Aerie Pharmaceuticals, Inc.
Q4 2015 Earnings Call Transcript

Published: 2 Mar 2016

[Operator:]

Good afternoon, ladies and gentlemen. Thank you for standing by and welcome to the Aerie Pharmaceuticals' Year End 2015 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. Today's conference will be recorded. It is now my pleasure to turn the floor over to Aerie's Chief Financial Officer, Rich Rubino. Please go ahead, sir.

[Rich Rubino:]

Thank you, Christy. Good afternoon and thank you for joining us today. With me today are Vince Anido, our Chief Executive Officer and Chairman, and Tom Mitro, our President and Chief Operating Officer. Today's call is also being webcast live on our website, investors.aeriepharma.com and it will be available for replay as indicated in our press release. Now for forward-looking statements and non-GAAP financial measures. On this call we will be making certain forward-looking statements, including statements forecasting guidance regarding our future financial and operating performance, cash burn, the success, timing, and cost of our clinical trials, the clinical effectiveness, commercial launch and potential future sales of our product candidates, the potential of our new preclinical research findings, as well as other statements related to future events. These statements are based on the beliefs and expectations of management as of today. Our actual results may differ materially from our expectations. Investors should read carefully the risks and uncertainties described in today's press release, as well as the risk factors included in our filings with the SEC. We assume no obligation to revise or update forward-looking statements whether as a result of new information, future events or otherwise. Please note that we expect to file our 10-K within the next 24 hours or so. In addition, during this call, we will be discussing certain adjusted or non-GAAP financial measures. For additional disclosures relating to these non-GAAP financial measures, including our reconciliation to the most directly comparable GAAP measures, please see today's press release which is posted on our website. As a quick financial update for the year, our full year 2015 GAAP net loss attributable to common stockholders was $74.4 million or $2.88 per share. The net loss for the year includes non-cash charges for stock-based compensation expense of $12.9 million. When excluding the non-cash stock-based compensation expense, 2015 adjusted operating expenses for R&D and G&A totaled $42.0 million and $20.2 million respectively. Total adjusted net loss for 2015 was $61.4 million and the $61.4 million adjusted net loss or $2.38 per share compares to $39.0 million for full year 2014. Our 2015 cash burn excluding financing activities came in slightly under the guidance of $60 million at $59 million. We ended 2015 with $150 million of cash, cash equivalents and investments on our balance sheet. In our preliminary guidance for 2016 is that we expect to burn approximately half of that or $75 million based on our current business plans. Of course this increase in cash burn has been expected for 2016 which we anticipate being our busiest year ever in the clinic with the tails of Rocket 2 and Rocket 3, the bulk of Rocket 4 along with the bulk of Mercury 1 and Mercury 2 taking place in 2016. We also have some potential initiatives that may result in additional cash burn this year. Beyond the guidance I just provided including start up efforts for a potential area manufacturing plant in Ireland, the potential commencement of clinical trials in Japan and the possibility of accelerating Mercury 3 in order to get a jump on the approval process for Roclatan in Europe. Vince will discuss some of these briefly. We will certainly keep you informed of updates as the year progresses. With that I will turn the call over to Vince.

[Vicente Anido:]

Thanks Rich, and good afternoon everybody. Thanks for joining us today. This should be a brief update since we had our call earlier probably about a couple of weeks ago when we talked about our 12 months safety and efficacy results for Rocket 2 which you may remember very positive. Our ongoing product stability work for Rhopressa is progressing very, very well and the plans for filing the NDA in Q3 of this year very, very much on track and as you can imagine everybody in the company is focused on that and that is a huge event for a company or size. As I mentioned on that call, all of our key milestones for 2016 are on track. Obviously I just said, the NDA the Rhopressa is on track for Q3 and also in Q3 we expect to announce results on Mercury 1 which is a 90 day efficacy read-out for Roclatan. We’re very excited about the prospects for that drug obviously and the enrollment is going very, very well probably a little over 80% at this point and we expect that to continue. Further we will start the other Roclatan trial, Mercury 2 that will start sometimes in the next few weeks. We've already selected the sites, they’ve already started looking at patients and going through the screening process et cetera, so we are hoping that those - expected those the first patient before the end of this quarter. As we mentioned a number of times, we are in launch mode at this point with the success of Rhopressa and with the pre-NDA meeting that we had with the FDA certainly we're looking forward to commercializing that product and so when we approach the commercialization for that drug and then for Roclatan, we’ve been very focused on understanding the current sentiment of payers in the U.S. Obviously pricing is major issue in our industry and we’re just wanting to make sure that we do everything that we can to understand what it is that we need to do. It is very clear especially after our last market research work where we talked to 10 managed care organizations that our product candidates have strong potential to be added for both commercial and Medicare Part D formularies depending on the contracting path we choose to take, we also believe the preferred brand tiering is a very, very good possibility. The outcomes of this research are consistent with the work that we've been doing over the last two or three years, there is nothing new here other than it continues to give us an awful lot of confidence about the potential for our products and our pricing and contracting strategies. Ex-U.S. we continue to do an awful lot of work. For example, we will be including some of our Canadian sites in Mercury 2 and we expect that that will give them the experience with both Rhopressa as well as Roclatan as we get a move forward toward launching the product in Canada about the same time or few months after we launch it in the U.S. We’ve also -as Rich mentioned, we began evaluating the timing of Mercury 3 commencement. Mercury 3 you may remember is the clinical trial that Roclatan that we are going to be conducing in Europe comparing our product Roclatan to a fixed dose combination that’s already marketed in Europe. Our current schedule has this trial commencing in the first half of 2017 but as we try to do in many cases, we’re going to try to accelerate that. Now as we said before, we continue to evaluate our plans for potential Aerie owned manufacturing facility in Ireland and we believe that this is a very, very important asset for us down the road from a broad supply chain and cost perspective, especially when you consider the fact that – I'm sure all of you remember that we did migrate our intellectual property our ex-North American intellectual property to our European subs in 2015. So obviously manufacturing in Europe is going to be very beneficial as we began commercializing our products. We're also looking in Japan. We continue to evaluate our path forward for the development of our products in Japan and in fact I'm scheduled to meet with the Japanese regulatory authorities in a few weeks. Before they clarify the path to approval in a country where a large portion of glaucoma patients have lower average intraocular pressures than we have here. In fact here in U.S. it’s about 21 millimeters of mercury, in Japan as we mentioned before is about 18 millimeters for mercury. And they have a much higher incidence of glaucoma, so we think it’s a market that is almost perfect for our products Rhopressa and Roclatan. And lastly there is a bit of preclinical research underway covering disease modification potential for Rhopressa and other attributes including neuroprotection as an example along with research that we’re doing on another small molecule from our – that's in our pipeline AR-13154 for wet-age related macular degeneration. We’re also working as we mentioned earlier in the middle of last year, we end licensed a product from Ramot at Tel Aviv University called EG-30 which is a small molecule a beta amyloid for neuroprotection and dry AMD. And then we also are exploring a number of different drug delivery systems including a company - a private company called GrayBug that we think has a very, very unique way of delivering small molecules for injection into the back of the eye. Some of the new research results that we have will be presented this week actually at the American Glaucoma Society meeting in Port Lauderdale. And I will ask you to keep your eye out for our next press release which should come out the morning of March 3, which will point to you to specific abstracts and where you can find them. Now I will turn over the call to the operator, for any questions that you may have.

[Operator:]

[Operator Instructions] Our first question comes from the line of Adnan Butt of RBC Capital Markets. Your line is open.

[Adnan Butt:]

Just an NDA question, Vince. Will Aerie be required to file the R4 data, and if so, is that an amendment that could change the timelines review?

[Vicente Anido:]

No, in talking to the FDA, Adnan, we talk to them about and they're aware that we are conducting other trials including Rocket 3 and Rocket 4 and based on the pre-NDA meeting, everybody was very, very clear that we're moving forward with the filing of both Rocket 2 as a pivotal and Rocket 1 as supportive. We don’t need to file the result of Rocket 4. We’ll have preliminary results in Q4 of this year that will be the 90 day efficacy, the 6 months safety will be available at the beginning of 2017 and we are required to file those at least to the IND and will advise the FDA that its available they want to look at it but we don't think that’s because it’s not a filing for approval, we don’t think it will swing the approval date beyond the 12 months. The FDA can look at it if they choose to.

[Adnan Butt:]

Okay. And then for Roclatan, will the Company announce when recruitment enrollment completes in M1?

[Vicente Anido:]

We actually do and will be consistent with what we did with the Rhopressa which if your remember, we did make that announcement when everything was said and done. And then everybody can just start counting and how long it takes us to announce results from that point.

[Adnan Butt:]

I am counting now, I will get back in line.

[Vicente Anido:]

I know, thanks.

[Operator:]

Thank you. Our next question is from Annabel Samimy with Stifel. Your line is open.

[Annabel Samimy:]

Adnan succeeded in asking all my questions, but I do have a cash question.

[Vicente Anido:]

He just tends to do that, doesn’t he?

[Annabel Samimy:]

Yes, that's alright. I asked you plenty of questions last week, or two weeks ago rather. You had mentioned that you are going to be using half of your $160 million in cash this year. If you are moving forward with manufacturing and as well as additional clinical trials in Japan for Mercury 3, are your cash still sufficient for commercial preparations, launch, et cetera?

[Vicente Anido:]

Yes, of course we’re in pretty good shape from a cash balance perspective, those additional items are not going to amount to material additional cash burn, they will likely be more toward the end of the year. And if each one of them happens, they would likely be mid single digit million range. So we still have a very solid cash balance at the end of the year.

[Annabel Samimy:]

Okay. And when did you say was going to continue through the cash? I know you didn't say this time, but maybe prior to that.

[Vicente Anido:]

We don't have of course our full commercialization strategy priced out yet but when you look at what we have on the balance sheet and the ATM that we currently have active that we are not using it, we’re going to take the company all the way through to commercialization.

[Annabel Samimy:]

Okay. All right and, sorry, I clearly missed this earlier, but you had mentioned that you had spoken to a number of managed care organizations and sorted out some kind of caring. Can you just go through that again quickly?

[Vicente Anido:]

Sure, so as I mentioned we have been doing market checks with managed care probably since early part of 2013. And so each time we look at different questions and things like that and we just completed the survey of 10 managed care organizations and I'm going to have – just have Rich just walk you through this - some of the highlights there.

[Rich Rubino:]

Right. So these organizations had a full profile of each of our products and we talk to payers representing probably about $150 million plus lives in the U.S. So it was a very meaningful sample. And essentially the messages from them was clear and consistent which is because of the novel MLA in particular both these products would likely be must adds to the formula. When you look at standard formulary structure, there are many custom structures out there but the typical three-tiered structures it is highly like we that we would immediately land on Tier 3. And that's generally a decision that's made by P&T committees at the various payers. It's more of a clinical perspective. Then ultimately the decision with regard to potentially getting into Tier 2 is more a matter of formulary contracting and that is often a different organization certainly in a large payers. But we are confident based on what we've heard that with pretty much in average amount of rebating, we can end up with net pricing that we’ve talking to all along which is in the $100 a month give-or-take range net and have a decent amount of our product on Tier 2, as well as Tier 3. The difference really between Tier 3 and Tier 2 or non-preferred versus preferred brand it's really a co-pay difference for the patient of $1 a day. So when Tier 3 is normally in our price range $2 a day, and in Tier 2 it would be about $1 a day. So ultimately it will be a very affordable job. We’re not expecting any meaningful restrictions, we’re not expecting any managed prior authorization programs nor any meaningful step therapy programs.

[Annabel Samimy:]

Okay, great. Just one more. Did I hear correctly you already had your pre-NDA meeting with the FDA?

[Rich Rubino:]

Yes on Rhopressa.

[Annabel Samimy:]

Okay, great. Excellent. Thank you.

[Operator:]

Thank you. Our next question is from Corey Davis of Canaccord. Your line is open.

[Corey Davis:]

Great. Now, Annabel stole all of my questions, too.

[Vicente Anido:]

I knew she was going to do that.

[Rich Rubino:]

You want me to talk about guidance again, I really enjoyed it.

[Corey Davis:]

You're going to burn half of all of your cash, halfway through this year you said?

[Rich Rubino:]

No. Let me try that again.

[Corey Davis:]

I am kidding.

[Rich Rubino:]

Thank you.

[Corey Davis:]

A lot of times ophthalmology drugs use formulation tweaks as lifecycle management, and it may be too soon to think about that. But do either one of these lend itself to changes in preservatives or putting a Y or a Z after the drug down the line?

[Vicente Anido:]

Corey we can always do those kinds of things and certainly changes in preservative or putting it in an uni-dose and doing all sorts of different things, and taking preservative completely out. Certainly make an awful lot of sense and maybe we can figure out ways of extending the patent life there as well. We think the -- perhaps another meaningful way of extending the patent life is the one that we have talked about, which is, we're very interested in working with a delivery company that we've identified, and on a Rhopressa front of the eye injection. We think that it is doable, we certainly have met with pretty good chunk of folks who have done an awful lot of work in delivery systems, and we think we found one that's pretty unique and is specific to our drug Rhopressa, where we can inject in the front of the eye for upwards of three to six months and then deliver the drug and bypass for example, having to put an eye drop in where obviously that will get rid of the redness issues and things like that. So that'll be a good thing. So, and it'll also give us further protection from a patent point of view and as a new delivery system. So, again, we'll look at all the options, but we certainly are already spending some time thinking about that, and doing some work on.

[Corey Davis:]

As far as you know, have there been any -- has there been any turnover in key personnel in the division that you are going through that is going to end up reviewing the drug and making some key decisions?

[Vicente Anido:]

As far as we know, the turnover in that division occurred about a year or two ago. At least that was the last -- few folks that we know that neither transferred out or has retired, but now it's a pretty stable group. We have generally the same folks, Wally Chambers is a major review guy, his boss, Rinata Albrecht has been there for a while, as is her boss, Ed Cox. So, and then below them certainly from a clinical review point of view, they seem to be pretty stable. On the CMC side, likewise, we've seen quite a bit of stability from this group which most of them came a number of years ago from the abstract -- I’m sorry, the transplant group. And the only real turnover we've seen, which is not uncommon at the FDA is at the project manager level.

[Corey Davis:]

And is CapEx to build the manufacturing plant baked into your guidance cash burn this year?

[Vicente Anido:]

No, no. We would -- we're at the very beginning of that process. If we started, that would be toward the end of the year. So, don’t expect much in terms of those kinds of capital expenditures this year.

[Corey Davis:]

How much total to build that plant?

[Vicente Anido:]

You can probably expect it to the tune of about $20 million or so. It'll be over a contracted period of time.

[Corey Davis:]

Okay. That's all I can think of, thanks.

[Operator:]

Thank you. Our next question is from Serge Belanger of Needham. Your line is open.

[Serge Belanger:]

I only have a few questions. First, on the ex-US strategy. You updated the results expectations for Rocket 4 today for fourth quarter 2016. Does that change your timeline for MAA filing next year?

[Vicente Anido:]

They Rocket 4 -- hey Serge -- the Rocket 4, 90 day efficacy has always been in Q4 of this year. But, remember for Europe, what we're really are interested in is a six month safety, which will be available in the first half of next year. So, that hasn’t changed at all. So, we're still thinking that European filing should be about a year or so lagging the U.S. filing.

[Serge Belanger:]

Okay.

[Vicente Anido:]

At least for Rhopressa, then with Roclatan, we're going to have to conduct Mercury 3, which is the study that we're planning on starting at the beginning of 2017. Hopefully we'll be able to move that up, but right now let's -- we’re thinking the first half of 2017, and then so that will also lag Roclatan approval in the U.S. by about a year.

[Serge Belanger:]

Okay. And once you meet with the Japanese regulatory authorities, I imagine there will be additional clinical trials to be run for Japanese filing. Do intend to run these trials on your own or get a partner?

[Vicente Anido:]

Right now we've decided to take the first step, which is, to meet with the regulatory authorities on a row and just work through what are the further requirements that we'll have on top of all the clinical trials we're running. We fully expect, for example, that we'll have to redo pharmacokinetics, which is about a 15 patient,$1 million dollar study that we'll have to run on Japanese patients. We may or may not have to do any other Phase 2 work, and then clearly the Phase 3 trials we'll have to run in Japan on Japanese patients. And so we’ll go down that path, we’ll let you know more in, call it, in the second half of this year, because we'll have two meetings with the Japanese authorities. The first one is more of a introductory meeting and is part of the process there to get to know them and then the second one is more roll up the sleeves and actually lay out the development plan. And in the mean time, we continue to talk to partners and so they're very interested in what we're doing in the drugs. And we think that if anything -- talking, for us to talk directly to the authorities in Japan should accelerate our discussions with Japanese partners. So, we can find one, do the development work great, and but if not its going to take too long to have them do it, and we'll consider it doing it ourselves.

[Serge Belanger:]

Okay. And I guess a question for Rich. Can you talk about some of the tax implications and may be benefits of the fellows in your manufacturing facility in Dublin?

[Rich Rubino:]

Sure, well of course in Ireland itself, there is a very low corporate tax rate. So, you're dealing with a tax rate that’s about 12.5% first orders and then it gets lower from there after other advantages. Very importantly, when that becomes a source of product for us in the U.S., there will be transfer pricing from that plant into the U.S., which effectively is a hedge against U.S. tax burn. So, it also gives us quite a bit of flexibility outside the U.S., so when we commercialize, for example, in Japan there's a tax treaty between Japan and Ireland and we would advantage from that as well. So, the non-U.S. income will be tax that are meaningfully lower rate than in the U.S., and in the U.S. our rate would be lowered by the mere fact that we are transfer pricing the product into the U.S. from Ireland.

[Serge Belanger:]

Okay. Thanks for the additional color.

[Operator:]

Thank you. Our next question is from Caroline Corner of Cantor Fitzgerald. Your line is open.

[Caroline Corner:]

I'm actually juggling a couple of calls, so apologies if you have touched on this already. But as we move forward toward Rhopressa's filing and hopefully the approval down the road, I know we have talked before about how Rhopressa fits into the competitive paradigm and how Roclatan fits into the other half of that pie. I was wondering if you could comment a little bit on how you think the Rhopressa competitive state, the landscape, might look around the time that you are getting approval? I know we have got potentially the Nicox VESNEO product looking at a PDUFA date in July of this year, which that one gets lumped into conversations about your Company and another company talking about new mechanisms of action to treat glaucoma. I am wondering how you think maybe that product and some of the other ones that are behind you guys will fit into that competitive landscape if we look out a year, 1.5 years from now.

[Rich Rubino:]

Sure. VESNEO is expected to have the PDUFA date some time in Q3 of this year. So, we'll see sort of how that works out based on the clinical work that they have put together, it appears that they're going to be direct competitors to prostaglandins, and certainly we would expect that it'll have a label that will look and feel a lot like all of the other prostaglandin labels. And so, we think that that's where they're going to be positioned in the marketplace as another prostaglandins. So, that's going to be their primary use. I think the -- it doesn’t change what Rhopressa is going to be, is we think VESNEO is going to be the only new product on the market certainly for the next couple of years. And until by the time we launch Rhopressa, that will be the only new product on the market in addition to VESNEO and we think by positioning it as the adjunct to any prostaglandin, we'll pick up use and if VESNEO like other prostaglandins just because of the product nature of the disease, and getting to a point where the patient needs another drug, that they'll choose Rhopressa and not a beta blocker or an alpha blocker et cetera. So, it doesn’t really change our positioning at end, and again it is just based -- we think VESNEO will have more of an impact -- whatever impact it has, it will be on the prostaglandin side of the market. Some of the other drugs that are being studied with different mechanisms of action for glaucoma, we think are probably, if we get Rhopressa approved in 2017, some of those may not get approved for couple of years after that. So it'll be a while before we see any of those on the market, and really to date we haven’t seen exactly how those products are going to be used, or the concentrations of the dosing schedule et cetera. So, it's really tough to comment because we haven't seen any that I would call hardcore efficacy data yet.

[Caroline Corner:]

Thanks. That's helpful. As I look through your abstracts that you are presenting later this week at the ATS, one definitely sticks out that is in nerve survival and regeneration. If you continue to get positive signals within nerve regeneration, it seems like a clinical trial to demonstrate that would be pretty lengthy and expensive. But is that something that you anticipate you will be able to go for that label in the future? Is it something you would want to do or are you going to continue to collect small studies to support that and convince doctors that way?

[Vicente Anido:]

Well, we think that the neuroprotection activity is kind of an interesting one to pursue. Clearly, the FDA has provided guidance not only way back when the original product was also being studied for Alzheimer's, is also study for neuroprotection, and Allergan spent a huge amount of money trying to chase that, but there is guidance out there. The interesting thing is the particular product that we're looking at for neuroprotection also has IOP-lowering effect. And so it really all depends -- we're looking at the need to inject that product in the back of the eye. We're also at the same time looking at it as if we inject it into the back of the eye, what kind of impact does it have on intraocular pressures. So, depending on sort of the outcome there, we may be able to get approval for one indication or another, but they are right now lengthy trials if we just simply pursue neuroprotection. But we'll see where the science leads us on this one. But we think there is a couple of different shops on go with that particular series of products.

[Caroline Corner:]

Thanks. Interesting stuff. I appreciate you taking my questions.

[Operator:]

Thank you. Our next question is from Difei Yang of Brean Capital. Your line is open.

[Difei Yang:]

Hi, good afternoon. Thanks for taking my questions. It gets harder and harder.

[Vicente Anido:]

You mean to come up with questions?

[Difei Yang:]

Yes. So, I was wondering if you can talk about on the launch dynamics. When Rhopressa gets lunched into the market place, do you in general see product adoption gets slower versus five years ago because of the managed care access issue?

[Vicente Anido:]

The answer is, we don’t think it's going to be dramatically different in terms of the up take for the products than we saw through four, five years ago. We think that the real issue here is going to be that, in the glaucoma space we have far more patients coming in, who've been on some medication that all of a sudden is not holding the pressures, they need something else to be added to it. We have more of those kind of patients than we have new patients. And so we think that launch for Rhopressa and then a year later or so for Roclatan, we'll be able to get some of the new patients on board, those typically take a little bit longer because it’s a new drug, and a doctor wants some experience. And so clearly for Rhopressa, we think that the positioning as additive therapy is perfect, because -- again there's more patients that need added therapy, and when you look at the results of our product being once a day etcetera versus the twice a day Timolol or three times a day Alphagan, et cetera, there's a lot of incremental benefits. And so we think we’ll get a lot of utilization. So, we think both from a physician point of view as well as a managed care point of view, we should be in good shape for an uptake, that won’t be any different then it was a few years ago.

[Difei Yang:]

Okay, thank you. And then with regards to Medicare and Medicaid contracting, what is your expectation with regards to a timeframe?

[Vicente Anido:]

Well, Medicaid is a different story. It will be a smaller piece of the action. From a Medicare perspective you contract under our part D plan, under what they call PDP plan, it's not terribly different than our commercial contract. One of the differences is that, whatever rebates you pay under a part D plan or go directly back to the patient, as oppose to where the commercial formulary. So the processes are very similar and based on the market surveys that we have done, the tiering or the positioning within the commercial, as well as the Medicare part D formularies will be very consistent, consistent with what I said earlier.

[Difei Yang:]

Okay, thank you. That's very helpful. So for Medicare, it is really just for my education, for Medicare contractor, is there such a thing it restarts every January? Or do you have to - is there a certain timeline you have to adhere to?

[Vicente Anido:]

Well the plans - patient sign up for their Medicare part D plans generally before the New Year starts but they often have provisions for people to enter in the course of the year as well but clearly the major enrolment would be a one, one of it.

[Difei Yang:]

Okay.

[Rich Rubino:]

Difei if it helps, we’ve already had to in order to be able to price our products and get them reimburse on Medicare on a timely basis. We've already had to register the company with CMS already this year in order to be known and be able to move forward with what we need to do from a pricing point of view with CMS and for the launch that we expect in 2017. So, the process for us has already started.

[Difei Yang:]

Would you say are you ahead of not necessarily your competitors, other Pharma companies in terms of tackling the Medicare coverage? Or do you think nowadays that is the standard practice everyone starts talking to CMS one year before? Actually not one year, two years before launch

[Vicente Anido:]

Well, we like to think that we are the smartest in the bunch but as probably not true. And so we think that that’s probably pretty much standard fair anymore and remember we are doing this for our first products. So the things that you have to do is to start up to sort of get out in front of the curve where other companies that have been commercial for a while have already done there, they've already done, they are registered. So it’s a little easier process for them.

[Difei Yang:]

Okay, thank you.

[Operator:]

Thank you. Our next question is from Donald Ellis of JMP Securities. Your line is open.

[Donald Ellis:]

Thank you very much. Last but not least then? Maybe you could tell us who's going to win the primaries tonight because that question hasn't been asked.

[Vicente Anido:]

I was surprised that Rich didn't make any comments about super Tuesday, I know he was practicing a bunch of those but he is just freaks out for all these calls so he just very focused.

[Donald Ellis:]

I actually do have a couple of questions. I do know that. When you're talking to the payers about, is there a difference in their feelings about positioning, tiering, for Rhopressa versus Roclatan?

[Rich Rubino:]

No, interestingly they were consistent really with both products, so there was a fairly similar approach that they would take with each product.

[Donald Ellis:]

Okay. And then next question, last question I have is about, what kind of timeframe, the wet and dry AMD markets are gigantic markets. What is the timeframe for when we can expect to see some data, some human data?

[Vicente Anido:]

So there are two different products right, so for our own internal products which is the AR-13154 we think that the early as we could be in humans is probably two years or so from now, two and half years from now because it’s not just the drug which we think seems to work pretty well, it’s the fact that we now also have to put it into a new delivery system and make sure we can deliver it over six month period. And so it will take us while to be able to do that. And then for the remote product on the dry AMD component, that product was studied for a number of years by another company as a topical agents. So there is a huge amount of toxicology work that has been done et cetera. So if we can convince ourselves on both the neuroprotection side, as well as on the geographic atrophy side, that we should move forward with that, that could be the internally developed product into the clinic.

[Donald Ellis:]

Is this a couple of years off, or five years off, or what's the rough timeframe?

[Vicente Anido:]

No, they are both in the two year timeframe.

[Donald Ellis:]

Okay, great. Thank you very much.

[Operator:]

Thank you. And that does conclude our Q&A session for today. I would now like to turn the call back to Vince Anido, Chairman and CEO for any further remarks.

[Vicente Anido:]

Thank you. I want to thank everybody for listening to the call. Again we are hoping to be able to provide a quick update which I think we've done. We are very excited about the prospects for all of our products and in fact that we seem to be hitting all of our milestones as we said and as you noticed, we try to accelerate the achievement of our milestones whenever we possibly can. So again I want to thank everybody for listening this afternoon and have a good evening.

[Operator:]

Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program. You may all disconnect. Everyone have a great day.