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ACADIA Pharmaceuticals Inc. (ACAD)

Q4 2007 Earnings Call· Wed, Mar 5, 2008

$22.76

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the ACADIA’s Pharmaceuticals Fourth Quarter and Full Year 2007 Financial Results Conference Call. My name is Staz, and I I'll be your coordinator for today. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. (Operator Instructions). I would now like to turn the presentation over to Ms. Lisa Barthelemy, Director of Investor Relations at ACADIA Pharmaceutical, who will review the Company's forward-looking statements. Please proceed. Lisa Barthelemy – Director of Investor Relations: Thank you. Good afternoon, and welcome to ACADIA Pharmaceuticals fourth quarter 2007 financial results conference call. This call is being recorded, and an archived copy will be available on our website at www.acadia-pharm.com through March 19. Before we proceed, I would like to remind you that during our call today we will be making a number of forward-looking statements, including statements regarding our anticipated financial results and our research and development programs. These forward-looking statements are based on current information and expectations that are inherently subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These factors and other risks associated with our business can be found in our filings made with the SEC, including our annual report on Form 10-K for the year ended December 31st 2007 filed today. You are cautioned not to place undue reliance on these forward-looking statements which are made only as of today's date. ACADIA disclaims any obligation to update these forward-looking statements. And it is now my pleasure to turn the call over to Dr. Uli Hacksell, our Chief Executive Officer. Uli Hacksell – Chief Executive Officer: Thank you, Lisa, and let me…

Uli Hacksell - Chief Executive Officer

Management

Thank you Tom. Let me now review our programs in more detail. ACADIA'S pipeline includes five mid-to-late-stage clinical programs. In our most advanced program, we are in Phase III development with Pimavanserin for the treatment of Parkinson's disease psychosis. We have delivered positive results from our Phase II trail in our program with Pimavanserin as a co-therapy for Schizophrenia. And we have two additional proprietary commercialization rights for all four of these proprietary programs. In addition, we have a neuropathic pain program in Phase II developments in collaboration with Allergan. My remarks today is mostly focused on our most advanced programs including our Phase III Parkinson disease psychosis program and our two schizophrenia programs. Let me start by discussing our Phase III clinical program with Pimavanserin as a treatment for Parkinson Disease Psychosis or PDP. PDP is a debilitating neuropsychiatric disease that occurs in up to 40% of patients with Parkinson's disease. There currently is no drug approved in the US for the treatment of PDP despite the fact that this is a very serious condition characterized by disturbing hallucinations and delusions. The progression of this disease is unrelenting and lacks remissions. Importantly, PDP often represents an inflection point in the treatment of patients with Parkinson's disease. The condition often disrupts the patient's ability to perform many of the activities of daily sleeping that keeps them independent and active. As a result, PDP associated with increased care givers burden, nursing home placements and increased mortality. We believe Pimavanserin is well positioned to be an important first and class treatment for PDP. The therapy that can effectively treat the psychosis in patient with Parkinson's disease while allowing for optimal motor control thereby significantly improving the quality of life for these patients and for their care givers. We continue to enroll patients…

Operator

Operator

(Operator Instructions). Your first question comes from Jim Birchenough from Lehman Brothers.

Jim Birchenough

Analyst

Yeah, hi guys. A couple of questions on ACP-104, just as we work ahead to the data, what would be determined to be a statistically significant improvement in PANSS in this trial and what would you view as a clinically relevant improvement beyond that?

Uli Hacksell

Analyst

So, thank you Jim, I will ask Roger to answer that question.

Roger Mills

Analyst

Well, probably, we have powered the study to look at a 20% drop in the PANSS scores and with that in context that the entry criteria is patients would come in with 70 or greater on PANSS.

Jim Birchenough

Analyst

And when we look at drugs like clozapine, what sort of improvements do we expect to see. So, I just wanted to get a sense of how clinically relevant that sort of improvement would be?

Roger Mills

Analyst

It is clinically relevant, I don’t have the comparative drops of that, but we would expect to see a fairly robust drop in the PANSS score and this is a Placebo controlled study, so it would be relative to Placebo.

Uli Hacksell

Analyst

Jim Birchenough

Analyst

And just a follow-up on the adverse event profile particularly looking at white blood cell effects. I am assuming that if there had been a case of a granulocytosis in the trial, we might have heard about it by now, so I want to make sure that assumption is right? And secondarily, in terms of reductions in white blood cell counts, what would you expect to see with clozapine so we have some frame of reference here?

Uli Hacksell

Analyst

Roger?

Roger Mills

Analyst

So, we are currently a little bit treatment phase of this study has now completed, that's sort of the patient treatment says. The study is too long going in respect of cleaning and then analyzing the data. So, we are not in a position to comment on the white blood cells per se. In terms of reports of any cases and I will put those caveat that we haven't got fully cleaned and reviewed the data in total yet. However, we are not aware of any repots of a granulocytosis in this study.

Jim Birchenough

Analyst

And so, then just a followup, just on what we would clozapine over a six week period and similar followup period, what would we expect in terms of white blood cell effects over this time period?

Uli Hacksell

Analyst

Jim it is a lot of variation in the literature when it comes to specific effects on white blood cells. But what you see are, first of all agranulocytosis is an observation that you don't see frequently with clozapine. You will see it in less than 1% of patients, perhaps 0.8%. But you see other effects on wide blood cells. You see leukopenia, you see neutropenia, and you would see that they are somewhat again relating to differences between different proportions between 4% to 8% of patients have had considerable drops in white blood cells which is clearly much more than what you expect to see in Placebo treated patients. So we believe that when we have looked at the data in detail, we will be able to see whether it is ACP-104 is having effects on white blood cells that are similar to what you would expect with Placebo or whether which we don't believe that it would be close up in light.

Jim Birchenough

Analyst

Thanks for taking my questions.

Uli Hacksell

Analyst

I think that trial will provide us with a good set of what to expect from ACP-104.

Jim Birchenough

Analyst

Perfect thanks.

Operator

Operator

Your next question comes from the line of Ted Tenthoff from Piper Jaffray.

Ted Tenthoff

Analyst

Great, thank you very much for taking the question. I guess just to sort of get this one out early. Obviously we are all anxiously awaiting the partnership here. Can you give us a little bit more detail on kind of where things stand and obviously we will wait for timing but have things changed in terms of your expectations? Have the types of companies that you are talking to changed? Can you give us any more color on sort of where the negotiations stand and what maybe some of the key points are surrounding the development potential of 103?

Uli Hacksell

Analyst

Hi Ted, thank you for your question. First of all let me say that we are not providing specific details regarding the ongoing discussions or timing for a deal. What we can say is that more general aspects of our view on these things and so let me try to recapitulate that. First of all, during this process we have really had many reasons to be pleased with, with the reaction from potential partners when it comes to what they see us as the commercial potential for Pimavanserin and the opportunity in terms of the drug and that is something that is that is very pleasing for ACADIA of course. What I also can say is that we remain confident that we have the right strategy in place and we have the right process in place to ensure that we can find a partnership that really provides us with a commercial potential, the opportunity to really maximize and optimize the commercial potential for Pimavanserin. That confidence is steadfast, if I can use that word. I also think it's very important to remember that we are moving forward full speed with PDP and that our phase III program with Pimavanserin provides a number of additives to other indications that we want to develop for the drug. So we are not sitting still in the boat. We are moving forward both when it comes to the partnership discussions and when it comes to the development of Pimavanserin. I have previously outlined what kind of partners that we are interested in talking to and basically we have talked about three different kinds of partners that we see as interesting for ACADIA in this context. One type of partner is a global pharmaceutical company that has a schizophrenia product on the market. Another potential partner is a global pharmaceutical company that has a strong CNS force. And the third kind of group of potential partner that we include in our process are partners that have a strong CNS sales force but more a regional customs. So these are the three different markets or partners, potential partners that we have seen as interesting to explore as part our process and as part our strategies.

Ted Tenthoff

Analyst

Great that’s very helpful. You know may be one quick follow up if I may, I know you are discussing some of the opportunities in other areas in psychosis and will be giving underway the words of Phase III trial for Parkinson's disease. Can you give us an update on sort of what your thoughts are of may be additional psychosis indication, is this something where we would push through with PDP first and then comeback and fill, or do you think there would be opportunities to began pivotal trials in other forms of psychosis or would that even be necessary?

Roger Mills

Analyst

It’s a very interesting person under cleaning, with a drug like Pimavanserin, with the TOEFL that we have of the drug we see multiple opportunities for line extensions beyond PDP and schizophrenia. Clearly, there are many, many other psychosis indications that could come in for play. These indications include psychosis in the elderly, psychosis in older disease that includes options to go beyond these different indications as well. So we see line exemption opportunities both into the neurology and into the neuropsychiatric indications which are very exciting to explore with Pimavanserin and these are clearly what we have talked about that we are interested in exploring bit with potential partners is the vision that the partner had for these kind of expansion opportunities, its very important component of the potential partnership for Acadia.

Ted Tenthoff

Analyst

I can understand that. Thank you.

Roger Mills

Analyst

Thanks.

Operator

Operator

Your next question comes from Alan Carr from Needham.

Alan Carr

Analyst

Hi, good afternoon everyone.

Tom Aasen

Analyst

Hi.

Alan Carr

Analyst

Tom, I was wondering if you could may be drill down the timelines for the PDP trial – that’s something maybe towards first half or the second half of ’09, and I’m also wondering how the timelines for this trial, if they fit into or how they fit into your partnership discussions?

Uli Hacksell

Analyst

So let me start out with the timing what we have said and what we can say today is that we expect to provide top line data from the first Phase III study in PDP during 2009. We have also said that the second Phase III PDP study that we will initiate in this month in March may have a compressed timeline as compared for the first efficacy study, but we haven’t provide a specific timing for the delivery of top line data from that study. Now as part of your second question how this impacts discussions with partners being that’s the effect that we are moving forward with Pimavanserin PDP is something that is just positive note in (Inaudible) 70 negative, that’s because it helps four times of the indications.

Alan Carr

Analyst

One other question, you have a couple of years the treatment experience if I can hear, open-label trial, the Phase II trial, I’m wondering if are learning anything new positively or negatively coming out of this longer treatment experience?

Uli Hacksell

Analyst

Yeah, in fact we have some patients that being on the drive for three years or more, Roger, do you want a comment on that?

Roger Mills

Analyst

Yeah, thanks Uli. I think what we are learning is that the drug is well tolerated in this patient population over what is – we extended treatment period so that’s all to the good, and we are not learning that there are any safety concerns, it seems to be very well tolerated in deed, and patients have done very well on it.

Alan Carr

Analyst

Okay. Thanks very much.

Uli Hacksell

Analyst

Thank you.

Operator

Operator

And your next question comes from the line of Charles Duncan with JMP Securities.

Charles Duncan

Analyst · JMP Securities.

Hi guys thanks for taking my question. Uli, I had a question about ACP-104 and what you are going to do with Phase IIb data, do you anticipate designing and launching of Phase III Program yet this year and if so, would you do that with or without a partner?

Uli Hacksell

Analyst · JMP Securities.

Thank you, Charles for your question. Clearly our general strategy is to seek a partner that can help us to complete our Phase III program and commercialize this product, but we are keeping our options open regarding timing. We are currently planning for the future development in this program and we will fine tune this plans following results from the Phase IIb trial

Charles Duncan

Analyst · JMP Securities.

And then if so specifically you would be prepared to design a trial based on those results and launch that as quickly as possible or do you anticipate wanting to partner the drug?

Uli Hacksell

Analyst · JMP Securities.

We are open to doing something additional with 104. It's something that we are currently discussing, it's an obvious kind of thing to talk about, but we want to keep all options open here.

Charles Duncan

Analyst · JMP Securities.

Okay and then with 103, I know you have always talked about doing a second study and you have always said it was going to be similar design. But, can you provide us any additional color on the design and really what additional clinical questions you are looking the answer with that second trial and just help us understand why, if you’re going to extend perhaps additional international sites or what's different about the second trial than the first trial. How you are going to be able to contract the timelines in that one?

Uli Hacksell

Analyst · JMP Securities.

Roger, maybe you can take that.

Roger Mills

Analyst · JMP Securities.

Yes Uli, thanks Charles. I mean, as with anything you learn as you go along. These are the largest studies that have everything been conducted in this patient population. So remember there are three studies that we are initiating in this program. There are the two pivotal, first the long term safety study which as Uli indicated earlier is open to patient's t rollover when they have completed the treatment portion of the pivotal studies. So first getting – it wasn’t just getting first study up and running, it was in fact ensuring that the long term safety study was also up and running so patients have the opportunity to rollover in a timely manner. As we previously indicate, these trials are very similar. So the idea is to do two equal pivotal studies. They are of similar design, similar in treatment duration and generally similar in nature. Both will be internationally driven studies. Naturally there will be differences in some of the countries that one study is in versus the other, but that is not by specific design. It's just to ensure that we get a timely enrollment into the program. You asked the differences between them? We are intending in the second study to incorporate healthy economic measures into that study as one would expect and additionally the doses used in the first trial of Pimavanserin 10 mg and 40 mg and in the second study we will be investigating 10 mg and 20 mg, and we expect this to enable us to fully explore the dose range and synergize this with the other development programs.

Charles Duncan

Analyst · JMP Securities.

Okay so slightly different dosing 10 and 20 versus 10 and 40?

Roger Mills

Analyst · JMP Securities.

Correct. That’s not in common in the psychotic area.

Charles Duncan

Analyst · JMP Securities.

Yeah. That make sense to me, but same end points and duration of treatment et cetera?

Roger Mills

Analyst · JMP Securities.

There will be exactly the same end point, so the studies are exactly the same in that respect.

Charles Duncan

Analyst · JMP Securities.

Okay. And then, if I could ask just one more follow up from Tom, if he could provide a little color on the R&D spend and whether or not you anticipate any milestone or upfront in your guidance?

Tom Aasen

Analyst · JMP Securities.

Yes, I would be happy to Charles. First of all what I did note when you look at the fourth quarter is that clearly as we had said before particular period can fluctuate depending upon the timing of different expenditures and in particular in this case, we had the acceleration of the enrollment that occurred in that Phase IIb enrolled quite dramatically and in fact we announced we completed it in December, so we did see that corresponding impact in the fourth quarter, so you saw very significant increase in the external cost component. As I mentioned that totaled about $10 million in the fourth quarter of our R&D expenses, and that was up quite remarkably since the comparable quarter a year ago. Again, this can fluctuate in given period, so that’s’ significantly hit on 104. We would expect that the expense is going forward and 104 would clearly be significantly lower as we just wrap up the financial conclusion of that trail, and then there will be other expenses. So, it will fluctuate, and we have not -- in terms of our guidance to be clear what we have said approximately is a two year runway. We have not factored in a partnership into that runway.

Charles Duncan

Analyst · JMP Securities.

Okay. Good thanks for the added color. Thanks guys.

Operator

Operator

David Amsellem

Analyst

Thanks for taking my question. Can you provide any more color on your plans for Pimavanserin in sleep maintenance insomnia? And given that it's. a totally different indication from the psychosis setting and you have a strong cash position. What if anything has precluded you from moving forward in the setting? Thanks

Uli Hacksell

Analyst

Thanks it's an area that is quite interesting for those of you who don't remember we conducted a proof of concept study in sleep maintenance insomnia with Pimavanserin a while ago and we saw some powerful robust increases in slow way sleep in the older healthy volunteer now. When we have those results in hand we shortly afterwards got the exciting schizophrenia data, the co-therapy data with schizophrenia, but said that with these exciting schizophrenia data, we want to make sure that we do the right kind of sleep studies to ensure that we sort of optimize the total clinical program around Pimavanserin. So we wanted to take a step back, we wanted to ensure that additional sleep studies would be consistent with a total development program that we want to develop together with a partner, and we think that there are many areas where we can look at the sleep properties of Pimavanserin as a great advantage. Not only the in patient's with specific sleep maintain insomnia and the general population, but also in patient's with neuropsychiatric and neurological disturbances where the sleep properties of Pimavanserin will provide an additional clinical advantage. So we want to make sure that we sort of utilize this clinical finding in the optimal way.

David Amsellem

Analyst

Okay. That's helpful and then one other question if I may. Just remind us if you have contemplated running any additional Pimavanserin co-therapy studies with other atypical antipsychotics in parallel with your ongoing discussions with potential partners?

Uli Hacksell

Analyst

Our strategy with the Pimavanserin as a co-therapy in schizophrenia has been that we really want to make sure that we have optimal input from the potential partner in the design of the development program in that area before we really embark on its full speed. Having said that, we have not exclude that we might do something but our current strategy is stands past and that is to seek that the optimum kind of input from potential partner in the schizophrenia development.

David Amsellem

Analyst

Okay. Thank you.

Uli Hacksell

Analyst

Thanks

Operator

Operator

Your next question comes from the line of Lucy Lu from Citi.

Lucy Lu

Analyst

Hi. Thank you. I have a couple of questions on 104. Basically just from reading the published literature it seems like patient are treated with Clozaril, the risks for developing a granulocytosis is highest between 6 and 18 weeks or even 12 and 18 weeks depending on which paper. And I am just wondering from a safety point of view of this Phase II study, exactly what kind of safety information do you really get in terms of comparing to Clozaril?

Uli Hacksell

Analyst

It’s a good question and we don't expect to be able to say anything specific about the risk for agranulocytosis based on the current study. For the specific reason that you mentioned and also for the fact that the agranulocytosis with clozapine is relatively rare only about 0.8% of patients develop agranulocytosis. But what we do expect to see from the study is a signal based on the general effects on white blood cells that receive Pimavanserin with 104. And compare that with what you would expect to see in clozapine-treated patients. And that signal we think is powerful because the agranulocytosis is clearly preceded by an effect on white blood cells which is more benign. So all those patients that develop agranulocytosis have some initial minor effect on the white blood cells; and that kind of effect should be observable in the clinical study and that’s why we hope to be able to as a result of this study really say whether ACP-104 has an effect on white blood cells that is more like what we would expect from Placebo-treated patients then what you would expect from clozapine-treated patients. And that will be an important signal with it.

Lucy Lu

Analyst

Right. And can I just ask on the safety side, what is the average age of patients in this trial?

Uli Hacksell

Analyst

I really have to refer to Roger.

Roger Mills

Analyst

We have not looked at, I couldn't comment on what the average age is. All I know across the board it’s a pretty standard psychosis study. So I'm not expecting the age to be different from anything previously.

Lucy Lu

Analyst

Okay.

Roger Mills

Analyst

I just don't have that information, couldn't tell you right now.

Lucy Lu

Analyst

Oh, that’s fine. And then in terms of efficacy endpoints, just wondering if we combine those versus Placebo or is it the higher dose 200 mg b.i.d. versus Placebo as a primary efficacy endpoint?

Roger Mills

Analyst

Yeah, it's basically larger.

Lucy Lu

Analyst

Okay. So it's basically 200 versus Placebo. And then just one more follow-up question on the 200 b.i.d. what kind of dose of Clozapine is it equivalent to approximately?

Uli Hacksell

Analyst

We cannot really say that. What we can say is that patients are treated with clozapine and those patients may receive from 300 to 900 milligrams a day of clozapine.

Lucy Lu

Analyst

Right.

Uli Hacksell

Analyst

They clearly develop cognitive concentrations of the metabolized 104, which are in the range of what we are studying here. We don't expect to have any problems here establishing efficacy with those doses.

Lucy Lu

Analyst

Alright. Thank you.

Uli Hacksell

Analyst

And I think again its – to make the direct comparison with clozapine is probably not the optimal way of looking at this, because ACP-104 has distinct differences as compared to clozapine. For example, its ability to stimulate muscarinic M1 receptors is something that we believe may not only be important in terms of its cognitive effects on the patients, but may also in fact enhance efficacy and psychotic efficacy in general.

Lucy Lu

Analyst

Right. Thank you.

Uli Hacksell

Analyst

Okay.

Operator

Operator

There are no further questions at this time. Dr. Hacksell, please proceed the closing remarks.

Uli Hacksell

Analyst

So thank you again to everyone for joining us on today's call and for your continued support. We look forward to the opportunity to update you again in the further on our on going progress. Thank you so much.

Operator

Operator

Thank you for your participation in today's conference call. This concludes the presentation. You may now disconnect. Good day.