Full Press Release Details
Reports First Quarter 2018 Financial Results
-Orion Feasibility Study on Track with
Encouraging Early Results and Four of Five Subjects Implanted -
- Completed Private Placement of $10
Los Angeles, CA - May 10, 2018 - Second
Sight Medical Products, Inc. (NASDAQ: EYES) ("Second Sight" or "the Company"), a developer, manufacturer
and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision to blind patients,
today reported financial results for the three months ended March 31, 2018.
Recent Corporate Highlights:
"We are making great progress towards achieving our 2018 objectives.
The Centers of Excellence commercial model in the U.S. is proving to be scalable with growth in our patient database and implant
volume. We are also on track to submit regulatory filings for our next-generation Argus II externals and are actively discussing
a label expansion for better-vision retinitis pigmentosa (RP) patients with the U.S. Food and Drug Administration (FDA).
"The five-patient Orion feasibility study in human subjects
is proceeding as expected with highly encouraging early results. Four subjects have now been implanted and the fifth surgery should
occur later this quarter. The first two subjects are repeatedly and reliably seeing light from all 60 electrodes and are currently
undergoing more advanced testing. Our goal with these initial subjects is to create artificial vision through real-time video input
from the eyewear in the near future. Subjects three and four were recently implanted and are expected to be activated in the next
few weeks. We have made our initial submission to the FDA as part of the Breakthrough Device Program and look forward to discussions
with them concerning the path to commercialization for Orion. Orion is an exciting technology which we believe has the potential
to provide useful vision to millions of individuals worldwide who currently have no option," said Will McGuire, President
and CEO of Second Sight.
First Quarter 2018 Financial Results
Total net sales on a GAAP basis were $1.0 million for the first
quarter of 2018 compared to $1.0 million in the first quarter of 2017. Revenue was recognized for nine units in both periods
and revenue from four units was deferred during the first quarter of 2018; revenue from two units was deferred in the prior year
Gross margin was $0.3 million for the first quarter of 2018 compared
to a gross loss of $0.1 million in the first quarter of 2017. The Company's overhead absorption rate for its unit costs are
subject to a high degree of variability based on its production volumes. The Company expects cost of goods on a per-unit basis
to stabilize, particularly related to overhead absorption and excess inventory reserve, as it produces more units.
Research and development expenses were $2.5 million during the first
quarter of 2018 compared to $1.9 million in the first quarter of 2017. The increase of $0.6 million was primarily driven by an
increase in personnel, outside services and internally produced prototypes for next generation products.
Clinical and regulatory expenses were $1.3 million during the first
quarter of 2018 compared to $0.6 million in the first quarter of 2017. The increase of $0.7 million primarily related to an increase
in enrollment in post-market studies due to the higher level of implants over the last 12 months and expenditures associated with
the Orion feasibility study.
Selling and marketing expenses were $3.0 million during the
first quarter of 2018 compared to $2.2 million in the first quarter of 2017. The increase of $0.8 million primarily related to
an increase in headcount and personnel related expenses of $0.3 million, including salaries, and $0.3 million related to market
development activities.
General and administrative expenses were $3.2 million in
first quarter of 2018 compared to $2.7 million in the first quarter of 2017. The increase of $0.5 million is primarily attributable
to $0.3 million of higher compensation costs and the remaining increase relates to outside services and infrastructure costs.
Net loss for the first quarter of 2018 was $9.8 million,
or a loss of $0.17 per share, compared to a net loss of $7.5 million, or a net loss of $0.16 per share, in the first
The non-GAAP net loss for the first quarter of 2018, excluding
certain non-cash items, was $8.5 million, or $0.14 per share, compared to a non-GAAP net loss of $7.2 million, or $0.16 per share
in the first quarter of 2017.
As of March 31, 2018, Second Sight had $5.0 million in cash
and cash equivalents. As announced this week, the Company received $10 million in gross proceeds from a private placement of common
stock with entities beneficially owned by its Chairman, Gregg Williams. This funding is expected to provide Second Sight with current-year
working capital to achieve key commercial and developmental milestones for its Argus II and Orion programs.
For a full reconciliation of non-GAAP financial measures to the
most comparable GAAP financial measures, please refer to the tables included with this press release.
As previously announced, Second Sight management will host its first
quarter 2018 conference call as follows:
| Date | Thursday, May 10, 2018 | |
| Time | 4:30 PM EDT | |
| Telephone U.S: | (800) 704-8312 | |
| International: | (303) 223-4374 | |
| Webcast (live and archive) | www.secondsight.com under the 'Investor Relations' section. |
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 21888918. The archived webcast will be available for 30 days via the aforementioned URL.
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 now manufactures and markets, the Argus II Retinal
Prosthesis System. Development of new hardware and software intended to improve the quality of the vision produced by the Argus
system is ongoing. Second Sight is also developing the Orion Visual Cortical Prosthesis to potentially restore some vision
to individuals who are blind due to many causes other than preventable or treatable conditions. Second Sight's U.S. headquarters
are in Los Angeles, California, and European headquarters are in Lausanne, Switzerland. For more information, please visit www.secondsight.com.
About the Argus II Retinal Prosthesis System
Sight's Argus II System provides electrical stimulation that bypasses defunct retinal cells and stimulates remaining viable cells
inducing visual perception in individuals with severe to profound retinitis pigmentosa (RP). 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 stimulate the retina's remaining
cells, intending to result in the perception of patterns of light in the brain. The patient must learn to interpret these visual
patterns, having the potential to regain some visual function. The Argus II was the first artificial retina to receive widespread
commercial approval, and is offered at approved centers in Canada, France, Germany, Iran, Italy, Russia, Saudi Arabia, Singapore,
South Korea, Spain, Taiwan, Turkey, the United Kingdom, and the United States. Further information on the long-term benefits and
risks can be found in the peer reviewed paper at: http://www.sciencedirect.com/science/article/pii/S0161642016305796
About the Orion Visual Cortical Prosthesis System
Like the Argus II, the Orion converts images captured by a miniature
video camera mounted on the patient's glasses into a series of small electrical pulses. The Orion is designed to transmit these
electrical pulses wirelessly to an array of electrodes implanted on the surface of the visual cortex, intended to result in the
perception of patterns of light. By bypassing the retina and optic nerve and directly stimulating the visual cortex, a cortical
prosthesis system has the potential to restore useful vision to many more patients than the Argus II, including patients completely
blinded due to many reasons, including glaucoma, diabetic retinopathy, or forms of cancer and trauma. The Company is currently
conducting a feasibility study in the U.S. at two centers: the Ronald Reagan UCLA Medical Center and Baylor College of Medicine
in Houston. No clinical data is yet available for the Orion.
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," "goal,"
or "planned," "seeks," "may," "will," "expects," "intends,"
"believes," "should," and similar expressions, or the negative versions thereof, and which also may be
identified by their context. All statements that address operating performance or events or developments that Second Sight expects
or anticipates will occur in the future, such as stated objectives or goals, or that are not otherwise historical facts, are forward-looking
statements. 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 our Annual Report, on Form 10-K, filed on March 20, 2018, and our other reports