Fourth Quarter ICL Sales Rise 41%; Full Year 2018 ICL Sales Rise 48%

GAAP Net Income of $0.02 Per Share in Fourth Quarter; $0.11 Per Share for Full Year 2018

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 fourth quarter and full year ended December 28, 2018.

Fourth Quarter 2018 Overview

  • Net Sales of $31.2 Million Up 26% from the Prior Year Quarter
  • ICL Sales Up 41% and Units Up 54% from the Prior Year Quarter
  • Gross Margin at 73.7% of Sales from 69.9% of Sales in the Prior Year Quarter
  • Fourth Quarter Net Income of $0.02 per Share vs. Prior Year Net Loss of ($0.00) Per Share
  • Cash, Cash Equivalents and Restricted Cash Ended the Quarter at $104.0 Million

Full Year 2018 Overview

  • Record Net Sales of $124.0 Million Up 37% from Prior Year
  • Record ICL Sales Up 48% and Units Up 54% from the Prior Year
  • Gross Margin Improved to 73.8% of Sales from 70.9% of Sales in the Prior Year
  • Full Year Net Income of $0.11 per Share vs. Prior Year Net Loss of ($0.05) Per Share

“2018 was a breakout year for STAAR. The transformation of the business over the past two years has created a strong trajectory toward paradigm change in refractive vision correction delivering visual freedom. Lens based correction of Myopia is becoming a preferred surgical solution and EVO ICL only clinics are opening in Asia and Europe. We expect our momentum to continue with strong clinical evidence from refractive surgeons publishing ever more data supporting the safety and effectiveness of the ICL,” said Caren Mason, President and CEO. “Surgeons refer to the ICL patient as their ‘happiest patients’ and 99.4% of patients in a Patient Registry said they would have the procedure again. As such, we far exceeded our projection of breaking the $100.0 million revenue mark in 2018 by achieving $124.0 million in revenue. In fact, our ICL sales alone recorded $101.1 million in sales. My appreciation to the entire STAAR team and our surgeon partners around the globe for such outstanding performance.”

Financial Overview – Q4 2018

Net sales were $31.2 million for the fourth quarter of 2018, up 26% compared to $24.9 million reported in the prior year quarter. The sales increase was driven by ICL revenue and unit growth of 41% and 54%, respectively. Other Product Sales decreased 20% compared to the prior year quarter. ICL revenue was 84% of total Net sales for the fourth quarter of 2018.

Gross profit margin for the fourth quarter of 2018, was 73.7% compared to the prior year period of 69.9%. The increase in gross profit margin for the quarter is due to favorable product mix resulting from increased sales of ICLs, and lower freight and inventory provisions, partially offset by the effect of lower average selling prices (ASPs) for lower diopter ICLs and large volume commitment strategic partners.

Operating expenses for the quarter were $21.8 million compared to the prior year quarter of $18.6 million. General and administrative expenses were $6.2 million compared to the prior year quarter of $5.1 million. The increase in general and administrative expenses was due to increased headcount and salary-related expenses including stock-based compensation and increased facility costs. Marketing and selling expenses were $9.9 million compared to the prior year quarter of $7.9 million. The increase in marketing and selling expenses was due to increased headcount and salary-related expenses including stock-based compensation and investments in digital, strategic, and consumer marketing. Research and development expenses were $5.7 million compared to the prior year quarter of $5.6 million. The increase in research and development expenses was due to an increase in headcount and salary-related expenses including stock-based compensation, and increased clinical expenses associated with our clinical trial for the next generation ICL with EDOF optic.

Net income for the fourth quarter of 2018 was $1.1 million or approximately $0.02 per share compared with a net loss of ($0.1) million or ($0.00) per share for the prior year quarter. Non-GAAP Adjusted Net Income for the fourth quarter of 2018 was $3.2 million or $0.07 per share compared to $0.8 million or $0.02 per 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.

Financial Overview – Full Year 2018

Net sales were $124.0 million for FY 2018, up 37% compared to $90.6 million reported in the prior year. The sales increase was driven by ICL revenue and unit growth of 48% and 54%, respectively. Other Products Sales increased 3% compared to the prior year. ICL revenue was 82% of total Net sales for FY 2018.

Gross profit margin for FY 2018 increased to 73.8% of revenue compared to 70.9% of revenue for fiscal 2017. The increase in gross profit margin for the year is due to favorable product mix resulting from increased sales of ICLs, and lower unit costs, freight costs, and inventory provisions, partially offset by the effect of lower ASPs for lower diopter ICLs and large volume commitment strategic partners.

Operating expenses for FY 2018 were $84.9 million compared to prior year of $67.9 million. The increase in operating expense is due to increased headcount and salary-related expenses including stock-based compensation and increased investments in digital, consumer, and strategic marketing.

Net income for full year 2018 was $5.0 million or approximately $0.11 per share compared with a net loss of $2.1 million or $0.05 per share for the prior year. Non-GAAP Adjusted Net Income for full year 2018 was $12.6 million or $0.28 per share, compared with a Non-GAAP Adjusted Net Income of $0.4 million or $0.01 per share for FY 2017. The reconciliation between GAAP and non-GAAP financial information is provided in the financial tables included with this release.

Cash, cash equivalents and restricted cash at December 28, 2018 totaled $104.0 million, compared to $18.6 million at the end of the fourth quarter of 2017. The Company generated $12.8 million in cash from operations in fiscal 2018 and raised $72.2 million in gross proceeds from the sale of approximately 2 million shares of common stock to increase its cash balances.

Outlook – Full Year 2019

The Company reaffirms its Outlook as follows:

  • ICL Unit Growth Percentage Target Increase of 30% over FY18
  • Company Overall Revenue Growth Percentage Target Increase of 20% over FY18; Overall Revenue Target Expected to be Impacted by Other Products Segment Sales Decline of Approximately $3.60M, including a $2.60M Reduction in Sales of Low Margin Injector Parts
  • GAAP Net Income Anticipated to Increase over FY18
  • Company Anticipates Achieving Positive Full Year Cash Flow and Cash Balance Increase.

Conference Call

The Company will host a conference call and webcast on Thursday, February 21, 2019 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 2888737), please dial 855-765-5684 for domestic participants and 262-912-6252 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 2888737) will be available beginning approximately one hour after the call’s conclusion for seven days. This replay can be accessed by dialing 855-859-2056 for domestic callers and 404-537-3406 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 (Loss)” as calculated in accordance with U.S. generally accepted accounting principles (“GAAP”): gain or loss on foreign currency transactions, stock-based compensation expenses, and quality remediation expenses. 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 excluded quality remediation expenses because their inclusion may mask underlying trends in our business performance.

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. 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 complexity and 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.

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 900,000 Visian ICLs have been implanted to date. To learn more about the ICL go to: www.discovericl.com. STAAR has approximately 400 full-time equivalent employees and markets lenses in over 75 countries. Headquartered in Monrovia, CA, the company operates manufacturing facilities in Aliso Viejo, CA and Monrovia, CA. 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, including those relating to the plans, strategies, and objectives of management for 2019 or prospects for achieving such plans, expectations for sales, revenue, or earnings, and any statements of assumptions underlying any of the foregoing. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the Company’s Annual Report on Form 10-K for the year ended December 29, 2017 and on the Company’s Current Report on Form 8-K on August 10, 2018, under the caption “Risk Factors,” respectively which are 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; potential 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  

December 28,

December 29,

ASSETS

2018

2017

Current assets: Cash and cash equivalents $ 103,877 $ 18,520 Accounts receivable trade, net 25,946 17,853 Inventories, net 16,704 13,310 Prepayments, deposits, and other current assets   5,045     4,207   Total current assets   151,572     53,890   Property, plant, and equipment, net 11,451 9,776 Intangible assets, net 243 271 Goodwill 1,786 1,786 Deferred income taxes 1,278 1,242 Other assets   1,009     967   Total assets $ 167,339   $ 67,932     LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Line of credit $ 3,780 $ 4,438 Accounts payable 6,524 6,033 Obligations under capital leases 1,098 1,278 Allowance for sales returns 2,895 - Other current liabilities   13,431     7,339   Total current liabilities   27,728     19,088   Obligations under capital leases 459 531 Deferred income taxes 1,022 350 Asset retirement obligations 206 202 Deferred rent 188 172 Pension liability   5,310     4,653   Total liabilities   34,913     24,996         Stockholders' equity: Common stock 442 414 Additional paid-in capital 289,584 204,920 Accumulated other comprehensive loss (1,320 ) (1,150 ) Accumulated deficit   (156,280 )   (161,248 ) Total stockholders' equity   132,426     42,936   Total liabilities and stockholders' equity $ 167,339   $ 67,932       Consolidated Statements of Operations (In 000's except for per share data) Unaudited                           Three Months Ended Twelve-Months Ended % of

December 28,

% of

December 29,

Fav (Unfav) % of

December 28,

% of

December 29,

Fav (Unfav) Sales

2018

Sales

2017

Amount %   Sales

2018

Sales

2017

Amount %   Net sales 100.0 % $ 31,186 100.0 % $ 24,852 $ 6,334 25.5 % 100.0 % $ 123,954 100.0 % $ 90,611 $ 33,343 36.8 %   Cost of sales 26.3 %   8,194   30.1 %   7,472     (722 ) -9.7 % 26.2 %   32,444   29.1 %   26,331     (6,113 ) -23.2 %   Gross profit 73.7 %   22,992   69.9 %   17,380     5,612   32.3 % 73.8 %   91,510   70.9 %   64,280     27,230   42.4 %   Selling, general and administrative expenses: General and administrative 20.0 % 6,233 20.5 % 5,085 (1,148 ) -22.6 % 19.6 % 24,287 21.5 % 19,465 (4,822 ) -24.8 % Marketing and selling 31.6 % 9,867 31.9 % 7,929 (1,938 ) -24.4 % 31.1 % 38,600 31.3 % 28,402 (10,198 ) -35.9 % Research and development 18.3 %   5,705   22.6 %   5,626     (79 ) -1.4 % 17.8 %   22,028   22.1 %   20,044     (1,984 ) -9.9 % Total selling, general, and administrative expenses 69.9 % 21,805 75.0 % 18,640 (3,165 ) -17.0 % 68.5 % 84,915 74.9 % 67,911 (17,004 ) -25.0 %   Operating income (loss) 3.8 %   1,187   -5.1 %   (1,260 )   2,447   194.2 % 5.3 %   6,595   -4.0 %   (3,631 )   10,226   281.6 %   Other income (expense): Interest expense, net 0.7 % 230 -0.1 % (24 ) 254 1058.3 % 0.1 % 165 -0.1 % (112 ) 277 247.3 % Gain (loss) on foreign currency transactions -0.9 % (291 ) 0.3 % 81 (372 ) -459.3 % -0.7 % (836 ) 0.9 % 819 (1,655 ) -202.1 % Royalty income 0.5 % 168 0.7 % 181 (13 ) -7.2 % 0.5 % 633 0.6 % 581 52 9.0 % Other income (expense), net 0.1 %   21   0.1 %   30     (9 ) -30.0 % 0.1 %   82   0.1 %   47     35   74.5 % Total other income (expense), net 0.4 %   128   1.0 %   268     (140 ) -52.2 % 0.0 %   44   1.5 %   1,335     (1,291 ) -96.7 %   Income (loss) before provision for income taxes 4.2 % 1,315 -4.1 % (992 ) 2,307 232.6 % 5.3 % 6,639 -2.5 % (2,296 ) 8,935 389.2 %   Provision for income taxes 0.7 %   219   -3.4 %   (854 )   (1,073 ) -125.6 % 1.3 %   1,671   -0.2 %   (157 )   (1,828 ) -1164.3 %   Net income (loss) 3.5 % $ 1,096   -0.7 % $ (138 ) $ 1,234   894.2 % 4.0 % $ 4,968   -2.3 % $ (2,139 ) $ 7,107   332.3 %     Net income (loss) per share - basic $ 0.02   $ -   $ 0.12   $ (0.05 ) Net income (loss) per share - diluted $ 0.02   $ -   $ 0.11   $ (0.05 )   Weighted average shares outstanding - basic   44,146     41,223     42,587     41,004   Weighted average shares outstanding - diluted   46,976     41,223     45,257     41,004       Consolidated Statements of Cash Flows (in 000's) Unaudited   Three Months Ended   Twelve-Months Ended

December 28, 2018

 

December 29, 2017

December 28, 2018

 

December 29, 2017

Cash flows from operating activities: Net income (loss) $ 1,096 $ (138 ) $ 4,968 $ (2,139 ) Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

 

Depreciation of property and equipment 638 789 2,430 3,133 Amortization of long-lived intangibles 8 55 34 221 Deferred income taxes 78 (711 ) 441 (547 ) Change in net pension liability (2 ) 91 231 186 Stock-based compensation expense 1,836 976 6,762 3,161 Loss on disposal of property and equipment 2 601 10 623 Provision for sales returns and bad debts 13 277 905 463 Inventory provision 292 472 1,473 1,739 Changes in working capital: Accounts receivable (2,051 ) (1,898 ) (6,040 ) (1,857 ) Inventories (569 ) (413 ) (4,194 ) 312 Prepayments, deposits and other current assets 423 700 (598 ) (64 ) Accounts payable (1,878 ) 250 243 (2,501 ) Other current liabilities   2,459     61     6,102     123   Net cash provided by operating activities   2,345     1,112     12,767     2,853     Cash flows from investing activities: Acquisition of property and equipment   (524 )   (77 )   (2,245 )   (1,046 ) Net cash used in investing activities   (524 )   (77 )   (2,245 )   (1,046 )   Cash flows from financing activities: Repayment on line of credit (496 ) - (747 ) - Repayment of capital lease obligations (511 ) (316 ) (1,907 ) (1,300 ) Net proceeds from public offering of common stock - - 72,150 - Repurchase of employee common stock for taxes withheld (54 ) - (54 ) (234 ) Proceeds from vested restricted stock and exercise of stock options   615     1,695     5,197     3,971  

Net cash provided by (used in) financing activities

  (446 )   1,379     74,639     2,437     Effect of exchange rate changes on cash, cash equivalents and restricted cash   308     (26 )   197     279     Increase in cash, cash equivalents and restricted cash 1,683 2,388 85,358 4,523 Cash, cash equivalents and restricted cash, at beginning of the period   102,316     16,253     18,641     14,118   Cash, cash equivalents and restricted cash, at end of the period $ 103,999   $ 18,641   $ 103,999   $ 18,641       Global Sales (in 000's) Unaudited                     Three Months Ended Twelve-Months Ended

December 28,

December 29,

% Change

December 28,

December 29,

% Change Sales by Region

2018

2017

Fav (Unfav)

2018

2017

Fav (Unfav) North America 7.4 % $ 2,314 9.0 % $ 2,228 3.9 % 7.0 % $ 8,671 9.9 % $ 9,014 -3.8 % Europe 20.5 % 6,408 23.9 % 5,950 7.7 % 20.7 % 25,698 24.8 % 22,449 14.5 % Middle East, Africa, Latin America 6.7 % 2,080 7.3 % 1,821 14.2 % 5.1 % 6,273 5.9 % 5,351 17.2 % Asia Pacific 65.4 %   20,384 59.8 %   14,853 37.2 % 67.2 %   83,312 59.4 %   53,797 54.9 % Total Sales 100.0 % $ 31,186 100.0 % $ 24,852 25.5 % 100.0 % $ 123,954 100.0 % $ 90,611 36.8 %     Core Product Sales ICLs 84.1 % $ 26,214 75.0 % $ 18,627 40.7 % 81.5 % $ 101,082

75.4

% $ 68,325 47.9 % Other Product Sales IOLs 13.2 % 4,125 17.6 % 4,383 -5.9 % 13.1 % 16,193 19.0 % 17,258 -6.2 % Injector Parts and Other 2.7 %   847 7.4 %   1,842 -54.0 % 5.4 %   6,679 5.6 %   5,028 32.8 % Total Other Sales 15.9 %   4,972 25.0 %   6,225 -20.1 % 18.5 %   22,872 24.6 %   22,286 2.6 % Total Sales 100.0 % $ 31,186 100.0 % $ 24,852 25.5 % 100.0 % $ 123,954 100.0 % $ 90,611 36.8 %     Reconciliation of Non-GAAP Financial Measure       (in 000's)   Unaudited Three Months Ended Twelve-Months Ended

December 28,

December 29,

December 28,

December 29,

 

2018

   

2017

   

2018

   

2017

  Net income (loss) - (as reported) $ 1,096 $ (138 ) $ 4,968 $ (2,139 ) Less: Foreign currency impact 291 (81 ) 836 (819 ) Stock-based compensation expense 1,836 976 6,762 3,161 Quality remediation expense   -     -     -     210   Net income (loss) - (adjusted) $ 3,223   $ 757   $ 12,566   $ 413     Net income (loss) per share, basic - (as reported) $ 0.02 $ - $ 0.12 $ (0.05 ) Foreign currency impact 0.01 - 0.02 (0.02 ) Stock-based compensation expense 0.04 0.02 0.16 0.08 Quality remediation expense   -     -     -     0.01   Net income (loss) per share, basic - (adjusted) $ 0.07   $ 0.02   $ 0.30   $ 0.01     Net income (loss) per share, diluted - (as reported) $ 0.02 $ - $ 0.11 $ (0.05 ) Foreign currency impact 0.01 - 0.02 (0.02 ) Stock-based compensation expense 0.04 0.02 0.15 0.08 Quality remediation expense   -     -     -     -   Net income (loss) per share, diluted - (adjusted) $ 0.07   $ 0.02   $ 0.28   $ 0.01     Weighted average shares outstanding - Basic 44,146 41,223 42,587 41,004 Weighted average shares outstanding - Diluted 46,976 42,823 45,257 42,096   Note: Net income (loss) per share (adjusted), basic and diluted, may not add due to rounding

Investors & MediaEVC GroupBrian Moore, 310-579-6199Doug Sherk, 415-652-9100

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