EyePoint Pharmaceuticals Inc (EYPT) 2009 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the fourth quarter 2009 pSivida Corp.

earnings conference call.

I will be your conference coordinator.

At this time, all participants are in a listen-only mode.

We will conduct a question-and-answer session towards the end of this conference.

(Operator Instructions).

As a reminder, this conference is being recorded for replay purposes.

I would now like to turn the call over to Lori Freedman, Vice President of Corporate Affairs, General Counsel and Corporate Secretary.

Please proceed.

Please proceed, Ms.

Freedman.

Thank you, Anita.

Good afternoon, everyone, and thank you for joining us.

After market close today we released the Q4 and full fiscal year financial results for pSivida.

If you do not have a copy of the release one may be found in the investor section of our website at www.pSivida.com.

On the call with me today are Dr.

Paul Ashton, President and Chief Executive Officer of pSivida, and Len Ross, Controller and Principal Accounting and Financial Officer.

Before I hand the call over to Paul I need to remind everyone that some of our prepared remarks, as well as answers to your questions will be forward-looking in nature.

These forward-looking statements are inherently to risks and uncertainties.

All statements, other than statements of historical fact, could be deem forward-looking statements and we cannot guarantee that the results and other expectations expressed, anticipated or implied will be realized and actual results could vary materially.

The Company undertakes no obligation to update any forward-looking statement in order to reflect events or circumstances that may arise after the date of this conference call.

For a more detailed discussion of the risk factors that could impact our future results and financial conditions I refer to our filings with the SEC, including our fiscal 2009 annual report on Form 10-K, which we expect to be filed tomorrow.

With that I'd like to turn the call over to Paul.

Great.

Thank you, Lori, and welcome, everyone.

We are pleased to be hosting our first earnings conference call and I appreciate all of you taking the time to join us today.

Over the past year we've made significant strides as the Company and today's call is another important step in the continuing evolution of pSivida.

Going forward we plan to host conference calls each quarter in conjunction with our earnings release.

Now, since there are a number of you on the call today who may not know us very well I would like to begin my remarks with a brief overview of pSivida and our business strategy.

At pSivida we develop miniaturized sustained release injectable drug delivery products.

By miniaturized we mean products that are small enough to be inserted into the body by an incision as small as 2,000th of an inch apart.

And by sustained release we mean the ability to release drugs for predetermined periods of time, ranging from months to years, with a single application.

Our goal is to become the world's leader of miniaturized drug delivery systems.

Our focus as a Company has been on developing drug delivery systems for ophthalmic applications.

To date we have developed two of the only three products approved by the FDA for long-term sustained delivery of drugs that treat diseases of the back of the eye.

In addition we have a robust pipeline of products in development for eye diseases and other localized diseases.

Our development efforts to date have been heavily focused on the eye and with good reason.

Historically it's been very difficult to develop drug treatments for blinding eye disease.

Now because of the effectiveness of the (inaudible) it's difficult to systemically administered drugs to reach the eye in sufficient quantities that have a beneficial effect without also having adverse side effects elsewhere in the body.

Now, with the other standard approach, eye drops, typically more of the 5% -- typically more than 95% of the drug drains into the nose almost immediately after application so very little of the applied drug reaches the front of the eye and virtually none gets to the back of the eye at all.

The next approach that people use, injections of drug directly into the eye, is certainly effective, but the drug typically is cleared out to the eye very fast, so with chronic diseases repeat injections are typically needed to tough up those levels in the eye.

Patients are then faced with prospect of regular injections, maybe every couple of months, directly into their eye for the rest of their lives.

Our goal at pSivida has been to solve this issue, and as I said, to date we have developed two of the only three sustained release back of the eye products approved by the FDA.

Before I get to our lead development product, which is the third generation of our (inaudible) technology, let me provide a bit of background on the history and progression of our technologies.

Our first generation product, Vitrasert, was approved by the FDA in 1996 and is marketed by Bausch & Lomb.

Vitrasert is approved for the treatment of CMV retinitis, a blinding eye disease that occurs in individuals at an advanced age typically when their CD4 count is below 50 or even 20.

Vitrasert is surgically implanted through a 5 to 6-millimeter incision and provides sustained treatments for six to eight months.

Our second generation product is Retisert, also marketed and sold in the US by Bausch & Lomb.

It was approved as an orphan drug for the treatment of (inaudible) uveitis in 2005.

About the size of a grain of rice, Retisert is significantly smaller than Vitrasert and goes through a smaller 3 to 4-millimeter incision compared to 5 to 6-millimeter required for Vitrasert.

Retisert delivers sustained levels of corticosteroid, fluocinolone acetonide, [for 30 months up to] two and a half years after an application.

And with that as a background let's move on to our third generation, Iluvien.

Iluvien is our lead development product.

We have licensed Iluvien to a great company, Alimera Sciences, and I'll discuss the terms of this collaboration in a moment.

Alimera is conducting Phase III clinical trials for Iluvien, with data expected late this year.

Iluvien is being studied as a treatment for DME, diabetic macular edema, a significant ophthalmic disease.

DME is, in fact, a leading cause of vision loss in Americans under the age of 65.

The number of people affected by DME is estimated at over a million and we believe that this is potentially $1 billion indication currently with no FDA-approved therapies.

Iluvien delivers the same drug as Retisert, fluocinolone acetonide, but represents the next evolution of stage and design.

It's so small it can be inserted into the eye by an incision only 2,000th of an inch.

This can be done in an office visit and that is obviously important.

Almost 1,000 patients have been enrolled in Phase III trials, which have been running for several years, and Alimera is expecting 24-month data at the end of this year.

The trial design looks at two doses of Iluvien against standard of care laser treatments over 36 months.

The primary clinical endpoint is a 15-letter improvement in visual acuity.

That's gaining three lines on an eye chart.

Alimera is also looking at secondary endpoints, which is diabetic retinopathy [severity score] and macular edema.

The trials, of course, monitor side effects and in particular we're looking at elevation of intra-ocular pressure, IOP, which is frequently associated with the use of corticosteroids.

The 24-month data due at the end of this year is very important because if that data is positive, our partner, Alimera, plans to file an NDA for Iluvien with this data in early 2010.

In addition to the DME trial, under our collaboration agreement with Alimera, (inaudible) the response of clinical trials of Iluvien in wet age-related macular degeneration, which is actually the leading cause of vision loss in people over 65; geographic atrophy, essentially a type of dry AMB; and as we announced yesterday retinal vein occlusion.

Under the terms of our collaboration agreement with Alimera we are not responsible for any development costs of these programs.

Now, let me briefly discuss the terms of our collaboration agreement with Alimera with respect to Iluvien.

Without getting overly detailed regarding all the legal terms I think the most important point for pSivida investors are that Alimera is obligated to pay all of the development costs for Iluvien, and upon approval of an NDA they will be obligated to pay us a $25 million milestone payment and we will be entitled to receive 20% of all profits on sales of Iluvien, regardless of the indication.

In addition, Alimera issued us a $15 million contingent note that currently carries an 8% annual interest rate, which we've receive quarterly.

In April of 2010 the interest on that note climbs to 20% and Alimera is required to start paying us the principal at $500,000 per month.

Under certain circumstances the note is, in fact, payable immediately.

Now, beyond the excellent economics of our collaboration agreement I believe an important fact long term is that we have an extremely good partner in Alimera and their management team has outstanding experience in the field.

Alimera is led by the former management team of Novartis Ophthalmics North America.

Dan Myers, the CEO of Alimera, was the head of ophthalmics -- sorry, of Novartis Ophthalmics North America.

The head of regulatory affairs, head of clinical, head of marketing at Alimera all held the same positions at Novartis under Dan.

This is the same team, by the way, that led the development, FDA approval and commercialization of Visudyne, a $300 million product for wet AMD.

Alimera is also well funded, having raised approximately $90 million (inaudible) financings, the most recent of which closed about a month ago.

They are very focused on the Iluvien.

It's their most advanced clinical stage product and they are well equipped to complete the remaining development work and to successfully launch the product if it's approved.

Now, while we are obviously very excited and optimistic regarding the outlook for clinical and market success for Iluvien, there are several other very important programs under way at pSivida.

We have a collaboration agreement with Pfizer under which we currently receive $500,000 a quarter for development costs.

Now, work is progressing well but due to confidentiality I can't give you any details at this time.

However, I hope to be able to provide more information in future calls as development work progresses.

Pfizer also invested in pSivida as part of the collaboration agreement and they are now our largest shareholder.

We're also hard at work on another key technology in our portfolio, BioSilicon.

BioSilicon is a fully erodable form of silicon that can be manufactured using techniques common in the semiconductor industry.

Basically we can create a honeycomb structure of nano pores in the silicon and the resulting structure is then bioerodible.

BioSilicon has the potential to deliver a wide variety of drugs, including small chemical entities, peptides and proteins.

We believe this technology system could be extremely valuable in the treatment of the whole range of diseases in many medical fields.

Our first product candidate using this technology system is BrachySil for pancreatic cancer.

We have completed the first clinical trial (inaudible) safety study and have now completed enrollment of a second dose-ranging trial.

Ultimately our plan is to see -- is to secure a partner which we will plan to do prior to Phase III clinical trials.

The past year has been a time of significant accomplishments and progress for pSivida and I expect next year could be truly a transformative year, with the reporting of Iluvien data, potential filing of an NDA, further progress of Iluvien in other conditions and the advancements of our other development programs.

And now I'm going to turn the call over to our Principal Accounting Officer and controller, Len Ross, who will take you through the financial results of the quarter and fiscal year.

After Len is finished I have a few summary remarks and then we will take questions.

Len?

Thank you, Paul.

Good afternoon, everyone.

I am going to start off today with a review of the fourth quarter results that we issued this afternoon and then review our full-year results.

In discussing revenue it is important to point out that virtually all of our financial statement revenue today is derived from our March 2008 amendment of our collaboration agreement with Alimera.

The aggregate up-front consideration we received at the time of the amendment was recorded as deferred revenue and is being recognized as revenue on a straight-line basis over 21.5 months through December of 2009, which is the period of our performance obligations.

Additional subsequent payments that we receive from Alimera, consisting of quarterly note interest and monthly reimbursement of approved development costs, are also recognized as revenue over the performance period, including an immediate revenue catch-up for the pro rata period for the amendment date to the date of each payment.

For the fourth quarter ended June 30, 2009, we reported revenues of $3.2 million, an increase of $500,000 from the $2.7 million that we reported in the fourth quarter of fiscal 2008.

This increase was largely the result of the revenue impact of payments received from Alimera during fiscal 2009, as I explained a moment ago.

Net loss for the fourth quarter was $534,000, or $0.03 per share, compared to a loss of $63.9 million, or $3.48 per share, for the prior-year period.

The fiscal 2008 net loss included a $60.1 million impairment charge to entirely write off goodwill related to prior acquisitions.

R&D expenses for the fourth quarter totaled $1.8 million, a $600,000 decrease from the $2.4 million reported in the fourth quarter of 2008.

This decrease was primarily due to reduced UK-based operating expenses, of which $280,000 was the direct result of the effective currency translation due to a significantly-stronger US dollar in the current-year period.

G&A expenses totaled $1.4 million in the fourth quarter compared to $5.3 million in the prior year, a decrease of $3.9 million.

Approximately $2.1 million of this decrease was due to the absence in the current-year quarter of costs incurred in the prior-year quarter in connection with the consummation of our reincorporation from Australia to the US.

Moving on to the full-year results.

For fiscal 2009 we reported revenues of $12.2 million, an increase of $8.7 million compared to $3.5 million for fiscal 2008.

Again, virtually all of this revenue is associated with our Alimera agreement.

Based on the terms of our existing collaboration agreement with Alimera, including continued receipt of scheduled note payments, we currently expect fiscal 2010 revenues attributable to Alimera of approximately $9.1 million.

Our net loss for fiscal year 2009 was $2.5 million, or $0.14 per share, compared to a net loss of $75.6 million, or $4.17 per share, for fiscal year 2008.

As noted previously, our fiscal 2008 net loss included a $60.1 million goodwill impairment charge.

Research and development expense for fiscal 2009 totaled $8 million, a $6.4 million decrease from the $14.4 million reported in fiscal 2008.

The largest component of this decrease was the absence in fiscal 2009 of $4.7 million of Iluvien co-development costs that we had incurred in fiscal 2008.

This resulted from the assumption by Alimera of all financial responsibility for the development costs as a result of the March 2008 amendment of our collaboration agreement.

The other significant contribution to the decrease was the reduction in our UK-based R&D costs, most of which, $1.1 million, was attributable to the favorable foreign currency effect in 2009 of operating expenses denominated in pound sterling and translated into US dollars.

G&A expense for fiscal 2009 totaled $8.8 million compared to $14 million in fiscal 2008, for a decrease of $5.2 million.

In fiscal 2008 we incurred approximately $3 million of expense directly attributable to the consummation of our June 2008 reincorporation to the US.

Also, our fiscal 2009 G&A expense reflected cost savings of approximately $900,000 in audit and audit-related fees as a result of having reincorporated to the US.

Fiscal 2009 G&A expense also included a $1 million increase provision for losses to fully reserve an outstanding note receivable from a prior-year sale of a subsidiary.

I would like to spend a minute to comment on other income, which totaled $1.2 million for fiscal 2009, compared to $8.9 million for fiscal 2008.

This decrease of $7.7 million was predominantly related to a non-cash item, which represents the change in valuation of certain outstanding warrants denominated in Australian dollars, which is different than the Company's US dollar functional currency.

The revaluation of these warrants on a quarterly basis, using the Black-Scholes model, is highly sensitive to changes in the Company's share price.

Changes in the fair values of these warrants are recognized as other income or expense, again a non-cash item, in our statement of operations, with a corresponding change in derivative liabilities on our balance sheet.

The change in fair value of these warrants could substantially affect our future operating results until the last to expire of these Australian dollar warrants, principally in April 2011.

Moving on to our cash balance, at June 30, 2009, we reported cash and cash equivalents of $6.9 million.

This represented a decrease of $1.1 million from last quarter, and a net decrease of $8.7 million from June 30 of 2008.

Based upon the assumptions of continued research funding from Pfizer, Alimera's continued funding of development of Iluvien, and our continued receipt of scheduled note payments from Alimera, we are comfortable that we can fund our operations as currently conducted through to the receipt of the $25 million milestone payment due from Alimera upon FDA approval of Iluvien without a need to go to the capital markets.

Through our collaboration agreements and cost control, we are in a stable position with the ability to advance our strategic plan and to meet the objectives that Paul has discussed.

I look forward to speaking with you next quarter.

I'll now hand the call back to Paul and I will be happy to take your questions during the Q&A.

Paul?

Great, thank you, Len.

So I have just a few quick comments before we move on to the Q&A.

We are entering a very important and exciting phase of development at pSivida.

Most importantly, in just a few short months the two-year data on the Iluvien and DME will be available.

If positive, we expect that will lead to the following of an NDA in early 2010.

Iluvien is also in clinical trials for three other serious eye diseases and we're making great strides of BioSilicon-based products, the most advanced of which, BrachySil in pancreatic cancer, is presently completing a dose ranging clinical trial in the UK.

With our current cash balance and cash from our existing agreements with Pfizer and Alimera, we have sufficient cash to reach the $25 million milestone payments due from Alimera from FDA approval of Iluvien in DME.

So we have an exciting time ahead and I'm looking forward to continuing the practice of holding quarterly conference calls with you.

I feel that by increasing the level and frequency of dialogues with the investment community we're making an important as a Company.

So, at this point we'd be happy to take your questions.

So, operator, will you please initiate the Q&A portion of the call?

(Operator Instructions).

Our first question comes from the line of Frank Pinkerton of SunTrust.

Please proceed.

Hi, can you hear me.

Yes.

Hi, great.

First a couple questions, I didn't hear cash burn for '09 and do you have a forecast for potential cash burn in fiscal 2010?

Well, thank you very much for your attention on the call.

Len, I believe you disclosed the cash burn for the last three quarters?

Yes, the total usage of cash during fiscal '09, was $8.7 million and that was a decrease from $15.6 million at the beginning of the year to $6.9 million at the end of the year.

And in each of the last three quarters that cash usage averaged approximately or slightly less than $1.5 million per quarter.

And then a forecast for fiscal '10?

We'd expect that'll be representative of our cash burn going forward.

Okay, great.

And then on the Pfizer R&D agreement, I know there's some stuff you don't want to talk about there, but can you just explain -- I know you're actively working on some of those projects.

How is that booked, because my understanding is that Pfizer does pay you on an as-go basis for the R&D, so does that come in on the revenue line?

And then can you also give us a timetable potentially when we might see the first milestone from Pfizer?

I'll answer the second part of that question first, if I may, which is, unfortunately, due to our confidentiality agreements with Pfizer we really can't comment on how things are progressing or, in fact, when milestone payments would be anticipated.

The first part of your question, however, is li -- requires a more detailed accounting and so, Len, if you would.

Yes.

The funds that we've received, the research funding portion of the Alim -- of the Pfizer collaboration agreement are all recorded on the balance sheet as deferred revenue.

Currently that is a result of not having made a final determination of what the performance period of our obligations under that agreement is.

That's a very complex process, as is typical in the biotech area, and until such time as we're able to properly frame and define that, those payments will be on the balance sheet and will not be recorded as revenue.

Okay, great.

And then, finally, as we come towards the end of the study here with the Iluvien device, is there any interim data that you can highlight with that?

You seem pretty confident with a filing coming as soon as that study data is out, and then so any data you can share would be great.

And secondarily, I know that from a standpoint of duration in the eye, maybe the device and some people may last a little longer than two years, what's the follow-up plan there to determine the ultimate duration of the device in the eye?

Thank you.

Okay.

So with respect to interim data we can't comment on the Phase III clinical trial that's currently under way, because you can't peek, as it were, at the data.

Alimera, however, has initiated a smaller study called a PK study -- stands pharmacokinetics -- which designed to enable us to look at things like blood levels and drug levels in the eye and things of that nature.

Well as part of that we're also able to look at the -- get a preliminary look at safety and efficacy in this smaller study.

Now this data was presented at the [Alza] meeting in March of this year so it's data -- it's one-year follow up on 37 patients.

We were extremely encouraged.

At one year 24% of patients on the high dose -- sorry, I'll get this right.

27% of patients on the high dose had experienced a three-line gain in vision and 24% of patients on the low-dose had experienced a three-line gain of vision.

That was very encouraging and very much in line with our expectations.

As a caution, of course, this is in a small sample size.

With respect to side effects, as I said earlier on the call, we're really quite focused on the incidence of elevated intra-ocular pressure, or IOP.

That I believe it was 25% of patients had an elevation of IOP in the high-dose and no patients in the low dose had an elevation of IOP, so we were very, very pleased to see that.

(inaudible) for the fact, one it's a study and two.

it's 12-month data.

Great.

Thank you for taking the questions.

Our next question comes from the line of Yale Jen with Maxim Group.

Please proceed.

Good afternoon, Paul, and it seems to be a very exciting time until waiting for the results for come.

Yes, thanks.

Hi, Yale, how is it going.

I'm doing fine, thank you.

Just a quick question in terms of the DME market, market size or expectation, does Alimera -- Alimera has provided us any kind of guidance so as the investor to get a better sense of that, although we know some of the economy you might receive from that -- the pharma products should it get approved?

I'm not aware that Alimera's provided any guidance as to market projections.

Okay.

But you -- is there any other thoughts as for investor to think about in terms of what the future -- what the Company thoughts might be and what is for other indications that you currently are approaching testing, including macular degenerate disease?

So the data I have seen [Cowen] put out a report on the size of their ophthalmic market, and particularly looking at DME, they pegged it as, I believe, $1.5 billion to $3 billion, I believe, in the US, that's for the DME market.

Right.

Dry macular degeneration is pretty vague.

Right, understood.

The difficulty that people have is, of course, because there are currently no products approved to guess what the market might be, but that cuts both ways, of course.

There are no products approved therefore one would hope to be able to have a fairly substantial portion of that market.

So given that in DME there's no product approved and potentially even this is (inaudible) invasive medication versus pill or in some other form of medication, this one has the potential to move up in terms of being used once it potentially -- once it get approved, or was that the thought shared by the -- you and your partners?

Just want to be clear.

The only other treatment that is available for DME right now that's approved, is laser treatments.

Right.

That's where you do focal laser burns directly on to the macula, which isn't always terribly effective and obviously has some issues, so I'm not aware of -- there are no FDA-approved treatments for DME.

Okay, great.

Okay, thanks, Paul, I appreciate it.

(Operator Instructions).

Our next question comes from the line of Suraj Kalia.

Please proceed.

Hey, Paul, how are you?

Good, thanks, how are you?

Paul, how do you reconcile from a clinical perspective, you have a low dose, you have a high dose and then if there are differences or conflicting trend lines in retinal thickness versus visual acuity versus intra-ocular pressure, how do you reconcile all that information clinically?

I guess what I'm really asking is, when the data comes out how should we parse through the data?

I think that the most important thing to look at will, of course, be visual acuity, and that's the primary point, of course, of the trial.

Other endpoints will be very interesting as one tries to gain more a scientific knowledge of how this product might be successful.

Suraj, I don't know if you've had a chance to look at the publications in Archives of Ophthalmology that came out this week on the SCORE clinical trial --

No, I did not.

-- on vein occlusion.

So this is an NEI study.

They did two trials, one of about 400 people in branch retinal vein and the other did, I think, 250 in central retinal vein and it was fascinating because they look at two different doses of steroid injected fairly frequently.

They found that both doses were as effective in visual acuity in CRVO, but there seems to be a difference in the influence on macular edema, i.e.

, retinal thickness.

So the higher dose was produced a greater change in retinal thickness but both doses were equally effective in terms of visual acuity.

So I think what we're perhaps seeing with that trial is that -- and this is pure hypothesis, of course, we're seeing perhaps one effect on edema, which one would expect, but also perhaps we may be seeing some newer protective effect of steroids, which have been suggested for some

[Okay.

And, Paul, one last question, and I'll hop back into the queue.

When you compare Medidur or Iluvien to lasers, let's assume in an scenario analysis right now that the initial no hypothesis, whatever the hypothesis is assumed in the trial, that is not proven, the thing works great and Iluvien works great -- it's better letter than laser, okay?

Now a two part question.

One, if pSivida looks to partner up with new guys, whomever it may be -- (inaudible), whatever -- would that necessitate a new trial of whatever new trial is designed a unit -- well let me take a step back.

If any competitors to pSivida look to partner up with anyone else, would it mean comparing to Iluvien, or would it still be comparing to lasers.

How would a competitor's clinical trial to be designed, assuming your trial is a success?]

I think, one, that is an excellent question.

It's one that we've kicked around for a while.

We had the same issues, I think, when we were looking at -- thousands of years ago, it seems, with Vitrasert.

It's whatever the FDA deems to be standard of care.

If the FDA deems Iluvien at that point to be standard of care, then that would be the comparator.

Now it certainly isn't for me to say what the FDA is likely to do under any set of circumstances.

The FDA's (inaudible) is to be correct.

(LAUGHTER) But that's a definite possi -- definite thought.

One of the issues, I think, for people now trying to develop drugs for wet AMD is that Iluvien is pretty much the standard of care if (inaudible).

(inaudible) Lucentis, so that is a comparator of (inaudible) for people which is causing some issues.

Hey, guys, thanks for taking my questions.

Our next question comes from the line of [Richard Barberich], private investor.

Please proceed.

[Good morning, guys.

It's morning here so I missed the first ten minutes.

My question is, if this trial was successful -- I know there's three other trials of cancer that you're on -- would you expect, obviously and the price would fall if this kind of trial was unsuccessful, would you please tell me how long are the other three trials running and how long would it take for the -- how long would you expect for the price to come back up considering the (inaudible)?Amd secondly, there's another (inaudible) as well in the (inaudible) company, did you expect the price to jump before so much?]

Sorry, I didn't hear your last question -- the last part of your question, I apologize.

Could you repeat that, please?

[I'm just -- what I was trying to say is, in case this trial don't produce the results we all expect there are other (inaudible) patents and also trials being run, how long would you -- could you tell us before the other cancer treatments would be finished the trials so that the price would then crawl up again?

I know it is a bit of a (inaudible) question.]

Yes, so I'll break that down into parts, if I may.

With respect to the Iluvien trial in diabetic eye disease, first of all, we're optimistic the data will be positive.

Second, there are varying degrees of failure or negative data, so depending on what the data actually is we'd need to very closely analyze that data and determine the best strategic path, because there are a number of paths open to us and we could choose.

The line we go down would, of course, be a function of what the data actually is.

With respect to the cancer products that we're devel -- that we're looking, i.e.

BrachySil in pancreatic cancer, there's a -- as you point out, there are a large number of other drugs being developed and other therapies being looked out.

The attraction of BrachySil in pancreatic cancer is that it can really be used in conjunction with other systemic drug therapies, so the clinical trials that we're running now we're looking at patients being treated with the existing drug, which is called Gemcitabine -- they all get that -- and in addition they get BrachySil because BrachySil is their localized therapy.

So lots of the side effects you'd normally worry about with combination therapies you shouldn't really expect to see.

Does that answer your question?

[Paul, I just want to know, say for worst case (inaudible), worst case scenario it wasn't positive, how long would it take before these other three current trials that you're running, how long would it take for them to complete for us (inaudible) the Company beyond the announcement, so (inaudible) and suddenly and quite aggressively, how long will it take for these other tri -- current trials of cancer to conclude so that we can see, I guess, some increase in price again?

That's my main question.

It would take several years.

Okay.

Other products are several years away from approval.

Even with these three current trails that are being (inaudible) for cancer?

The three trials that we're running with Iluvien, just say if I was -- and I apologize if I was unclear on this -- the trials for Iluvien right now are diabetic eye disease, and then we have three others on the -- an investigative (inaudible) for wet age-related macular degeneration, which is an eye disease associated with aging population; dry age-related AMD, also a particular form called geographic atrophy; and the third is retinal vein occlusion, which is, again, an eye disease.

So we're looking at three other eye diseases and those trials, like the first one, are being really run by Alimera Sciences.

They also are also early-stage clinical trial, so they're quite some way away from approval.

Okay, I apologize, I was under assumption that there was another cancer trial being run.

Thank you very much.

At this time there are no further questions.

I'll now turn the call over to Dr.

Ashton.

Please proceed.

Great.

Well, thank you very much, I'd like to thank you all for joining us today and I look forward to speaking again next quarter.

In the meantime, if you have any additional questions, please feel free to contact us and we will be happy to talk.

So, thank you.

Thank you for your participation in today's conference.

This concludes the presentation.

You may now disconnect and have a great day.