Alimera Sciences Inc (ALIM) 2015 Q2 法說會逐字稿

Good day ladies and gentlemen, and welcome to the Alimera Sciences' second-quarter 2015 earnings conference call.

(Operator Instructions)

As a reminder, this conference call is being recorded. I would now like to turn the conference over to Rick Eiswirth, Chief Operating Officer and Chief Financial Officer. Please begin.

Thank you. Good afternoon everyone, and welcome to the Alimera Sciences' conference call to update you on our progress with ILUVIEN, our sustained-release intravitreal implant for diabetic macular edema, or DME and to review our second quarter 2015 financial results. A press release regarding these results was issued this afternoon and is available on our website. On the call with me today is Dan Myers, our President and Chief Executive Officer.

Before we begin our prepared remarks, I would like to remind you that various statements we make during this call about the Company's future results of operations and financial position, business strategy, and plans and objectives for Alimera's future operations are considered forward-looking statements within the meaning of the federal securities laws. Our forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. These risks are described in the risk factors and management's discussion and analysis of financial conditions and results of operations sections of Alimera's annual report on Form 10-K for the fiscal year ended December 31, 2014, our Form 10-Q for the quarter ended March 31, 2015, which is on file with the SEC and available on the SEC's and Alimera websites, and the form 10-Q for the quarter ended June 30, 2015 which we expect to file today. We encourage all investors to read these reports and our other SEC filings. All the information we provide on this conference call is provided only as of today, and we undertake no obligation to update any forward-looking statements we may make on this call on account of new information, future events or otherwise.

Please be advised that today's call is being recorded [via] webcast. Additionally, adjusted net loss and adjusted net loss per share will be discussed on this conference call. A reconciliation of these measures to GAAP can be found in the press release which is available on the SEC's and Alimera's websites. Now I would like to turn the call over to Dan Myers.

Thanks Rick, and thanks to everyone for joining our second-quarter 2015 conference call. We are pleased to provide you with an update now that we have full-quarter sales of ILUVIEN in the US market, as well as another quarter in Europe. After my comments, I will pass the call back over to Rick who will discuss in more detail our financial and operational results. We will then open up the call for questions.

Overall, we reach second quarter total sales of $5.8 million, an increase of 164% compared to the same period a year ago. A majority of this increase came from the US, where we have begin to see market penetration following our recent commercial launch. The US market accounted for $3.8 million, which is an increase of 58% over the first quarter results of $2.4 million. Outside the US we saw strength as well with the sales of $2.0 million, an increase of 33% over quarter one of this year.

I will start with the recently launched US business. We are excited with the traction me again so far, and while it is still early, we have seen clinical interest in ILUVIEN continuing to expand with the number of ILUVIEN sales downstream from our distributors to physicians and pharmacies growing 180% in the second quarter versus the first quarter. The total number of retina practices purchasing product tripled in the second quarter and we now have over 161 accounts ordering ILUVIEN.

In regard to reorders, we had 14% of our accounts reordering ILUVIEN at the end of the first quarter, and through the end of June 38% of those accounts had placed more than one order. We had anticipated a relatively low percentage of reorders as it was believed it is typical in a buy-and build launch for physician practices to use a limited number of units initially and wait to see if they are reimbursed. We believe the rising number of reorders is an early indicator that claims are now beginning to be paid. In fact, we have now confirmed fully paid claims for all the Medicare carriers throughout the country, as well as numerous commercial plans. This is the type of activity that will help instill confidence in those accounts which are still hesitant to expand the usage because of payment concerns. We are really excited to see that payments are beginning to come in and expect to see this have a positive impact on orders going forward. As you may recall, submission of a benefit investigation is a step to determining insurance coverage and is a sign of underlying demand. As of June 30 we had 290 physicians that have submitted a total of 766 benefit investigations for patients, with 99% of those benefit investigations considered covered. Another sign of demand is acceptance onto formularies at major institutions. This quarter we have successful been added to many important formularies including the Johns Hopkins Wimer Eye Institute, the Massachusetts Eyes and Ears infirmary, and the New England Eye Center.

I would now like to turn our attention to the European business and share some key highlights. We are pleased to report sales growth in Germany of more than 80% versus the first quarter of 2015. You may remember that we ended the first quarter with a decision to embark on a relaunch of ILUVIEN in Germany in 2015 Our strategy to bring ILUVIEN back to growth as quickly as possible included focus on three key areas. Number one, gaining inclusion of ILUVIEN into reimbursement contracts. Number two, broadening the base of experience through a short-term period of sampling. And number three, addressing the commercial attractiveness of ILUVIEN versus other intravitreal products in the hospital setting. Our German team has done a great job executing in all three areas, which has resulted in significant progress. ILUVIEN is now included in multiple reimbursement contracts covering more than half the population of Germany. The short-term period of sampling has given valuable experience to new adopters of ILUVIEN during a time when they could not otherwise gain access for patients, now a new source of orders. And contract with the hospitals has resulting in ILUVIEN being in front of mind when the patient needs it and available in the pharmacy.

In Portugal we more than doubled our sales in the second quarter versus the first quarter. You may remember we previously reported on hospital contracting as a gating factor. This has proven to continue to be the case during the second quarter. However, clinical advocacy for ILUVIEN is strong in Portugal, and consequently in a significant number of hospitals, ophthalmologist are now waiting to treat their patients. After the summer break, we anticipate that clinical support will become an important factor in the pursuit of contracting to free up access to ILUVIEN. This in turn is expected to lead to continued growth in our business in Portugal.

In the United Kingdom we have continued to see significant growth in our injection rate, which has nearly doubled in the first half of 2015 versus the same period in 2014. In addition, second-quarter sales were our strongest since we launched in the UK. As a result, we have taken the decision to expand our sales force from five clinical account specialists to eight. I have also described before how our UK team works to educate centers on ILUVIEN's role in the treatment paradigm by directing and building center-specific treatment pathways with the clinical teams. The first centers to have adopt ILUVIEN in their pathways are now reporting results from their cohorts, and we are encouraged by the strong efficacy results and also the manageable safety profile. Doctors are seeing efficacy in clinical practice that is actually better than what we saw in our clinical trials. Further, the incident of IOP requiring treatment has been much lower then we saw in the same study, and more importantly, the vast majority of patients requiring treatment have been managed with topical drops. We need to bring this information to the US to demonstrate the benefits of ILUVIEN to patients and -- and physicians and their patients. Our experience in Europe having now treated over 2,000 eyes in the clinical setting is a great asset that we can leverage with our customers here in the US because we believe that this efficacy and safety profile will be (technical difficulties) in the US.

In the second quarter we initiated the PALADIN study to accumulate data in a real-world setting. The PALADIN study will focus on patients treated in accordance with the US label. We believe the PALADIN study will demonstrate that possible IOP side effects, especially IOP-related surgery, associated with ILUVIEN will be less frequent than what was seen in the population in the FAME study. As a reminder, in our FAME Phase III population, the subset of patients who had a prior ocular steroid injection did not experience any IOP-lowering surgery. All of the IOP-lowering surgeries for ILUVIEN patients occurred in those patients who had no history of prior ocular steroid injection. Our goal is to enroll 300 patients in up to 50 clinical sites and follow these patients for three years. Because this study is not mass, we expect to make interim assessments of the safety and efficacy of ILUVIEN as the sample size grows. This will generate additional data for physicians to aid in their assessment of ILUVIEN.

We are pleased to have recently announced distribution agreement with Knight Therapeutics Incorporated, a Canadian specialty pharmaceutical company, to handle all regulatory and commercial activities for ILUVIEN in Canada. This is another market that offers a great opportunity for long-term growth. We're excited to be working with Knight's proven management team.

Outside of our existing European and US markets, we now have distribution agreements for ILUVIEN in Canada, Israel and Australia, where we anticipate generating incremental revenue as early as 2017. We're continuing to evaluate other opportunities for the geographical expansion of the availability of ILUVIEN by actively looking for distribution arrangements in the Asian and Middle Eastern markets. With that, I will now turn the call back over to Rick.

Thank you, Dan. Turning to our financial results. Year-over-year revenue growth for the second quarter was 164%, from $2.2 million to $5.8 million. This represented sequential growth of 49% from $3.9 million in the first quarter of 2015. This was primarily due to an increase in US sales following the launch of ILUVIEN in February of this year from $2.4 million in the first quarter to $3.8 million in the current quarter. It is important to note that a significant portion of our sales in the first quarter of this year represented an initial stocking sales to our special distributors in the US and that downstream sales from those distributors to end customers, which we believe represents true market demand, increased 180% from quarter to quarter. Now that our specialty distributors have stocked their shelves, we expect our sales to approximate end-user demand going forward.

Our international sales derived from the United Kingdom, Germany and Portugal increased 33% from $1.5 million in the first quarter to $2 million in the second quarter. Cost of goods sold remained flat at approximately $380,000 in comparison to the second quarter of 2014 despite the higher sales volume, primarily due to an inventory reserve of $210,000 recorded in to 2014 for German inventory. Gross margin in the second quarter was approximately 90%. For the second quarter 2015 research and development and medical affairs expenses increased by approximately 100% to $3.8 million from $1.9 million in the prior-year period. This increase is primarily a result of increased spending on clinical trials, medical science liaisons and scientific communications to further the understanding of ILUVIEN in the medical community. General and administrative expenses and the first quarter of 2015 increased approximately 36% to $3.8 million compared to $2.8 million in the prior-year period. This increase was primarily attributable to increased employee costs associated with our growth to support the launch of ILUVIEN in the United States and our international growth. For the second quarter of 2015 sales and marketing expenses increased approximately 130% to $6.9 million compared to $3 million in the prior-year period. This increase was formerly attributable to increased personnel and travel costs associated with the hiring of a US field force, as well as increased promotional and marketing costs associated with the launch and commercialization of ILUVIEN in the United States.

GAAP net loss for the second quarter of 2015 was $8.6 million compared to a GAAP net income attributable to common stockholders of $1.1 million for the second quarter of 2014. GAAP net loss for the quarters ended June 30, 2015 and 2014 was affected by certain non-cash items including changes in the fair value of a derivative warrant liability, unrealized foreign currency gains and losses, and reserves for potential inventory expiration. GAAP basic and diluted net loss per share for the second quarter of 2015 was $0.19 based on 44.4 million weighted average shares outstanding compared with GAAP basic earnings per share and diluted loss per share for the three months ended June 30, 2014, income of $0.03 and a loss of $0.16 respectively based on 40.3 million and 42.5 weighted average shares outstanding were respectively.

Non-GAAP adjusted net loss for the second quarter of 2015 was $10.9 million compared to non-GAAP adjusted net loss for the second quarter of 2014 of $6.1 million. Non-GAAP adjusted basic loss per share for the three months ended June 30, 2015 and 2014 were $0.25 per share and $0.15 per share respectively. Non-GAAP adjusted diluted loss per share is not presented, as all outstanding common stock equivalents are anti-dilutive. Net loss for basic weighted average shares outstanding attributable to common stockholders per share and non-GAAP adjusted net loss attributable common stockholders per share was based on 44-point million (sic - see press release, "44.4 million) weighted average shares outstanding for the second quarter of 2015 and 40.3 million weighted average shares outstanding for the second quarter of 2014.

As of June 30, 2015, we had cash and cash equivalents of approximately $48.1 million compared to approximately $61.3 million as of March 31, 2015. Our cash burn of approximately $13.2 million for the quarter was impacted by a significant increase in accounts receivable in the US due to the extended terms provided to our distributors and further downstream to the end customers. With that, I will turn the call back to Dan for closing comments.

Operator at this time we will take -- we'll open the call to questions.

(Operator Instructions)

Caroline Corner, Cantor Fitzgerald.

Hello. Congratulations on all progress. Couple of questions from me. First of all, just real quick on your gross margin. It looks like you reported around 93% again. Given the blend of direct and distributor models that you have, do you think that 93% is sustainable going forward and a good number to use?

Yes, we do. That will change when we get to cash profitability and we start to having make some profiteer payments to pSivida. As far from an operational standpoint, 93% is where it should be, yes.

Great, thank you. And then your sales force, you mentioned you are adding three salespeople in the UK. Is that going to be a 2015 event? Can you just remind us of the size of your different sales forces globally? Broad terms?

Previously we had five sales reps in the UK. And we just decided to expand that because we felt like more feet on the street, more face time with the physicians than time in the hospitals was more important. So we sort of redeployed some dollars. We have three additions that will be coming onto that team in September.

Okay.

In Germany we have five reps. In Portugal we have two, and we have a MSL in Portugal, as well. And an MSL and medical people in Germany. In the US I believe we now have 32 reps in the field.

Okay, great. That is helpful. It sounds like your making great progress with claims being paid. And we have had several conversations. You have spoken in the past to this first year post-launch before your J-code is in place, revenues potentially being kind of lumpy as physicians try out the product and then have to get their claims paid. The previous conversation, you had mentioned that some physicians might be trying the product for three or four times.

They like it, but they're potentially waiting until a J-code is in place before they use it on a more regular basis. Given the progress that you have had lately with claims being paid, you said all Medicare providers have paid and most of the privates as well, are using less of that now where people -- are doctors feeling more comfortable going ahead and using ILUVIEN with the assurance that they are going to get paid in relatively short order?

Caroline, this is Dan. I think we're some of seeing the difference of the 14% reorders into the first quarter to 38%. Obviously that is a good trend. I think it is, quite frankly, a little more sluggish then we had originally anticipated. And one of the phenomenas that it is hard to specifically quantify, but when you look at some of the numbers, there is approximately 2000 retina specialists, depending which data source you use, but that is a pretty good number. We have had 1000 doctors sign up for AccessPlus, which of course is the program they can get assistance in these benefit investigations, et cetera. So that is a pretty good hit of 50%.

And the 2000 number I gave you is not necessarily doctors treating DME. That is just the number of retinal specialists. Some may or may not treat DME. We're pretty happy with 1000 doctors who have signed up for this benefit.

When you look at how many doctors have actually submitted benefit investigations, I quoted earlier a number that gets you to about roughly 25%, 30% of those patients -- excuse me, doctors who signed up with AccessPlus, which leads you to the think you might want to see that number be a little higher at this stage. We also have heard from our clinical account specialist and field personnel is that some of these AccessPlus doctors, in other words, the 1000 that signed up, maybe in a multi-specialty practice.

For example, there might be three people signed up with those 1000 that are in the same account. And in some cases we are finding that one doctor may go ahead and do two or three patients. The other two doctors in the practice just wait and see what his or her experience has been from the clinical outcome as well as from the reimbursement.

And so it is a little hard to quantify because obviously if you see the glass as half-full, as soon as that one doctor in the group sees a positive experience, we not only get reordered from him or her, but now the associates feels comfortable saying, all right, we have seen the beta test here and pick up. So it is a little difficult for us to have transparency here in, what, the fifth week of the third quarter or so, to have a really good feel for what's that ramp look like in September/October. And that is where I'm most keen on seeing in the third quarter, is what will be the step-up from these successful reimbursements? Will it continue to be a little bit of a slog, or will we see kind of an incremental step because some of these doctors have been waiting to see how their associates have done.

Okay. That is helpful. Thanks.

My last question. The J-code, I think we're expecting to hear news on that in November for it to be effective in January. Can you just talk a little bit about, I think the Street certainly built that into their numbers and adoption after January. But can you just talk a little bit about what are the chances, as you see it, of that code being in place January 1? Are there any risks that we need to be aware of with that not happening? And if so, then you just continue selling until the following January 1?

Carolyn, we are not aware of any risks. We have been notified that it will be coming and that it will be in place and effective on January 1. I think from a practical perspective, it will take the course of the first quarter for it to really be implemented throughout the system so that all the offices use it effectively and that the insurers actually use it effectively as well. We of course will have our team of reimbursement account specialists in the field, like we have now, that will help make sure that gets used more efficiently. But I think it will take the course of the first quarter to be implemented.

Super. Thanks. Congratulations on the quarter.

Thanks.

Jim Molloy, Laidlaw.

Thanks, again. Thanks for taking the question

. I was wondering if you could talk a little bit about some of the differences that you are seeing in the UK market versus, say, Germany, France? I know France, you are waiting on the pricing issue. So the success in the UK versus Germany. And then in the US, certainly a nice move-up in the quarter. Did you say 14% reorder rate, and 38% of those have greater than one RX, or was it 38% this quarter that reordered? My apologies.

Jim, this is Dan.

I will take the last part and And let Rick give you kind of update on the -- to your question around the UK and German and French market. To be clear, that is 14% of the 161 accounts reordered, by the end of the first quarter. And now 38% of the 161 accounts have now reordered. So you have a delta between the 14% and the 38% of the 161 account base. As far as the other, Rick, I'll let you take it.

Jim, I think the primary difference we see between what happens in the UK versus Germany, in the UK, almost 100% of the sales are through the National Health System and so the doctors are not compensated to do an intravitreal injections. We are on par right out of the gate with Lucentis or anything else. There is not a different economic incentive for a doctor to use one intravitreal injection maybe more frequently versus another one. I think also they have specific treatment paradigms in place in each one of the hospitals that take the doctors through what they should be using.

And then third, because of the way the NICE guidance works, ILUVIEN is available in certain situations where Lucentis is not. Lucentis is only available for patients that have a retinal thickness of greater than 400 microns. So that leaves a bucket of patients that might be less than 400 microns where ILUVIEN will be available. There's several differences there.

I think in Germany, the challenge we've had before now, is we weren't fit into some of the reimbursement contracts and the injection fee arrangements between the doctors. So we were at a little bit of a disadvantage in the way the doctors get paid. However, as Dan alluded to in his comments, a lot of that has been rewritten over the first half of the year or is still being rewritten. We seem to be getting into a better position in some of those reimbursement contracts in Germany. Hopefully we will be catching up over the rest of the year there.

Great, thanks. I remember on the first-quarter call, you guys talking about -- a little bit about pushback on ILUVIEN, a three-year implant and the concern about IOP. Hopefully, as time would go by your thinking would be that would be mitigated. With another quarter under your belt, have you had success in getting the message across that the counter detail that you have to worry about IOP is sort of silly, because what other treatment can you give these patients if you take them off of steroids? How has the anecdotal evidence in the field been on the counter detail to the three-year plan?

I think in the US it is still kind of a day-to-day grind. I don't think we, by any means, won that battle of the mind, if you will. But I think what has really been sort of a breakthrough you for us since the ARVO meeting in Denver, which is a large R&D ophthalmic-driven meeting, where we presented this cohort of UK patients that I had mentioned in my comments earlier. And what we saw there was efficacy numbers that are far better than the FAME trial numbers and IOP treatment of pretty much only topical drops.

Just a quick number, by the way. We have now done 2000 patients in the EU and reported filtration surgery is 2. Now, some could argue that is not as rigorous reporting as it is an FDA-mandated trial. And I certainly take that point. But still, filtration surgeries are taken very seriously and you would think that would be reported. And so I am not suggesting that I would take it to the bank that is the percentage we will see going forward. I do know that of our early two years or so in the EU, we have seen 2 filtration thought of 2000 eyes injected.

And we are seeing better efficacy in these cohorts where doctors know better where to use ILUVIEN then they did in a trial done back in 2005 when there was no anti-VEGF. So my point is, I think our real job is now to leverage that experience in the EU where it does become a comment where you will hear retinal specialists saying, I am much more comfortable now moving from anti-VEGF after two or three or four injections, because I am more confident in the efficacy than I saw in the FAME trial. And I simply have not seen the side effect profile that I was concerned about in the FAME data. And as you said, that is being used in some counter detail.

What we really need to do, and working diligently on that, is get that data published and get it to the place where we can use that to our advantage in the US because as you know, it becomes just basically medical marketing. One company says one thing and the other says the other. The best answer is real-time data in the clinical commercial setting. I'm really happy to see that.

I think that information is to our advantage and is to our favor. We've got to get that into our medical science liaisons' hands in the US and get doctors educated that in the real-world setting, we think they are going to see better efficacy and better safety profile than they saw in the FAME data.

But as you know, it is five months into the launch. I think we're making progress. But clearly we can always do better at that.

Great. Thank you. Last question. Any thoughts on a DTC campaign? I know I wouldn't be think of a nationwide thing, that something directed at the specialists? And what type of pricing bar do you think you see in the US? At what point do you start thinking, as typical with pharma, 5%, 6% price increases?

That is a tough question. It is a good question. It is one we are struggling with a bit because clearly we have seen right away what we anticipated, that the benefit of an injection once every three years is clearly something that not only the patient, but the caregiver, is holding in high regard. I think the retinal specialists probably will come to grow to appreciate that more as patients begin to talk more about it. Some of the retinal specialists, I think, probably underestimate that value as much as the patients.

And it is a good question, Jim, because we are pretty confident that a program like that would be highly successful in marketing to the caregiver or to the patient. It comes down to a little bit of economics. But it also comes down to a bit timing. I'm comfortable telling you that there will be a period of time in the next few quarters, we will move to some form of DTC. I always jokingly say there's -- capital DTC and there is lowercase DTC. And Dave Holland, our Head of Sales and Marketing, has done both of these in his career at Novartis and here at Alimera.

So we're going to start looking at that. I think to move too quickly on that is probably not doing justice to the ophthalmologist and retinal specialists. I think we need to kind of make sure we get our message to them, they understand the features and benefits of ILUVIEN before we start moving beyond them to the caregiver and the patient.

But I think your point is well-taken. It would certainly be wise for us to start thinking about that. And then looking at the economics, because as you know, that is sometimes very costly. The quicker we can move to profitability and see our cash flow position improve, the quicker I would be willing to move in that area.

As far as the price increase side of it, that is a little more difficult in a buy-and-bill then you see in a typical big pharma distribution where you are moving product through the wholesales and the retail chains. I don't anticipate in the near future taking a price increase on ILUVIEN.

Thanks for taking the questions.

(Operator Instructions)

Boris Peaker, Cowen.

Hi. Congratulations on the quarter. This is George calling in for Boris. I was just wondering if you could provide some more granularity on what happened sequentially to sales in Germany? And whether or not these new [Ivon] contracts are using the same pricing that we saw before?

Sequentially sales in Germany were up a little bit over 80%.

(Multiple speakers) said they're up over 80%?

They are up over 80%, quarter over quarter. That is correct.

Okay.

Got into some of these hospital contracts and got products on the shelves in the pharmacy to drive their presence, as Dan said. With respect to the Ivon contracts, I don't -- our pricing is not different. Our list price still remains at EUR7975 in Germany. I cannot comment on what the pricing is inside those Ivon contracts for the reimbursement to the doctors there now.

Okay, great. That is fair. Also, can you talk about with the gross net adjustment for US is, for the US sales?

Sure. That is typically going to be, on the Medicaid rebates, VA rebates as well as some of our patient assistance programs. The subsidized co-pays in the US

No, sorry. I meant quantitatively, what is the gross-to-net adjustment on the list price?

About 5%.

Got it. Great. Thanks for taking my questions.

Guy Dietrich, Dietrich Capital.

You referenced payments to pSivida. I'd like to know how much they have been to date.

They have been immaterial to date. De minimus amounts just based on cash flow at times. We have been operating at a cash loss in all of our countries to date. We expect that to start to turn maybe in some geographies toward the end of the year.

Okay. And Dan, you referenced a 300-patient study. I was -- wonder if you could just elaborate on that a little bit more, the cost of that would be?

To take the last part first, we anticipate the cost to be roughly $2.5 million, over the course of the study. It is really designed to give doctors an opportunity to enroll patients in a trial that will be able to look at both IOP over time, as well as efficacy. And of course, getting back to what I said to Jim's question, it is a hopeful that we can escalate what we have seen in Europe in real time here in the US It is nice to have EU data with their peers across the ocean that shows what we think is very compelling data. But as you know, doctors would love to have US data, as well.

It is a parallel program that with these 300 patients who have had a previous course of corticosteroid are now being moved onto ILUVIEN. Pretty much, watching them on label and being able to take time-point checks and give, again, an insight into what is the experience in today's world with what we now know about DME and how we treat DME, versus the FAME trail that was done back in 2005?

Okay. Just a follow-up final question. On your burn rate, what is your number volume of procedures do you need to see you at cash flow breakeven? Right now, it looks like you are going to be pretty stretched for cash four or five quarters out.

The burn rate is continuing to come down. We burned $13.2 million this quarter And a little over $3.5 million of that, or approximately $3.5 million relates to the increasing receivables because we're not collecting anything in the US yet. We believe that we have enough to fund ourselves to a positive cash flow.

As far as what we need, we need to be about an annual run rate of about $70 million to be positive cash flow. The number of units depends on the mix, obviously, in which countries that is coming from. It is about a $70-million run rate we need to get to.

Okay, thank you.

There are no further questions in queue at this time. I will turn the call back over for closing remarks.

As you can see, we are pleased with our progress year to date. And we are now at a point where the first UK centers to have adopted ILUVIEN in their pathways are now reporting results from their cohorts. We are encouraged by their strong safety results and also the management safety profile.

Efficacy has surpassed even the FAME studies, I said earlier. And the incidence of IOP requiring treatment have been significantly lower than we saw in the study. Most importantly, those patients requiring treatment have been managed through standard practice. It's data like this that we think will be usable in the US, and I am very excited about us carrying forward and we'll be looking forward to reporting you on our next quarter earnings call. Thank you.

Thank you. Ladies and gentlemen, this concludes today's conference. You may now disconnect. Good day.