Second Sight Medical Products' (EYES) CEO Will McGuire on Q4 2017 Results - Earnings Call Transcript
Second Sight Medical Products (EYES) Q4 2017 Earnings Conference Call March 7, 2018 4:30 PM ET
Executives
Lisa Wilson - IR
Robert Greenberg - Chairman
Will McGuire - President & CEO
Tom Miller - CFO
Analysts
Dan Weston - Pinnacle
Amit Dayal - H. C. Wainwright & Co.
Operator
Ladies and gentlemen, thank you for standing by and welcome to the Second Sight Fourth Quarter 2017 Results Conference Call.
Now during today's conference, all telephone participants will start in a listen-only mode, but later we'll conduct a question-and-answer session. [Operator Instructions]. And a quick reminder, today's conference is being recorded, it's Wednesday, March 07, 2018.
All right. It's now my pleasure to introduce Lisa Wilson, Investor Relations. Please go ahead.
Lisa Wilson
Thank you, David. Good afternoon and welcome to Second Sight's fourth quarter and full year 2017 earnings call. This is Lisa Wilson, Investor Relations for Second Sight.
With me on today's call are Dr. Robert Greenberg, Chairman of the Board of Directors; Will McGuire, President and Chief Executive Officer; and Tom Miller, Chief Financial Officer.
At the close of market, the company issued a press release detailing financial results for the three and 12 months ended December 31, 2017. The press release can be accessed through the Investor Relations section of the Second Sight website at secondsight.com. You can also access the webcast of this call from there.
Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance, may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to Second Sight's management as of today and involve risks and uncertainties, including those noted in this afternoon's press release and Second Sight's SEC filings. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. Second Sight specifically disclaims any intent or obligation to update these forward-looking statements except as required by law.
A telephone replay of the call will be available shortly after completion of this call for the next two weeks. You'll find the dial-in information in today's press release. The archived webcast will be available for one month on the company's website, secondsight.com.
For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on March 07, 2018. Since then, Second Sight may have made announcements related to the topics discussed. So, please reference the company's most recent press releases and SEC filings.
And with that, I'll turn the call over to Second Sight's Chairman, Dr. Robert Greenberg.
Robert Greenberg
Thank you, Lisa and thank you all for joining our call this afternoon.
We've begun 2018 with significant momentum as a direct result of the efforts we implemented last year. 2017 was an important year for Second Sight in which we implanted 75 patients with the Argus II while validating our centers of excellence strategy and growing our funnel of new patients in the U.S.
We expanded our reach into new markets around the world and took steps to strengthen our position in Europe and Asia. Importantly, we see the momentum we achieved in 2017 continuing into 2018.
Second Sight is also well-positioned to capitalize on expansion of our addressable markets as we advance our R&D and clinical research efforts. Just a few short weeks ago, we successfully implanted and also activated our first in human subject with the Orion cortical visual prosthesis at UCLA. This is a significant achievement for the company and an important milestone in advancing Orion.
The patient was able to see phosphenes, or spots of light on nearly every electrode tested. This patient is doing well with no serious adverse events. We plan to continue with an additional four patients in this feasibility study at UCLA and the Baylor College of Medicine in Houston this year.
Our efforts also extend to the expansion of our treatable RP market, to include better sighted individuals who otherwise suffer from no real usable vision. Next generation externals are currently undergoing verification and validation and anticipate having a regulatory submission ready by midyear and a launch by year-end.
In the U.S. we submitted a humanitarian device exemption supplement to the FDA requesting a label expansion that would allow us to treat better vision RP patients in the U.S. With regard to our AMD trial in the U.K. we've opted to finish out the study in Manchester, but not extend or expand it at this time.
Current performance does not justify enrolling additional patients. Instead, we intend to focus on the exciting opportunities provided by our better vision RP efforts and advancing the Orion.
2018 looks to be another significant year for Second Sight and we look forward to updating you on our continued commercial R&D and clinical research progress.
And with that, I'd like to now turn the call over to Tom to review our fourth quarter and full-year financial results. Tom?
Tom Miller
Thank you, Bob. For the fourth quarter of 2017, net sales increased to $3.1 million compared to $715,000 in the fourth quarter of 2016, driven mainly by the higher number of implants. For the year, net sales more than doubled to $8 million compared to $4 million in 2016, driven by a higher number of implants and a higher average revenue per implant.
Our implant volume during the fourth quarter of 2017 increased to a record 30 units, compared to seven during the prior year quarter. For the year, we had 75 implants compared to 42 in 2016. The average revenue per implant was $106,000 in 2017 compared to $95,000 in 2016, reflecting the benefit of higher CMS pricing and the higher mix of North American implants, where selling prices are generally higher.
During the quarter, 14 implants were performed in North America and 16 in Europe, the Middle East and Asia. For the year, 38 implants were performed in North America with the remaining 37 in markets outside of North America.
We generated gross profit of $1.2 million in the quarter, compared to a gross loss of $2.6 million in the fourth quarter of 2016. Gross profit in the fourth quarter of 2014 included a credit of $1.4 million to partially reverse a previously established reserve for slow-moving inventory and an $800,000 charge for unabsorbed overhead costs.
The gross loss for the fourth quarter of 2016 included a $2.1 million reserve for slow-moving inventory and a $700,000 charge for unabsorbed overhead costs. Gross profit for the full year was $2.8 million compared to a gross loss of $6.1 million in 2016.
R&D expense including the offset due to grant revenue was $2.3 million during the fourth quarter of 2017 compared to $2.1 million in the prior year quarter. Grant revenue was $121,000 in the fourth quarter of 2017 compared to approximately $381,000 in the fourth quarter of 2016 due to a grant that was fully utilized by the end of the first quarter of 2017.
Excluding this grant revenue, R&D cost decreased by 3% or about $70,000 in the fourth quarter of 2017 versus the fourth quarter of 2016, mainly due to lower spending on outside consultants and supplies in the current quarter. For the year, R&D costs were $7.9 million compared to $5.3 million as a result of the decrease in grant revenue for the year and higher spending on new products.
Clinical and regulatory costs increased during the fourth quarter of 2017 to $1.1 million compared to $748,000 in the prior year quarter. The increase reflects our investment in clinical staff and outside consultants as we prepare for clinical testing of Orion at Argus II better vision patient trials in Germany.
For the year, clinical and regulatory costs were $3.1 million compared to $2.7 million in 2016. Selling, general and administrative costs were up 6% during the fourth quarter of 2017 compared to 2016, increasing from $5 million to $5.3 million. For the year, SG&A increased by 7% to $20.5 million in 2017 compared to $19.1 million in 2016.
The increase reflects our expanded commercial efforts related to the Argus II as well as higher legal and compensation costs in the current year. Net loss for the fourth quarter of 2017 was $7.4 million or a loss of $0.13 per share. This compares to a net loss of $10.4 million or a loss of $0.24 per share in 2016.
2017 net loss was $28.5 million or a loss of $0.53 per share compared to a net loss of $33.2 million or a loss of $0.84 per share in 2016. Our non-GAAP net loss for the fourth quarter was $0.14 per share compared to a non-GAAP net loss of $0.17 in the fourth quarter of 2016.
Full year non-GAAP net loss was $0.51 per share compared to a non-GAAP net loss of $0.63 per share in 2016. A full reconciliation of our GAAP net loss to our non-GAAP net loss including a per-share reconciliation can be found in the tables at the end of our earnings release.
Moving to the balance sheet, as of December 31, 2017, we had $7.8 million of cash in money market funds with no debt. The year-end balance includes $1.2 million that we raised as part of our Aftermarket Financing Arrangement or ATM. Since yearend, we've raised another $4 million as part of the ATM.
I'd also like to note, that based on recent stock prices, the registration statement on Form S3 that we filed in the fourth quarter now qualifies as a full-size shelf registration. This means that we are no longer subject to $13.6 million annual limitation noted on our original filing.
With that, I'd turn the call over to Will to review our business results. Will?
Will McGuire
Thank you, Tom and thank you all for joining us today. Before I discuss the successful activation of our first human patient with the Orion, I'd like to begin by stating that I'm pleased with our progress in 2017 and excited about our opportunities in 2018.
If you will recall, in 2017 we set out to achieve three primary objectives. Our first objective was for Steve Oakland and the North America team to demonstrate traction with our Centers of Excellence or COE commercial model. As Tom stated, we completed 14 Argus surgeries during Q4 in North America. More importantly, as we begin the new year we believe 10 of our North American centers meet our COE definition and are committed to performing one or more Argus implants per quarter in 2018.
By way of comparison, we had no North American centers performing at this level in 2016. I am confident that we now understand what it takes to establish and support an Argus Center of Excellence. The key part of the commercial strategy in North America is the development of our patient database to ensure a flow of patients to each center of excellence. Today that database has over 125 clinician qualified U.S. patients, up from 89 at the end of the third quarter and as of January 01 of this year, 10 different sites have four or more clinician-qualified patients awaiting scheduling, a goal we set in the second half of 2017.
As evidence of the importance of the database eight of the 14 North America patients that we treated in Q4 were identified through our patient outreach efforts in the first quarter of 2017. We believe a majority of the patients in the database will ultimately receive the Argus II implant or could be considered for expanded treatment options such as the Orion in the future.
I'd like to complement Frank Vandeputte and the team in Europe on a fantastic Q4 with 16 Argus surgeries. The team also opened up the Iranian market with three implants in Q4 as well as adding a new center in Singapore during January. The business in Europe, the Middle East and Asia is quite complex with many different markets and much more potential for variability than the North American market.
With that said, I am confident that Frank and the team will grow the business as we refine our overall commercial strategy and continue securing reimbursement in the various markets.
Our second objective was to expand the addressable market for the Argus II and demonstrate our ability to treat better vision patients who otherwise have no real usable vision. There are multiple efforts underway to achieve this goal, including the development of new externals, the development of advanced stimulation programs and the calculation of supporting clinical data.
As discussed in past calls, we are developing next generation externals, which include the eyewear camera and VPU. Engineering work is essentially complete and the system is currently undergoing verification and validation testing. We expect to complete regulatory submissions midyear with a launch anticipated in the second half of 2018.
These new externals are important and that they will serve as a platform for the future, enabling regular software upgrades as well as providing the processing power to support implementation of our advanced stimulation programs.
During the second half of 2017, we completed testing of various stimulation programs in 16 patients. Results are varied by patient and performance is somewhat limited by their current generation externals, specifically the hardware and software. Our goal this year will be to add stimulation program algorithms to the aforementioned NextGen externals and continue patient testing on a newer, more capable platform.
Pursuant to an expanded label in the U.S. we recently submitted a Humanitarian Device Exemption our HDE supplement to the FDA. This submission takes data gathered outside of the U.S. on a broader patient population and request the label expansion in the U.S. to include some better vision patients. We expect a response from the FDA in the second quarter of 2018.
We also began screening patients for a better vision RP study at several sites in Germany. The startup of this trial has been hampered by personnel issues at several of the clinical sites and we're evaluating the best path forward.
As Bob mentioned, we implanted and activated our first in human subject with Orion earlier this quarter. You may recall, that this was our third and most ambitious goal of 2017. This is a tremendous achievement for the Second Sight team and truly a breakthrough for the blind.
Our first Orion patient was implanted on January 30, 2018 at UCLA. The patient is doing well and there have been no reported serious adverse events. The testing is phased with encouraging results up to the first phase during which 60 electrodes were individually stimulated. The patient reported seeing phosphenes, or spots of light with almost all of the electrodes.
Over the next few quarters, testing will continue as we advance to the point of the Orion system utilizing real-time video input from the eyewear to create artificial vision via a stimulation of multiple electrodes in appropriate patterns. The early results certainly have met or exceeded my expectations.
Our plan is to include a total of five subjects in the study. UCLA is recruiting additional subjects as is Baylor Medical Center in Houston. We've been running radio-ads for Orion in both markets. The ads generated over 200 calls during the first week indicating strong interest. I'm confident that we'll be able to recruit all five subjects for the trial and remain on track with our internal timelines.
As previously disclosed, during the fourth quarter of 2017, Orion was officially designated as a breakthrough device by the FDA, making it eligible for priority review and potentially allowing us to commercialize the technology faster.
We plan to request our first meeting with the FDA soon and our goal over the course of multiple discussions will be to agree on a data development plan from feasibility through pivotal to post market evaluation. The progress to-date is a testament to the deep R&D regulatory and clinical teams assembled at Second Sight.
Over the past year, we have assembled the strongest team in artificial vision and added experts from the field of brain stimulation as well as expertise in project execution to become even stronger. We look forward to providing further updates relative to Orion as we continue advancing this breakthrough technology.
Before concluding with 2018 objectives, I'd like to touch on a few additional updates relating to reimbursement. As reported earlier this week, we received notice that Palmetto GBA formerly Cahaba, is the latest MAC to provide coverage for the Argus II and the related surgical procedure.
As a result of this decision coverage will now include Alabama, Georgia and Tennessee. This brings the total coverage of the Argus II to 31 states, two territories in the District of Columbia. We are actively working with the remaining two MACs with nine coverage policies to further expand our coverage nationwide.
We are also engaged in our annual discussions with CMS regarding the Medicare outpatient payment rate for the Argus II in the associated surgical procedure. As CMS publishes updates to the proposed 2019 payment rate, we will update investors accordingly.
Outside of the U.S. we expect to start implanting patients in England during the second half of this year, as part of the NHS England CTE Innovation Funding Program. In France as you may recall, Second Sight was the first recipient of the French Government National Healthcare Reimbursement entitled Forfait Innovation. We are preparing a submission that will go to French authorities by mid-year that will start the process of moving from Forfait coverage to national reimbursement.
The process will likely take a year to complete, but if approved we could expand from three current sites to additional sites treating larger patient populations across the country. In our newer indirect or distributor markets, overall progress on reimbursement is positive and we continue to work to secure coverage in each market.
In closing, I'd like to outline our goals for 2018. We plan to number one complete Orion feasibility trial enrolment and prepare for the initiation of the pivotal trial. Number two, gain increased visibility to Orion’s commercialization path, including pivotal trial and market requirements for the FDA breakthrough device program.
Number three, submit regulatory filings for next gen Argus II externals and execute a commercial watch before yearend. Number four, pursue Argus II label expansion in the US to include better vision RP patients. And number five, demonstrate the scalability of the COE model as we grow the number of implanting centers in the US patient database and overall implant numbers in North America.
Before opening the call for questions I'd also like to note that we have sufficient cash to fund the company into the second half of June 2018. We are currently reviewing options for financing the company with the board and feel highly confident that we have several viable options available. As always, we will update investors as appropriate.
With that I'll open the call for questions. Operator, please proceed with instructions.
Question-and-Answer Session
Operator
Yes sir. [Operator Instruction] The first question is coming from the line of Dan Weston. You may now proceed.
Dan Weston
Yeah hi, good afternoon, guys. Thanks for taking the questions and congratulations on your year and your progress, especially on the successful Orion implant. I had a couple questions just in terms, first on the expected ramp that you see happening for implant on Argus throughout 2018. Should I look at that as kind of a linear continuous ramp or how should we be looking at that?
Will McGuire
Hi Dan, this is Will, I’ll take that. Yeah, we're not going to give actual guidance for 2018, but I would like to make a couple of comments about what I expect. First of all, in North America, I have really great confidence in our ability to ramp volumes going forward and I attribute much of that to the Centers of Excellence strategy as we've discussed.
I think we've got most of the issues at the centers addressed and we understand what kind of support they need in order to do a higher volume of Argus procedures.
I'd say there's probably three main things that will drive the continued ramp and will drive greater volumes in the future, one, would be the patient database. Obviously, we've got to be able to funnel these patients to each one of these centers and as we as we said in the remarks, the database has grown to 125 clinician-qualified candidates and we'll keep growing that every quarter.
The second thing that's important is predictable reimbursement coverage. We've done a good job of expanding our coverage. We still have a pretty good swath of the U.S. to go to add Medicare coverage and we're also working on all the other ancillary things that need coverage whether it be you know rehabilitation, programming, upgrades etcetera, etcetera.
But again, we're making good progress and our intent is to maintain that momentum and make sure the reimbursement is kind of consistent going forward. And then finally is account expansion, overall in the U.S. right now we have approaching 20 centers. And as I said in the remarks, we think 10 of these are functioning at the level of what we expect from a center of excellence.
But still with that number of centers we still have 50% of North America that is not covered. So, we have quite a few areas to add centers, which means there's just a lot of underserved or not served population that's still out there for us.
So again, a lot of confidence that you'll see continued growth, continued ramp in North America. Just a couple of comments on outside of North America and it's really -- it's a pretty complex geography. We're in 11 different countries. We did implants in seven or eight I think eight different countries last year.
Some markets are direct and others are served with our distributor partners and then the majority of these markets we're still working to get national reimbursement and we also don't have the patient outreach programs in place like we do in the U.S.
So again, I think we'll have growth in those markets, but I want to make it clear that I could -- that you could see and I do expect more volatility in the markets outside of North America going forward. But again, I feel very confident what Frank and the team is doing there and I think you'll see growth in that market as well in 2018 and beyond.
Dan Weston
Very good. I have a couple more if you don't mind. Just you're touching on the -- on your Centers of Excellence, I wanted to know or get a little better handle on the strategy there for maybe expansion of Centers of Excellence and how the centers of excellence strategy can relate to the overall ramp and implant volume?
Will McGuire
Sure. I don't think we're ready to give I guess a prediction on how many centers we’ll add this year. I would say it would be more than last year, which was only four, so probably certainly in the five to 10 center range and we do expect all of the new centers that we add Dan to perform at the one or two units per quarter rate.
So, we've had good -- and we've had good success. If you look at 2017, we added four new centers and those centers contributed 14 units for the year. And then if you just look at when they were added and calculate kind of a rate they all were performing at the rate of one to two units per quarter.
So, I think we demonstrated last year that we could add the right centers and that they would perform. And now we will add more of those centers in 2018 and I fully expect that, that they will perform at this one to two units per quarter as well.
So, yes, a short answer would be the new centers that we add could be a very significant driver to the growth in 2018 versus 2017.
Dan Weston
That's great. Well I appreciate that. My last question just in terms of the competitive landscape, what should we all be looking for out there in terms of other competition, whether it be in gene therapy or maybe one of the companies out in Europe, I think it's Pixium and how that relates to your company? Maybe you can just discuss that in general?
Will McGuire
Sure. Great. I'd be glad to. I will make a few comments concerning Pixium and then Bob can probably jump in and address your gene therapy. So, from Pixium, there's been really two announcements -- two major announcements from Pixium over the last 90 to 120 days.
First, they did announce that they received two approvals to start two feasibility studies for their newest device which is called PRIMA and it's a sub retinal device and they announced to five patient feasibility study in Paris, France and then a five-patient feasibility study in Pittsburgh at UPMC.
In both of these studies they're targeting dry AMD, so they're targeting AMD patients. So far, the update has been that they have implanted to patients in Paris, they said implanted and activated and they said there was a successful activation.
The second, I guess, bit of news from Pixium was that they withdrew their product called IRIS II, and it was the device that had a CE mark and is more similar to Argus, it’s a epiretinal device. They withdrew it from the European market due to earlier than expected device failures in a trial and then they also announced the postponement developments to the IRIS II. So, they were they were going to do some developments to improve the implants life-expectancy but they postpone that.
So, in essence I guess the bottom line is you know they have removed the product that was probably our most significant competitor in Europe. They removed it from the market. They're not actively working to improve it to get it back on the market. And they're really focusing on this new sub retinal device, PRIMA, which is just now entering feasibility studies.
Robert Greenberg
Bob thanks. Thanks Dan for the question. So, on your question about gene therapy there has been some progress in gene therapy that's been in the news lately as a company Spark Therapeutics has a product that was approved by the FDA in December.
It's for a very particular gene defect and RP. So there -- in retinitis pigmentosa, which the Argus currently treats, there there's well over 100 different genes that cause the disease. And Spark’s approvals is for one of those one of those genes, one of those 100 plus genes.
The particular gene that they chose is one that affects children primarily. And so, the, I think the average age in their trial was around 15. And they're also treating patients who haven't lost their vision completely.
So, they showed in their trial that they were able to improve light the ability of patients to navigate amaze and lower light lower light conditions. So, these are sighted partially sighted patients that were able to use their sight and lower light conditions, as a result of this of this gene therapy.
So, we don't think it's going to have a significant impact at all on our Argus sales. Their patient population is quite small perhaps as small as 500 patients in the U.S. and the - it really doesn't overlap with our current indications for Argus even small population.
One of the things that is interesting about them is they've announced their pricing $850,000 for this onetime treatment and that's something that Medicare has not agreed to yet, but it's something that we're following quite closely.
They're looking at novel payment plans including instalment plans and success-based plans. And so those are things that could positively impact Argus if the industry moves to this much higher payment levels for therapies of these patients.
Dan Weston
That's a great point Bob. I think what I'm going to jump back in queue. Let somebody else have a chance. I just want to say congratulations especially on Orion. And that's really exciting news. Congratulations.
Robert Greenberg
Okay. Thank you very much.
Operator
[Operator Instruction] Next question comes from the line of Dayal from H. C. Wainwright & Co. you may now proceed.
Amit Dayal
Thank you. Good afternoon, guys. Good to see all the progress. Congratulations. Just in terms of how Orion progresses from here. I know you broke out some of the steps that are coming up, could you give us a little bit more granularity from a timeline perspective Q2, Q3, Q4, like what we should expect in terms of the company's milestones against Orion coming through?
Robert Greenberg
Sure Amit. This is Bob. I'll take that one. So, the -- you maybe let me go back and tell you a little bit more about the patient that we implanted and kind of what our plans are going forward. So, as we mentioned on the call, our plans -- this study is for a five-patient study and we implanted our first patient so far and our plan is to implant the remaining patients this year.
The patient that we implanted, the surgery was a two-hour surgery and that compares to the early Argus surgeries that were four hours. So, to give you an idea, this is about half the time of an Argus surgery. It was a quite straightforward surgery today. The Argus surgery is average about three hours. Patient went home the next day. Sutures came out a week later and we activated them a week after that.
So, the plans going forward for this patient, we mentioned that we've tested individual electrodes and every electrode was able to produce visual perception. So, the plan is to activate multiple electrodes on the way to running full video, so that we can begin to assess the clinical benefit.
And then so obviously we're going to implant the additional four patients, is the plan and another important milestone that we'll be talking about is we mentioned that the FDA has given us the breakthrough status for the Orion system.
So that begins a negotiation process with the FDA as to exactly what our plan to market will be. So, what additional work might be required to get to a market approval and what work will be required for the post-market.
As far as, what's going to happen, which quarter, I don't think we're ready to break things down to that granularity, but we certainly expect to have agreement with the FDA this year and also have all five patients from this feasibility trial implanted and operating with full video.
Amit Dayal
Awesome. Perfect. And then regards to reimbursement rates, I think Will commented that you're still waiting for CMS to come through with data for the year. Do you know when we should expect this by?
Will McGuire
Yes. So, we're almost constant contact with CMS. So we already have begun I guess early discussions about what the 2019 rate would be and the timeline is very, very similar to the last few years and that they will put together a preliminary rate that will be published that's published sometime around July, around July 4 and then there is a comment period after that Amit for to get it 60 or 90-day comment period in which then they will move to have a final rate and that's usually published just after Halloween.
So sometime around the first or second week of November, there would be a final rate that we should get a preliminary rate as I said sometime around the July 4 timeline.
Amit Dayal
Understood. And then in regards to Germany, the study or therefore the better sighted RP patients, how is that progressing, are patients enrolled? Any color on how that is going?
Will McGuire
Yes. We've started screaming the patients. As I said in the comments, it started slower. We're frankly a little disappointed in the start, but there's been a couple of issues that we certainly can't go into much detail over at the sites. One of them, we have our primary investigator who for personal reasons can only spend at the most one day in the lab right now.
So, it's really hampered that site's ability to work to get up and running and enroll patients and then another site we had some issues with the person or persons who were actually going to do the screening of the patients. They actually, together they left the institution or got reassigned. So, we didn't have anyone there to do the screening. So, a kind of slow start. We're kind of assessing right now the best path forward, and which could include just more resources at the sites, it could include considering other sites etcetera, etcetera.
We're not really ready to say yet, but looking for the best path forward. Still interested in gathering some data and still believe it will get some very useful data there. I would say that you know, we did have kind of an additional part of our strategy that we talked about, which is in the U.S. trying to move forward without collecting any additional data.
So, you know as we said, we're putting together this HDE supplement and we're putting some data in there from outside the U.S. and submitting that to the FDA in hopes that we can expand the label in the U.S. without waiting for additional data. We think we've got some strong data there that could support a label expansion, and that's key as we've talked about in the past, it's key for us to expand our label not only in the U.S. but outside the U.S., but key to expand our label so that we can start treating more of those patients that have better vision, but still really have no usable vision and there is quite a -- quite a large numbers of those patients out there as we've talked about in the past.
Amit Dayal
And is it going to be part of the second quarter response that you're expecting from the FDA?
Will McGuire
The response, we'll see, the response could be, everything is great or it could be -- we don't agree with your proposal. We want more data. It could be any of the above Amit, so we'll just have to wait and see and based upon their response, we will respond accordingly and then when we know something more definitive we'll of course inform investors.
Amit Dayal
Just one final one for me in terms of what you guys are doing in terms of building the patient by-plan? I know there were some initiatives taken last year in the U.S. It looks like you're seeing some results from that. Is there anything new you're doing this year or you're just building on those efforts from last year?
Will McGuire
I think for the most part, we're building on the efforts. I would say, we've probably gotten more aggressive and probably doing more advertising now. So, in the past, we were focused in areas where we had centers that we felt would be centers of excellence for us and we were doing ads just typically in local radio, talk radio or news radio. And I've gotten quite a few phone calls recently because we expanded that at the end of last year and started doing national ads on Sirius XM.
So, we feel comfortable that we're going to expand within the U.S. this year, expand the number of centers and we thought it would be good to go ahead and start advertising more broadly in the U.S. on Sirius XM. So, response to that has been great. As we also mentioned, we've done some building up the pipeline if you will for Orion and did some local advertisements in LA and in Houston and had a tremendous response from that as well.
But I'd tell you so far Amit, business as usual, doing the radio ads. We did talk about quite a bit last year and I'll mention again, that we added an extra step. So when we say clinician qualified, that's the extra step that we added last year, which means that we actually have a clinician or coordinator from one of our sites, that has a discussion with the potential candidate and basically gives them a green check and says yeah, from the discussion we had on the phone, this seems like a good surgical candidate and we should move them to the next step, which is referring them to a site and having a examination at the site. So, we have much higher confidence in those candidates than we did candidates a year ago,
Amit Dayal
Got it. That's all I have. Thank you so much.
Will McGuire
Thank you.
Operator
All right. There is no further questions in queue. Let me turn the call back over to Will.
Will McGuire
Okay. Thanks again to the Second Sight team and thank you for your participation in our call today. Have a great day.
Operator
And ladies and gentlemen, that will conclude the conference call for today. Thank you for your participation and you may now disconnect your lines. Thank you.
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