of currency fluctuations on net sales. The Company conducts a significant part of its activities outside the U.S. It receives sales revenue and pays expenses principally in U.S. dollars, Swiss francs, Japanese yen and euros. The exchange rates between dollars and non-U.S. currencies can fluctuate greatly and can have a significant effect on the Company’s results when reported in U.S. dollars. In order to compare the Company's performance from period to period without the effect of currency, the Company will apply the same average exchange rate applicable in the prior period, or the "constant currency" rate to sales or expenses in the current period as well. Because changes in currency are outside of the control of the Company and its managers, management finds this non-GAAP measure useful in determining the long-term progress of its initiatives and determining whether its managers are achieving their performance goals. The Company believes that the non-GAAP constant-currency sales results measures provided in this press release are similarly useful to investors to give insight on long term trends in the Company's performance without the external effect of changes in relative currency values. The table below shows sales results calculated in accordance with GAAP, the effect of currency, and the resulting non-GAAP measure expressed in constant currency.

About STAAR Surgical

STAAR, which has been dedicated solely to ophthalmic surgery for over 30 years, designs, develops, manufactures and markets implantable lenses for the eye with companion delivery systems. These lenses are intended to provide visual freedom for patients, lessening or eliminating the reliance on glasses or contact lenses. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR’s lens used in refractive surgery is called an Implantable Collamer® Lens or “ICL,” which includes the EVO Visian ICL™ product line. More than 1,000,000 Visian® ICLs have been implanted to date and STAAR markets these lenses in over 75 countries. To learn more about the ICL go to: www.discovericl.com. Headquartered in Lake Forest, CA, the company operates manufacturing and packaging facilities in Aliso Viejo, CA, Monrovia, CA and Nidau, Switzerland. For more information, please visit the Company’s website at www.staar.com.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: any financial projections, plans, strategies, and objectives of management for 2020 or prospects for achieving such plans, expectations for sales, revenue, or earnings, the expected impact of the COVID-19 pandemic and related public health measures (including but not limited to its impact on sales, operations or clinical trials globally), product safety or effectiveness, the status of our pipeline of ICL products with regulators, including our EVO family of lenses in the U.S., and any statements of assumptions underlying any of the foregoing, including those relating to our product pipeline and market expansion activities. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include risks and uncertainties related to the COVID-19 pandemic and related public health measures, as well as the factors set forth in the Company’s Quarterly Report on Form 10-Q for the quarter ended April 3, 2020, and Annual Report on Form 10-K for the year ended January 3, 2020 under the caption “Risk Factors,” which is on file with the Securities and Exchange Commission and available in the “Investor Information” section of the company’s website under the heading “SEC Filings.” We disclaim any intention or obligation to update or revise any financial projections or forward-looking statement due to new information or events. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include the following: global economic conditions; the discretion of regulatory agencies to approve or reject existing, new or improved products, or to require additional actions before approval, or to take enforcement action; international trade disputes; and the willingness of surgeons and patients to adopt a new or improved product and procedure. The Visian ICL with CentraFLOW, now known as EVO Visian ICL, is not yet approved for sale in the United States.

Consolidated Balance Sheets (in 000's) Unaudited July 3, 2020 January 3, 2020 ASSETS Current assets: Cash and cash equivalents

$

116,315

 

$

119,968

 

Accounts receivable trade, net

 

39,469

 

 

30,996

 

Inventories, net

 

17,836

 

 

17,142

 

Prepayments, deposits, and other current assets

 

8,897

 

 

6,560

 

Total current assets

 

182,517

 

 

174,666

 

Property, plant, and equipment, net

 

21,478

 

 

17,065

 

Finance lease right-of-use assets, net

 

687

 

 

1,867

 

Operating lease right-of-use assets, net

 

5,587

 

 

6,684

 

Intangible assets, net

 

280

 

 

296

 

Goodwill

 

1,785

 

 

1,786

 

Deferred income taxes

 

5,114

 

 

3,750

 

Other assets

 

591

 

 

751

 

Total assets

$

218,039

 

$

206,865

 

  LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Line of credit

$

1,325

 

$

1,827

 

Accounts payable

 

8,890

 

 

8,050

 

Obligations under finance leases

 

493

 

 

560

 

Obligations under operating leases

 

2,355

 

 

2,700

 

Allowance for sales returns

 

4,285

 

 

3,644

 

Other current liabilities

 

14,241

 

 

17,697

 

Total current liabilities

 

31,589

 

 

34,478

 

Obligations under finance leases

 

108

 

 

366

 

Obligations under operating leases

 

3,320

 

 

4,086

 

Asset retirement obligations

 

212

 

 

211

 

Pension liability

 

8,136

 

 

7,840

 

Total liabilities

 

43,365

 

 

46,981

 

  Stockholders' equity: Common stock

 

458

 

 

448

 

Additional paid-in capital

 

320,235

 

 

304,288

 

Accumulated other comprehensive loss

 

(2,909

)

 

(3,048

)

Accumulated deficit

 

(143,110

)

 

(141,804

)

Total stockholders' equity

 

174,674

 

 

159,884

 

Total liabilities and stockholders' equity

$

218,039

 

$

206,865

 

Consolidated Statements of Operations (In 000's except for per share data) Unaudited Three Months Ended % of   July 3, 2020 % of   June 28, 2019 Fav (Unfav) Sales   Sales   Amount % Net sales

100.0

%

 

$

35,194

 

100.0

%

 

$

39,664

$

(4,470

)

-11.3

%

      Cost of sales

30.6

%

 

 

10,764

 

24.6

%

 

 

9,765

 

(999

)

-10.2

%

      Gross profit

69.4

%

 

 

24,430

 

75.4

%

 

 

29,899

 

(5,469

)

-18.3

%

      Selling, general and administrative expenses:     General and administrative

22.3

%

 

 

7,848

 

18.9

%

 

 

7,508

 

(340

)

-4.5

%

Marketing and selling

29.3

%

 

 

10,326

 

29.5

%

 

 

11,682

 

1,356

 

11.6

%

Research and development

20.8

%

 

 

7,311

 

15.4

%

 

 

6,098

 

(1,213

)

-19.9

%

Total selling, general, and administrative expenses

72.4

%

 

 

25,485

 

63.8

%

 

 

25,288

 

(197

)

-0.8

%

      Operating income (loss)

-3.0

%

 

 

(1,055

)

11.6

%

 

 

4,611

 

(5,666

)

-122.9

%

      Other income (expense):     Interest income, net

0.1

%

 

 

20

 

0.7

%

 

 

259

 

(239

)

-92.3

%

Gain (loss) on foreign currency transactions

1.1

%

 

 

388

 

0.0

%

 

 

11

 

377

 

3427.3

%

Royalty income

0.1

%

 

 

52

 

0.4

%

 

 

163

 

(111

)

-68.1

%

Other income (expense), net

-0.1

%

 

 

(21

)

0.0

%

 

 

1

 

(22

)

-2200.0

%

Total other income, net

1.2

%

 

 

439

 

1.1

%

 

 

434

 

5

 

1.2

%

      Income (loss) before provision for income taxes

-1.8

%

 

 

(616

)

12.7

%

 

 

5,045

 

(5,661

)

-112.2

%

      Provision (benefit) for income taxes

1.5

%

 

 

556

 

2.9

%

 

 

1,131

 

575

 

50.8

%

      Net income (loss)

-3.3

%

 

$

(1,172

)

9.8

%

 

$

3,914

$

(5,086

)

-129.9

%

            Net income (loss) per share - basic  

$

(0.03

)

 

$

0.09

Net income (loss) per share - diluted  

$

(0.03

)

 

$

0.08

      Weighted average shares outstanding - basic  

 

45,354

 

 

 

44,479

Weighted average shares outstanding - diluted  

 

45,354

 

 

 

46,733

Consolidated Statements of Cash Flows (in 000's) Unaudited Three Months Ended Six Months Ended July 3, 2020 June 28, 2019 July 3, 2020 June 28, 2019   Cash flows from operating activities: Net income (loss)

$

(1,172

)

$

3,914

 

$

(1,306

)

$

5,281

 

Adjustments to reconcile net income (loss) to net cash provided by operating activities: Depreciation of property and equipment

 

752

 

 

761

 

 

1,518

 

 

1,983

 

Amortization of long-lived intangibles

 

8

 

 

9

 

 

17

 

 

17

 

Deferred income taxes

 

-

 

 

314

 

 

(1,369

)

 

393

 

Change in net pension liability

 

203

 

 

84

 

 

376

 

 

203

 

Stock-based compensation expense

 

2,918

 

 

2,579

 

 

5,839

 

 

5,220

 

Loss on disposal of property and equipment

 

-

 

 

-

 

 

3

 

 

-

 

Provision for sales returns and bad debts

 

525

 

 

2

 

 

605

 

 

(32

)

Inventory provision

 

480

 

 

332

 

 

816

 

 

787

 

Changes in working capital: Accounts receivable

 

(4,947

)

 

(5,979

)

 

(8,409

)

 

(6,533

)

Inventories

 

(441

)

 

113

 

 

(932

)

 

106

 

Prepayments, deposits and other current assets

 

274

 

 

1,163

 

 

(2,172

)

 

(1,154

)

Accounts payable

 

(610

)

 

748

 

 

297

 

 

563

 

Other current liabilities

 

1,993

 

 

(563

)

 

(3,471

)

 

(2,626

)

Net cash provided by (used in) operating activities

 

(17

)

 

3,477

 

 

(8,188

)

 

4,208

 

  Cash flows from investing activities: Acquisition of property and equipment

 

(2,025

)

 

(2,398

)

 

(4,210

)

 

(4,601

)

Increase in patents and licenses

 

-

 

 

-

 

 

-

 

 

(30

)

Net cash used in investing activities

 

(2,025

)

 

(2,398

)

 

(4,210

)

 

(4,631

)

  Cash flows from financing activities: Repayment on line of credit

 

(3

)

 

(500

)

 

(508

)

 

(999

)

Repayment of finance lease obligations

 

(110

)

 

(316

)

 

(346

)

 

(681

)

Proceeds from vested restricted stock and exercise of stock options

 

7,553

 

 

488

 

 

9,558

 

 

1,112

 

Net cash provided by (used in) financing activities

 

7,440

 

 

(328

)

 

8,704

 

 

(568

)

  Effect of exchange rate changes on cash and cash equivalents

 

66

 

 

267

 

 

41

 

 

243

 

  Increase (decrease) in cash and cash equivalents

 

5,464

 

 

1,018

 

 

(3,653

)

 

(748

)

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

 

110,851

 

 

102,233

 

 

119,968

 

 

103,999

 

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

$

116,315

 

$

103,251

 

$

116,315

 

$

103,251

 

Reconciliation of Non-GAAP Financial Measure Adjusted Net Income (Loss) and Net Income (Loss) Per Share (in 000's) Unaudited   Three Months Ended Six Months Ended   July 3, 2020   June 28, 2019 July 3, 2020   June 28, 2019         Net income (loss) (as reported)  

$

(1,172

)

 

$

3,914

 

$

(1,306

)

 

$

5,281

Less:       Foreign currency impact  

 

(388

)

 

 

(11

)

 

80

 

 

 

237

Stock-based compensation expense  

 

2,918

 

 

 

2,579

 

 

5,839

 

 

 

5,220

Valuation allowance adjustment  

 

-

 

 

 

-

 

 

(1,369

)

 

 

-

Net income (adjusted)  

$

1,358

 

 

$

6,482

 

$

3,244

 

 

$

10,738

        Net income (loss) per share, basic (as reported)  

$

(0.03

)

 

$

0.09

 

$

(0.03

)

 

$

0.12

Foreign currency impact  

 

-

 

 

 

-

 

 

-

 

 

 

-

Stock-based compensation expense  

 

0.06

 

 

 

0.06

 

 

0.13

 

 

 

0.12

Valuation allowance adjustment  

 

-

 

 

 

-

 

 

(0.03

)

 

 

-

Net income per share, basic (adjusted)  

$

0.03

 

 

$

0.15

 

$

0.07

 

 

$

0.24

        Net income (loss) per share, diluted (as reported)  

$

(0.03

)

 

$

0.08

 

$

(0.03

)

 

$

0.11

Foreign currency impact  

 

-

 

 

 

-

 

 

-

 

 

 

0.01

Stock-based compensation expense  

 

0.06

 

 

 

0.06

 

 

0.12

 

 

 

0.11

Valuation allowance adjustment  

 

-

 

 

 

-

 

 

(0.02

)

 

 

-

Net income per share, diluted (adjusted)  

$

0.03

 

 

$

0.14

 

$

0.07

 

 

$

0.23

        Weighted average shares outstanding - Basic  

 

45,354

 

 

 

44,479

 

 

45,152

 

 

 

44,357

Weighted average shares outstanding - Diluted  

 

47,546

 

 

 

46,733

 

 

47,328

 

 

 

46,842

        Note: Net income per share (adjusted), basic and diluted, may not add due to rounding STAAR Surgical Company Reconciliation of Non-GAAP Financial Measure Constant Currency Sales (in 000's) Unaudited   Three Months Ended       July 3, 2020   Effect of   Constant June 28, 2019 As Reported Constant Currency Sales     Currency   Currency $ Change   % Change $ Change   % Change ICL  

$

30,728

 

$

(6

)

 

$

30,722

$

34,432

$

(3,704

)

 

-10.8

%

$

(3,710

)

 

-10.8

%

            IOL  

 

2,561

 

 

(41

)

 

 

2,520

 

3,874

 

(1,313

)

 

-33.9

%

 

(1,354

)

 

-35.0

%

Other  

 

1,905

 

 

(67

)

 

 

1,838

 

1,358

 

547

 

 

40.3

%

 

480

 

 

35.3

%

Other Products  

 

4,466

 

 

(108

)

 

 

4,358

 

5,232

 

(766

)

 

-14.6

%

 

(874

)

 

-16.7

%

            Total Sales  

$

35,194

 

$

(114

)

 

$

35,080

$

39,664

$

(4,470

)

 

-11.3

%

$

(4,584

)

 

-11.6

%

              Six Months Ended       July 3, 2020   Effect of   Constant June 28, 2019 As Reported Constant Currency Sales     Currency   Currency $ Change   % Change $ Change   % Change ICL  

$

60,068

 

$

95

 

 

$

60,163

$

62,218

$

(2,150

)

 

-3.5

%

$

(2,055

)

 

-3.3

%

            IOL  

 

6,555

 

 

(41

)

 

 

6,514

 

7,891

 

(1,336

)

 

-16.9

%

 

(1,377

)

 

-17.5

%

Other  

 

3,758

 

 

(67

)

 

 

3,691

 

2,138

 

1,620

 

 

75.8

%

 

1,553

 

 

72.6

%

Other Products  

 

10,313

 

 

(108

)

 

 

10,205

 

10,029

 

284

 

 

2.8

%

 

176

 

 

1.8

%

            Total Sales  

$

70,381

 

$

(13

)

 

$

70,368

$

72,247

$

(1,866

)

 

-2.6

%

$

(1,879

)

 

-2.6

%

 

Investors & Media Brian Moore Vice President, Investor, Media Relations and Corporate Development (626) 303-7902, Ext. 3023 bmoore@staar.com