Alimera Sciences Inc (ALIM) 2014 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Alimera Sciences Inc fourth-quarter 2014 earnings conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time.

(Operator Instructions)

As a reminder, this call is being recorded.

I would now like to introduce your host for today's conference, Rick Eiswirth, Chief Operating Officer and Chief Financial Officer. Sir, you may begin.

Thank you. Good afternoon, everyone.

Welcome to the Alimera Sciences conference call to update you on our progress with ILUVIEN, our sustained-release intravitreal implant for diabetic macro edema, or DME, and to review our fourth-quarter and full-year 2014 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 quarterly report on Form 10-Q for the quarter ended September 30, 2014, which is on file with the SEC and available on the SEC's and Alimera's websites.

Additional factors may also be set forth in those sections of Alimera's annual report on Form 10-K for the year ended December 31, 2014, to be filed with the SEC. 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 and webcast.

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

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

Thanks, Rick.

We are excited to recap the events of 2014, noting the changes to our business in that time. We had an outstanding year, perhaps the most significant year in our Company's history.

We entered 2014 with ILUVIEN approval in only seven European countries. And although ILUVIEN was commercially available in Germany and the United Kingdom, UK NICE guidance for its reimbursement had not yet been implemented and its usage in the [eight] UK NHS was very limited.

In the US, we still had no assurance that ILUVIEN would be approved, and we believed, if approved, the label would be limited to a small segment of the DME population. From a balance sheet perspective, we ended the year with less than $13 million in cash and needed additional financing.

Rolling the clock forward, we now have ILUVIEN approval in the United States, 15 European countries and Norway, and I'm pleased to say we just received approval in the Czech Republic this week, leaving Poland as our last pending approval. The NICE reimbursement guidance for ILUVIEN in the United Kingdom was implemented in the first quarter of 2014, and over 1,400 patient eyes have now been treated with ILUVIEN in Europe. We also completed a distribution agreement in Australia and recently launched ILUVIEN in Portugal, expanding our geographic reach.

In the United States, we received approval of ILUVIEN from the FDA in late 2014. As we previously shared, the US indication is broader than we anticipated at the start of the year with no restrictions related to the duration of the disease, prior drug failures, or lens status.

As a result, we have entered 2015 with greater expectation for the potential ILUVIEN patient opportunity. Following that approval, we built our US commercial team and are very proud to say transition from a development Company to a commercial enterprise with a formal launch and national availability of ILUVIEN on Monday of last week.

From a balance sheet perspective, we ended 2014 in a stronger position with more than $76 million in cash after two equity raises and a debt refinancing adding seasoned healthcare investors to our shareholder base, we are now able to focus on the commercial execution of our plans for ILUVIEN in 2015. Looking at our financials in 2014, we ended the year with total revenue of $8.4 million, almost entirely in sales from Germany and the UK.

Although we saw revenue growth over the first three quarters of 2014, we did experience a decrease from the third quarter to the fourth quarter recognizing revenue of $1.7 million in the fourth quarter. We believe three factors contributed to lower sales levels in the fourth quarter.

First, as we expected, seasonality impacted our business in Europe with the December holidays reducing the number of patients visiting to the offices, thereby reducing the number of patients being evaluated for, and therefore treated with ILUVIEN. This was seen in both Germany and the UK.

Secondly, we continue to face increasing reimbursement challenges in Germany. Further, during the first quarter -- fourth quarter of 2014, the exchange rate fluctuations in Europe with the euro and British pound weakening against the US dollar impacted a translation of our European revenues into US dollars.

In Germany, the uptick of ILUVIEN remains hamstrung by the lack of reimbursement due to the changes to the reimbursement of intravitreal injection procedures announced in the middle of 2014. Implementation of the changes has been problematic, variable from region to region, and consequently slower than we had expected.

The impact has been evident since the middle of the year but more pronounced during the fourth quarter. However, we are beginning to see encouraging signs early in 2015.

A large doctors' union that handles approximately 50% of all intravitreal ophthalmic injections in Germany has verbally indicated that ILUVIEN will be included in its amended service contract. Meaning that doctors in this union will receive a known reimbursement amount for the injections that is on par with other intravitreal injections. We anticipate this contract being finalized in the second quarter.

Additionally, one of the larger statutory insurance funds has indicated an interest in discussing and providing a higher injection fee specifically for ILUVIEN in comparison to other intravitreal injections like Lucentis, Eylea, or Avastin. Such an increase could put ILUVIEN more on par with alternative therapies as we believe it will reduce the economic incentive for German physicians to continue recurrent injections of those therapies.

This insurance company has recognized the economic advantages of ILUVIEN injection over the course of three years as an alternative to more frequent anti-VEGF injections. We believe that these are very encouraging signs. We expect to continue to engage in negotiations to secure open access to ILUVIEN where possible.

Frankly, in Germany, we've also struggled with getting the right people in place. We've made recent hires to address this.

You may remember we began our operations in a collaboration with Quintiles with the original team being hired by them. Performance issues led to significant turnover of our sales team and a change of approach.

During Q3, we began the process of hiring new staff directly. And in Q4, we trained and equipped them for selling. Having been with this new team personally at a recent European sales meeting, I believe they get it and will be a valuable asset moving forward.

In an effort to ensure the successful onboarding of our new sales team, our European sales operation head has relocated to Germany for the first quarter of 2015. We believe he's making a very positive impact on the development of the team, and the progress is encouraging. And, finally, we've also just brought in new local leadership with a seasoned sales and marketing executive from Bayer who has worked in both Germany and the US.

The German DME market is a significant one for us and is one that we believe we can penetrate that has been and will be in the short-term expect to continue to be a slower process than in vision. Although we are very pleased with the launch in the UK in 2014, we believe the market is a largely untapped opportunity.

As you might recall, anti-VEGF treatment only became reimbursed and therefore available in the UK in mid-2013, unlike in the US were anti-VEGF therapy has been used off-label to treat DME for several years. As a result, some hospitals are still establishing a service for this indication and are still gaining experience using anti-VEGF treatments for DME and learning where anti-VEGF therapy may or may not be sufficient in treating DME.

As a result, ILUVIEN was used in approximately 50% of the hospitals during the first three quarters of 2014. We are seeing a growing momentum for ILUVIEN orders and continue to believe that we can further penetrate this untapped DME market. Our UK sales and medical team added 10 new accounts during the fourth quarter of 2014 bringing the total in the UK to 82, or 57% of the attainable accounts, and we're working towards increased usage in these existing accounts.

In Portugal, we attended the National Congress in December where we supported both a promotional booth and a scientific symposium. The feedback from ophthalmologists was very positive, providing us with a high degree of confidence for this smaller market. In January, we achieved the first sales of ILUVIEN in Portugal and look forward to providing you more feedback on the launch in our next earnings call.

In France, the pricing and reimbursement process continues with further submission to the economic committee planned in Q1 of 2015. Previous submissions have been met with offers of a public price but at a level not acceptable to us.

We are reluctant to agree to a reduced public price in France that could negatively impact pricing in other countries. The protracted process is a source of frustration leading to a decision to rein back resources committed to France, both in terms of numbers of employees and also budget.

Further with the launch of ILUVIEN in the US in 2015, we believe it is prudent to focus our resources on ensuring an effective launch in our largest available market and controlling expenditures outside of the US. Therefore, we are not in a rush to agree to a suboptimal price in France and would not anticipate a commercial launch in France until late in the year, if at all. We will continue to keep you apprised of our progress towards achieving an acceptable price in France on future calls.

We see significant potential in the European markets and will continue to aggressively market in those countries in which we believe we can generate the stronger sales of ILUVIEN and the greatest impact for patients suffering from the debilitating effects of DME.

As you are aware, we began national shipments of ILUVIEN in the US last week and held a unique, live national webinar launch event on Monday night. The event featured eight retinal specialists, three live on stage from Scottsdale, Arizona, and five on satellite feeds across the US, to share their initial patient selection and injection experiences.

A glaucoma specialist participated to discuss the management and risk of intraocular pressure increases in comparison to the risk of the continued progression of DME. A key message was that IOP is not glaucoma and not all IOP is related to glaucoma, and that IOP can be effectively managed in the majority of cases. There was also a montage presented of the first 20 physicians who injected patients last week.

Television coverage of ILUVIEN in our first week has been encouraging. Television stations in Austin, Texas, Albany, New York, and Harlingen, Texas, have filmed injections and interviewed physicians and their patients who have undergone the treatment providing both on-air and Internet coverage. It's an exciting time for us and the retinal community.

We are pleased with the preparation and execution of the launch leading up this past week. Immediately after approval, we brought in our sales management team, some of our key managed market directors, and the medical science liaisons to begin communicating with key stakeholders. We are fortunate that three of our sales managers who were with us when we had first hoped to launch ILUVIEN returned, and we hired a fourth who has extensive retinal management experience.

We hired 32 sales representatives for the launch with over 70% of them coming from retinal sales experience, as well as buy-and-bill experience and reimbursement experience. It's a critical skill to have when selling a Part D drug to physicians in their practices. Nearly all have joined with ophthalmic experience in their careers.

Our Vice President of marketing, who had responsibility at Novartis for the marketing portion of the Visudyne launch when I was the President of Novartis Ophthalmics, has developed a similarly solid campaign and unique support materials here at Alimera including Monday?s innovative webinar.

We are quite cognizant of the importance of reimbursement and the need to instill confidence in the practices that use ILUVIEN. Our VP of managed markets, who had previous experience with the launch of Macugen, has recruited top talent to call on commercial and government accounts and has built a very strong market access support program called AccessPlus.

I think it's also important to provide some insights into the selling cycle that we expect from our team and the metrics we have to track growth. In order to result in a sale of ILUVIEN or any retinal buy-and-bill product, our people must introduce Alimera and ILUVIEN to the practice.

Once beyond that, we must educate the physician on the clinical benefit. We then need to explain the reimbursement relative to ILUVIEN to encourage physicians to sign up with the AccessPlus program.

One good thing about our program is that the physician only needs to sign up once. Following this, or in conjunction, patients need be identified and then a benefits investigation needs to be performed with either Medicare or a commercial plan. This is critical in the launch phase to provide more assurance to the practice that they will be reimbursed.

At this point then, the practice would order product through their specialty distributor. Because ophthalmology is not a significant portion of managed care budgets, we believe any early reimbursement obstacles are an issue of adjudication and not coverage.

Our goal with the AccessPlus program is to simplify the process of adjudication for the physician practice. This program provides an Alimera-sponsored hub to support the patient benefit investigations and to facilitate co-pay assistance. We will have webinars running two days a week and are aggressively signing up practices and enrolling patients in the program.

Looking at the metrics to date, over 200 physicians have enrolled in the AccessPlus program, and over 100 patient benefit investigations have been initiated. We believe both of these metrics are indicators of the early interest in and demand for ILUVIEN. The AccessPlus program is supported by our Alimera field-based reimbursement specialists who visit practices, providing them with the information they need to properly submit claims and support reimbursement submissions.

On the payer side, we were seeing some early wins among commercial plans with Anthem WellPoint and Blue Cross/Blue Shield plans extending coverage for ILUVIEN when prescribed on label. In total, eight significant commercial plans have already initiated coverage to over 68 million lives, we believe that is a result of plans seeing the economic value of ILUVIEN in comparison to alternative therapy over the course of three years.

We left the national launch meeting two weeks ago believing that our commercial team was educated, motivated, confident, and ready to communicate that ILUVIEN can provide treatment to a percentage of the 575,000 people suffering from clinically significant DME. They are encouraged by our label because the term prior use of corticosteroids addresses a concern over one of the corticosteroid class side effects.

Our trial date has showed that, of the patients in the same study who had previously been treated on corticosteroids, none of them had progressed to any surgery. This is a key message we can communicate.

This team is energized by ILUVIEN's ability to deliver drug for 36 months, a clear differentiation over any other competitor. And, they are excited to bring a product to market to help address what our market research and published clinical data shows. That 40% to 50% of patients are not achieving outcomes they had hoped to attain on current therapy.

I'll now turn the call back over to Rick to discuss our third-quarter financials.

Thank you, Dan.

Turning to our financial results for the fourth quarter and full year 2014, we see that our net revenue increased $760,000, or 81%, to $1.7 million in the fourth quarter of 2014, compared to $940,000 in the prior-year period. For the full year ended December 31, 2014, net revenue increased approximately $6.5 million, or 342%, to $8.4 million, compared to net revenue of $1.9 million for the full year ended December 31, 2013.

We initiated the launch of ILUVIEN in the UK and in Germany during the second quarter 2013 and began recognizing revenue at that time.

GAAP cost of goods sold decreased by approximately $1.7 million, or 94% to $130,000 for the fourth quarter of 2014, compared to $1.8 million in the fourth quarter of 2013. GAAP cost of goods sold decreased year over year by approximately $500,000 or 26%, to approximately $1.4 million for the year ended December 31, 2014, from approximately $1.9 million for the year ended December 31, 2013.

GAAP cost of goods sold were impacted by inventory write-offs and reserves in the fourth quarter of 2013 and the year ended December 31, 2014. Non-GAAP adjusted cost of goods sold increased by approximately $70,000, or 175%, to $110,000 for the fourth quarter of 2014, compared to $40,000 in the fourth quarter of the prior year.

Non-GAAP adjusted cost of goods sold increased year over year by approximately $500,000, or 455%, to approximately $610,000 for the year ended December 31, 2014, from approximately $110,000 for the year ended December 31, 2013. We began recognizing cost of goods sold upon the initial launch of ILUVIEN in the UK and Germany.

For the fourth quarter of 2014, research and development expenses increased by approximately 25% to $3 million, compared to $2.4 million in the prior-year period. Research and development expenses for the year ended December 31,2014, increased by approximately $3 million, or 36%, to $11.4 million, compared to $8.4 million for the full year ended December 31, 2013. The increases were due to medical and clinical personnel added to support our commercial efforts and a consultant engaged to assist with the pursuit of FDA approval in the US.

General and administrative expenses in the fourth quarter of 2014 increased approximately 54% to $3.7 million, compared to $2.4 million in the prior-year period. For the year ended December 31, 2014, general and administrative expenses increased by approximately $2.9 million, or 31%, to $12.4 million, compared to $9.5 million for the year ended December 31, 2013. The increase was primarily attributable to increases in personnel costs as we expanded our team to support the expanding infrastructure in Europe and the recent launch of ILUVIEN in US.

For the fourth quarter of 2014, sales and marketing expenses increased approximately 56% to $5.3 million, compared to $3.4 million in the prior-year quarter. The increase is driven by the preparation for the recent launch of ILUVIEN in the US. Sales and marketing expenses for the full year ended December 31, 2014, decreased by approximately $900,000, or 6%, to $15.5 million, compared to $16.4 million in the prior year.

The decrease was primarily attributable to decreases in costs incurred with Quintiles' commercial for market access assistance in the UK in 2013 in preparation for the implementation of the NICE guidance for reimbursement and nonrecurring marketing costs incurred in connection with the commercial launches in the EU in 2013.

GAAP net loss attributable to common stockholders for the fourth quarter of 2014 was $10 million, or $0.23 per common share, compared with a GAAP net loss attributable to common stockholders of $14.8 million, or $0.47 per common share for the fourth quarter of 2013. GAAP net loss applicable to common stockholders for the year ended December 31, 2014 was $36.7 million, compared with GAAP net loss applicable to the common stockholders of $51.2 million for the year ended December 31, 2013.

GAAP net loss applicable to common stockholders for the years ended December 31, 2014 and 2013, were affected by certain non-cash items. Excluding the non-cash items and certain items that are expected to be nonrecurring in nature, non-GAAP adjusted net loss applicable to common stockholders was approximately $12.2 million for the quarter ended December 31, 2014, compared to non-GAAP adjusted net loss applicable to common stockholders of approximately $7.5 million for year ended December 31, 2013.

Non-GAAP adjusted loss per share for the quarters ended December 31, 2014 and 2013, were $0.28 per share and $0.24 per share, respectively. Excluding the non-cash items and certain items that are expected to be nonrecurring in nature, non-GAAP adjusted net loss applicable to common stockholders was approximately $34.4 million for the full year ended December 31, 2014, compared to $33.2 million for the full year ended December 31, 2013. Non-GAAP adjusted loss per share for the year ended December 31,2014 and 2013, were $0.85 and $1.05 per share, respectively.

GAAP and non-GAAP loss per share for the quarter ended December 31, 2014, was based on 44.3 million weighted average shares outstanding. GAAP and non-GAAP loss per share for the quarter ended December 31, 2013 was based on 31.6 million weighted average shares outstanding.

GAAP loss per share for the year ended December 31, 2014, was based on 40.4 million weighted average shares outstanding. And, finally, GAAP loss per share for the full year ended December 31, 2013, was based on 31.6 million weighted average shares outstanding.

As of December 31, 2014, we had cash and cash equivalents of approximately $76.7 million, compared to $12.6 million as of December 31, 2013. In December, we sold $50 million of our Series B preferred stock to Deerfield Management and its affiliates. We believe that we have sufficient funds to execute our US and Portuguese launches of ILUVIEN during the first quarter of 2015 and support the continued sales and marketing efforts in the UK and Germany.

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

2014 was a pivotal year for us in many ways. We obtained 10 additional approvals in Europe. We continued growth in our commercialized markets, improved our balance sheet, and obtained FDA approval in the US. ILUVIEN is now commercially available in 4 countries and has market authorization in 17 countries.

We believe we're gaining momentum as we continue to further educate physicians and patients on the benefits of a drug that lasts for 36 months with one injection. With the launch of ILUVIEN in the US two weeks ago, we believe that US patients and their physicians will find that ILUVIEN was well worth the wait and will embrace this multi-year treatment for DME.

With that, I'll now turn it back over to the operator for any potential questions.

(Operator Instructions)

Caroline Corner, Cantor Fitzgerald.

Thanks for all the updates. Can you hear me okay?

We can hear you fine.

Just some questions first about Europe then. You said there was seasonality in the UK markets, which I think you had mentioned before, and we were expecting. But, should we see a rebound in the first quarter after the holidays for patients that were put off around Christmas time? And, perhaps would be interested in getting the injections early in the year?

We do expect that we will see -- we've seen a rebound. I wouldn't say that there's a bolus or backlog that's created by the seasonality so I wouldn't expect a spike in January by any means that wouldn't be carried on. We're back to the steady-state that we were in October and November.

Okay, very good. And then, given that you have significant ex-US sales right now in front of the US launch -- or at the very beginning of the US launch. What are you doing, or what can you do to hedge a bit about these exchange rates that are affecting your business?

Well, most of our issues on the exchange rates relate to a lot of our inter-Company balances and everything. At this point, we've funded the European operations with euros that are on the ground in Europe so we don't expect to deal with the challenge of that going forward. We will always have issues in consolidation because of fluctuations in the exchange rate, and we just translate the dollars -- excuse me, the euros back to US dollars. And, that's really what the challenge we were hit with this year is.

And then, thanks for the updates on the progress with German reimbursement. It seems like something may happen later in the year to help things along a bit. Are you completely direct in Germany now? Or, are you still working with Quintiles?

We're within a couple of weeks of being completely direct. I think that the transition of the last couple of employees will be complete by the end of March.

Okay, very good. And then, just moving to the US, I know it's super early days there. You mentioned your AccessPlus program. You said that 200 physicians are enrolled right now. Previously, when we've talked about the market, you've said that there's 300 retinal centers that will be about 70% of your business that you're expecting initially. Those 200 physicians -- how do they fit into that 300 retinal centers?

I think early on they're pretty well distributed right now so we found -- we have found that primarily one of the more senior level physicians have tried ILUVIEN initially, so it's pretty well dispersed in that we do not have multiple physicians in one center. So, those 200 represent pretty much individual centers going across so it's a pretty good disbursement and it's not highly concentrated such that, for example, we have 10 physicians from one center. So, I'm encouraged that right now it's -- as you might want -- it's broader and thinner rather than having an intense user base from one particular institution.

Great. Thanks. I'll let someone asks some questions now -- someone else.

(Operator Instructions)

Mitchell Drucker, Ladenburg.

Congratulations on a great year. Great successes, Rick and Dan. I'm Mitch Drucker from Ladenburg. Dan, I had heard you again mention that 575,000 patients are affected with DME, and going over my notes, I see it's $8,000, $9,000, $7,000 to do a procedure. And, when you did the survey with doctors before we got the approval -- the survey was -- as I remember in your last call; your survey was -- I don't want to call tinted but was curtailed because we didn't know we'd get a label with no restrictions. How do you see that now going forward where you thought perhaps 100,000 patients or 150,000 patients of the 575,000 patients would be candidates right away for this procedure?

Well, I think, Mitch, what you're referring to is we have market research we've talked about before that said that doctors had told us they would use ILUVIEN in about 16.6% of their patients.

Correct.

And, I think -- I don't think that that changes. I think that that fits with where doctors right now, without having our sales force in the field and the team marketing and educating them on IOP, et cetera -- think they would use ILUVIEN ultimately based on the cataract side effect in the IOP profile. We think that the market opportunity for us is obviously much bigger than that. If you just look at the 575,000 patients and you simply said that 40% to 50% of those didn't respond sufficiently to the anti-VEGFs, you have a patient opportunity of 250,000 to 300,000 patients. We think the opportunity is much bigger than the 16.6%, but that's what the sales team is out there in the field to do -- is to educate the doctors, get them more experienced with the side effect profile of ILUVIEN and expand that.

Okay, thank you. Every year more and more people, of course, because of the way we eat in the United States and our diets -- breakdown or come down with diabetes which I think, I guess is one of the leading things that leads to DME. It's 575,000 patients that have been identified, so to speak, but every year, it just seems to probably add to that.

Yes. That's correct, Mitch. We think the incidence of DME is about 115,000 patients a year now. That's clearly not a net increase because a lot of these patients suffer mortality and the net increase is quite a bit less. But, I think we estimate about in 2019 that the population will be a little bit over 600,000. So, it certainly will grow, but on a net basis, it's not as quite as much as you would think.

Caroline Corner, Cantor Fitzgerald.

I'll just ask another one since there's space. You mentioned your clinical data and your safety profile which has been really great and obviously critical to the commercial efforts as well. Can you speak a little bit to, now that you actually have -- I think you said 100 -- or 1,400 patient eyes treated in the EU. Have you had any surgical interventions reported back to you from -- now that the products actually in the field and in the hands of actual surgeons, outside of the clinical trial, where they are using it on label, we assume. But, there's of course variations out there.

Yes, Caroline. This is Dan. Actually, I have the advantage of having Philip Ashman, who is our general manager for the EU on mute so in case [there was interest]. I can tell you from the top line -- I'll let Philip speak specifically. We've been very encouraged commercially in the experience in managing the IOP and the very limited number of patients that have really had to have this whole issue around IOP as in any way a side effect. So, I think we're seeing what we thought that the FAME trial was done back in 2005 to 2009 and what we know today about managing IOP, about laser SLT and ALT -- we think it's going to be a much brighter picture of patients dealing with the issue of IOP. Having said that, to answer your question specifically, I know we have Philip on mute. Philip, are you there now? Could you speak to maybe just very quickly the experience we've now had with those 1,400 patients in Europe per Caroline's question?

Can you hear me Dan?

Yes, we can.

Yes, we've been watching very closely, Caroline, because, obviously that's the kind of side effect that under European rules would be reported so it would come back through to -- or directly to the authorities. And, to date, we don't have any reports which is very encouraging. But, when we look at case studies, there's definitely cases of IOP. But, what we see is that that pressure is controlled typically with one drop. Sometimes, we see occasional patients who need two, and there have been some use of laser to do SLT as we would have expected.

But, I think to Dan's point, the relatively low levels versus the FAME experience is what we expected because the treatment of intraocular pressure has changed so much just like treatment of the retina. So, it's reassuring to see that coming through. We'll keep an eye on it, and, of course, we'd let people know if we do see anything. But, so far, so good.

Great. Thanks very much, Dan. Thanks Philip.

At this time, I'm not showing any further questions. I'd like to turn the call back to management for any closing comments.

We thank you for attending our call today. Obviously, we're very excited about the next coming months as we get into the doctor's office and have an opportunity to begin the see the effect of a very seasoned sales and marketing team in the US, as well as expanding our footprint in the EU. And, I look very much forward to updating you in future calls. Thank you for your time.

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