STAAR Surgical Reports Third Quarter 2017 Results

Quarterly net sales of $23.5 million up 17% from the prior year quarter.

 
[08-November-2017]
 
 

MONROVIA, Calif., Nov. 8, 2017 /PRNewswire/ -- 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 third quarter ended September 29, 2017.

Third Quarter 2017 Overview

  • Quarterly Net Sales of $23.5 Million Up 17% from the Prior Year Quarter
  • ICL Sales Up 22% and Units Up 18% from the Prior Year Quarter
  • IOL Sales Down 16% and Units Down 6% from the Prior Year Quarter
  • Gross Margin at 71.8% of Sales from 74.2% of Sales in the Prior Year Quarter due to Larger Volume of Lower Margin Injector Sales
  • Quarterly Net Earnings per Share of $0.03 vs. Prior Year Quarter Net Loss of ($0.04) per Share
  • Cash, Cash Equivalents and Restricted Cash Ended the Quarter at $16.3 Million
  • Signed New and Extended Existing Strategic Agreements with Providers in China, Korea, Europe
  • Continued First-in-Man Clinical Evaluation of EVO Visian ™ Implantable Collamer Lenses with EDOF for Presbyopia Correction - EU Clinical Study to Commence in Q1 2018

"During Q3, we achieved a number of milestones for the company. We were pleased to deliver a profitable quarter with $0.03 positive earnings per share and approximately $3.1 million in positive cash flow from operations. We achieved record revenue and gross profit for the quarter while benefiting from planned expense management and a shift in marketing expense for our Experts Meeting and ESCRS to the fourth quarter. Top line results include record ICL sales and record ICL units with Canada units up 200%, China units up 76%, Japan units up 48%, Germany units up 28% and Global Distributors units up 22% over the prior year quarter. China's demand was especially strong as the third quarter encompasses the largest procedure volume of the year. As we have expanded our business substantially in China, the largest refractive surgery market globally, we now will be planning for greater revenue in Q3 in future years than in previous years," said Caren Mason, President and CEO.

"Our first-in-man clinical trial for the next generation ICL with EDOF optic is nearly finished and the results continue to meet intended outcomes. We plan to begin our pivotal clinical trial during the first quarter of 2018 to evaluate the performance of an EDOF optic design to treat Presbyopia on the approved EVO Visian Implantable Collamer Lens platform. With regard to FDA remediation, we completed our internal work in the first quarter of 2017 and notified the FDA in March that we are ready for inspection," added Ms. Mason.

Financial Overview

Net sales were $23.5 million for the third quarter of 2017, up 17% compared to $20.1 million reported in the prior year quarter. The sales increase was driven by ICL revenue and unit growth of 22% and 18%, respectively, and strong injector part sales. Sales of IOLs decreased 16% compared to the prior year quarter.

Gross profit margin for the third quarter of 2017, was 71.8% compared to the prior year period of 74.2%. 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.

Operating expenses for the quarter were $15.8 million compared to the prior year quarter of $16.6 million. The decrease in operating expenses for the quarter was due to planned expense management and the timing of our Experts Meeting and the ESCRS, which were held and expensed in the third quarter of 2016 versus being held and expensed in the fourth quarter of 2017.

Net income for the third quarter of 2017 was $1.2 million or approximately $0.03 per diluted share compared with a net loss of $1.8 million or $0.04 per share for the prior year quarter.

Adjusted Net Income for the third quarter of 2017 was $1.5 million or $0.04 per diluted share, compared with an Adjusted Net Loss of $0.9 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.

Cash, cash equivalents and restricted cash at September 29, 2017 totaled $16.3 million, compared to $14.1 million at the end of the fourth quarter of 2016 and $14.4 million at the end of the third quarter of 2016. Continued focus on optimizing the Company's cash position through revenue growth, expense mitigation, and working capital management enabled the Company to effectively increase its cash balances.

Conference Call

The Company will host a conference call and webcast on Wednesday, November 8, 2017 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 6998278), 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 6998278) 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 (Loss)" and "Adjusted Net Income (Loss) 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 (Loss)" and "Adjusted Net Income (Loss) 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 (Loss) and Adjusted Net Income (Loss) 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 700,000 Visian ICLs have been implanted to date. To learn more about the ICL go to: www.discovericl.com. STAAR has approximately 340 full-time equivalent employees and markets lenses in over 60 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 future operations or prospects for achieving such plans, expectations for sales, revenue, earnings, marketing and clinical initiatives, completion of remediation or other expense, or expense timing, success and timing of new or improved products, clinical trials, research and development activities, investment imperatives, 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 30, 2016 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: our limited capital resources and limited access to financing; global economic conditions; changes in currency exchange rates; the discretion of regulatory agencies to approve or reject existing, new or improved products, or to require additional actions before approval (including but not limited to FDA requirements regarding the Visian Toric ICL and/or actions related to the FDA Warning Letter and Form FDA-483s), or to take enforcement action; research and development efforts; the purchasing patterns of our distributors carrying inventory in the market; and the willingness of surgeons and patients to adopt a new or improved product and procedure. The Visian Toric ICL and the Visian ICL with CentraFLOW, now known as EVO Visian ICL, are not yet approved for sale in the United States.

    CONTACT:                          Investors & Media

                                      EVC Group

                                      Brian Moore, 310-579-6199

                                      Doug Sherk, 415-652-9100

 

    STAAR Surgical Company

    Consolidated Balance Sheets

    (in 000's)

    Unaudited


                                               September 29,         December 30,

                            ASSETS                              2017                  2016
                            ------                              ----                  ----

    Current assets:

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

    Accounts receivable trade, net                            16,237                16,344

    Inventories, net                                          13,274                14,825

    Insurance receivable                                       7,000                     ?

    Prepayments, deposits, and other
     current assets                                            4,936                 4,349

       Total current assets                                   57,580                49,517
                                                              ------                ------

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

    Intangible assets, net                                       326                   473

    Goodwill                                                   1,786                 1,786

    Deferred income taxes                                      1,043                 1,105

    Other assets                                                 969                   772
                                                                 ---                   ---

       Total assets                                          $72,703               $65,443
                                                             =======               =======


                 LIABILITIES AND STOCKHOLDERS'
                             EQUITY
                 -----------------------------

    Current liabilities:

    Line of credit                                            $4,442                $4,283

    Accounts payable                                           5,734                 8,311

    Obligations under capital leases                           1,269                 1,198

    Litigation settlement obligation                           7,000                     ?

    Other current liabilities                                  7,253                 7,275
                                                               -----                 -----

       Total current liabilities                              25,698                21,067
                                                              ------                ------

    Obligations under capital leases                             834                 1,339

    Deferred income taxes                                        984                   881

    Asset retirement obligations                                 203                   195

    Deferred rent                                                184                    59

    Pension liability                                          4,138                 3,997
                                                               -----                 -----

       Total liabilities                                      32,041                27,538
                                                              ------                ------




    Stockholders' equity:

    Common stock                                                 412                   407

    Additional paid-in capital                               202,148               197,657

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

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

       Total stockholders' equity                             40,662                37,905
                                                              ------                ------

       Total liabilities and
        stockholders' equity                                 $72,703               $65,443
                                                             =======               =======

 

 

    STAAR Surgical Company

    Consolidated Statements of Operations

    (In 000's except for per share data)

    Unaudited


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

                                          % of                    September 29,         % of          September 30,                        Fav (Unfav)         % of           September 29,                         % of September 30,                   Fav (Unfav)
                                                                                                                                            ----------                                                                                                   ----------

                                          Sales                                    2017  Sales                              2016                Amount             %                        Sales             2017                Sales                2016          Amount            %
                                                                                   ----                                     ----                ------            ---                                         ----                                     ----          ------           ---

    Net sales                                   100.0%                          $23,473        100.0%                    $20,052                        $3,421          17.1%                      100.0%   $65,759                       100.0%     $60,295                   $5,464           9.1%


    Cost of sales                                28.2%                            6,624         25.8%                      5,180                       (1,444)        -27.9%                       28.7%    18,859                        29.5%      17,804                  (1,055)         -5.9%
                                                                                  -----                                    -----                        ------                                               ------                                   ------                   ------


    Gross profit                                 71.8%                           16,849         74.2%                     14,872                         1,977          13.3%                       71.3%    46,900                        70.5%      42,491                    4,409          10.4%
                                                                                 ------                                   ------                         -----                                               ------                                   ------                    -----


    Selling, general and administrative
     expenses:

    General and administrative                   21.1%                            4,946         24.9%                      4,985                            39           0.8%                       22.9%    15,065                        30.5%      18,378                    3,313          18.0%

    Marketing and selling                        27.4%                            6,431         35.7%                      7,149                           718          10.0%                       30.8%    20,282                        36.5%      22,006                    1,724           7.8%

    Research and development                     18.9%                            4,429         22.2%                      4,453                            24           0.5%                       21.2%    13,924                        26.6%      16,018                    2,094          13.1%
                                                                                  -----                                    -----                           ---                                               ------                                   ------                    -----

    Total selling, general, and
     administrative expenses                     67.4%                           15,806         82.8%                     16,587                           781           4.7%                       74.9%    49,271                        93.6%      56,402                    7,131          12.6%


    Operating income (loss)                       4.4%                            1,043         -8.6%                    (1,715)                        2,758         160.8%                       -3.6%   (2,371)                      -23.1%    (13,911)                  11,540          83.0%
                                                                                  -----                                   ------                         -----                                               ------                                  -------                   ------


    Other income (expense):

    Interest expense, net                        -0.1%                             (27)        -0.1%                       (29)                            2           6.9%                       -0.1%      (88)                       -0.1%        (85)                     (3)         -3.5%

    Gain (loss) on foreign currency
     transactions                                 1.9%                              444         -0.1%                       (29)                          473              -                        1.1%       738                         0.0%          13                      725              -

    Royalty income                                0.6%                              141          0.7%                        134                             7           5.2%                        0.6%       400                         0.8%         507                    (107)        -21.1%

    Other income (expense), net                  -0.1%                             (19)        -0.3%                       (68)                           49              -                        0.0%        17                        -0.2%       (150)                     167              -
                                                                                    ---                                      ---                           ---                                                  ---                                     ----                      ---

    Total other income, net                       2.3%                              539          0.2%                          8                           531              -                        1.6%     1,067                         0.5%         285                      782         274.4%
                                                                                    ---                                      ---                           ---                                                -----                                      ---                      ---


    Income (loss) before provision
     (benefit) for income taxes                   6.7%                            1,582         -8.4%                    (1,707)                        3,289         192.7%                       -2.0%   (1,304)                      -22.6%    (13,626)                  12,322          90.4%


    Provision (benefit) for income taxes          1.7%                              409          0.4%                         71                         (338)             -                        1.1%       697                        -2.8%     (1,664)                   2,361              -
                                                                                    ---                                      ---                          ----                                                  ---                                   ------                    -----


    Net income (loss)                             5.0%                           $1,173         -8.8%                   $(1,778)                       $2,951         166.0%                       -3.1%  $(2,001)                      -19.8%   $(11,962)                  $9,961          83.3%
                                                                                 ======                                  =======                        ======                                              =======                                 ========                   ======



    Net income (loss) per share - basic                                           $0.03                                  $(0.04)                                                                          $(0.05)                                 $(0.30)
                                                                                  =====                                   ======                                                                            ======                                   ======

    Net income (loss) per share - diluted                                         $0.03                                  $(0.04)                                                                          $(0.05)                                 $(0.30)
                                                                                  =====                                   ======                                                                            ======                                   ======


    Weighted average shares outstanding -
     basic                                                                       41,110                                   40,486                                                                            40,939                                   40,227
                                                                                 ======                                   ======                                                                            ======                                   ======

    Weighted average shares outstanding -
     diluted                                                                     42,104                                   40,486                                                                            40,939                                   40,227
                                                                                 ======                                   ======                                                                            ======                                   ======

 

 

    STAAR Surgical Company

    Consolidated Statements of Cash Flows

    (in 000's)

    Unaudited


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

                                                                                September 29,               September 30,            September 29,                     September 30,

                                                                                                   2017                      2016                               2017                     2016
                                                                                                   ----                      ----                               ----                     ----

    Cash flows from operating
     activities:

       Net income (loss)                                                 $1,173                   $(1,778)                 $(2,001)                         $(11,962)

       Adjustments to reconcile net income
        (loss) to net cash provided by
        (used in) operating activities:

                                            Depreciation of property and
                                            equipment                                                 796                       696                              2,344                    1,933

                                            Amortization of long-lived
                                            intangibles                                                56                        60                                166                      171

                                           Deferred income taxes                                      155                       (4)                               164                  (1,806)

                                           Change in net pension liability                             65                       170                                 95                      390

                                           Stock-based compensation expense                           807                       385                              2,185                    8,143

                                            Loss on disposal of property and
                                            equipment                                                  22                        48                                 22                       65

                                            Provision for sales returns and bad
                                            debts                                                     120                        10                                186                       99

                                           Inventory provision                                        478                       197                              1,267                    1,379

       Changes in working capital:

                                           Accounts receivable                                         62                     1,772                                 41                    1,707

                                           Inventories                                              (183)                    (209)                               725                      222

                                            Prepayments, deposits and other
                                            current assets                                          (486)                    (700)                             (764)                 (1,118)

                                           Accounts payable                                         (984)                    (688)                           (2,751)                     594

                                           Other current liabilities                                1,023                     1,428                                 62                    1,104

                                                 Net cash provided by operating
                                                  activities                                        3,104                     1,387                              1,741                      921



    Cash flows from investing
     activities:

                                            Acquisition of property and
                                            equipment                                               (345)                    (718)                             (969)                 (2,709)

                                                 Net cash used in investing
                                                  activities                                        (345)                    (718)                             (969)                 (2,709)



    Cash flows from financing
     activities:

                                            Repayment of capital lease
                                            obligations                                             (323)                    (118)                             (984)                   (302)

                                            Proceeds from sale-leaseback
                                            transactions                                                -                        -                                 -                   1,154

                                            Repurchase of employee common stock
                                            for taxes withheld                                          -                        -                             (234)                   (611)

                                            Proceeds from vested resricted
                                            stock and exercise of stock
                                            options                                                   313                       915                              2,276                    1,652

                                                 Net cash provided by (used in)
                                                  financing activities                               (10)                      797                              1,058                    1,893



    Effect of exchange rate changes on
     cash, cash equivalents and
     restricted cash                                                                              (54)                      130                                305                      777
                                                                                                   ---                       ---                                ---                      ---


    Increase in cash, cash equivalents
     and restricted cash                                                                         2,695                     1,596                              2,135                      882

    Cash, cash equivalents and
     restricted cash, at beginning of
     the period                                                                                 13,558                    12,807                             14,118                   13,521

    Cash, cash equivalents and
     restricted cash, at end of the
     period                                                             $16,253                    $14,403                   $16,253                            $14,403
                                                                        =======                    =======                   =======                            =======

 

 

    STAAR Surgical Company

    Global Sales

    (in 000's)

    Unaudited


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

                           September 29,                            September 30,          % Change                      September 29,           September 30,            % Change

    Sales by Region                 2017                                      2016          Fav (Unfav)                             2017                     2016            Fav (Unfav)
                                    ----                                      ----          ----------                              ----                     ----            ----------

    North
     America                        9.3%                     $2,192          12.5%  $2,502                      -12.4%             10.3%  $6,786            12.8%  $7,726                -12.2%

    Europe,
     Middle
     East,
     Africa,
     Latin
     America                       27.4%                      6,441          29.8%   5,985                        7.6%             30.5%  20,033            31.1%  18,764                  6.8%

    Asia
     Pacific                       63.3%                     14,840          57.7%  11,565                       28.3%             59.2%  38,940            56.1%  33,805                 15.2%

        Total
         Sales                    100.0%                    $23,473         100.0% $20,052                       17.1%            100.0% $65,759           100.0% $60,295                  9.1%
                                                            =====                  =====                                                 =====                    =====



    Product Sales

        ICLs                       77.2%                    $18,110          73.8% $14,801                       22.4%             75.6% $49,698            72.0% $43,389                 14.5%

        IOLs                       16.6%                      3,892          23.2%   4,649                      -16.3%             19.6%  12,875            24.5%  14,783                -12.9%

        Other                       6.2%                      1,471           3.0%     602                      144.4%              4.8%   3,186             3.5%   2,123                 50.1%
                                                              ---                    ---                                                   ---                      ---

        Total
         Sales                    100.0%                    $23,473         100.0% $20,052                       17.1%            100.0% $65,759           100.0% $60,295                  9.1%
                                                            =====                  =====                                                 =====                    =====

 

 

    STAAR Surgical Company

    Reconciliation of Non-GAAP Financial Measure

    (in 000's)

    Unaudited


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

                                                   September 29,           September 30,                            September 29,           September 30,

                                                                      2017                   2016                                      2017                      2016
                                                                      ----                   ----                                      ----                      ----

    Net income (loss) -(as
     reported)                                                      $1,173               $(1,778)                                 $(2,001)                $(11,962)

    Less:

      Foreign currency impact                                        (444)                    29                                     (738)                     (13)

      Stock-based compensation
       expense                                                         807                    385                                     2,185                     8,143

      Quality remediation expense                                        -                   485                                       210                     1,484

    Net income (loss) -
     (adjusted)                                                     $1,536                 $(879)                                   $(344)                 $(2,348)
                                                                    ======                  =====                                     =====                   =======


    Net income (loss) per share,
     basic -(as reported)                                            $0.03                $(0.04)                                  $(0.05)                  $(0.30)

      Foreign currency impact                                       (0.01)                  0.00                                    (0.02)                   (0.00)

      Stock-based compensation
       expense                                                       $0.02                   0.01                                      0.05                      0.20

      Quality remediation expense                                        -                  0.01                                      0.01                      0.04

    Net income (loss) per share,
     basic -(adjusted)                                               $0.04                $(0.02)                                  $(0.01)                  $(0.06)
                                                                     =====                 ======                                    ======                    ======


    Net income (loss) per share,
     diluted -(as reported)                                          $0.03                $(0.04)                                  $(0.05)                  $(0.30)

      Foreign currency impact                                       (0.01)                  0.00                                    (0.02)                   (0.00)

      Stock-based compensation
       expense                                                        0.02                   0.01                                      0.05                      0.20

      Quality remediation expense                                        -                  0.01                                      0.01                      0.04

    Net income (loss) per share,
     diluted -(adjusted)                                             $0.04                $(0.02)                                  $(0.01)                  $(0.06)
                                                                     =====                 ======                                    ======                    ======


    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

    Note:  Net income (loss) per
     share (adjusted), basic and
     diluted, may not add due to
     rounding

 

 

 

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SOURCE STAAR Surgical Company

 
 
Company Codes: NASDAQ-NMS:STAA
 
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