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STAAR Surgical Reports Fourth Quarter

Key Takeaway: STAAR Surgical Reports Fourth Quarter MONROVIA, CA, March 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 fourth quarter ende

Full Press Release Details

STAAR Surgical Reports Fourth Quarter
MONROVIA, CA, March 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 fourth quarter ended December 30, 2016.
Fourth Quarter 2016 Overview
Full Year 2016 Overview
"We delivered solid fourth quarter performance
that included record quarterly sales for STAAR, record quarterly ICL sales and units and gross margin improvement of
1.4 points as compared to prior year fourth quarter," said Caren Mason, President and CEO. "The 2016 investments
in the clinical, quality, regulatory, research and development, marketing and operations headcount and programs resulted
in appreciable progress toward the achievement of three year transformational goals targeted for completion in
2017. Significantly, we ended the year having completed remediation and quality system internal commitments due in 2016 in
response to past FDA observations. We expect that in 2017, we will complete this work and remediation expense should be
reduced while the upgrade and increase in number of dedicated quality personnel, new quality management software system
implementation and continual process management and improvements will remain as an integral base business expense. As we
enter the third year of our three-year transformation, we again expect double digit ICL unit growth and expanding gross
margins as compared with year-end 2016. We will continue to increase our investments in clinical affairs, corporate
infrastructure, sales and marketing and research and development. Total operating expenses may trend higher in
2017 as we achieve the base business spending level to fortify the business and prepare for growth. Also of note, our
first-in-man clinical trial for the next generation ICL with EDOF continued in the fourth quarter and the results continue to
be positive. Our goal is to introduce this upgraded lens in 2017," added Ms. Mason.
Net sales were $22.1 million for the fourth quarter of 2016,
up 6% compared to $20.9 million reported in the prior year quarter. The sales increase was driven by ICL revenue and unit growth
of 11% and 10%, respectively. Sales of injector parts grew by 2% with IOL revenue flat compared to the prior year quarter. For
the full year, ICL revenue and units increased 15% and 11%, respectively.
For the fourth quarter of 2016, gross profit margin was 71.7%
compared to the prior year period of 70.3%. An increased mix of higher margin ICL units and lower inventory reserves drove the
margin improvement of 1.4 points.
Operating expenses for the quarter decreased $0.1 million to
$14.6 million compared to the prior year quarter. General and administrative expense was $3.9 million, $1.0 million lower than
the prior year quarter primarily due to lower compensation costs. Marketing and selling expense was $6.4 million, $0.6 million
higher than the prior year quarter primarily due to international selling and promotional costs. Research and development expense
was $4.3 million, $0.3 million higher than the prior year quarter due to investments in project-related spending and quality system
improvements, partially offset by lower clinical and FDA remediation expenses. Remediation expense for the quarter was on budget.
The net loss for the fourth quarter of 2016 was $0.2 million
or approximately breakeven per share compared with a net loss of $0.8 million or $0.02 per share for the prior year quarter.
The adjusted net income for the fourth quarter of 2016 was $0.8
million or $0.02 per diluted share, compared with an adjusted net income of $0.5 million or $0.01 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
Cash and cash equivalents at December 30, 2016 totaled $14.0
million, compared to $13.4 million at the end of the fourth quarter of 2015 and $14.3 million at the end of the third quarter of
2016. Continued focus on optimizing the Company's cash position through revenue growth, expense mitigation, working capital
management, and equipment leasing generated an increase in cash of $0.7 million, offset by the effect of exchange rate changes
on cash and cash equivalents of $1.0 million. The Company generated $1.0 million in cash from operating activities during the year.
The Company will host a conference
call and webcast on Thursday, March 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 73119606), 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 73119606) 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 (or Loss)"
excludes the following items that are included in "Net Income (or 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 (or Loss)"
and "Adjusted Net Income (or 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 (or Loss) 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 670,000 Visian ICLs have been implanted
to date. To learn more about the ICL go to: www.discovericl.com. STAAR has approximately 336 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, remediation or other expense, success and timing of new
or improved products, investment imperatives, and any statements of assumptions underlying any of the foregoing. Important additional
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; the negative effect of unstable global economic conditions on sales of products,
especially products such as the ICL used in non-reimbursed elective procedures; 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 may not be successful or may be delayed in
Last updated: Mar 2, 2017