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ACADIA Pharmaceuticals Inc. (ACAD)

Q3 2014 Earnings Call· Mon, Nov 10, 2014

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals’ Third Quarter 2014 Financial Results Conference Call. My name is Jacqueline, and I will be your coordinator for today. (Operator Instructions) I would now like to turn the presentation over to Ms. Lisa Barthelemy, Director of Investor Relations at ACADIA. Please proceed ma’am.

Lisa Barthelemy

Management

Thank you. Good afternoon and welcome to ACADIA’s third 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 November 24, 2014. Joining me on the call today from ACADIA are Dr. Uli Hacksell, our Chief Executive Officer; Steve Davis, our Executive Vice President, Chief Financial Officer and Chief Business 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 NUPLAZID development program and complete commercial activity and then we will then open the floor up 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, our commercialization plan and our strategy, including the timing, results or implications of clinical trials or manufacturing development, the benefits or advantages to be derived from, future approval of and the commercial potential for product candidates in each case including NUPLAZID, the timing, content or likelihood of regulatory meetings, filings or approvals, future development and launch commercialization of NUPLAZID, the expansion of pimavanserin into additional indication and our future expenses, cash position and usage and growth potential. During our call today, we may use words such as anticipate, believe, could, expect, intend, may, plan, potential, predict, project, should or the negative of those terms and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. 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 including a report on Form 10-Q filed earlier 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. 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. To start off, let me address our third quarter and recent highlights including what we mentioned in our press release today about the change in timing of our NDA submission of NUPLAZID. As you’re aware in our plan to submit the NUPLAZID NDA for Parkinson's disease Psychosis or PDP in the first quarter of 2015, we have previously planned to submit the NDA may the end of this year. The decision to move back the planned submission is based on additional time required to complete preparations needed to support the FDA’s review of NUPLAZID. The change in submission timing is not a result of any change to NUPLAZID’s clinical or safety profile nor it is the result of any interaction with or a quest for information from the FDA. We also reported today that we have successfully completed our drug-drug interaction program and our stability program for registration batches. This past quarter, we announced that the FDA granted breakthrough therapy designation for NUPLAZID. This was a major achievement for our team on the program, reinforcing the large unmet medical need for the treatment of PDP and underscoring the importance of the NUPLAZID program. Also in this quarter, we announced that the FDA has provisionally approved NUPLAZID as our grade name for pimavanserin. In addition to providing a therapy for PDP, we believe that pimavanserin has the potential to transform the treatment of psychosis in a wide range of other neurologic and psychiatric disorders that are fully served by existing and psychotic graphs. Alzheimer`s disease psychosis or ADP is another area with severe unmet medical needs. We continue to advance enrollment in our Phase 2 study of…

Stephen R. Davis

Management

Thank you very much, Uli. Let me start by saying that our financial results for the third quarter continue to track our operating plan and reflect the strategy that we previously describe. And that is to do two things that I think at probably pretty self-evident to everyone on this call that they are important. That is first to increase our R&D investment in order to aggressively advance and build value in our NUPLAZID pimavanserin franchise. And second, to invest in preparing the organization for U.S. launch of NUPLAZID. R&D expenses for the quarter increased to $17 million from $7.3 million for the comparable quarter of 2013. As noted in the release, this is due primarily to increase cost incurred in our development program for NUPLAZID. I should also note that R&D expenses for the just completed quarter include $1.4 million in stock-based compensation expense. G&A expenses increased to $8.1 million for the third quarter from $3.8 million for the comparable quarter of 2013, this reflects our continued investment in commercial preparations for the planned launch of NUPLAZID, and I will note here too the G&A expenses for the just completed quarter include $2.5 million in non-cash stock-based compensation expense. I’ll now turn to our cash position. I think as everyone on this call probably recalls, at March of this year, we completed an equity offering raising net proceeds of approximately $197 million. This significantly bolstered our financial position. Today, we continue to maintain a strong cash position, we ended the third quarter with $337.8 million in cash and investment securities. In future periods, we expect our cash used in operations to increase as we continue to advance our PDP program to an NDA, conduct commercial activities and execute on our pimavanserin life cycle management program and other indications. Importantly, we have a strong cash runway that we believe will enable us to expand and build additional value in our pimavanserin franchise and fund commercial activities. And these activities include pre-launch activities designed to optimize positioning for the plan PDP launch, as well as subsequent sales and marketing efforts through and beyond the projected timeframe of our market launch. We currently anticipate that under our current operating plan, our cash resources will be sufficient to fund our operations into at least the second half of 2016. With that I’ve concluded remarks regarding our financial results and I’ll turn the call over to Roger who will provide you with an update on our NUPLAZID development program.

Roger G. Mills

Management

Thank you, Steve, and good afternoon. Let me first start with an update of the NUPLAZID program for PDP. And then I will discuss additional studies in other areas of unmet medical need. As Uli mentioned, in the beginning of the call, we are planning to submit our NDA in the first quarter of 2015, in order to complete preparations needed to support the review of NUPLAZID. We are diligently completing these preparations. Importantly, we have made good progress in our advancing key areas of our NUPLAZID program toward registration. This includes completing our DDI program and completing our registration stability program. In parallel, we continue to conduct their ongoing Phase III PDP open-label safety extension trial, referred to the 015 Study, which is designed to continue until NUPLAZIN is commercially available. This study has allowed us to generate a large amount of valuable long-term safety data regarding the use of pimavanserin in patients with PDP. We have far exceeded the ICH guidelines for a quite one-year exposures with well over 250 patients have been treated for one year or longer. In fact, through our 015 study and the similar extension study tied to our earlier phase II trial, we have well over 100 patients who have been treated with pimavanserin for at least two years, and our longest single-patient exposure exceeds nine years. Our long-term safety data provides support for the potential of pimavanserin to offer significant advantages relative to current anti-psychotic frequently used off-label for the treatment of PDP. As you hear from early Uli, we would delighted by FDAs recent decision to grow breakthrough therapy designation for NUPLAZID for Parkinson's disease psychosis. As a way of background, the breakthrough therapy designation was created by FDA to expedite the development and review of drugs that are intended to…

Uli Hacksell

Management

Thank you, Terry. In summary, we are working diligently on moving the NUPLAZID program toward registration, preparing for submission of the NDA in the first quarter of 2015, followed by submission of the MAA in Europe, six to nine months thereafter. We continue to make important progress in building our commercial capabilities. And on the development side, we are actively pursuing a number of indications in which pimavanserin may represent a novel approach to treating certain disorders. We continue to make important additions to our team and are putting significant effort into hiring high quality and experienced leaders as we build out key areas of the organization to manage the plan launch and commercialization of NUPLAZID. Importantly, we are in a strong financial position to launch our lead drug candidate NUPLAZID for PDP and also to further explore other areas where pimavanserin can have profound impact in the treatment of other disorders. It is an exciting time to be at ACADIA. All of us here remain deeply driven by our collective goal in bringing forward new medicines like NUPLAZID to patients suffering from neurological and related CNS disorders. Operator, you may now proceed for the Q&A session.

Operator

Operator

(Operator Instructions) And your first question comes from the line of Alan Carr with Needham. Please proceed. Alan Carr – Needham & Company, LLC: Hi, thanks for taking my questions. A couple of them. One of them, do you see this – the NDA submission as something that is going to be earlier in the first quarter or later in the first quarter, and would you be able to compress the timeline between the NDA submission and the MAA submission? Then, also, does this shift have any impact on the commercial prep timing? Are you delaying any of the commercialization prep work? And then, I guess, a bigger picture. You have talked about spending your resources on lifecycle management for pimavanserin, but do you have any plans, any business development plans? Thanks.

Uli Hacksell

Management

So many questions, Alan. So let me start with NDA submission. Always we guide on is that we expect to submit in the first quarter of 2015. When it comes to timing for the submission of the MAA to Europe we have guided somewhere between six to nine months, we don’t want to guide any closer than that because we expect that it will take some time to really go through the translation of the submission to the FDA before we can submit the European application. The commercial preparation work is moving on as planned, and we, are, in fact, not delaying anything. We are ready for all kinds of scenarios, and we just want to make sure that everything really is done to ensure a successful commercial launch. You had a fourth or fifth question. I don’t remember which one that was? Terrence O. Moore I think it related to life cycle – life cycle management and business development.

Uli Hacksell

Management

Yes, life cycle, yes. Okay. So when it comes to business development, first of all, when it comes to pimavanserin or NUPLAZID itself, all we have said is that we obviously want to do it alone in the U.S. When it comes to potential partnerships ex-U.S., we may decide to partner pimavanserin ex-U.S., but we have not made such a decision now. Really what we are doing, which I think is the smart thing to do, is to build additional value in pimavanserin and before we make a decision. We may made very well make a decision to do it alone in Europe as well, but again, we will come back to that. When it comes to other aspects of PD such as potentially adding compounds that would supplement NUPLAZID on the market, what we have said is that we really take a close look at what is available out there, but we have no specific plans at the present. Alan Carr – Needham & Company, LLC: Great. Thanks very much.

Uli Hacksell

Management

Thanks.

Operator

Operator

And your next question comes from the line of Cory Kasimov with JPMorgan. Please proceed. Cory Kasimov – JPMorgan Chase & Co.: Hey guys, good afternoon, Thanks for taking the questions. The first one I have for you is regarding NDA timing. And this is something that has been in the works with a similar timeline on it for quite a while now. So I guess I'm trying to get a little bit of a better understanding of why do you need this extra time at this point, even though it's still a relatively short amount of time. Are there additional analyses that you decided to do after meeting with the FDA or as part of the submission you sent them to get the breakthrough designation?

Uli Hacksell

Management

No. So what we really can say is that the timing change is related to the fact that we have the decent preparations that are required to support the FDA's review of NUPLAZID, and that is not really related to any kind of major hurdles. We have completed the drug-drug interaction program. We have stability as required in our registration program. We have not any kind of interactions with the FDA that pushes this. It’s just that we need some more time to complete the preparations. It is just a timing issue nothing else. Cory Kasimov – JPMorgan Chase & Co.: Okay. Fair enough. And then I had one follow-up question for you regarding the market research, and I appreciate you providing all the details this afternoon on that. Just curious if you’ve done or begun to or really started doing a similar type of exercise as with regards to Europe and curious how you believe that may compare with the US? Terrence O. Moore Hi, Cory, this is Terry. We do have a plan in place for our market research in Europe where we have got things in place to move forward with that. It’s really too early to tell how that is going to compare until we have the research in. Cory Kasimov – JPMorgan Chase & Co.: Okay. Thanks guys. Terrence O. Moore Thank you.

Operator

Operator

(Operator Instructions) And your next question comes from the line of Charles Duncan with Piper Jaffray. Please proceed. Charles C. Duncan – Piper Jaffray & Co.: Hi, guys. Thanks for taking my question, and I guess I need to ask a similar question. It doesn't appear to be a big deal in the grand scheme of things, but I am wondering if the timing with regard to the NDA is related to any new observation with regard to that drug-drug interaction study or the stability work that you have been doing, or is this simply a Gantt chart thing where you are preparing the submission for making the submission?

Roger G. Mills

Management

Hi, Charles, this is Roger. So I think you probably hit it on the last bit there. With regard to the data, we’ve got no data that would suggest, we’ve develop any problem with clinical data with the drug product. All those things have gone according to plan, not just drug the drug interaction, but the sterility program all have gone pretty smoothly. Importantly, looking at the safety profile the drug it really continues to be very consistent with everything we seen in the past. And obviously, with the basis of that was really the submission that we made to FDA, and there is nothing change in terms of the risk benefit of the drug.

Uli Hacksell

Management

So I think you expressed it pretty well. It’s just a matter of timing. You can call it again shortly its up to your wish. Charles C. Duncan – Piper Jaffray & Co.: Okay. Good deal. That's helpful. Thank you. Then with regard to the ADP progress, I doubt you will tell us exactly where you're at in terms of enrollment, but could you let us know when you think that will be completed? And then when you look at ADP, the psychosis component versus some of the other things you are studying such as the Alzheimer's education component, what do you think is the most important thing to be looking at within that study?

Stephen R. Davis

Management

So let me start simply by saying that what we have guided is that the study will take about two years. And that we started the study late last year. Uli, you can take the second part of the question?

Uli Hacksell

Management

Right, in terms of the outcome to study, this study is designed for Alzheimer's psychosis, and that will remain the primary focus of the study and how you should view the data coming out. And that’s inline with the definition of the condition and what has been agreed with the FDA. However, pimavanserin interesting drug and the potential that it has may well impact other aspects of patients’ lives with the late stage Alzheimer’s disease in the broader aspects of the behavioral disturbances. This is a Phase II study and I think it would be – one it would be a shame, and two it would be an injustice to the drug not to consider that there may well be other benefits that are given to patients using to pimavanserin during this condition. And also, it will help us in terms of looking at what the next steps off following the data from the study. It may well be that it either helps us refine populations or in flat, we could potentially look at the other indications within the spectrum of the behavioral disturbance. Charles C. Duncan – Piper Jaffray & Co.: Last question is regarding formulation work and possibly lifecycle management. Have you looked at the drug within different formulations in which you might be able to give the drug over time or for a longer-term dosage formulation such as a DEPO?

Uli Hacksell

Management

Hi, it’s very interesting question. Now we already have it a long-duration of the compound. So in fact, even if a patient doesn’t takes the drug one day, the plasma level will be about the same when he or she has reached the plasma equilibrium. The molecule itself doesn’t lean itself to be coupled to a long chain fatty ester. So it cannot do what companies tend to do with their antipsychotic drugs here what we could do potentially, and we still haven’t developed the full lifecycle management plan for pimavanserin yet is to obtain other kinds of long-duration preparations of pimavanserin. I think there are other things that we’re considering, and we would certainly provide more information on that overtime. Charles Duncan – Piper Jaffray & Co.: Thanks, Uli. Thanks, Rodger, for the added information.

Operator

Operator

Ladies and gentlemen, with no further questions, I would like to ask Dr. Hacksell to proceed with closing remarks.

Uli Hacksell

Management

Right. So, 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.