Second Sight Medical Products, Inc. (NASDAQ: EYES) ("Second Sight" or
"the Company"), a developer, manufacturer and marketer of implantable
visual prosthetics to provide some useful vision to blind patients,
today reported financial results for the three-month period ended March
31, 2016.
Recent Company Highlights:
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Generated net sales of $1.1 million in the first quarter of 2016
compared to $1.7 million in the first quarter of 2015;
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Implanted 10 Argus® II Retinal Prosthesis Systems ("Argus II")
worldwide during the first quarter of 2016 compared to 19 implants in
the first quarter of 2015;
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Added two new implanting centers during the first quarter of 2016;
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Published positive results in 3-Year FLORA study of the Argus II in
the Australian journal Clinical And Experimental Optometry;
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Implanted the fifth and final subject in the Company’s Dry-Age-Related
Macular Degeneration (“AMD”) study;
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Completed 11 animal implants to date in the Orion™ I Visual Cortical
Prosthesis (“Orion I”) study and are on track to file with the FDA
this year for a human feasibility study to commence in 2017;
-
Appointed Steve Okland as Commercial Vice President, U.S. and Canada;
and,
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Entered into an exclusive agreement with Kisantech Co. Ltd. to
distribute the Argus II in South Korea.
“Despite anticipated challenges due to a change in the 2016 Medicare
outpatient payment rate that affected our U.S. implant volumes in the
first quarter, we believe Second Sight is well-positioned for future
growth,” stated Will McGuire, President and CEO of Second Sight. “In
late February we began temporarily discounting the Argus II in the U.S.
to continue to make our life-changing technology available to qualified
patients. We are confident that this decision will allow implant volumes
in the U.S. to rebound over the next several quarters. In fact, we are
pleased with the level of activity that we are seeing with customers who
are currently assessing patients and scheduling surgeries,” McGuire
added.
“Looking ahead, we are excited about the multiple opportunities for
Second Sight to serve a growing population of individuals that have lost
their sight. We are developing significant enhancements to the Argus II
externals and advanced software improvements are on the horizon. Our
Dry-AMD trial is now fully enrolled and for the Orion I, we have
concurrence with the FDA on key pre-clinical tests that pave the way for
a human feasibility study in 2017. Taken together, we are building a
solid platform that will deliver long-term growth and move us closer to
our ultimate goal of restoring vision to the blind and improving their
overall quality of life,” concluded McGuire.
First Quarter 2016 Financial Results
Total revenue was $1.1 for the first quarter of 2016, compared with $1.7
million in the first quarter of 2015. There were 10 Argus II retinal
prostheses implanted in the first quarter of 2016, compared to 19 for
the first quarter of 2015. The decline was primarily driven by a
reduction in U.S. implant volumes as a result of customer concerns that
the new Medicare outpatient payment rate, which became effective on
January 1, 2016, would be insufficient to cover costs of the Argus II
and related surgical procedure. As a result, the Company made a decision
to temporarily discount the Argus II in late February to address this
concern and expects implant volumes to rebound in future quarters.
Gross profit was $141,000 in the first quarter of 2016, compared to
$404,000 in the first quarter of 2015. Gross margin was lower, largely
due to lower sales and production volumes in the current quarter.
Total operating expenses in the first quarter of 2016 were $6.0 million,
compared with $5.4 million in the first quarter of 2015, reflecting
higher clinical and stock based compensation costs, offset by lower
research and development expenses net of grants.
Net loss in the first quarter of 2016 was $5.8 million, or $0.16 per
share, compared with a net loss of $5.0 million, or $0.14 per share, in
the prior year quarter. The Company recorded non-cash charges of $1.0
million and $0.6 million during the first quarters of 2016 and 2015,
respectively.
Non-GAAP adjusted net loss in the first quarter of 2016, excluding
non-cash charges, was $4.8 million, or a non-GAAP net loss of $0.13 per
share, compared to a non-GAAP adjusted net loss of $4.4 million, or
$0.12 per share, in the first quarter of 2015.
2016 Objectives
-
Secure coverage with additional Medicare Administrative Contractors
(MACs) in the U.S. as well as other key markets globally;
-
Work with CMS to establish Medicare reimbursement rates that cover the
costs related to furnishing the Argus II to patients in 2017 and
beyond;
-
Expand global footprint by continuing to grow the number of implanting
centers and enter additional markets;
-
Improve the Argus II technology, including significant R&D milestones
for the next generation externals and advanced software;
-
Complete enrollment of the Dry Age-Related Macular Degeneration
feasibility clinical trial and finalize a go-forward strategy; and
-
Complete animal testing and file the Investigational Device Exemption
(IDE) application with the FDA to test the Orion I in humans.
Conference Call
As previously announced, Second Sight management will host its first
quarter 2016 conference call as follows:
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Date
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April 28, 2016
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Time
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4:30 PM EDT
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Telephone U.S:
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(800) 950-7243
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International:
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(212) 231-2919
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Webcast (live and archive)
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www.secondsight.com
under the 'Investor Relations' section.
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A replay of the conference call will be available for two weeks after
the call's completion by dialing (800) 633-8284 (U.S.) or (402) 977-9140
(International). The conference ID for the replay is 21810024. The
archived webcast will be available for 30 days via the aforementioned
URL.
About the Argus II® Retinal Prosthesis System
Second Sight's Argus II System provides electrical stimulation that
bypasses the defunct retinal cells and stimulates remaining viable cells
inducing visual perception in individuals with severe to profound
Retinitis Pigmentosa. The Argus II works by converting images captured
by a miniature video camera mounted on the patient's glasses into a
series of small electrical pulses, which are transmitted wirelessly to
an array of electrodes implanted on the surface of the retina. These
pulses are intended to stimulate the retina's remaining cells, resulting
in the perception of patterns of light in the brain. The patient then
learns to interpret these visual patterns, thereby regaining some visual
function. The Argus II is the first artificial retina to receive
widespread approval, and is offered at approved centers in Canada,
France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland,
Turkey, United Kingdom, and the U.S.
About Second Sight
Second Sight's mission is to develop, manufacture and market innovative
implantable visual prosthetics to enable blind individuals to achieve
greater independence. Second Sight has developed and manufactures the
Argus® II Retinal Prosthesis System. Enrollment has been completed in a
trial to test the safety and utility of the Argus II in individuals with
Dry Age-Related Macular Degeneration. Second Sight is also developing
the Orion™ I Visual Cortical Prosthesis to restore some vision to
individuals who are blind due to causes other than preventable or
treatable conditions. U.S. Headquarters are in Sylmar, California, and
European Headquarters are in Lausanne, Switzerland. For more
information, visit www.secondsight.com.
Safe Harbor
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange and Exchange Act of 1934, as
amended, which are intended to be covered by the "safe harbor" created
by those sections. All statements in this release that are not based on
historical fact are "forward looking statements." These statements may
be identified by words such as "estimates," "anticipates," "projects,"
"plans," or "planned," "seeks," "may," "will," "expects," "intends,"
"believes," "should," "potentially," "objectives," and similar
expressions or the negative versions thereof and which also may be
identified by their context. While management has based any forward
looking statements included in this release on its current expectations,
the information on which such expectations were based may change.
Forward-looking statements involve inherent risks and uncertainties
which could cause actual results to differ materially from those in the
forward-looking statements, as a result of various factors including
those risks and uncertainties described in the Risk Factors and in
Management's Discussion and Analysis of Financial Condition and Results
of Operations sections of the Company’s Annual Report on Form 10-K as
filed on March 11, 2016 and the Company’s other reports filed from time
to time with the Securities and Exchange Commission. We urge you to
consider those risks and uncertainties in evaluating the Company’s
forward-looking statements. We caution readers not to place undue
reliance upon any such forward-looking statements, which speak only as
of the date made. Except as otherwise required by the federal securities
laws, we disclaim any obligation or undertaking to publicly release any
updates or revisions to any forward-looking statement contained herein
(or elsewhere) to reflect any change in the Company’s expectations with
regard thereto or any change in events, conditions or circumstances on
which any such statement is based.
Reconciliation to Non-GAAP Financial Measures
In addition to reporting all financial information required in
accordance with generally accepted accounting principles (GAAP), the
Company is also reporting Non-GAAP net loss and Non-GAAP net loss per
share which are non-GAAP financial measures. Non-GAAP net loss and
Non-GAAP net loss per share are not measurements of financial
performance under GAAP and should not be used in isolation or as a
substitute or alternative to net income, operating income or any other
performance measure derived in accordance with GAAP, or as a substitute
or alternative to cash flow from operating activities or a measure of
the Company’s liquidity. In addition, the Company's definition of
Non-GAAP net loss and Non-GAAP net loss per share may not be comparable
to similarly titled non-GAAP financial measures reported by other
companies. Non-GAAP net loss and Non-GAAP net loss per share, as defined
by the Company, represent net loss adjusted for non-cash stock-based
compensation. Management believes that these non-GAAP financial measures
provide useful supplemental information regarding the performance of the
Company’s business operations and facilitates comparisons to the
Company’s historical operating results. For a full reconciliation of
Non-GAAP net loss to the most comparable GAAP financial measures, please
see the tables at the end of this press release.
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SECOND SIGHT MEDICAL PRODUCTS, INC.
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AND SUBSIDIARY
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Condensed Consolidated Balance Sheets
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(in thousands)
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|
|
|
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March 31,
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December 31,
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2016
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2015
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(unaudited)
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ASSETS
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Current assets:
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Cash
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$
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459
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$
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239
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Money market funds
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9,786
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15,721
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Accounts receivable
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822
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1,501
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Inventories, net
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9,081
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|
|
|
|
8,209
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Prepaid expenses and other current assets
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|
|
|
|
932
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|
|
|
|
|
1,094
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|
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|
|
|
|
|
|
|
|
|
|
|
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|
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Total current assets
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|
|
|
|
|
|
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21,080
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26,764
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|
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|
|
|
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Property and equipment, net
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1,429
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|
|
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|
1,432
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Deposits and other assets
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50
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49
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Total assets
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$
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22,559
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$
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28,245
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LIABILITIES AND EQUITY
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Current liabilities:
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|
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Accounts payable
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$
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707
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$
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710
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Accrued expenses
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1,664
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|
|
|
|
|
2,068
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Accrued compensation expense
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1,696
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|
|
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|
2,069
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Accrued clinical trial expense
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601
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616
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Deferred revenue
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|
325
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|
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|
322
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Deferred grant revenue
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1,630
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2,197
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Total current liabilities
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6,623
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7,982
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Commitments and contingencies
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|
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Stockholders’ equity
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|
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|
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|
15,936
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|
|
|
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20,263
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|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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Total liabilities and stockholders’ equity
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|
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|
$
|
22,559
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|
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$
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28,245
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|
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|
|
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SECOND SIGHT MEDICAL PRODUCTS, INC.
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AND SUBSIDIARY
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|
|
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Condensed Consolidated Statements of Operations
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(in thousands, except per share data)
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|
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|
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|
|
|
|
|
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|
|
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Three Months Ended
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March 31,
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|
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2016
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2015
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(unaudited)
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|
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|
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Net sales
|
|
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|
|
|
$
|
1,053
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|
|
|
|
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$
|
1,700
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Cost of sales
|
|
|
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|
|
912
|
|
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|
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|
1,296
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|
Gross profit
|
|
|
|
|
|
|
141
|
|
|
|
|
|
|
404
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|
|
|
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|
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|
|
|
|
|
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|
|
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Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
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Research and development, net of grants
|
|
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|
|
|
762
|
|
|
|
|
|
|
1,048
|
|
Clinical and regulatory
|
|
|
|
|
|
|
778
|
|
|
|
|
|
|
666
|
|
Selling and marketing
|
|
|
|
|
|
|
2,012
|
|
|
|
|
|
|
1,995
|
|
General and administrative
|
|
|
|
|
|
|
2,410
|
|
|
|
|
|
|
1,656
|
|
Total operating expenses
|
|
|
|
|
|
|
5,962
|
|
|
|
|
|
|
5,365
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
|
|
|
(5,821)
|
|
|
|
|
|
|
(4,961)
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|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Interest and other income, net
|
|
|
|
|
|
|
5
|
|
|
|
|
|
|
5
|
|
|
|
|
|
|
|
|
|
|
|
|
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Net loss
|
|
|
|
|
|
$
|
(5,816)
|
|
|
|
|
|
$
|
(4,956)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Net loss per common share – basic and diluted
|
|
|
|
|
$
|
(0.16)
|
|
|
|
|
|
$
|
(0.14)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding – basic and diluted
|
|
|
|
|
35,971
|
|
|
|
|
|
|
35,301
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|
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|
|
|
|
|
|
|
|
|
|
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SECOND SIGHT MEDICAL PRODUCTS, INC.
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AND SUBSIDIARY
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of Non-GAAP Information to Most Comparable GAAP
Measures
|
|
(in thousands, except per share data)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Three Months Ended
|
|
|
|
|
|
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March 31,
|
|
|
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
$
|
(5,816)
|
|
|
|
$
|
(4,956)
|
|
|
|
|
|
|
|
|
|
|
|
|
Add back non-cash charges:
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
|
|
|
1,021
|
|
|
|
|
568
|
|
Non GAAP net loss
|
|
|
|
|
$
|
(4,795)
|
|
|
|
$
|
(4,388)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
|
|
|
|
$
|
(0.16)
|
|
|
|
$
|
(0.14)
|
|
|
|
|
|
|
|
|
|
|
|
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Add back non-cash charges:
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
|
|
|
0.03
|
|
|
|
|
0.02
|
|
Non GAAP net loss per share
|
|
|
|
|
$
|
(0.13)
|
|
|
|
$
|
(0.12)
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View source version on businesswire.com: http://www.businesswire.com/news/home/20160428006782/en/
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