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Avanir Pharmaceuticals, Inc. (NASDAQ:AVNR)

Deutsche Bank Securities Annual Health Care Conference Call

May 8, 2012 2:50 pm ET


Keith A. Katkin – President and Chief Executive Officer


Robyn Karnauskas – Deutsche Bank Securities, Inc.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Good afternoon, thanks for joining us this afternoon. Next, we have Avanir. And speaking for Avanir, we have Keith Katkin, the President and CEO. For those of you listening on the webcast, if you have questions, we’d like to ask them anonymously, you can go to our website [] and ask questions anonymously we will read them here.

With that, I will turn it over to Keith.

Keith A. Katkin

Thanks, Robyn. And good afternoon everyone. Thank you for joining us for the Avanir corporate presentation. I would like to start with the forward-looking statements, as I will be making statements that are forward-looking in nature. I’d encourage everyone to visit our publically available documents on the SEC website or on the Avanir website as well.

So Avanir is a specialty biopharmaceutical company focused on CNS therapies. And our lead product is NUEDEXTA, as the first and only FDA approved therapy for the treatment of pseudobulbar affect. Pseudobulbar affect is a very large market with a high unmet medical need, and I go into a little more detail on PBA later in the presentation.

And importantly from a mechanistic perspective, NUEDEXTA is an NMDA receptor antagonist and a sigma-1 agonist, a very well known and well understood mechanism of action, which we believe supports the potential use of NUEDEXTA in a number of other additional indications.

And you can see some of those additional follow on indications on the slide there, including central neuropathic pain in multiple sclerosis, behavioral disturbances and Alzheimer's disease, as well as Diabetic Peripheral Neuropathic Pain.

Taking a look at our pipeline, NUEDEXTA, as I mentioned, is approved for the treatment of pseudobulbar affect. Looking at our central neuropathic pain study in multiple sclerosis, that’s a Phase II study, now underway, that I’ll go into a more detail little later in the presentation.

Our behavioral disturbances in Alzheimer's program, that will be filing the IND before the end of this quarter, and expect to enroll the first quarter patient into our Phase II study by the end of the third calendar quarter. And then our Diabetic Peripheral Neuropathic Pain program is on hold pending the outcome of our central neuropathic pain in multiple sclerosis. And on the bottom, you can see some additional legacy programs that we have some of which are currently generating revenue and some of which are the potential to generate revenue in the future.

So I’d like to start with an overview of NUEDEXTA, which is an innovative combination of the dextromethorphan and quinidine. And as I mentioned, if you look on a mechanistic level of NUEDEXTA works in the brain, it is an NMDA receptor antagonist and a sigma-1 agonist. So we think about some commercially available products like Memantine or Namenda.

We have a very similar mechanism of action. Whereas however, whereas Memantine just works on NMDA. We have the additional benefit of sigma-1, so we believe that we can modulate glutamate both pre and post-synaptically, unlike a product like Memantine, which only modulates glutamate at the NMDA level.

And because of this well-known and well understood mechanism of action, this really allows us to think about the potential uses of NUEDEXTA quite broadly. And as I mentioned, we’re approved for PBA, but additionally, you’ve got neuropathic pain which studies are underway, behavioral disturbances, also we have studies underway, and then a host of other potential applications everything from Huntington's Chorea to Parkinson’s dyskinesia, depression, autism and memory and cognition just a name a few really falling in the three major areas.

Movement disorders, pain and then also behavioral disturbances. And if you take a look at how NUEDEXTA works in the pharmokinetic and pharmacology basis, you can see that the quinidine is acting as a metabolic inhibitor allowing or actually stopping the body from metabolizing dextromethorphan.

So as you can see here on the graph on the left, if you just were to take say 45 milligrams of dextromethorphan by itself, you get very little dextromethorphan in the plasma as indicated by the dark blue line on the bottom.

However if you give just a small amount of quinidine in the case of NUEDEXTA, only 10 milligrams of quinidine, you can see the very large increase in the availability of dextromethorphan within the plasma, and then on the right, you can see the receptor binding both the sigma-1 and NMDA that occurs with NUEDEXTA.

Now I will spend a little bit of time talking about the PBA market for those of you not familiar with PBA, PBA is an underlying neurologic condition that must occur secondary to some type of neurologic disease or injury.

So it affects patients with stroke, Alzheimer’s disease and other forms of dementia, traumatic brain injury, ALS, MS and Parkinson’s, as well as a number of other neurologic disorders. In the way PBA manifest is as uncontrolled emotional outburst in our studies, we studied laughing and crying. So these PBA patients have a disconnect between the front and the back of the brain, and that disconnect causes a lack in ability to control once emotional effect, leading to these episodes of laughing and crying, and as we’ve heard in our clinical studies, the average patient was having roughly 40 to 50 episodes a week.

So you can imagine trying to cope with an underlying condition like multiple sclerosis, or just had a stroke and on top of that disease having PBA with 40 to 50 uncontrolled outbursts occurring throughout the week adds a significant burden to these patients and one study that we conducted at Avanir was looking at the overall impact at PBA on quality of life and here we see the – looking at the SF-36 score, we looked at the patients with underlying neurologic conditions with PBA and without PBA and put them side-by-side.

And here you can see across the health status portion of the SF-36 on vitality, social functioning, roll emotional and mental health in all categories of patients that have PBA had significantly lower quality of life scores than patients that had the underlying neurologic disease or injury but did not have PBA really demonstrating the impact that PBA has on the lives of these patients and also their caregivers.

Turning now to an overview of NUEDEXTA, pulled a few slides from our Phase III clinical study. The first year with the primary efficacy endpoint, which was a reduction in episodes that we’ve observed during the study and you can see NUEDEXTA, the NUEDEXTA treatment arm in dark blue with a very rapid and the same response with episodes dropping approximately 60% within the first two weeks of the study, and increasing to approximately an 80% reduction by week five and maintaining that 80% reduction throughout the reminder of the study, so very rapid and durable response not typically observed with products that work within the CNS.

And additionally, for some patients having one episode is too much. So on of our pre-specified analysis of the primary end point was remission and will define remission as no episodes during the last two weeks of the study. And here we can see that over half of NUEDEXTA treated patients 51% of the patients had no episodes during the last two weeks. So quite remarkable impact considering these patients were having 40 to 50 episodes at the start of the study going down to no episodes during the last two weeks of the study.

Now turning to the commercialization of NUEDEXTA, we launched NUEDEXTA about a year and three months ago and we believe the launch has been going quite well and here on slight 16 you can see our current prescription trends going back to our launch in February of last year. And this morning, we reported our second fiscal quarter earnings and as part of that earnings we reported a $9.2 million in gross NUEDEXTA revenues representing growth of 42% over the previous quarter.

And if you take a look at the trajectory of prescriptions, you can see we hit an all-time high in March with over 7,300 prescriptions and March represented a growth of approximately 16% over February.

In addition, as we look to April, April is off to a very strong start. The three weeks of April versus the first three weeks of January showing approximately a 42% growth in prescription numbers and if you look at the first three weeks of April over the first three weeks of March, month-over-month we are growing at approximately 14% or continuing on that very nice run rate as it relates to prescriptions.

Additionally, if you look at the split between the business, between our institutional sell effort and our retail selling effort, you can see that institutional sales now account for more than 50% of our business, roughly 4,000 prescriptions in the month of March as compared to about 3,000 prescriptions in the month of March.

However I should note that both books of business are doing quite well. So if you look at the first calendar quarter growth of institutional prescriptions over the fourth calendar quarter, growth was approximately 57%. If you look at the same time period for retail, that growth was approximately 17%. So we are seeing nice growth in both side of the business, however we are seeing more robust growth on the institutional side of the business.

So now spending a few minutes on our commercialization strategies; we have four main strategies underlying the commercialization of NUEDEXTA. First is to expand the physician adoption of NUEDEXTA, second is the increased diagnosis and treatment of PDA, third is to motivate patients to request NUEDEXTA and fourth is to maximize patient access.

And I’ll just spend a few minutes on the first one, expanding physician adoption of NUEDEXTA. And here our number one way to expanding physician adoption is through our specialty field sales force and we have two separate field sales forces. One, outpatient or retail sales force, which is approximately 71 sales representatives, the other are institutional sales force, which we recently announced we’re increasing to 42 sales representatives, an increase of about 30% over the previous size of 32.

And between those two sales forces, we are really optimizing the long-term potential of our business, taking into accounts the rapid and robust growth that we’re seeing within the institutional market and also though taking advantage of the long-term potential that we see within the retail setting.

Sales forces are targeting neurologists, psychiatrists, and geriatricians, as well as Medical Directors that are responsible for taking care of a number of different institutions. And with the Medical Director, we found that it’s an audience that you can change behavior and that change will have an impact in multiple facilities that the medical director is responsible for.

In addition, key aspects of our program include Physician Speaker Bureau, where we have a lot peer-to-peer education going on, so that doctors that are having positive experiences with NUEDEXTA can share those positive experiences with their colleagues and also as you saw with the high level and robust early efficacy of NUEDEXTA, samples are becoming important aspect of our retails business, getting patients started on NUEDEXTA, seeing the benefit and then continuing forward with their use of NUEDEXTA.

So I would now like spend the rest of presentation really focused on the future opportunities for NUEDEXTA, which we refer to as AVP-923 in the clinic.

First study I’ll talk about is our Phase II study in central neuropathic pain in multiple sclerosis, this is a very large Phase II study that’s currently enrolling. It’s approximately 400 patients in four different treatment arms, you can see three different doses of dextromethorphan and quinidine ranging in 20 milligrams of dextromethorphan up to 45 milligrams of dextromethorphan combined with 10 milligrams of quinidine given twice daily and those will be compared to placebo.

Primary end point of the study is the 11-point Likert Pain Rating Scale, we’re also looking at a number of secondary end points, which are very important to the multiple sclerosis community. This includes fatigue which we saw signal in fatigue benefit in our STAR trial looking at the MS population. After the MS impact scale which is a quality of life question here specifically directed in MS patients.

The Pittsburgh Sleep Quality Index and in our previous Diabetic Peripheral Neuropathic Pain studies we saw benefit in sleep. The MS Neuropsych questionnaire, which is meant to look at cognitive impairment or hopefully in the case of NUEDEXTA cognitive improvement associated with NUEDEXTA therapy and then also the Beck Depression Inventory and the spasticity scale. The study will enroll some of between 65 and 80 sites throughout the U.S., we got approximately 40 sites in the U.S. and that are currently enrolling patients and sites in Latin America and Europe have recently come online as we look to enroll the study. Our goal is to have data available in the second half of 2013.

Now switching gears to what one of the studies that I’m personally very excited about which is behavioral disturbances in Alzheimer’s and you can see this excerpt from a paper looking at some of the most commonly absorbed behavioral symptoms in Alzheimer’s patients and what you can see from this is that, very quickly after initial diagnosis of Alzheimer’s you see agitation, irritability and aggression being quite prevalent in these Alzheimer’s patients particularly in those that have moderate severe Alzheimer’s. So certainly a high unmet medical need is there are no approved therapies out there right now after the treatment of behavioral disturbances in Alzheimer’s after the treatment of agitation in Alzheimer’s.

So this slide, slide 22 is relatively new to our corporate presentation and what this slide shows is the results of NUEDEXTA on agitation in our PBA STAR trial. So in our PBA STAR trial, we did have a neuropsych inventory or the NPI as part of the secondary end points, so we did is, we wanted to look at the patients who had agitation at the start of the study using the agitation sub scale of the NPI. So here you can see that about 13 patients in each of the treatment arm had moderate to severe agitation at the start of our Phase III STAR trial for PBA.

And what you can see here is at the end of the study, we have a very dramatic reduction in the number of patients having moderate to severe agitation in both NUEDEXTA treatment arms, the 3010 arm and the 2010 arm with over 50% of patients having reduction in their agitation from moderate to severe to no agitation or mild agitation.

And compare and contrast that to placebo where we actually saw an increase in the number of patients that had moderate to severe agitation. So certainly from a mechanistic perspective there's a good case to be made that NUEDEXTA could have a benefit on behavioral disturbances in Alzheimer's, particularly agitation, and here we see based on the clinical data from the STAR trial, we actually see that proving out in the Phase III studies within MS and ALS patients.

So that led us to our Phase II study and behavioral disturbances in Alzheimer's, as I mentioned our goal to file the IND for the study by the end of this calendar quarter, so by the end of June, with goal getting the first patient enrolled into the study by the end of the third calendar quarter or at the end of September.

This will be a two arm study of approximately 100 patients per arm, 200 patients in total, 10-week double-blind study, and as you can see first there will be starting dose of NUEDEXTA 2010 and then we will be dose escalating to a 3010 dose and that will be compared to placebo.

The main efficacy end point will be looking at is the MPI specifically the agitation sub scale of the MPI, we will also be looking at other very commonly used endpoints within the Alzheimer’s space including the mini-mental exam, the activities of daily living, the ADAS-cog as well as quality of life depression and caregiver strain.

The study will be conducted in the U.S. and we have approximately 20 sites will be enrolling patients, and we have designed the study in conjunction with some of the leading dementia experts with in the U.S.

So very excited to get this IND in with the FDA and start the study enrolling another high unmet medical need area and one that we think we can really make a difference with NUEDEXTA in.

And now I'd like to turn the talk a little bit about due to deuterated dextromethorphan and a number of weeks ago, we announced a licensing deal with Concert Pharmaceuticals for deuterated dextromethorphan and essentially what dextromethorphan is its taking our current compound and is replacing hydrogen with heavy hydrogen.

And that goal of replacing hydrogen with a heavy hydrogen is ideally to eliminate the need for quinidine, and we do believe that based on what we’ve seen in the early modeling if there is a possibility to either significantly reduce or eliminate quinidine, thereby making a next generation NUEDEXTA, if you will. Additionally, if you look at the activity at the receptor level, it does appear that deuterated dextromethorphan operates both at NMDA and sigma-1, just like NUEDEXTA does.

And so, taking a look at some of that data, here on the top part of the slide, you can see the reduced metabolism by the CYP enzymes there with the [deuterated] methorphan in red [Part C] 1003 versus dextromethorphan in black, thereby suggesting that deuterated dextromethorphan should stay in the plasma longer when it is administered in humans and you can see the very similar receptor binding, both at NMDA level and at sigma-1 level on the chart on the bottom.

So this program is a very exciting one for us. I’d believe that it is protects and expands our current NUEDEXTA franchise and our focus on sigma-1 and NMDA because it does have that very similar mechanism of action to NUEDEXTA, but with the potential ability to have reduced or eliminate [Q] entirely, does give us that refreshed IT with composition of matter of patterns through 2030 before any pattern term extension.

And what’s very nice about this program is we’ve learned the experiment. We know what happens in the body if you inhibit 2D6 and we did that experiment with NUEDEXTA using quinidine. So we don’t expect that there will be any surprising findings when we first get into humans and conduct our PK study.

So our goal for this program is to get our PK studies up and running by the end of this year and have PK data available early in 2013 and what that would potentially allow us to do would be to move deuterated dextromethorphan into the continued development of ADP 923 either within the pain space or potentially within the Alzheimer’s and agitation space, and seamlessly integrate deuterated dextromethorphan into our existing programs and additionally give us the possibility of exploring many of those other indications that I talked about early in the presentation, including Korea, including autism and many others.

So I’d like to wrap with our financial summary and our 2012 goals and objectives. From a financial summary perspective, we ended the quarter March 31, as we reported this morning with $69 million in cash. That is before the $30 million of debt that we announced this morning. So to add that $30 million to the $69 million, roughly $100 million of cash available on the balance sheet.

Total net revenues reported of $10 million and net NUEDEXTA revenues of $9.1 million should also add that our operating burn for the second fiscal quarter was $30 million. So assuming no additional growth in NUEDEXTA sales, this will give us approximately two years of cash. Certainly with growing NUEDEXTA sales, we would expect that to be longer.

And then finally, on operating expense guidance, we guided to the higher end of our range of $85 million to $92 million, expect we’ll come in between $90 million and $92 million and those numbers do exclude costs associated with FAS 123 or stock option expense.

So as we look forward to 2012 we’ve got a number of important objectives for the company. First and foremost, it’s to continue to build the PBA market and grow NUEDEXTA sales. This will happen through direct-to-patient campaigns, improved reimbursement coverage and continuing to focus on this institutional opportunity with our expanded sales force. We’ll continue to enroll both the MS case study, which is known as PRIME as well as get the behavioral disturbances study underway and get the first patient enrolled here at the end of the third quarter. And I didn’t spend a lot of time talking about the EMA, but we continue to be on track with the EMA and for the approval of NUEDEXTA and PBA.

We received our 120-day questions in mid-March according on right on schedule with EMA timelines. We are working to answer those questions. To-date it’s been a similar dialogue. This is a dialogue we had with the FDA during the FDA approval process. So surprises and we look forward to continue to working with the EMA on the approval of NUEDEXTA within Europe. And then finally, and importantly, continuing to advance deuterated dextromethorphan through preclinical activities and ultimately into humans.

With that, I would like to thank you for joining us for the AVANIR Corp. presentation. And then I’d like to open up to questions either from our host [driving] or from anyone in the audience.

Question-and-Answer Session

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Any question from the audience?

Unidentified Analyst


Keith A. Katkin

The question for those of you listening via webcast is have we ever seen any data from central neuropathic pain [second to] multiple sclerosis. And the answer to that, question is yes we have. It was actually another secondary endpoint in our PBA study. And so applications in our START trial that had multiple sclerosis, we were looking at Pain Rating Scale on 11-point Likert Pain Rating Scale. So very similar to the study that we’re enrolling.

What we found is that will be approximately 130 or so MS patients that we enrolled. About 25 per arm had moderate-to-severe pain. So very nice sample size, and then looking at that data, if you look at the 30/10 dose formulation versus placebo, we actually showed that statically significant reduction in pain relative to placebo and we had about a 4-point reduction overall going from around 6-point and 11-point Likert Pain Rating Scale. So about 2-point and roughly a little less than a one point differential versus placebo. So a very nice robust response in that study and one that my colleague next to you probably could show you on the break, if you’re interested to see.

Unidentified Analyst

Since your data rating in the second half of 2013 for that trial, can you help walk us through some potential timelines for the Alzheimer's studies, yeah, for the Alzheimer's studies and maybe any other indications?

Keith A. Katkin

Sure, absolutely, so for the people who services in Alzheimer's study as I mentioned both get the first patient enrolled by the end of the third calendar quarter. This is a new area for the company, so we’re not certain exactly how long it will take for enrollment, so we’re estimating that around 12 months to 15 months to enroll the 200 patients across the 20 sites. So you’re looking around after one patient per site, per month and that would give us a top line data for that study in late 2013 and early 2014.

Unidentified Analyst

And the cash the tiers of cash that you have is basically would have enough cash to get through this data read out?

Keith A. Katkin

Yeah, from a cash perspective, if you look at our current revenue growth rate combined with our expense management and we’ve been real clear this morning in our conference call, we believe that this topping off of the balance sheet if you will with $30 million debt instrument showed in the minds of everyone send the strong signal that we have no plans to go back to the equity markets for any type of significantly diluted financing and that any financing the company would need to do in the future would be opportunistic in nature.

Robyn Karnauskas – Deutsche Bank Securities, Inc.


Unidentified Analyst


Keith A. Katkin

And the question for those of you listening was for deuterium dextromethorphan would we expect that we might see a clinical advantage either in terms of a therapeutic window or another aspects of the program. I think overall it’s obviously too early to tell and we need to obviously get into humans and see what kind of PK/PD date is generated, but I think certainly the reduction or elimination of quinidine could strengthen with already a very strong package insert of NUEDEXTA.

if you look at the NUEDEXTA package insert and you look at the warnings and precautions that are in the package insert. although we believe very clean and then we’re very happy with the label the only ones that are in their associated with quinidine. So if you could imagine a new package insert with even fewer warnings and precautions certainly that is something that I think would be in patients best interest and additionally as we look at other potential indications what the deuterated program does that gives us access to other potential indications that we can get to right now with NUEDEXTA, because we don’t have intellectual property protection. So things like autism which has a possibility of being very exciting possibility of tardive dyskinesia for example or Huntington’s chorea. So a number of different areas that we think we can fully explore an NMDA receptor antagonists and sigma-1 agonists through deuterated dextromethorphan.

Unidentified Analyst

On the institutional program, so forth, are they calling the doctors at the institutions or in your office?

Keith A. Katkin

And the question was for the institutional sales force, are they calling on the doctors in the institutions or within their offices? And it’s really a mix, the institutional selling effort is a little bit broader than your traditional retail selling effort, because there are number of stakeholders that are involved in the prescribing process. So typically, we are in start, it starts with the medical director, who will have responsibility for anywhere from one to a dozen different facilities.

And once you get the medical director bought in, and that could happen either within their office or some times within their facility as well. And then typically, what our sales team does as they go to the institution, and actually doing in service with the institution, they get the staff in the institution on-board, they get them looking forward, PBA patients, because PBA patient identification is much easier than the institutional setting, because these healthcare providers are with these patients, pretty much 24 hours a day, so they get them identifying the patients and then really the final part is, with the consulting neurologists or consulting psychiatrist, typically, wants to approve any additional medications that are being given to the patients there, and then once that can place that is very easy for an institution to start prescribing NUEDEXTA for a number of patients.

Unidentified Analyst

And in terms of that, how would you describe at this point your coverage of the institutional base in the U.S.?

Keith A. Katkin

Yeah, and the question was our coverage of the institutional base in the U.S., and there is two ways to look at coverage. One way to look at it is looking at Medical Directors and because Medical Directors as I mentioned typically responsible for a number of facilities, it’s a much smaller number of Medical Directors you need to get to in order to cover those Directors that are responsible for a majority of the patients.

On the facility level there is about 15,000 individual facilities that are out there. So you can imagine that with our sales force of 32 and now 42, really just scratching the surface in terms of access of the individual facility level. So still a tremendous, tremendous opportunity within the institutional setting.

That said, when you look at what other companies are traditionally doing within this space, they are fully sized field sales teams are usually somewhere around 55 to 70 people and then they will be calling and as I mentioned the Medical Directors as well as the larger facilities that are throughout the U.S.

So our goal is really to, as long as we continue to see a robust update like we’re seeing right now within the institutional setting, really trying to automize around that 55% to 70%

Unidentified Analyst

So refill rates?

Keith A. Katkin

Question is about refill rate, the illusive refill rate, I should add. So the refill rate is, it is complicated by two aspects, one is in the institutional setting that the person who is writing the script very often from month to month can change, so might start with a Medical Director or start with a consulting psychiatrist and then switch back and forth. So it’s very hard to get a sense of what the true compliance a refill rate is within the long-term care setting and its similar with retail as well. What we have done is, we look at retail is, we benchmarked ourselves to so commonly use the CNS drugs out there and what we found is that at this point of launch for about three to four points better with a refill rates then some commonly use CNS drugs.

And within long-term care, what we started our institution side, what we started to do, as we started to look at refill rates, so reorder rates at the institutional level, and we’re finding is that over 80% of the institutions are reordering and that’s our best target for compliance in our mind it means that they’re happy with the results they are seeing, and they’re either putting on additional patients or maintaining the patients they have on NUEDEXTA.

Unidentified Analyst

Once you have passed the, accessing the institutions, moving to the patient trying to get more patients to up in (inaudible), what is the strategy?

Keith A. Katkin

Sure, well, there is certainly still tremendous, tremendous opportunity, I will give you census in long-term care for example, and there’s estimated to be about 1.5 million patients that are within the institutional settings in the U.S. and about a 1 million of those were believe had some type of neurologic disease or injury, primary Alzheimer’s, stroke or Parkinson’s disease.

So if you look at the PBA prevalence rates that you see within those population on the low side, it would be estimated that there is about a 100,000 PBA patients within the institutional setting. And then in our current price that represents to about $600 million a year opportunity within the institutional setting alone, and if you consider retail, there is a significant opportunity within the retail business even larger than what on the institutional side, just take longer to access that that part of the business.

So our focus is pretty clear. We want to continue to optimize within the institutional setting, continue to grow our base, get more medical directors on board, get use in more and more facilities, because we think we can solve very important problem of PBA within these institutions, and then also on the retail side, there we’re going into a little bit more to the consumer with a direct-to-patient campaign, trying to target the patients that have these underlying neurologic conditions, and driving them to have a conversation with their doctor, NUEDEXTA as a possible treatment for their PBA.

Unidentified Analyst

Is there more rapid up-tick in certain populations like ALS or certain populations where they’re start seeing use more?

Keith A. Katkin

Yeah, it’s exception. If you consider the population sizes, there is some pretty big differences. So if you look at a health conversation, at least it’d somewhere between 5 million and 6 million health conversations in the U.S. About 5 million dramatic brain injury survivors, 5 million stroke survivors, about 400,000 MS patients and about 30,000 ALS patients. So we believe that our use is very much in line with those percentages, perhaps a little more heavily weighted towards the Alzheimer population because they are so prevalent in the institutional setting.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Great. Any last questions, all right. Thank you.

Keith A. Katkin

Okay, thank you very much. We appreciate your time and attention.

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