Full Press Release Details
STAAR Surgical ICL Sales Up 67%;
Company Raises Outlook for 2018
MONROVIA, CA, August 1, 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 second quarter ended June 29, 2018.
Second Quarter 2018 Overview
"STAAR generated record quarterly sales of $33.9 Million,
a 55% increase from prior year, driven by the continuing expansive growth of our EVO Visian ICL family of lenses,"
said Caren Mason, President and CEO. "ICL unit growth highlights for the quarter included Japan up 131%, China up 127%, Canada
up 64% and India up 61% with solid 30% unit growth in Germany and 20% growth from our European distributors. We continue to see
a high level of momentum in our key international markets and therefore believe our second half sales growth may exceed 20% even
taking into account our strong finish to 2017. In addition, we believe our full year fiscal 2018 sales growth may now exceed 25%
compared with our prior target for sales growth closer to 20% over 2017, based on current market conditions."
"Operating expense growth during the second quarter remained
comfortably below our rate of sales growth resulting in positive leverage and earnings per share. For fiscal 2018 we now believe
we can achieve at least breakeven GAAP net income as we balance prudent growth spending with targeted levels of profitability.
We believe that the previously announced lifting of the 2014 Warning Letter in the U.S. is a positive step towards moving forward
with the required regulatory approval processes for our Toric and EVO family of lenses in the United States," concluded Ms.
Financial Overview - Q2 2018
Net sales were $33.9 million for the second quarter of 2018,
up 55% compared to $21.9 million reported in the prior year quarter. The sales increase was driven by ICL revenue and unit growth
of 67% and 66%, respectively and strong injector part sales.
Gross profit margin for the second quarter of 2018, was 74.4%
compared to the prior year period of 70.5%. The improvement in gross margin resulted from lower unit costs and lower inventory
Operating expenses for the second quarter of 2018 were $22.2
million compared to the prior year quarter of $16.8 million. General and administrative expenses were $6.2 million compared to
the prior year quarter of $4.7 million. The increase in general and administrative expenses was due to an increase in salary-related
expenses including bonus and stock compensation as well as additional expense in finance and information systems and increased
facility costs versus prior year. Marketing and selling expenses were $10.7 million compared to the prior year quarter of $7.3
million. The increase in marketing and selling expenses was due to increased investments in digital, consumer, and strategic marketing
and commercial infrastructure. Research and development expenses were $5.3 million compared to the prior year quarter of $4.8 million.
The increase in research and development expenses was due to an increase in Medical Affairs expense and initial clinical expenses
associated with our clinical trial for the next generation ICL with EDOF optic, which is in the early stages.
Net income for the second quarter of 2018 was approximately
$1.8 million or $0.04 per share compared with a net loss of $1.0 million or $0.02 per share for the prior year quarter. Adjusted
Net Income for the second quarter of 2018 was $3.9 million or $0.09 per share, compared to an Adjusted Net Loss in the prior year
quarter of $0.4 million or $0.01 per share. 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 29, 2018
totaled $21.4 million, compared to $18.6 million at the end of the fourth quarter of 2017, and $20.9 at the end of the first quarter
The Company will host a conference call and webcast today,
Wednesday, August 1, 2018 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 9764509), 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 9764509)
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 Income (Loss)," "Adjusted Net Income (Loss) Per Share" and "Non-GAAP Earnings
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)," "Adjusted Net Income (Loss) Per Share" and "Non-GAAP Earnings 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 800,000 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.
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,
regulatory approvals, quality, operations and 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 29, 2017 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
EVO family of lenses), or to take enforcement action; research and development efforts; potential international trade disputes;
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 approved for sale in the United States.
Brian Moore, 310-579-6199
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