Alimera Sciences Inc (ALIM) 2015 Q4 法說會逐字稿

Greetings, and welcome to the Alimera Sciences fourth quarter 2015 earnings results call. At this time all participants are in a listen-only mode. A brief question and answer session will follow the presentation. (Operator Instructions). As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rich Cockrell. Thank you, Mr. Cockrell, you may begin.

Thank you Brenda. Good morning everyone, and thank you for joining us today for the Alimera Sciences fourth quarter and year-end financial results conference call. With me on the call today are Dan Myers, Chief Executive Officer, and Rick Eiswirth, President and Chief Financial Officer. Yesterday evening Alimera Sciences was pleased to issue a press release announcing fourth quarter and year-end 2015 financial results. Today's call is being webcast, and will also include a slide presentation which has been posted to the Company's website. Following remarks by management the call will be open to your questions.

During the course of this call management may make certain forward-looking statements regarding future events and the Company's future expected performance. These forward-looking statements reflect Alimera's current perspective on existing trends and information, and can be identified by such words as expect, plan, will, may, anticipate, believe, should, intend, and other words containing more meaning. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties.

These risks are described in the Risk Factors and Management Discussion and Analysis section of financial conditions of Alimera's Annual Report on Form 10-K for the fiscal year-ended December 31st, 2015, and Alimera's quarterly report on Form 10-Q for the quarter ended September 30th, 2015, which are on file with the Securities and Exchange Commission. And available on the SEC's website. Additional factors may also be set forth in those sections of Alimera's Annual Report on Form 10-K for the year-ended December 15th, 2015, to be filed with the SEC in the first quarter of 2016.

In addition, any unaudited or proforma financial information is preliminary, and does not purport to project future financial positions or operating results of the Company. Actual results may differ materially. For the benefit of those of you who may be listening to the replay, this call was held and recorded on Thursday, March 3rd at approximately 10 AM Eastern Time. Since then Alimera may have made additional announcements related to the topics discussed herein. Please reference Alimera's most recent press releases and current filings with the SEC. All forward-looking statements contained in the presentation are expressly qualified by the cautionary statements contained or referred to in this presentation. Alimera cautions investors not to rely too heavily on the forward-looking statements it makes, or that are made on its behalf. These forward-looking statements speak only as of the date of this presentation. Alimera undertakes no obligation, and specifically declines any obligation to publicly update or revise any such forward-looking statements, whether as a result of new information, future events, or otherwise. Alimera declines any obligation to update these forward-looking statements, except as required by applicable law. Now with that, I would like to turn the call over to Dan Myers, CEO of Alimera.

Thank you Rich. It doesn't seem possible that one year ago we were launching our commercial organization in the US. In 2015 we expanded to the point where more than three times as many patients have access to ILUVIEN, our intravitreal implant for diabetic macular edema. In 2015 we achieved record sales of $22.4 million, a 167% increase in revenue over 2014, with $15.2 million being attributed to sales in the US, and $7.3 million to sales in our international segment. This growth is primarily attributed to our launch in the US, where we built our sales infrastructure early in 2015. ILUVIEN was also launched in Portugal, and was successfully relaunched in Germany.

Furthermore we expanded our opportunity for the future of availability of ILUVIEN in additional markets by entering into partnerships in Canada, Italy, and the Middle East. In the fourth quarter of 2015 we realized a 241% increase in revenue over the same period in 2014, yielding a $5.8 million net revenue, US sales accounted for $3.9 million of that revenue, and international sales were $1.9 million in the quarter. Notable highlights in the quarter included the granting of the permanent J-code in the United States, which became available on the 1st of January 2016. In Germany we saw the continued growth of ILUVIEN sales, with fourth quarter unit sales matching our previous best quarter.

We expanded our opportunities for growth in significant DME market, by partnering with MEAgate International, headquartered in the United Arab Emirates, to distribute ILUVIEN throughout much of the Middle East, where the diabetic population is significant. We believe availability of ILUVIEN's J-Code will have a significant impact on our business in 2016. This code, a permanent code that identifies ILUVIEN significantly in the reimbursement process, has led to the unlocking of certain accounts that were closed to us in 2015 due to reimbursement concerns. It has also resulted in a substantial uptick in Benefit Investigations, referred to as BIs, in the first quarter of 2016.

As a matter of fact BIs for new patients year-to-date 2016 have already exceeded total fourth quarter BIs for new patients in 2015. We see these investigations as a leading indicator of interest in ILUVIEN, as it represents true patient identification for retinal specialists. While the demand creation evidenced by BIs has been encouraging, the conversion process to actual injections in the first quarter is taking longer than anticipated, resulting in lower monthly sales. In addition to driving this demand, our sales representatives are working with physician offices to ensure these patients are scheduled and treated.

As of December 31st, 2015 our US sales force has grown to include 37 sales executives. We have added additional head count to increase our presence with key accounts. We closed 2015 with 312 accounts having purchased ILUVIEN in the US, prior to the activation of the J-code in 2016. In our international segment as a whole, Q4 unit volume was 7% higher than in the same period in 2014. Results were strongest in Germany which delivered a 63% increase in volume compared with the same period in 2014. We continued to broaden the inclusion of ILUVIEN in reimbursement contracts, and are very pleased that Germany is once again our largest source of revenue in our international segment. Portugal finished 2015 with record quarterly sales. This small but significant market was a challenge from a market access perspective. However by the end of quarter four, we executed contracts in more than 50% of our target accounts, thereby significantly increasing coverage of the DME population.

It's this access to funding that has led to the strong results we saw in the quarter, and we look forward to further increasing the level of access during 2016. As expected, the increased competition following the NICE approval for Ozurdex and EYLEA for the treatment of DME, resulted in a slowdown in UK sales that continued in quarter for. The slowdown we have experienced is directly related to the consideration of EYLEA and Ozurdex guidance, and their place in UK treatment algorithms for DME. We believe we'll absorb this slowdown, and return to growth in the UK in 2016 for two reasons. First, with respect to EYLEA, data from the recent DRCR.net's protocol T 2-year readout, indicated there are no significant differences in outcomes between the licensed anti-VEGF treatments. Therefore the number of patients insufficiently responsive to these treatments will not change. Second, with response to Ozurdex, we believe that the emerging real-world data indicates that ILUVIEN performs better to or equal to than it did in the famed study. This correlation has not been observed with Ozurdex. With that, I would like to turn it over to our President and CFO, Rick Eiswirth.

Thank you Dan. Thank you all for joining us today. Consolidated net revenue increased by approximate $4.1 million, or 241% to approximately $5.8 million for the three months ended December 31st, 2015, compared to net revenue of approximately $1.7 million for the three months ended December 31st, 2014. Consolidated net revenues increased by approximately $14 million or 167%, to approximately $22.4 million for the year-ended December 31st, 2015, compared to net revenue of approximately $8.4 million for the year-ended December 31st, 2014. These increases were primarily driven by increased sales of ILUVIEN in the US following our launch in the US in the first quarter of 2015.

Fourth quarter 2015 revenues were affected by seasonality, as well as some US accounts deferring treatments of patients into 2016, to take advantage of the newly announced J-code. We believe that the specific J-code reimbursement will drive additional use, and reduce some reimbursement concerns from US practices in 2016. US net revenue was $3.9 million in the fourth quarter of 2015. For the year-ended December 31st, 2015, US net revenue was approximately $15.2 million. US net revenue in 2015 was as a result of the commercial launch and use of ILUVIEN by retinal physicians. There were no significant ILUVIEN sales in the US in 2014.

Our international revenue increased by approximately $200,000, or 12%, to approximately $1.9 million for the three months ended December 31st, 2015 compared to approximately $1.7 million for the three months ended December 31st, 2014. The increase was primarily attributable to unit sales in Germany, offset by lower sales in the UK, and the impact of decreases in the value of the British Pound Sterling and the Euro. International net revenue decreased by approximately $1.1 million, or 13%, to approximately $7.3 million for the year-ended December 31st, 2015, compared to approximately $8.4 million for the year ended December 31st, 2014. The decrease was primarily attributable to a decrease in German unit sales, and decreases in the value of the British Pound Sterling and the Euro, offset by incremental sales associated with the commercial launch of ILUVIEN in Portugal in 2015.

Consolidated gross profit increased by $3.8 million, or 238%, to approximately $5.4 million for the three months ended December 31st, 2015, compared to $1.6 million for the three months ended December 31st, 2014. Gross margin was 92% and 93% for the three months ended December 31st, 2015 and 2014 respectively. Consolidated gross profit increased by $13.7 million, or 196%, to $20.7 million for the year-ended December 31st, 2015, compared to approximately $7 million for the year-ended December 31st, 2014.

Gross margin was 92% and 83% for the years ended December 31st, 2015 and 2014 respectively. Consolidated research development and medical affairs expenses for the fourth quarter of 2015 increased to approximately $3.6 million, compared to approximately $3 million during the fourth quarter of 2014. Research, development and medical affairs expenses for fiscal year-ended 2015 increased to approximately $14.8 million compared to $11.8 million during fiscal 2014. These increases were primarily due to the hiring of medical science liaisons, and expanded scientific and medical communication in 2015, to support the US commercial launch of ILUVIEN and ongoing post-marketing studies of ILUVIEN.

Consolidated general and administrative expenses remained flat for the fourth quarter of 2015 compared to the fourth quarter of 2014 at approximately $3.7 million. Consolidated general and administrative expenses for the year-ended 2015 increased to approximately $14.2 million compared to approximately $12.4 million during the fiscal year 2014. This increase is due to the growth in our infrastructure to support our global business. Consolidated sales and marketing expenses increased $1.8 million, or 34%, to approximately $7.1 million for the three months ended December 31st, 2015, compared to approximately $5.3 million for the three months ended December 31st, 2014. Consolidated sales and marketing expenses increased $13 million, or 86%, to $28.1 million for the year-ended December 31st, 2015, compared to approximately $15.1 million for the year-ended December 31st, 2014. This increase in expense was primarily related to our investment in the US commercial launch team that supported ILUVIEN in the US.

GAAP net loss applicable to common stockholders for the three months ended December 31st, 2015 was approximately $10.7 million, compared to approximately $10 million for the three months ended December 31st, 2014. GAAP, basic and diluted net loss per share for the fourth quarter of 2015 was $0.24 per share, on 44.6 million weighted average shares outstanding, compared with GAAP, basic and diluted net loss per share of $0.23 per share on 44.3 million weighted average shares outstanding during the fourth quarter of 2014. GAAP net loss applicable to common stockholders for the year-ended December 31st, 2015 was approximately $30.6 million, compared to approximately $36.7 million for the year-ended December 31st, 2014.

GAAP basic and diluted net loss per share for the year-ended December 2015 was $0.69 per share on 44.5 million weighted average shares outstanding, compared to GAAP, basic and diluted net loss per share of $0.91 per share on 40.4 million weighted average shares outstanding during the year-ended December 31st, 2015. As of December 31st, 2015 we had cash and cash equivalents of $31.1 million, due to less than expected sales of ILUVIEN in January and February of 2016, we are not currently in compliance with the revenue covenants of our debt facility with Hercules Technology Growth Capital. Hercules has not accelerated or otherwise made demands for any amounts owing under this agreement. We are currently in discussions with Hercules regarding an amendment to this debt facility which would bring us into compliance. We currently anticipate completing this amendment prior to the filing this month of our Annual Report on Form 10-K for the year-ended December 31st, 2015. With that, I'll turn it back to Dan for closing comments.

Thanks Rick. We increased the impact of ILUVIEN in 2015 by launching in the critical US market and progressing in current European countries. While we wait for the opportunity to expand organically into additional international markets, we have aligned with proven commercial partners where it makes sense to do so, including in the Middle East. We continue to believe that the DME market is underserved by other treatments, and recent studies consistently report that 35% to 50% of patients failed to gain significant benefit from treatment with anti-VEGF therapies.

As I've already said, very recent data for the DRCR net Protocol T confirms that at 24 months there's no significant difference between approved anti-VEGF therapies for DME. There is a clear need for further effective options like ILUVIEN. Our road forward is challenging, as we are establishing a paradigm change, bringing the only long-term continuous delivery implant, to this large population of patients who require persistent treatment of this disease. Each day we are more and more encouraged by the real world data that we are seeing. The data supports both the safety and efficacy of ILUVIEN. We are excited by the future, which includes planned presentations at key ophthalmic meetings this year, where we plan to share new data, including as early as this May. We look forward to sharing this and other news on our next call in May. And I thank you for joining us today, and for your interest in Alimera Sciences. I'll now turn the call over to the moderator to begin our Q&A session.

(Operator Instructions). Our first question comes from the line of Caroline Corner with Cantor Fitzgerald. Please go ahead with your questions.

Hi guys. Thank you for the color today. So looking at your January and February revenues, you mentioned that they came in a bit lower than expected. You mentioned that converting customers to the actual injections after they have signed up for an injection is taking longer than you thought. Can you talk us through a little bit what's happening there, given that these patients are going blind. They have already deferred some injections from 4Q into 1Q, but why are we not pulling the trigger and actually getting these injections done? And then can you also talk a little bit about what you're going to do in order to change this, to actually drive the injections to actually happen?

Sure, so Caroline, unfortunately the answer to that question is somewhat, it depends, because there's a variety as to what happens out there in the workplace. You have some physicians that will submit a benefit investigation, get that benefit investigation completed. And then we can then schedule that patient to come back in and treat them for the DME with ILUVIEN right away. In other circumstances you have a physician that determines they would like to use ILUVIEN on a patient, they will submit the benefit investigation. But at the visit when they make that determination, they will inject that patient with an Ozurdex or an EYLEA or a Lucentis, and those patients then are therefore treated for 2 to 3 months, 4 months on the outside, depending how far out the doctor wants to stretch out the treatment with Ozurdex. Then that patient gets injected. So we think that the average time is somewhere between 2 to 3 months that it takes to get that converted. We are looking at better ways to make sure that each one of our individual reps can track the open BIs that we have within the HIPPA rules and the privacy rules we have for those patients. But allowing those reps to track the open BIs, so that they can be following up with the practices, to make sure that those patients are rescheduled on a timely basis.

Okay, thanks. And then you said that you have 312 accounts open as of the end of the year before the J-code was in place. That was up from, I think, about 160 in second quarter. So that's solid progress there. How many accounts total do you see? And was the J-code as you see it, is that a big gating factor for open end accounts?

We think there's somewhere between 1,000 and 1,500 accounts probably out there that we would be targeting. So there's probably 20% to 30% penetration, depending on how you want to look at that. We did have some accounts that opened up that actually called us proactively after January 1, that had withheld treatment of the J-code. I don't want to mislead you and say that that's a huge number. More of it is us going back and approaching all those accounts where the J-code was cited as an issue, and pushing those. We have seen an increase in accounts in January and February, so we do think that is continuing to grow, and some of that is the impact of the J-code.

And then this is the last one for me: You've talked a little bit about driving towards profitability. Especially you're in a bit of a cash crunch right now. Do you think that the peak sales of ILUVIEN, in some of your comments before we've talked about what is that number. Assuming that ILUVIEN is only targeting the DME market, where do you see that number for peak sales for ILUVIEN? Like $400 million or so? And where do you think you need to be in order to hit profitability?

Caroline, we have never guidance on what we thought the peak would be. I don't think anybody here at Alimera Sciences, their enthusiasm dampened for the long-term prospects of the product. We do have the advantage of knowing that this product works. We get anecdotal evidence from patients and doctors in the field on a daily basis, in terms of success stories with ILUVIEN. It is taking a little bit longer than we wanted it to, because of some of the challenges on reimbursement, and we just simply have a higher priced product, and we are facing competition in the marketplace. We think we will get there. We are determined to manage the Company to breakeven EBITDA in the fourth quarter of this year. That's the challenge we have in front of us, we're very focused on that in Europe. And we do think that the demand of the BIs, that we have seen over the course of January and February, that Dan alluded to, is exceeding what we saw in the fourth quarter is a good indication that demand is there, and we will be able to grow sales throughout 2016.

Great. Thank you very much.

Our next question comes from the line of Boris Peaker of Cowen and Company. Please go ahead with your questions.

Good morning. I want to explore a little bit more about this compliance with debt covenant. Could you comment, how far away were you from it, and what are the conditions in the debt agreement if the covenant is not met?

Boris, we haven't disclosed the specific guidance and projections we provided Hercules, so we're not prepared to do it on this call. We obviously missed our own internal predictions that we had shared with Hercules there. The reality is Hercules does have all of the remedies, the many remedies, they could effectively call the debt if they chose to do so. But as we stated in the call, they haven't done that, and we have an agreement to work forward over the next ten days before, that K is issued, to complete that re-negotiation, and put us back in compliance.

I see. So is there a monthly check, so for example, in March and April, could they wait to see those numbers, or you need to basically resolve it based on just January and February data?

Historically there has been a monthly check. But part of the amendment that we were working on will address that prospectively.

Got you. And also just from a patient perspective, are you getting patients that were previously treated on Ozurdex, or I guess what fraction of patients who are on ILUVIEN have been previously on Ozurdex, versus new to a delayed steroid?

We certainly are getting patients that have been on Ozurdex before. I think that there are certain physicians out there that may use alternative steroids as the check or the test to see how a patient might respond from an IOP's perspective to a steroid, before they're treated with ILUVIEN. But for the foreseeable future, I think the assumption is that the vast majority of patients will have received Ozurdex, or more than one Ozurdex before they are on an ILUVIEN. Dan alluded to earlier, how we are definitely seeing a shift in the marketplace of physicians being able to earlier identify a patient that is not responding sufficiently to an anti-VEGF therapy, and doctors are making that change faster. We are certainly seeing that in Europe, and beginning to see some of that trend in the US. I think we will continue to face the same challenge with Ozurdex for a while, and that physicians may want to do multiple Ozurdex, and we need to work on getting them to make that switch sooner. As Dan also alluded to in his comments, we believe the data out there in the marketplace, and data that continues to emerge indicates that Ozurdex simply doesn't drive the same level of efficacy as ILUVIEN did in its clinical trials or does in clinical practice and that we will be eventually be able to convert these doctors on an earlier time schedule.

Got you. And my last question is you mentioned that there was some, I guess, warehousing of patients for the beginning of 2016 due to a J-code coming online? Curious--

Yes, we do know that there was some deferral in the fourth quarter, of physicians either giving us a benefit investigation in the month of December and saying not to run it until January, when the new insurance benefits would be in place. And we also had some re-submissions from physicians who had identified a doctor and submitted a benefit investigation in October, November or December. And because of the lag I had referenced earlier in speaking with Caroline, those patients rolled over into 2016, and they resubmitted a benefit investigation. So we do know that there's a substantial number out there that we're in the process of trying to convert.

No, I understand that. But my question was, do you have a sense in terms of sales revenue, how much was rolled over into 1Q from 4Q, that otherwise maybe would have been captured in 4Q if not for this J-code coming up?

It would be an estimate, Boris, and I don't think we're prepared to try to estimate that on this call today.

Okay. Great. Well, thank you for taking my questions.

Thank you. (Operator Instructions). Our next question comes from the line of Jim Molloy with Laidlaw. Please go ahead with your question.

Hey guys, thanks for taking my question. I was wondering, could you talk a little bit we're here into March, almost through the first quarter on the trend in the fourth quarter due to the issues that you addressed about the J-code, and obviously down 22% quarter to quarter. Not what you're looking for. Is that a trend that's continuing in the first quarter, or has that changed or is it flat? Any trend compared to the third quarter or fourth quarter trend last year?

Well, Jim, I can answer that from a BI standpoint. As Rick has said, we're not prepared on this call to give guidance into the first quarter on a revenue basis, but as you look at BIs, which have traditionally been a leading indicator for us, January/February has been very encouraging as it relates to BIs coming through. Some of that is J-code, as Boris mentioned, warehousing, if you will. But if you just take new patient BIs, which is of course the demand created by the sales force being in the office, and the issuance of the permanent J-code, we've certainly seen an uptick of new patients over the previous quarter. In addition, of course we've got the lag of patients who came out of January.

Right now if you look at what we think is kind of the leading indicator of demand, from that standpoint we're pretty close to what we expected to see as demand in January and February. So that's the good news. As I said earlier, and as Rick has reiterated, the conversion of that "demand" that's pretty much on track where we expect it into actual revenue, has been a little bit slower than we anticipated. So I guess if I can look at the quarter without getting into the actual numbers, right now I think we feel pretty good about the demand creation per our expectations. But certainly we would have to confess that we were a little more optimistic that with the permanent J-code, the system would be more fluid, and we would see those patients moving through with less of a lag time.

As Rick said it's still taking somewhere between 2 and 3 months for a BI to become a sale. And so of course that makes it very difficult, and kind of the wild card for the quarter, how many of those BIs that have built up in January and February that looks pretty encouraging, will actually occur or turn into sales that occur in March, or will they drift into April, which of course has an impact on whether that's a first quarter sale or a second quarter sale. So I really almost think we have to kind of see the effect of this over the course of two quarters, because you could see movement from the last part of March into the first part of April, that you would argue is sort of first quarter demand, but may not be reflected in revenue until either March or April or May.

Thank you. In the fourth quarter last year, did the non-deferred BIs, you mentioned a lot of BIs said, hey, wait for the benefit of the investigation, and don't activate it until January because I want to wait for the J-code. But the actual BIs that came in and weren't waiting for the J-code, were they down sharply in the fourth quarter in line with ILUVIEN. I guess I'm trying to get an idea of how, historically over the last year, how indicative have the BIs been of sales pull-through?

Jim, I would say that October and November were pretty consistent with what we had seen earlier in the year. You did see a very sharp tail-off in December, which I think generally is what we said about the fourth quarter was as a result of both the seasonality, and physicians wanting to wait to inject into January and February with the J-code. So you did definitely see a tail-off in December.

Got it. Thank you. And then in the real-world experience, it's been out there for a year now, I know you mentioned previously in the real world it seems to be working better than in the trials. How has the incidence of IOP been in comparison to the trials, so the incidence of the surgery to correct IOPs, as compared to in the trials over the last year?

Yes, and that's one of the comments that I had made about trying to get a lot of the real world experience. It's been very positive in Europe into the US market. And we're going to begin that with the Royal College of Ophthalmology presentations in May. That was my reference earlier. And how much of that is staying in compliance in the US, of course, bringing it into the US market is a real critical piece of our marketing over the next six months. But to answer your question specifically, we've now got over 4,000 injections globally. Maybe 60% of that or so is in the EU.

And at this point in time we still only have reported, or have had reported to us two incidents of filtration surgery, or glaucoma surgery, which some people like to call it. Which if you remember in our trial, in what some of our competitors and some of the US doctors continued to reference was about 5% in the FAME data set, of course reminding you, that the FAME trial was done back in 2005 through 2008, and of course we know a lot more about DME and how to treat DME now, almost a decade later. So we still remain very encouraged that the actual incident rate of glaucoma filtration surgery, which at the end of the day is what the doctors are most worried about. I certainly know that managing IOP is a concern that retinal specialists will have to grow to learn how to manage IOP.

I think it's just a way of life as we move forward, looking at the treatment paradigm of steroids now being more applicable to DME. We're just going, we're going to continue to grow and learn about managing it. I think when you talk to doctors specifically in the US, they're concerned about the incidence of glaucoma surgery and we continue to be very bullish, and at this point in time now, after 2.5 years launched, we still have only had two filtration surgeries in the world. So I feel very good about the safety profile as it relates to the surgical procedures.

Two out of 4,000 is certainly lower than 5%. That's a good number.

And, Jim, let me just to contextualize that, to be fair, not all of those patients have been completely through the three years. But now we have hundreds of patients who have completed three years. Certainly the two incidents were of that early group. So while one could suggest that, well, you have 4,000 injections, not all of them have been exposed to the treatment of a steroid for three years, but still, even if it's two cases out of just several hundred, we still feel very good about that. But clearly we want to keep watching that. But I think early on right now we feel very bullish.

Excellent. And Rick, you had mentioned the fourth quarter you're expecting to be EBITDA breakeven by fourth quarter 2016 if you hit your internal projections. What does that say about your expenses? I mean, your R&D up about $4 million from the prior year. Can you walk through, are those going to stay consistent G&A sales and marketing, do they need to move dramatically, stay roughly where they are, if you hit your numbers? Can you walk through what gets spent on R&D, what the $14.8 million is being used for?

Yes, I think overall what you will see is that the expense run-rate that you're seeing in the fourth quarter, which is fairly consistent with what you saw in the third quarter will stay about the same. So for 2016. The R&D spend is really a lot more around the medical affairs side of things right now. It's the medical science liaisons and scientific communications, medical communications in the field, to support building the knowledge base of ILUVIEN. It's the things in the discussions that our medical team that can have, that our sales reps can't have out into the in the field to drive the awareness of ILUVIEN. It's also the 800-patient registry study that's being run in Europe, as part of the regulatory requirement there, but that also will provide us some real world evidence over the course of 2016. And it's also the PALADIN study where we are looking at what the side effect profile of what an ILUVIEN looks like after that prior course of corticosteroids.

Great. Thank you very much for taking my questions.

Thank you. Next for follow-up questions from the line of Caroline Corner with Cantor Fitzgerald. Please go ahead with your questions.

Hi guys. So just looking at that 2 to 3-month lag that you talked about, when patients are coming in and getting treated with something else while they're waiting for the benefits investigation, that makes sense and explains why we would see a bit of a delay. But when do you feel like you'll be comfortable giving us revenue guidance? When do you think this is going to shake out where you'll be able to predict actual adoption? Should we expect to get some revenue guidance on the July call, or what are your thoughts there?

I would probably say it's more likely going to be the July call before we would consider doing that at this point.

Okay. Thanks. That's helpful.

Thank you. This concludes today's question and answer session. I would like to turn the floor back to Dan Myers.

Thanks again for your attendance on the website and the call. I appreciate the questions, and the opportunity to perform explain further how our performance and our excitement going forward. We look forward to our earnings call in May, and giving you further update on progress with ILUVIEN. Thank you.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time, and thank you for your participation.