Full Press Release Details
STAAR Surgical Reports Second Quarter 2017
MONROVIA, CA, August 2, 2017---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 June 30, 2017.
Second Quarter 2017 Overview
"Our work to advance the ICL to its rightful position
as a premium and primary refractive vision correction solution continues to spur strong growth in many countries globally. Unit
growth in Q1 of 20% followed by unit growth of 11% in Q2 in spite of anticipated challenges in the India and Korea markets for
the quarter are an indicator of continued strong progress. During Q2, the Toric ICL achieved another new quarterly record for shipments.
ICL unit highlights for Q2 include growth in Canada of 119%, China of 57%, and Japan of 24%. Region growth was strong in ICL units
as well with North America and Asia Pacific Regions recording 15% unit growth respectively. With the positioning of the sale of
the ICL for the more competitive lower diopter range lenses and the addition of strategic accounts with incentivized volume commitments;
our average selling prices have been appropriately adjusted to gain share in targeted markets. Our position as market leader and
superior refractive surgical solution for high Myopes, however, continues to earn premium pricing," said Caren Mason, President
"Our first-in-man clinical trial for the next generation
ICL with EDOF continued during the quarter and the results continue to be positive. In July, DEKRA, our European Union notified
regulatory body, re-certified our facilities as compliant with ISO 13485 and re-certified the CE marking for all of our currently
certified and commercially available medical devices. With regard to FDA remediation, we completed our internal work in the first
quarter of 2017 and have notified the FDA that we are ready for inspection," added Ms. Mason.
Net sales were $21.9 million for the second quarter of 2017,
up 5% compared to $21.0 million reported in the prior year quarter. The sales increase was driven by ICL revenue and unit growth
of 6% and 11%, respectively, and strong injector part sales. Sales of IOLs decreased 14% compared to the prior year quarter.
For the second quarter of 2017, gross
profit margin was 70.5% compared to the prior year period of 69.7%. The increase in gross margin for the quarter is due
to a 12% increase in Toric ICL sales (our highest margin product), a reduction in inventory reserves and improved unit costs,
partially offset by lower average selling prices and unfavorable product mix due to increased sales of low margin injector
parts. Inventory provisions in 2016 were unfavorably impacted by the discontinuance of silicone IOL sales in the U.S. and
V4b ICL sales internationally.
Operating expenses for the quarter were
flat at $16.8 million compared to the prior year quarter. General and administrative expense was $4.8 million, 3.4% lower
than the prior year quarter. Marketing and selling expense was $7.3 million, up 1.9% compared to the prior year quarter.
Research and development expense was $4.7 million, up 1.1% compared to the prior year quarter.
The net loss for the second quarter of 2017 was $1.0 million
or approximately $0.02 per share compared with a net loss of $2.1 million or $0.05 per share for the prior year quarter.
The Adjusted Net Loss for the second quarter of 2017 was $0.4
million or $0.01 Adjusted Net Loss Per Share, compared with an Adjusted Net Loss of $1.0 million or $0.02 Adjusted Net Loss 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 June 30, 2017
totaled $13.6 million, compared to $14.1 million at the end of the fourth quarter of 2016 and $12.8 million at the end of the second
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 maintain a cash balance consistent with the $13.6 million reported for the end
of the first quarter of 2017.
The Company will host a conference call and webcast on Wednesday,
August 2, 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 54127075), 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 54127075)
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
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 Loss"
and "Adjusted Net Loss Per Share" exclude the following items that are included in "Net 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 Loss" and
"Adjusted Net 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 Loss and Adjusted Net 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". 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.
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, marketing and clinical initiatives, completion of remediation or other expense, 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
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
Brian Moore, 310-579-6199
Doug Sherk, 415-652-9100
STAAR Surgical Company
Consolidated Balance Sheets
| June 30, | December 30, | |||||||
| ASSETS | 2017 | 2016 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 13,438 | $ | 13,999 | ||||
| Accounts receivable trade, net | 16,426 | 16,344 | ||||||
| Inventories, net | 13,458 | 14,825 | ||||||
| Prepayments, deposits, and other current assets | 4,474 | 4,349 | ||||||
| Total current assets | 47,796 | 49,517 | ||||||
| Property, plant, and equipment, net | 11,619 | 11,790 | ||||||
| Intangible assets, net | 383 | 473 | ||||||
| Goodwill | 1,786 | 1,786 | ||||||
| Deferred income taxes | 1,104 | 1,105 | ||||||
| Other assets | 948 | 772 | ||||||
| Total assets | $ | 63,636 | $ | 65,443 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Line of credit | $ | 4,460 | $ | 4,283 | ||||
| Accounts payable | 6,917 | 8,311 | ||||||
| Obligations under capital leases | 1,252 | 1,198 | ||||||
| Other current liabilities | 6,353 | 7,275 | ||||||
| Total current liabilities | 18,982 | 21,067 | ||||||
| Obligations under capital leases | 1,128 | 1,339 | ||||||
| Deferred income taxes | 889 | 881 | ||||||
| Asset retirement obligations | 203 | 195 | ||||||
| Deferred rent | 61 | 59 | ||||||
| Pension liability | 4,080 | 3,997 | ||||||
| Total liabilities | 25,343 | 27,538 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 411 | 407 | ||||||
| Additional paid-in capital | 200,921 | 197,657 | ||||||
| Accumulated other comprehensive loss | (756 | ) | (1,050 | ) | ||||
| Accumulated deficit | (162,283 | ) | (159,109 | ) | ||||
| Total stockholders' equity | 38,293 | 37,905 | ||||||
| Total liabilities and stockholders' equity | $ | 63,636 | $ | 65,443 |