Second Sight Medical (EYES) Sees FY Revenue of $6.5-$6.9 million

Full Year 2018 net revenue estimated to be in the range of $6.5-$6.9 million --

-- 6th Orion patient scheduled for implantation at Baylor Medical Center --

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 for blind individuals, today reported a business update for the three months, and full year, ended December 31, 2018.

Business and Financial Highlights:

• Implanted 16 Argus® II Retinal Prosthesis Systems (Argus II) worldwide in Q4 2018 for a total of 69 implants in 2018;
• Net revenue estimated to be in the range of $6.5 - $6.9 million for the full year 2018 (pending completion of the Company’s annual GAAP accounting close procedures and audit);
• As of December 31, 2018, Second Sight had $4.5 million in cash and cash equivalents;
• Continued good progress with the Orion® feasibility study:- Five subjects implanted,- Sixth subject scheduled to be implanted in January 2019 at Baylor Medical Center in Houston, TX,- At six months post implant, performance of the Orion subjects appears comparable overall to the performance of Argus II users, and- The safety profile remains very good with only one previously reported Serious Adverse Event (SAE);
• Completed the previously announced restructuring of operations outside of North America to align with the company’s overall corporate strategy, for expected annual savings in operating expenses of approximately $3 million; and
• Announced a rights offering on January 7, 2019 to raise approximately $40 million to support several important ongoing corporate initiatives. Gregg Williams, Chairman of the Board, has indicated his non-binding intention to participate in the rights offering up to $20 million.

“In 2018, Second Sight advanced multiple important initiatives to reposition the Company for growth. I am very pleased with the performance of Orion in the feasibility study. As expected, the performance varies by subject, and I am encouraged with several Orion subjects whose performance compares positively to our typical Argus II users. Recent observations from artificial vision rehabilitation sessions with Orion subjects include them using system to identify parked cars and driveways while walking down a sidewalk as well as identifying the cue ball and striped balls on a pool table. Orion subjects will continue working with our artificial vision rehabilitation specialists in the coming months to further increase their proficiency with the Orion system, while allowing us to better define the expected performance of Orion subjects in a larger pivotal study,” stated Will McGuire, President and CEO of Second Sight.

“Discussions with the U.S. Food and Drug Administration (“FDA”) regarding Orion as part of the Breakthrough Device program are ongoing and continue to be constructive. Our Orion feasibility study is providing important clinical data that will help refine our overall clinical and regulatory path. We are proceeding with planning for a larger pivotal study while also considering the option of requesting an expansion to our feasibility study to gather additional clinical data to aid in the final trial design,” continued McGuire.

“The Argus 2s clinical validation study is now underway in the U.S. with early positive feedback from subjects who are current Argus II users. We expect to gain valuable clinical feedback on our next generation eyewear and video processing unit during this validation study and look forward to a commercial launch of this system later this year,” added McGuire.

“This morning, we are announcing a rights offering to raise approximately $40 million to support the important initiatives we are advancing. Gregg Williams, Chairman of our Board of Directors, has indicated his intention to participate in the offering up to $20 million, reflecting his continued belief in our path forward and the future of our business. Given our current plans, we believe these funds will be sufficient to support our activities through the first half of 2020 as we launch the Argus 2s and advance our Orion clinical and development programs,” concluded McGuire.

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