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ACADIA Pharmaceuticals Inc. (ACAD)

Q1 2014 Earnings Call· Tue, May 6, 2014

$22.76

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals' First Quarter 2014 Financial Results Conference Call. My name is Sy, and I will be your coordinator for today. At this time all participants are in 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 Lisa Barthelemy, Director of Investor Relations at ACADIA. Please proceed.

Lisa Barthelemy

Management

Good afternoon, and welcome to ACADIA's first quarter 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 May 20, 2014. Joining me on the call today from ACADIA are Dr. Uli Hacksell, our Chief Executive Officer; Dr. Roger Mills, our Executive Vice President of Development and Chief Medical Officer; and Terry Moore, our Executive Vice President and Chief Commercial Officer. We will begin our call today with some introductory remarks and brief comments regarding our recently announced financial results. Following this we will provide you with an update on our development program and business, and we will then open the floor to your questions. Before we proceed I would first like to remind you that during our call today we will be making a number of forward-looking statements, including statements regarding our research and development programs and plans and our strategy including the timing, results or implications of clinical trials or CMC development; the benefits to be derived from, future approval of and the commercial potential for product candidates in each case, including pimavanserin, the timing, content or likelihood of regulatory meetings, filings or approvals, future development and commercialization of pimavanserin, the expansion of the pimavanserin franchise and its value; and our future expenses, cash position and usage and growth potential. These forward-looking statements are based on current information, assumptions 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 31, 2013, and other filings. 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. I'll now turn the call over to Uli Hacksell, our Chief Executive Officer.

Uli Hacksell

Management

Thank you, Lisa, and good afternoon. Let me first take this opportunity to thank all of you for joining us on today's conference call. The first quarter of 2014 was another decent productive period for ACADIA helping to set the stage for what we expect to be a very exciting year. Most importantly, we have continued to make outstanding progress in advancing our Phase III Parkison's Disease Psychosis or PDP program toward registration. With this progress I am delighted to report today that we remain on track for our planned submission of a new drug application or NDA near the end of this year. Currently, no drug is approved in the United States to treat the disease, a debilitating disorder that can have devastating effects on patients as well as their caregivers and families. Pimavanserin offers an innovative non-dopaminergic therapy and has the potential to be the first safe and effective medicine to treat PDP without compromising motor control. From currently with advancing towards our NDA submission we have recruited additional professionals to round out our core commercial team during the first quarter. This highly experienced team is busy progressing with the wide range of pre-commercial activities designed to position ACADIA for success in the planned PDP launch. Meanwhile, in parallel with completing our PDP program we are pursuing an aggressive life cycle management program to strategically broaden our pimavanserin franchise. Because of pimavanserin's selective mechanism of action and its efficacy and safety profile observed to date in elderly patients with PDP we believe that it also maybe ideally suited to address other major neurological and psychiatric disorders that are poorly served by currently available therapeutics. Our initial focus in our life cycle program is Alzheimer's disease psychosis or ADP where we are conducting the Phase II trial that we…

Roger G. Mills

Management

Thank you Uli and good afternoon. As Uli mentioned we’re off to a great start to what we expect we’ll be in another good year for ACADIA. Our team has remained focused on completing the remaining activities in our pimavanserin PDP development program that are needed for submission of our NDA. This includes aspects of the CMC development, including stability testing of pimavanserin registration batches and supportive studies, including customary drug-drug interaction studies. Once again I'm pleased to report that we remain on track for planned NDA submission at the end of 2014. Firstly we've made steady progress in our CMC program. You may recall that our three required registration batches of pimavanserin were successfully manufactured at the commercial launch scale, and registration stability testing on these drug product batches was initiated last October. During the first quarter we completed an assessment on the initial three months of stability data from these registration lots and importantly confirmed that these data are consistent with historical data observed with our clinical trial formulations. Registration batches use the same manufacturing suppliers and general processes as our clinical trial formulation, for which we have previously established long-term stability of pimavanserin covering a three year period. The initial three months stability data on our registration batches provides an important bridge between our regulatory and clinical formulations and increases our confidence in the performance and stability of our pimavanserin commercial scale batches. We are continuing to accumulate data in our registration stability program and expect to have six months stability data on our registration lots available this quarter. This program is designed to comply with ICH guidelines and meet the regulatory filing requirements for major markets worldwide. Secondly, we’ve also made substantial progress with supportive studies which include customary short duration drug-drug interaction or DDR studies.…

Uli Hacksell

Management

Thank you, Roger. We continue to be excited with the progress in our PDP program, which moves us closer to our ultimate goal of bringing innovative medicines like pimavanserin to market to improve the lives of patients with neurological and related central nervous system disorders. PDP represents what we believe is an ideal lead indication in our specialty market opportunity for pimavanserin. Our strategy is to commercialize pimavanserin for this indication in the U.S. by establishing a specialty sales force focused primarily on neurologists. During the first quarter our core commercial team continued to conduct pre-commercial activities in preparation for the planned future launch of pimavanserin in PDP. These ongoing efforts are designed to ensure that a robust commercialization process and optimal strategy are in place to position ACADIA for success in the planned U.S. market launch. As part of these efforts we conducted extensive market research with over 700 PDP treating physicians including a through review of the market landscape to provide us with a deep understanding of the PDP patient journey. Importantly this assessment of PDP patient journey has confirmed our prior insights into the market, highlighting the large unmet medical need and reinforcing our understanding that prescribers are in need of safe and effective alternatives to the off-label use of antipsychotics. PDP substantially contributes to the burden of Parkinson's disease. As a result patients frequently suffer from limitations in daily activities, strained relationships with family members and social isolation. PDP is also recognized as a key contributor to nursing home admissions. In addition to disturbing hallucinations and illusions our research indicates that over half of PDP patients also suffer from sleep disturbances, often including day time sedation. Caregivers also observed that the drug’s currently prescribed for psychosis exacerbated this problem often causing patients to sleep throughout the…

Operator

Operator

(Operator Instructions). Your first question comes from the line of Charles Duncan, Piper Jaffray. Please go ahead. Charles C. Duncan - Piper Jaffray & Company: Hi Uli, thanks for taking the question and thanks for the update today. My first question is on the European regulatory strategy. I appreciate that you've been meeting with member states, but I'm kind of wondering when they if you have like goals not date or timeframe but when do you think that you can provide additional clarity on steps forward for Europe?

Uli Hacksell

Management

Well we have guided that we expect to have that clarity by the end of this year. We have initiated the process as we have talked about publicly by meeting with the country representatives and learned about their views. We have the interactions with our European advisors which are top advisors in the regulatory area. And as we have said they expect to have a care path forward established near the end of this year. Charles C. Duncan - Piper Jaffray & Company: Okay, that's helpful. And then what is your perspective on Asia. We've never really talked about that, but it seems like there is an opportunity there as well.

Uli Hacksell

Management

Yeah, it's good question Charles. Obviously Asia is a very different thing. We have not yet approached Asian regulatory authorities. It something that we intend to do probably together with a partner. Asia is a scenario where we don't expect ACADIA to have to play a commercial role in particular not in Japan. So eventually you will see that we will seek help to both go through the regulatory process in patient count for in Japan and also to get out from the commercial side. But I can't say it's also that obviously in Japan in particular, we will need to conduct a briefing program and that's another reason why we think we would benefit from having a partner that helps us with that. Charles C. Duncan - Piper Jaffray & Company: Okay, and then finally my last question on Alzheimer's psychosis study, lots of information provided, but wondering how easy enrollment going in terms of patient the characterization of patients. Are you getting the kind of patients you thought you would do and any update in terms of number of patients if not number it just kind a timeline to that trial being fully enrolled. Thanks.

Roger G. Mills

Management

Hi Charles this is Roger. Just to as you probably know we don't give guidance on enrollment in clinical studies. However we are really pleased with the way the study is you've going. We purposely placed the study in a center of excellence, and a center that is well versed in doing nursing home studies and also getting the view from NPI NH. And as we've kind a following before is important that we were able to build in a number of the factors that we believe really help with the success of 020 PDP study. It's with the -- I'm happy to say is that in working with the team at Kings, it's very clear that they understand nature and the exact patients that we want in the study and they are performing the study to a high level as we fully expect that they will do. Charles C. Duncan - Piper Jaffray & Company: Okay. And with regard to that is it at all possible that could serve as a label expansion study or really just inform the next study on broader study.

Roger G. Mills

Management

I think what now the important thing is well, this is the first time we've explored attention to pimavanserin in Alzheimer's patients. And I think you need to run the study and get the data look at it and then decide next steps. Charles C. Duncan - Piper Jaffray & Company: Okay great. Thanks for the added color guys.

Operator

Operator

Thank you and your next question is from Thomas Wei, Jefferies. Please go ahead. Thomas Wei - Jefferies & Co. LLC: Thanks on the U.S. filing strategy. I just wanted to clarify I know you had said you were last time in the midst as meeting with the agency about your filing. Have you had the discussions with the FDA on how much stability data would be required and we know now that the definitive answer is 12 months of stability data or are you still waiting to clarify or finalize that point?

Uli Hacksell

Management

Yes we have -- Tom we have not yet had our NDA meetings with agencies we have scheduled them and have them later on this quarter and so we don’t have an answer for that question currently. Thomas Wei - Jefferies & Co. LLC: Okay that’s helpful and then I wanted to ask about the QT prolongation profile just to double check we all know from the -- paper you have disclosed 7.3 millisecond increase in the QT interval but I can’t remember what you have said about your thorough QT study and whether or not you can share with us the specific on data of what happened at both the therapeutic dose and the super therapeutic dose that you tested? Thanks very much.

Uli Hacksell

Management

I think we saw the QT signal what we saw in the 020 study we feel is very much in line with the drugs that are currently approved in the antipsychotic arena and certainly at the lower end of the QT signals in there. In terms of the QT study we did complete that, it was a group study and the study was done in healthy volunteers and the signal that we saw in patients was perfectly in line with what is expected from that study. So that really fits with the high predictability of the PK patients, with not a great deal of inter-patient or in intra-patient PK variability. In terms of the implications of it and our meeting with FDA last year all are there to including the QT data were in the briefing package that we sent to FDA in order for them to make an informed decision around our request to submit an NDA for PDP and they were very clear in their response that they were comfortable in moving forward with that NDA submission in the light of all the data, both the short term, the long term and importantly the volunteer studies that we’ve done including QT. Thomas Wei - Jefferies & Co. LLC: Can you share with us what the super therapeutic exposure was that you tested like what fold over the therapeutics dose does it represent?

Uli Hacksell

Management

So in terms of the actual dosage we explored 80 milligrams on the top end and as I say we in terms of the modeling the data that we saw in the PDP population which by the way is an elderly very fragile population was perfectly in line and we’ve not seen any concerns from QT in our programs. Thomas Wei - Jefferies & Co. LLC: Great thank you.

Operator

Operator

Thank you. And your next question comes from Alan Carr, Needham. Alan Carr - Needham & Company : Hi, thanks for taking my questions. Wondering if you could I guess specify exactly what the next step is in dealing with the EU process there and then also are you considering with respect to business any bringing something into the company and what’s the timing for bringing those early stage pre-clinical programs into the clinic? Thanks.

Uli Hacksell

Management

So let me start with the first part of your question Alan. So that was related to Europe and what we have said is that we currently are interacting with our European advisors to establish the next step and that we’re following, if we will follow that will lead to clarity later on this year. In accounts to other questions, so come back to the second part Alan Carr - Needham & Company : Yeah well in terms of -- so you’ll submit a protocol to the EMA after you meet with -- after your discussions with the advisors or…?

Uli Hacksell

Management

Well we have not yet decided exactly how we're going to proceed. So this is my process that we really want deal with very carefully in the best possible way. And so we will certainly over the rest of this year work through that process carefully. And the intention is to have that clarity on how can proceed in Europe over the end of this year. Alan Carr - Needham & Company : Okay fair enough. The other question was around business development potential for inbound

Uli Hacksell

Management

That's clearly something that we want to think about overtime. Obviously we think that in order to really keep our sales force busy we will need eventually something that will complement pimavanserin, that can be used with the same prescribers that prescribe pimavanserin daily. So this is something that we have started to try to look at. We are not in a rush to do anything because we are not on the market with pimavanserin yet. But obviously it becomes more and more interesting over time and long term it's a popular strategy to complement pimavanserin with additional assets. And the other -- let me count through the programs that we have in our portfolio. Obviously Allergan has the rights to the glaucoma and the common pain programs. So we don't consider to commercialize those programs. But when it comes to the early stage programs they are still not yet in for full development. So it will take quite some time before we think about commercializing those programs. So I think in terms of bringing other programs to help pimavanserin on the market we will need to access such assets by other means. Alan Carr - Needham & Company : One other question I have is around your plans for sleep. What sort of extra work would you need to do to in the label around improvements to sleep?

Uli Hacksell

Management

Roger, you want to take that?

Roger G. Mills

Management

Yes sure sleep will be run under a separate IND. The PDP and ADP are the same part of the psychosis position with FDA sleep is everything [inaudible]. And obviously as part of this process we will be interacting with that division to determine the part of sleep. But I think it feels the great we've seen really consistent benefits in these populations which confirm the improvements in sleep that we saw in our trial and much lower than in our healthy normal volunteer sleep study. And what's nice now is that we've seen a very clear consistent benefit study-to- study in terms of improvements in sleep in a population for which sleep disturbance is not simply an annoyance, It is something which can really need to clinical outcomes patients that are not good. So I think it is a pretty good recognition certainly from the physicians and the experts in the area and quite -- it really is I think we are little bit excited that we are going to explore that area. Alan Carr - Needham & Company : Is your thought at this point that any you would start with the population that with the some sort of disorder that also have sleep disturbance is that how are you approach to answering that question?

Roger G. Mills.

Analyst

I think we not outlined the design of the study. But it is fair to say in parent with Parkinson's disease and actually with Alzheimer's disease as well sleep disturbances are pretty common through the patient populations. In fact in the studies we've done on PDP, there were no entry criteria that were embedded in protocols to enroll patients for sleep disturbances. The entry criteria rolled around psychosis. So the study is in no way enriched for sleep disturbance. So very clearly there are large numbers of patients in those studies that did exhibit disturbances and hence we were able to share that benefit. So I think we would be really looking at one of these populations and that's likely going to be the PDP population. Alan Carr - Needham & Company : Okay. Thanks very much.

Operator

Operator

Thank you. (Operator Instructions). And your next question comes from the line of Jason Butler of JMP Securities.

Jason N. Butler - JMP Securities LLC

Analyst

Hi. Thanks for taking the question. Just wanted to follow up on the sleep disturbance work. So it makes sense that the drug might not have the same detrimental impact on sleep and wake that other instance like. But do you have any mechanistic rationale as to why there would actually be improvements in sleep and wake for example, is there any impact on circadian regulation?

Uli Hacksell

Management

Perhaps I can take that. It's well known that molecules for the mechanism of action that we have with pimavanserin agonist mechanism, but we have an impact on architecture in such a way that increase the time spent in deep sleep and that you will decrease the time spent in superficial sleep. You do not affect REM sleep or other sleep parameters, you do not increase or speedup the onset of sleep and they don't patients at all. So the only thing is that to reset the sleep architectures so that you sleep more like a baby and less like an older person who frequently tends to wake up at night. This can be seen both in animal experiments and in clinical trials.

Jason N. Butler - JMP Securities LLC

Analyst

Great. Thanks for the added color.

Uli Hacksell

Management

Yeah.

Operator

Operator

Thank you. Dr. Hacksell please proceed with closing remarks.

Uli Hacksell

Management

Well thanks again to everyone for joining us on today's call and for your continued support. We look forward to updating you in the future on our ongoing progress. Thank you.