Alimera Sciences Inc (ALIM) 2015 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Alimera Sciences third-quarter 2015 conference call. (Operator Instructions).

As a reminder, this call may be recorded.

I would now like to introduce your host for today's conference. Rick Eiswirth, you may 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 third-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; and our Form 10-Q for the quarter ended June 30, 2015, which is on file with the SEC and available on the SEC's and Alimera's websites; and the Form 10-Q for the quarter ended September 30, 2015, which we expect to file tomorrow. 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 make on this call on account of new information, future events, or otherwise. Please be advised that today's call is being recorded and webcast.

Additionally, the non-GAAP financial measures of adjusted cost of goods sold, adjusted gross margin, adjusted net loss attributed to common stockholders, and adjusted net loss per share, will be discussed on this conference call. A reconciliation of these measures to GAAP can be found in our press release.

Now I'd like to turn the call over to Dan Myers.

Thanks, Rick. And thanks, everyone, for joining our third-quarter 2015 conference call. We achieved third-quarter total sales of $6.9 million, an increase of 188% compared to the same period a year ago, and an increase of 19% over the second quarter. This growth was driven by the continued ramp of US sales, which increased 32% from $3.8 million in the previous quarter to $5 million in the current quarter.

In the US, we had completed seven months of our ILUVIEN launch at quarter's end. And the third quarter was our strongest to date, which we believe represents a growing market acceptance of our product. We continue to see growth in the number of accounts trying ILUVIEN. We now have 251 accounts who have ordered ILUVIEN, an increase of 57% in the third quarter.

The depth of usage also continues to improve, as 55% of our accounts have placed more than one order through the end of Q3 compared to 38% at the end of the second quarter. In regard to physician usage, 15% of our targeted population of 2,300 physicians have injected ILUVIEN. This improvement in breadth and depth is good progress for the first seven months of our launch. But it also indicates that there is a great opportunity to expand the footprint of our 12-month projected $20 million run rate in the US.

Although we are pleased with the progress we have made to date, we have higher expectations for ILUVIEN. Our revenues have been tempered by a couple of items that, quite frankly, we did not anticipate. First, we believe that we underestimated the willingness of doctors to use ILUVIEN under the buy-and-bill model without a J-code. You might recall that a specific J-code for a product is a permanent code that identifies ILUVIEN, specifically in the reimbursement process.

Although physicians and practices have experience with miscellaneous J-codes, we did not fully understand the reimbursement challenges physicians have recently faced with these products. In reality, the risk associated with reimbursement has been less tolerable for doctors when they have three short-term treatment options available that have specific J-codes. With these options, they can delay the use of ILUVIEN until their practices are more comfortable with the reimbursement process.

As a result, certain physicians are trying a limited number of units of ILUVIEN and waiting for reimbursement, while others are withholding initial usage until the J-code is available.

The second item we did not anticipate was that certain physicians would adopt ILUVIEN with a, quote, watch-and-wait approach, as a very small sample of patients to evaluate the safety and efficacy, rather than relying on our prior FAME data. We know some physicians are watching and waiting to see how ILUVIEN performs in their current patients before ordering on a consistent basis.

As of September 30, 66% of our accounts had ordered three or fewer units, indicating that there are indeed many physicians trying ILUVIEN and evaluating reimbursement, safety, and efficacy. We believe this provides us a great opportunity for growth as we move physicians through these evaluation periods.

From a reimbursement perspective, we know that practices are being paid by the payers, so providing doctors confidence in this area is only a matter of time. This should be made even easier with the availability of a specific J-code for ILUVIEN in 2016.

In fact, we are pleased to announce that this week the Center for Medicare and Medicaid services, CMS, posted a new permanent code, J7313. This code should provide retina specialists with a new coding option for ILUVIEN, effective January 1, to replace the use of the unspecified J-code currently being required by some payers, and should offer practices the opportunity for more streamlined reimbursement in 2016.

On the safety and efficacy side, we are confident that physicians will emerge from these trial periods with confidence in ILUVIEN as a treatment for DME in their practice. We know we have a product that works. We expect doctors to see that. Our real world experience to date in Europe confirms this, and we've been making an effort to make this data available.

In September, we issued a release on a review paper entitled Real-world Experience of Fluocinolone Acetonide Intravitreal Implant in the Treatment of Diabetic Macular Oedema, authored by Dr. Fahd Quhill, an ophthalmologist at Hallamshire Hospital in the UK.

In that paper, case reports of 28 injections of ILUVIEN from a total of 10 sites in Germany and the UK were analyzed. The mean follow-up after injection of ILUVIEN was 13 weeks in these case reports. The average change in the ETDRS letter score from baseline was an increase of 14 letters with 15 eyes, or 54%, achieving greater than 10 letters of improvement; and 9 eyes, 32%, achieving greater than 15 letters improvement.

The average decrease in central foveal thickness, CFT, was 167 microns; while in 15 eyes, or 54%, CFT decreased below 300 microns. In these cases, the introduction of IOP-lowering medication was required in only two eyes, or 7%, compared with 38% in the FAME study, our pivotal Phase 3 study. This data demonstrates efficacy equivalent to that seen in the FAME study. But also in a limited number of cases reported in the public domain, the number of patients experiencing elevation in IOP were fewer than reported in the FAME study.

We also revealed interim six-month data on ILUVIEN from the ongoing study referred to as RESPOND, a non-randomized, open-label study conducted at four sites in Portugal, with 12 patients enrolled under our European label. The interim six-month results show that ILUVIEN was well tolerated and effective in reducing retinal thickness and increasing visual acuity.

Of 11 patients completing their six-month visit, nine or 82% maintained or improved their best corrected visual acuity from baseline. And 10 patients or 91% experienced a decrease in central subfield thickness. The 11 patients with six months of follow-up gained an average of 7.1 letters in BCVA from baseline, and experienced an average decrease in CST of 300.6 microns from baseline.

Importantly, the coordinating investigator stated that ILUVIEN provides a confirmed, sustained, and fast efficacy with less safety concerns that initially presumed.

Now I'd like to turn to our results in Europe. In Germany, our second-largest market opportunity, we saw our best unit sales quarter since the third quarter of last year. We also saw a 26% growth in revenue over the previous quarter. We believe this is a sign of strengthening business behind our three key initiatives, which we are dedicated to and have been actively implementing in recent months.

First, our sampling program to grow the user base was successful and has increased new product experience. Second, we have worked closely with hospital-based KOLs to build support for ILUVIEN, resulting in increased clinical presentations and outcome discussions. Third, we've seen increased inclusion in the reimbursement contracts and medical guidelines, which has improved the position of ILUVIEN as a treatment for DME.

We expect sales growth to strengthen further in Germany, and now believe that this market will assume a more prominent place in delivering European revenues consistent with the market opportunity.

Despite the positive growth in the US and Germany, we did experience downturns in the UK and Portugal. In the UK, we believe this is attributed to the recent positive recommendations from NICE for the reimbursement of both Ozurdex and Eylea by the National Health Service. Remember that our indication in Europe is for patients that are insufficiently responsive to available therapies.

In the UK, treatment is often based on rigorous treatment algorithms, and we believe physicians are working through how to include Ozurdex and Eylea in these treatment regimens as available therapies. We believe this slowdown is only temporary, and does not impact the potential for ILUVIEN in the UK, long-term.

Data from the DRCR.net's Protocol T indicates that a large percentage of patients are expected to be insufficiently responsive to either anti-VEGF therapy and will need to move to another treatment modality such as corticosteroids.

With regard to Ozurdex, we continue to believe that the inconsistent dosing makes it an inferior option to ILUVIEN over the course of time, and that Ozurdex will ultimately be used as a, quote, steroid test, if at all, once physicians gain experience.

To combat potential market share loss in the near term, we increased the size of our salesforce in the UK, and also strengthened our medical liaison capabilities.

In Portugal, we saw seasonal variations of holidays in the summer months, but have seen an upward turn in September and October. And we believe Portugal represents a small but significant market opportunity, and we'll continue to explore ideas and opportunities to grow this business.

We continue to look for opportunities to expand the geographical reach of ILUVIEN. And in the third quarter, we announced an agreement with SIFI for the distribution of ILUVIEN to Italy, San Marino and Vatican City. SIFI will handle all promotion, marketing and commercial activities in those locations for ILUVIEN. The agreement provides for royalties from SIFI to Alimera on sales of product in the territory. Currently, SIFI is focused on establishing a reimbursed price in Italy. We do not expect revenue from this partnership until 2017, at the earliest.

We also announced an agreement with Knight Therapeutics for the distribution of ILUVIEN in Canada. Knight will handle all regulatory and commercial activities for ILUVIEN in Canada. And the agreement provides for milestones based upon the achievement of certain regulatory and reimbursement goals in Canada, as well as royalties on units sold in the territory. Knight's initial activities are centered on pursuing regulatory approval for ILUVIEN in Canada. We do not have specific expectations regarding the timing of revenue.

We are excited about these types of agreements that help us enter additional markets by working with strong partners, and we'll continue to seek these types of opportunities.

In the second quarter, we also told you about the PALADIN study that was initiated to accumulate data in a real-world setting, focused on patients treated in accordance the US label. As previously discussed, we believe the PALADIN study will demonstrate the possible IOP side effects -- especially IOP related to surgery associated with ILUVIEN -- will be less frequent than what was seen in the full population in the FAME study.

To date, we have signed up 28 sites of our 50-site target, and have enrolled over 30 patients, or close to 10% of the trial's goal. We expect these numbers to increase as we bring on more sites, and doctors become more comfortable using ILUVIEN.

With that, but like to turn the call back over to Rick to discuss our third-quarter financial results.

Thanks, Dan. As Dan mentioned earlier, total net revenue for the third quarter of 2015 came in at $6.9 million, an increase of 188% compared to the same period a year ago, and an increase of 19% over the previous quarter. Breaking this down by segment, revenue in the US increased 32% sequentially, from $3.8 million in the second quarter of 2015 to $5 million in the current quarter.

International sales -- which are derived from sales in the United Kingdom, Germany, and Portugal -- decreased 5% from $2 million in the second quarter to $1.9 million in the third quarter. As Dan mentioned, we continued our growth in Germany, but that growth was slightly offset by downturns in the UK and Portugal.

We expect fourth-quarter revenues to be affected by the typical seasonality, as well as lack of clarity about the possible impact of the now-announced J-code in the US. This may cause some doctors to postpone treatment until the J-code is available in January 2016.

As a result, we expect full-year 2015 revenues to be in the low $20 million range. We believe that the specific J-code reimbursement will drive additional use and market acceptance of ILUVIEN; and, therefore, we expect significant growth in 2016.

Cost of goods sold, excluding depreciation and amortization, was approximately $630,000 for the quarter compared to approximately $370,000 in the prior-year period. This increase was primarily driven by increased sales. Research, development and medical affairs expenses for the third quarter of 2015 remained relatively flat, at $4.1 million compared to $4.1 million in the third quarter of 2014.

General and administrative expenses for the third quarter of 2015 also remained flat, at approximately $3 million compared to approximately $3 million in the third quarter of 2014.

For the third quarter of 2015, sales and marketing expenses increased by $3.4 million or 97% to $6.9 million compared to $3.5 million in the third quarter of 2014. This increase was primarily attributable to increased personnel and travel costs associated with the US field force, and promotional and marketing costs associated with the launch and commercialization of ILUVIEN in the United States in the first quarter of 2015.

GAAP net loss applicable to common stockholders for the third quarter of 2015 was approximately $1.5 million compared with GAAP net loss applicable to common stockholders of approximately $7 million for the third quarter of 2014. GAAP net loss attributable to common stockholders for the quarters ended September 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 from potential inventory expiration.

GAAP basic and diluted net loss per share for the third quarter of 2015 was $0.03 per share, based on 44.4 million weighted average shares outstanding; compared with GAAP basic and diluted net loss per share for the third quarter 2014 of $0.17 per share, based on 41.1 million weighted average shares outstanding.

Non-GAAP adjusted net loss attributable to the common stockholders for the third quarter of 2015 was $9.6 million compared to a non-GAAP adjusted net loss attributable to common stockholders for the third quarter of 2014 of $8.9 million. Non-GAAP adjusted basic and diluted loss per share for the third quarter of 2015 and 2014 were $0.21 per share and $0.22 per share, respectively.

Net loss for basic and diluted attributable to common stockholders per share, and non-GAAP adjusted net loss attributable to common stockholders per share, was based on 44.4 million weighted average shares outstanding for the third quarter of 2015, and 41.1 million weighted average shares outstanding for the third quarter of 2014.

Reconciliation of GAAP cost of goods sold to non-GAAP adjusted cost of goods sold, GAAP profit to non-GAAP adjusted gross profit, GAAP net loss attributable to common stockholders to non-GAAP adjusted net loss attributable to come stockholders, and GAAP net loss per share to non-GAAP adjusted net loss per share, is included in the press release in the table titled reconciliation of GAAP measures to non-GAAP adjusted measures.

Our cash burn for the third quarter was $8.8 million, down from $15.4 million in the first quarter and $13.2 million in the second quarter. As of September 30, 2015, Alimera had cash and cash equivalents of approximately $39.3 million compared to approximately $48.1 million as of June 30, 2015.

With that, I will turn the call back to Dan for closing comments.

As you have heard, ILUVIEN's third-quarter growth in the US and Germany was encouraging, despite ongoing reimbursement challenges. With the availability of the J-code in 2016 in the US and the continuing emergence of positive real-world data, we anticipate exiting 2015 with a solid platform for growth in 2016.

With that, I will now turn the call over to the moderator for questions.

(Operator Instructions). Caroline Corner, Cantor.

Congratulations on all of the progress, and on the US ramp. My first question is around the J-codes. Now that the code is assigned, should we assume that the doctors' offices are getting ready for January 1, and that they'll start to get the paperwork in place, et cetera? And perhaps there won't be as much of an implementation type of delay through the first quarter that we might have been expecting.

Caroline, I don't think that this would have any change on the fact that it will be implemented over the course of the first quarter or first half of the year, depending on the practice. It's typical that these J-codes do come out in November, as we said. And you'll still have delays on the payer side -- yes, the payer side -- because some of the commercial payers, it will depend on when they implement the J-code into their system just as much, too.

So I wouldn't expect it to change based on the announcement today, other than it's good news that we finally have it, and we know it's here because we received a lot of questions about how certain we were of that coming.

Okay, great. Thanks, that's helpful. And then you said you have $39.3 million in cash right now. Are you still anticipating that you will be cash flow positive in 2016? And can you give us some comments about how you feel about your cash position right now?

You know, we still feel good that we have enough cash to get to positive cash flow. The growth that we have, we are very proud of, as Dan had alluded to. But we are a little bit behind our expectations. So we are comfortable that the cash will get us to positive cash flow; whether or not it comes in 2016 or early 2017, a little bit of uncertainty of that, at this point in time.

We do feel good about the cash. As we always do, we will continue to look at ways to strengthen our balance sheet, as we did with the extension we completed with Hercules and announced earlier in the week.

Okay. And then fourth-quarter revenues -- obviously we're over a month into those, and you've got it to the low $20 million range. Can you talk a bit about the seasonality expected, such as the holidays that weigh on that? Or is there something to do with HSA plans, or anything like that, where you also have elective surgeries (multiple speakers)?

Yes. I think when we say that -- certainly DME -- I think we've all come to understand that DME, while a very serious disease, doesn't quite deal with the sense of urgency that a patient with wet AMD might be brought in. So certainly there is some variability to the patient flow around the holiday season; not necessarily a consistent pattern, but we just know that would be an issue that typically would come up around the holiday season.

What I think we would like to make sure people understand, and we have been trying to get our heads around for the last month or so, is now with the J-code in place, the good news is, of course, doctors can begin to expect that patients can come in and we would be -- and they would be reimbursed in January.

It's going to be real incumbent upon our salesforce to be out there and continue to push the sense of urgency to have patients come in and get the implant done, rather than delaying until January knowing that the miscellaneous J-code will be no longer a problem, and they can just move right into the J-code.

So on the one hand, the J-code is obviously very good news for us. But I think what we're wanting to make sure people understand is, it does create a bit of an uncertainty into how many doctors will just decide to wait to move a patient from, let's say, the second week of December; why don't we just wait until the second week of January? So that's a hard thing for us to calibrate. But we still feel pretty good about coming in in the low 20s, as Rick said.

Okay. Great, thanks. And then finally from me -- and apologies; I missed the very beginning of the call, if you've provided this information -- but can you give us an overview of your US salesforce, how many people you have right now? And then of that salesforce, where they are kind of in the ramp-up phase, and how many of them are fully contributing, or fully ramped up and trained and ready to go.

Well just to answer the question specifically, we have 31 sales reps out in the territories. And we've continually monitored with our regional sales directors the coverage factor, now that we've been out there seven months. You model the coverage and doctor locations and hope you've got it right. And our regional directors have come back to us consistently saying that 31 seemed to be right number that we're not having people with reach and frequency, that we are getting into doctors' offices, and that we are getting our fair share of the time in the office.

So I'm pretty comfortable now that 31 is the right number, and we would not be looking to add any of the headcount after the initial launch.

As far as the ramp of salesforce, we've retained almost all of those reps through the seven months. We did have a couple of empty territories that we had to replace. So those sales reps, of course, have received training in the last couple of months.

So with rare exception, all of the sales reps have now been on board with us for seven months and are fully trained. We had a national sales meeting back in February where they all trained. So for the most part, they've all been with us.

As with any salesforce, we've got probably about a third who are really, really hitting it, and have gotten a lot of impact in the doctors' office. And I would say that there's still a few that we've still got a chance to get some extra training in. But, all in all, I think it's a pretty typical performance where you have the classic overachievers, the middle of the pack, and those that we need to continue to reevaluate.

Got it. Thank you. That's all I have. Thanks very much, guys, and congratulations.

Jim Molloy, Laidlaw.

So quickly, first question: I was just wondering, can you walk us through a little more on the reimbursement picture in Germany and the UK? And is France still in the picture at all, or is that kind of all done with?

Yes, so with respect to the various European countries, Germany -- we are continuing to make progress and getting more and more contracts with respect to both the doctors' unions and the statutory insurance companies. Right now, we believe that we have 51% coverage of the country across IVOM contracts, which are the intravitreal ophthalmic medication injection contracts. That's where the doctors get reimbursed. So we have about 51% coverage of those, and we are chipping away at the statutory health insurance fund contracts, as well. So we've definitely seen that make an improvement.

I would say equally as important is some of the stocking plans we've made to make sure product is on the shelf in Germany, and it's available to be used; and when it's available to be used, it's getting paid for.

In the UK, nothing has really changed with respect to our reimbursement. We still have the nice guidance. The one change that Dan alluded to on the call is now that Ozurdex and Eylea are being reimbursed or paid for by the NHS in the treatment of DME, you have a little bit of shuffling going on in the NHS hospitals in their treatment algorithms, and how they use these other drugs.

We don't think it changes anything in the long-term for us. Because we still think 40% to 50% of these patients don't respond sufficiently to the anti-VEGFs, regardless of which one you're using. And we feel extremely comfortable that we have a significantly better steroid than anything else that's available on the market.

And then with respect to France, we are having ongoing discussions with the CEPS to receive the price there. As you know, we've been delayed several times there trying to figure out what the market comparator is. In Ozurdex, now it is approved for DME in France, does have a price there and we are working through some comparative pricing with respect to that.

The goal is, in a good scenario, we could have a price by the end of the year. But it's probably more likely going to be sometime in the first quarter that we would have an announcement in France.

Great, great. All right, thanks. Also just a follow-up. So how much -- in terms of the EU sales going down a little bit, I know you split it up in terms of Germany, Portugal, and the UK. But how much of it is due, would you say -- relatively, is due more to the foreign exchange, and how much would be more attributable to sales? I guess Germany has been going well. But in terms of UK, how much -- can you split that up a little bit?

We typically don't give that level of granular detail to country sales, as far as dollar numbers. I believe we did say that the German sales grew about 26% sequentially quarter-to-quarter, and most of that offset just comes out of decreased volume in the UK. There wasn't a significant impact from foreign currency changes from the second quarter to the third quarter.

Now, there was a much more significant impact if you look back to the third quarter of 2014, where a lot of the change in that comparison comes from foreign currency changes over the year.

Okay, great. And have you guys been seeing -- the early adopting US docs, have they begun to reorder ILUVIEN, or is that not happening?

Yes, if you look at, I believe we disclosed that statistic on the call. We had about 251 accounts through the end of the third quarter. And at that point in time, 55% of our doctors have ordered more than one. So we are certainly seeing increased orders and increased volume there. At the same time, we alluded to about two-thirds of the doctors have used three or less units, [sitting] there on that trial period.

So we're seeing reorders and re-usage; at the same time, a lot of opportunity for some low-volume users that are getting that trial, whether it be with respect to reimbursement efficacy or safety at this time.

Great, great. And one lasts question: can you give us an update a little bit on the DTC campaign?

Well at this point, there is not a DTC campaign. I think on the last call -- and Jim, you might have asked the question -- that we will consider that at the right time. I think the feeling we have right now is there are some creative things we can do. And we certainly believe DTC can have an impact and be a strategy in 2016.

I think one of the things about DTC is you have to make sure you've got at least your physician base to appoint of that minimum neutrality, if not advocates, before you [begin to] draw patients into the office to a DTC campaign.

So, I think we've got a little more work to do in the office to make sure that we've got a broad base of users who are familiar and comfortable with ILUVIEN, so that when patients come in, they are more receptive to an outside stimulus like a DTC campaign. But we are certainly going to look at it strongly at 2016.

All right. Great. This is actually Frank on for Jim. But, thanks, that's it for questions for me.

(Operator Instructions) Mitchell [Derger], [Ladenburg] and Company.

Again, Dan and Rick, I want to add the congratulations for a very nice, improved quarter. My question is -- I heard that we penetrated to 250 or so doctors to try ILUVIEN. And now with the J-code being posted that starts January 1, I guess for Medicare and Medicaid patients, I would think we'd be all over those 250 physicians -- that they have three or four months to take care of their balance sheet on the payment. This seems like a no-brainer that these 250 physicians would want all you can give them.

Well, certainly, that will be one of the jobs of our salesforce in the next two months, is to bring the message to these 251 accounts. And accounts, by the way, they continue to grow. We didn't give that data today, but we think that that's expanding.

Our timing, Mitch, was very fortuitous in that the American Academy of Ophthalmology begins next Saturday, the -- I think that's 14 November. And so we had done some preparation work anticipating that we might have a J-code, so that we could make that announcement have promotional campaign at our booth at the AAO; which, of course, is the largest attended meeting in the US -- well, in the world, actually.

So I think we'll be able to make a big splash at the AAO, announce the J-code, get doctors very aware that, as we've said earlier, get yourself ready because in January you're through with the days of the miscellaneous J-code.

So, you're right; we'll be very much intensely on these doctors to let them know that it's time to start thinking about how the flow of payments should be a lot easier, coming forward.

It would seem to me -- and I'm just making an observation, because I've been very involved in your Company as a financial advisor for 35 years -- and this is not the right word, unethical -- that these physicians, once they are aware of the effectiveness of ILUVIEN, that they would give any other treatment to a patient, or submit a patient to getting a shot every 30 or 45 days when they can get this treatment every three years and be much more effective.

Certainly, we think that ILUVIEN is a wonderful option for the patient. And clearly there's a lot of things that come into deciding the treatment algorithm for DME patients. And I think we're making great progress that when doctors do get a chance to step back and think about what ILUVIEN means in quality of life for patients, once they get themselves comfortable that the risk-benefit of the efficacy of ILUVIEN -- which we certainly continue to hear that ILUVIEN works -- balanced with what we think will be a very positive risk-benefit profile.

When you get to that place and you are comfortable with that, then I think what you say makes a lot of sense for the patient. Because, clearly, if you go to the patient groups and ask them, obviously, would they rather have an injection every month, every two months, versus once every three years? That's an easy answer.

So in our job is to get the doctor to a point where the benefit-risk assessment to him makes sense. And then I think your comment becomes very challenging as to why we wouldn't see a large number of patients getting ILUVIEN going forward.

Last but not least, if I read it right, at the ophthalmology conference [Dr. Wyckoff] is making the keynote speech. Is that correct?

That's true. That is true. So were very excited that his paper got into the latebreaking news. That's not easy to get in. And we were very excited about that. He'll be presenting Saturday morning at the retinal subspecialty day. So more to come on that.

And obviously you'll be present at that conference?

That's correct.

Great, great, I'm looking forward to this. It sounds great. Keynote speech, and we're going to see that these doctors know that Mrs. Jones or Mrs. Jones gets a shot every three years; they get a shot with a less invasive needle, if I'm right about that; less invasive side effects, if I'm correct about that. It seems like a no-brainer.

We certainly hope so.

Thanks, Mitch. We appreciate your support.

Thanks.

Thank you.

And I'm showing of further questions at this time.

I'd like to turn it back to Dan Myers for closing remarks.

Well thank you, everyone, for listening into the Alimera third-quarter analyst call. We look forward to updating you on the fourth-quarter performance early in 2016. Thank you.

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