ACADIA Pharmaceuticals Inc (ACAD) 2007 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

  • Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals second quarter 2007 financial results conference call. My name is Shaun, and I'll be your coordinator on today's call. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session toward the end of today's call. (OPERATOR INSTRUCTIONS) I would now like to turn the presentation over to your host, Mr. Tom Aasen, the Chief Financial Officer of Acadia Pharmaceuticals who will review the Company's forward-looking statements.

  • - CFO

  • Thank you. Good afternoon, and welcome to Acadia Pharmaceuticals second quarter 2007 financial results conference call. This call is being recorded and an archived copy will be available at our website at www.acadia-PHARM.com through August 20.

  • 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 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 31, 2006, and subsequent 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 Dr. Uli Hacksell, our Chief Executive Officer.

  • - CEO

  • Thank you, Tom. And let me take this opportunity to thank all of you for joining us on today's conference call. Also joining us on the call today is Dr. Roger Mills, our Executive Vice President of Development. I will begin the call by covering some of our recent highlights. I will then ask Tom to review our financial results for the second quarter and following these remarks we will briefly review our clinical programs. We will then open the floor to your questions.

  • This is a very busy and exciting time for all of us at Acadia. During the second quarter of 2007, we achieved several important milestones and continued to gain momentum in our development programs and business. During the quarter Acadia fully transitioned to a Phase III stage company with the initiation of our first pivotal PhPhase IIIrial with pimavanserin for Parkinson's disease psychosis. At the same time, we also started a Phase IIB trial in our program with ACP-104 as a stand-alone treatment for Schizophrenia. Meanwhile, we achieved another important objective by completing the full analysis of the data from our Phase II Schizophrenia co-therapy trial with pimavanserin.

  • This further confirmed the robustness of the topline results reported in March, which showed the compelling benefits of co-therapy with pimavanserin when combined with a submaximal dose of Risperidone. The full analysis has increased our excitement regarding the medical and commercial potential for pimavanserin. We believe that these recent clinical milestones coupled with the strengthening on our balance sheet through the successful completion of our public offering positions Acadia well to continue to aggressively advance our pipeline and execute on our business strategy. Before we review our clinical programs and our upcoming milestones in more detail, I will ask Tom to discuss our recent financial results.

  • - CFO

  • Thank you, Uli. I'll provide you with a brief overview of our second quarter financial results, which were reported in our press release and Form 10-Q issued earlier today. Once again I'm pleased to report that our financial results for the quarter were in-line with our expectations. We reported a net loss of $10.8 million or $0.29 per common share for the second quarter of 2007 compared to a net loss of $11.9 million or $0.43 per common share for the second quarter of 2006. Our cash and investment securities totaled $153.9 million at June 30, 2007, compared to $83.3 million at December 31, 2006.

  • Let's briefly look at some of the components of our second quarter results. Our revenues totaled $2.1 million for the second quarter and were once again comprised of revenues from our collaborations with Sepracor and Allergan, as well as our agreements with the Stanley Medical Research Institute and other parties. This compared to revenues of $1.9 million for the second quarter of 2006.

  • Research and development expenses totaled $11.5 million for the second quarter of 2007, including $705,000 in stock-based compensation compared do $11.4 million for the second quarter of 2006, including $315,000 in stock-based compensation. Increased personnel and other costs associated with the expansion of our development organization and additional stock compensation charges were largely offset by lower fees paid to external service providers. External service costs decreased to $4.1 million during the second quarter of 2007 from $5 million for the second quarter of 2006, primarily due to lower external costs associated with pimavanserin following the completion of our Phase II schizophrenia co-therapy trial. We anticipate that our external costs will increase during the second half of 2007, following the initiation in June of the pivotal trial in our Phase III program with pimavanserin for PDP and the Phase IIB trial in our program with ACP-104 for Schizophrenia.

  • General and administrative expenses totaled $3.2 million for the second quarter of 2007 compared to $3.1 million for the second quarter of 2006, as increased costs associated with expansion of our administrative infrastructure were largely offset by lower professional fees.

  • Finally, let me update you on our cash position and outlook. As previously mentioned, we closed the second quarter with a total of $153.9 million in cash and investment securities, reflecting the proceeds from our public offering, which closed in April. With this financing, we have established a strong cash position and we believe that we are well positioned to continue to advance our proprietary clinical pipeline and explore strategic alliances in our Schizophrenia Co-therapy program. As it relates to guidance, we continue to expect that our cash and investment securities will be greater than $120 million at December 31, 2007, and that our existing cash resources, including the expected payments from our collaborators, will be sufficient to fund our operations through 2009. I'll now turn the call back over to Uli.

  • - CEO

  • Thank you, Tom. Let me now review our program 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. In March 2007, we reported positive topline results from a Phase II trial in a second program with pimavanserin, as a co-therapy for Schizophrenia. We also have two proprietary Phase II stage clinical programs, including ACP-104 for the treatment of Schizophrenia, and pimavanserin for the treatment of sleep maintenance insomnia. We have retained worldwide commercialization rights for all four of these programs. In addition, we have a neuropathic pain program in Phase II clinical trials in collaboration with Allergan.

  • My remarks today will mostly focus on our Phase III Parkinson's Disease Psychosis program and our two clinical programs in schizophrenia. Let me start by discussing our program with pimavanserin for the treatment of Parkinson's Disease Psychosis, or PDP. PDP is the debilitating neuropsychiatric disease that occurs in up to 40% of patients with Parkinson's disease.

  • There currently is no drug approved in the U.S. for the treatment of PDP. This is a serious condition characterized by disturbing hallucinations and delusions and normally places a heavy burden on caregivers. In fact, PDP is the most common factor leading to nursing home placements of patients with Parkinson's disease. We were very excited to initiate the first of two planned pivotal Phase III efficacy trials in June in our program with pimavanserin for the treatment of PDP. This was a major milestone for Acadia and reflects the continuing maturity of both our clinical pipeline and our development organization.

  • Let me now take a moment to review the design and key objectives of this study. This Phase III trial is a multicenter, double blind placebo-controlled study that is designed to evaluate the safety and efficacy of pimavanserin in approximately 214 patients with PDP. Patients in the study are randomized to three different study arms, including two different doses of pimavanserin, 10 and 40 milligrams, and one placebo arm. Patients receive oral doses of pimavanserin or placebo once daily for six weeks in addition to stable doses of their existing dopamine replacement therapy.

  • The primary end point of the trial is efficacy as measured using the scale for the assessment of positive symptoms, or SAPS. Psychosis associated with Parkinson's disease is manifested mainly by positive symptoms, specifically hallucinations and delusions. The SAPS is the widely accepted tool to measure positive symptoms and was considered the preferred scale to measure the psychosis in Parkinson's Disease.

  • (Inaudible) tolerability is another important end point. It's the secondary end point in the trial and it's measured using the Unified Parkinson's Disease Rating Scale, or UPDRS. We finalized the design of this pivotal trial following a productive end of Phase II meeting that we held with the FDA the fall of last year. Our development team finalized all preparations in June to initiate enrollment in the first of two planned pivotal Phase III trials. We anticipate enrolling patients in this trial over time a top [215] clinical site, located both in the United States and Europe.

  • We currently plan to round the two pivotal trials in a staggered fashion. Our PDP development team is dedicating its resources to getting this first trial fully up and running and we then plan to initiate the second Phase III pivotal trial. By doing so we expect to enhance our execution while also seeking to compress the overall development time frame.

  • We are offering patients who complete the Phase III pivotal trials the opportunity to enroll in an open label safety extension study as a way to provide continued treatment options to these patients. This open label study will also support our safety requirements. We remain very excited about our PDP program and the potential for pimavanserin to be the first in class treatment for this debilitating disease. We believe that pimavanserin will clearly differentiate itself from off label use advanced psychotics by effectively treating the psychosis in patients with Parkinson's disease without impairing motor functions or adding further side effects.

  • Let me now turn to our clinical program with pimavanserin as a co-therapy for Schizophrenia. Despite the commercial success of achieving antipsychotics, which exceed $15 billion in worldwide sales, current drugs used to treat Schizophrenia have substantial limitations, including severe side effects and inadequate efficacy. We believe that co-therapy with pimavanserin combined with a submaximal dose of atypical antipsychotics can significantly improve the way schizophrenia is treated today.

  • Following our announcement in March of positive topline results from our Phase II Schizophrenia co-therapy trial, we have been very busy conducting the full analysis of the data from the trial and planning for additional development activities as we advance our Phase III pimavanserin program in PDP. I'm very pleased to report that we completed the full analysis of the data from this trial as planned. This analysis further confirms the robustness of the topline trial results, which demonstrate its several key advantages of co-therapy with pimavanserin when combined with a submaximal dose of Risperidone. These advantages included enhanced efficacy, the faster onset of antipsychotic action, and an improved side effect profile. The full analysis has also provided additional data in support of the benefits of pimavanserin co-therapy and has served to further increase our excitement over the medical and commercial potential of pimavanserin.

  • We look forward to presenting data from the trial at a suitable medical meeting during the second half of 2007. We have been exploring potential conference venues and we plan to announce the specific venue after we have secured a presentation slot.

  • In the period since our announcement of the topline results, we have been very pleased to see the overwhelmingly positive and enthusiastic reaction from both the medical and pharmaceutical communities. We believe that we are now well positioned to explore potential strategic alliances to optimize the commercial opportunity for pimavanserin co-therapy in Schizophrenia.

  • As indicated earlier, following the completion of our full data analysis, we have initiated our process to explore potential strategic analyses -- sorry, potential strategic alliances beginning this summer. We see significant value in our pimavanserin assets and we are very pleased with the strong level of interest that we have already seen from potential partners to evaluate this opportunity. We intend to thoroughly explore our commercial opportunities with pimavanserin. Our focus is to ensure that in the alliances -- any alliance captures the proper commercial value of Acadia with strong involvement and incentives for both parties. As we conduct this careful assessment, you can appreciate that we don't intend to comment or provide specific details regarding our reporting process or the potential timing.

  • Meanwhile, importantly, we are continuing to take pimavanserin forward in Phase III development through our PDP program and planning for potential studies in other programs. We believe that many of the studies in our PhPhase IIIDP program may be leveraged to benefit the development in other programs with pimavanserin. We continue to believe that pimavanserin has the potential to change the way schizophrenia and related disorders are treated today by providing a therapy with enhanced antipsychotic efficacy combined with an improved side effect profile.

  • Let me now turn to our second schizophrenia program, which is ACP-104, as a stand-alone treatment for schizophrenia. ACP-104's unique pharmacological profile combining 10-1 (inaudible), reverse agonist, and D2 and D3 partial agonist provides the potential for a superior atypical and psychotic efficacy profile with enhanced cognition. Current treatments are generally not effective in addressing negative symptoms and are also not effective or may in fact worsen cognitive disturbances associated with Schizophrenia. In late June we delivered another important milestone with the initiation of our Phase IIb trial in this program. Let me now briefly review the design and objectives of this trial.

  • The Phase IIb trial is a multicenter, double blind placebo-controlled study designed to evaluate the safety and efficacy of ACP-104 in approximately 250 patients with Schizophrenia who are experiencing [subacute] psychotic episodes. Patients in this trial are randomized to three different study arms, which include two different doses of ACP-104 administered twice daily, 100 milligrams and 200 milligrams, and one placebo arm. The dose selection was based on the analysis of the three initial clinical studies conducted with ACP-104 in patients with Schizophrenia. The primary end point of the trial is antipsychotic efficacy as measured using the Positive And Negative Syndrome Scale, PANSS. An industry standard rating scale commonly used in registration Schizophrenia trials.

  • We are very excited at the potential for ACP-104 and Roger and his team have done an excellent job of finalizing all the preparations to get this important trial initiated on time. In addition to the significant progress that we have made in these advanced clinical programs, we have continued to move forward our earlier stage pipeline consisting of both internal program, as well as our collaborative programs. We recently announced the advancement of our muscarinic agonist that we discovered and are developing in one of our collaborations with Allergan that is focused on novel treatments for glaucoma. We are very pleased that Allergan is moving this program into man with the initiation of a explorative clinical study. We are proud of our long-standing and highly productive alliance with Allergan, which also includes some exciting Phase II program in the area of neuropathic pain.

  • In closing, I would like to thank our dedicated employees who have continued Acadia's strong track record of delivering on its milestones. With the recent initiation of two key clinical trials, the completion of our analysis of the Phase II data for pimavanserin and Schizophrenia, and the strengthening of our financial position through our public offering, I believe that Acadia is well positioned to continue this momentum and play a leadership in providing next generation therapy for patients that suffer from neuropsychiatric diseases and other TNS disorders. That completes our update, and we'll now be happy to entertain any questions that you may have.

  • Operator

  • (OPERATOR INSTRUCTIONS) Your first question comes from the line of Ed Tenthoff with Piper Jaffray. Please proceed.

  • - Analyst

  • Thank you very much for taking the call and congratulations on all the success so far this year. We're definitely looking forward to a busy back half. To that point, I know you started to go into some detail on the potential for partnering 103, but could you just give us a little bit more color on what your primary goals are there, what you're looking for? I'm sure there are a lot of different types of deals that could be considered, but just maybe walk us through a little bit more color on that.

  • - CEO

  • Thank you, Ed. What we can say is that we clearly intend to thoroughly explore the commercial opportunities with pimavanserin and focus on the right alliance structure that will have a strong involvement and incentives for both parties. In a general sense, we are interested in a potential alliance that could help us to complete the comprehensive Phase III program and that really can help us optimize the marketing around the commercial opportunity for pimavanserin. Our strategy is to retain rights to participate in commercialization in areas such as Parkinson's Disease Psychosis in North America, but we think that we can do well with a limited size sales force. While we don't want to get into further details now, our focus is to ensure that any deal is the right commercial deal for Acadia.

  • - Analyst

  • Okay, great. That's helpful. Thank you.

  • Operator

  • Your next question comes from the line of Charles Duncan with JMP Securities. Please proceed.

  • - Analyst

  • Hi, guys. Sorry for the background noise. I'm in an airport. Wanted to ask you about the design of the second PDP trial. If you can provide us a little bit more color on the size of the that you envision as well as the timing for that?

  • - CEO

  • Hi, Charles. I will ask Roger Mills to answer that question.

  • - EVP, Development

  • Thanks, Uli. Hi, Charles. The design of the second study will be very similar to the first. So these will be two matching Phase III pivotal studies. So it will be the same number of patients and will be very, very similar study.

  • - Analyst

  • And then a second question is, in terms of the full analysis for the Schizophrenia data, any new takeaways -- thank you for reminding us of what you guys had learned -- but any new takeaways that you would like to highlight here for us or perhaps brightline?

  • - CEO

  • Well, Charles, I think the key take-home is first of all, that we confirmed the key results from the topline analysis. Second, that the full analysis made us even more excited about the program, because we got additional indications of the advantageous side effect profile. And we will again present those results later on this year.

  • - Analyst

  • Okay. I'm looking forward to those. And then a final thing. Data in ACP-104 for the Phase IIb, when do you anticipate being able to present that? Sorry if I missed that.

  • - EVP, Development

  • Yes, I'll take this one, Charles. We obviously look at the size of the study and then what the situation is like in the investigational community right now. So we'd really be looking at running that study within a pretty standard time frame. You could think somewhere between 12 to 18 months.

  • - Analyst

  • Okay. Thanks, guys, for the added color and let me add my congratulations.

  • - CEO

  • Thank you.

  • Operator

  • Your next question comes from the line of William Ho with Banc of America Securities. Please proceed.

  • - Analyst

  • Hi, guys. Thanks for taking my call. A few questions. First of all, with respect to pimavanserin and PDP, can you go over a little bit of the powering assumptions on the SAPS end point? If I recall correctly in the Phase II, you had 60 patients and they demonstrated a 27% difference between the placebo and the drug cohorts. What were the powering assumptions used in this particular design?

  • - CEO

  • Roger, will you take that?

  • - EVP, Development

  • Yes, sure. So I think the -- in terms of the -- what we're looking for in the Phase III would be very similar to the difference that we saw in the Phase II. We have two doses here with the 10 and 40 milligrams and a placebo arm, and we believe that by enrolling about 80 patients per arm, we should see a meaningful margin.

  • - Analyst

  • Do you have any particular hurdle in terms of the difference between, I guess between the ACP and placebo that you're shooting for. Do we have to see a 20% difference or 30% in order to get a P value of what, are we at 0.05 or 0.01?

  • - EVP, Development

  • We haven't stated exactly what we're aiming to achieve there, but I think you can look at the Phase II and look that we would be aiming to achieve similar responses.

  • - CEO

  • Let me just add that in the first Phase II study that we conducted with pimavanserin, in Parkinson's disease patients with psychosis the primary end point was motoric tolerability. So we used the SAPS scale as a secondary end point, knowing that the study wasn't necessarily powered to show any significant activity there. With the current large study, where we have 80 rather than 30 patients per arm, we expect to get very different results.

  • - EVP, Development

  • So the efficacy is a primary end point in this study with motoric control being a second end point.

  • - Analyst

  • I hope you get that endpoint. Also, can you just speak with respect to the Schizophrenia? I recall in the past you had mentioned that you were doing some work on the patents, where are you with that?

  • - CEO

  • We have an extremely strong patent situation with pimavanserin and related molecules. What we have said is that we are continuously expanding the IP assets or portfolio around pimavanserin. So what we currently have is a patent that provides such with a compositional (inaudible) patent to person 21. But then we have the non(inaudible) additional patents and patent applications that provides us with an even stronger IP around the drug, around use of the drug in combinations, formulations, some production pattern, et cetera, et cetera, et cetera. So we're working this just as a big Pharma company would do it.

  • - Analyst

  • Would this potentially protect you because Lily, If I recall, does have a 50228 inverse agonist in their pipeline.

  • - CEO

  • They have a pipeline called provanserin as far as I know. A 50228 compound which they are developing for sleep. I don't know if they -- I have no knowledge about them moving that compound forward in Schizophrenia. When it comes to our IP around combinations of pimavanserin and other drugs, we have a strong situation where we claim combinations of pimavanserin with others -- with different kinds of antipsychotic drugs, in fact, some of them that were on the market. We also have general claims for combinations between 50228 compounds and antipsychotic drugs.

  • - Analyst

  • Great. Just finally, are you full-fledged you can go out there and actively -- very actively go out and shop this around, or is there anything preventing you from seeking a partnership now or that you're still working on?

  • - CEO

  • I think this is a -- we're moving forward consistently with what we have said earlier on. Following the completion of the full analysis of the study, we are very excited about moving forward and we have initiated our process to explore potential strategic alliances. What we will do here is that we will come back when we have something real. Until then, we will not comment further on details regarding the process or the discussions or the timing. What we can say is we have initiated the process now.

  • - Analyst

  • Great. Congratulations.

  • - CEO

  • Thank you.

  • Operator

  • Your next question comes from the line of Mike King with Rodman & Renshaw. Please proceed.

  • - Analyst

  • Thanks for taking my question. I just had a couple of line items. First wanted to ask Tom about spending. I guess just timing-wise, just the way clinical trials ebb and flow accounts for a relatively flat spend on the R&D line. I know you expect more -- greater spending in the second half, but I wonder if you wouldn't mind giving us perhaps a total expected spend for R&D by the end of the year?

  • - CFO

  • Yes. Thanks, Mike. We have not provided specifics in terms of the magnitude, but you're absolutely right. The expenditures and the payments do fluctuate from period to period and the timing of the payments and expenses on the trials are a major factor. What we can -- what I can only guide you to is we do expect, as we mentioned that the expenses, when you look at the second half relative to the first will be higher. And then within the framework of the overall guidance we've provided, so we're very comfortable in saying, as we have before, that we expect to have more than 120 million past the end of the year.

  • - Analyst

  • Okay. So that's the only financial guidance you want to give at this time? Right. You would expect -- you can look into the rest of the line items, it's pretty straight forward. Okay. Then can we -- I know you mentioned 103 and sleep maintenance insomnia, but can we get an update on the progression of clinical trials in that indication?

  • - CEO

  • Well, Mike, what we have decided to do with the sleep maintenance indication for pimavanserin is to take a step back, reevaluate the clinical program there considering the very exciting findings that we have in our other two pimavanserin programs in Schizophrenia and in Parkinson's Disease Psychosis. The reason for that is that we want to make sure that we do the right thing here. We don't want to do things in sleep maintenance that isn't inconsistent with what we are doing in the other two indications. So really come back when we have completed that re-evaluation of the sleep maintenance indication.

  • - Analyst

  • Okay. Would it be possible to look at that end point in a population of Schizophrenic patients? Is insomnia secondary to the underlying disease?

  • - CEO

  • I think you are saying something that we are certainly thinking about internally. There are many different kinds of indications that have sleep disturbances that include schizophrenics, it includes Parkinson's patients, it includes depressed patients. Those are three of the things that we are currently considering.

  • - Analyst

  • I see. Any idea when we might have an update on the plan there?

  • - CEO

  • We don't want to provide guidance on that today.

  • - Analyst

  • Okay. Finally, I was wondering if you might discuss the Phase II trial for ACP-104. In terms of acute psychotic episodes, the challenges of getting patients to take their oral medication twice daily, is there anything that you want to say about how you can structure the trial or enroll certain centers that are expert at administering drugs to acutely psychotic patients?

  • - EVP, Development

  • Those are (inaudible) that we are including in the program and we are confident that we will be able to perform a good acute Schizophrenia study with the drug.

  • - Analyst

  • Thanks. I'll step back in queue.

  • - CEO

  • Thanks.

  • Operator

  • Your next question comes from the line of Patrick Moriarty with Fortis. Please proceed.

  • - Analyst

  • Hi, good afternoon. Thanks for taking my question. I just wanted to maybe get a little bit more color on the pimavanserin co-therapy results now that they're analyzed, but specifically the faster onset of efficacy. Was that seen in all symptom areas, including the positive, negative, and cognitive domains?

  • - CEO

  • Hi, Patrick. I'll let Roger take that question.

  • - Analyst

  • Thanks.

  • - EVP, Development

  • We're not providing breakdown further than we've outlined today, but we saw a very good clear response across both positive and negative symptoms in the results that we have previously outlined.

  • - Analyst

  • Right. Okay, thanks.

  • Operator

  • Your next question comes from the line of Mark Monane with Needham and Company.

  • - Analyst

  • Hi, its Alan Carr for Mark. Good afternoon, everyone.

  • - CEO

  • Good afternoon.

  • - Analyst

  • I want to get a little more information on the pimavanserin trial and Parkinson's disease with respect to time line. How long do you think it will take to get enrollment wrapped up and get started with the second trial? Is that something that's going to happen by the end of the year?

  • - EVP, Development

  • I'll take this one, Uli. So we just got both the Parkinson's and the 104 study up and running in June, so we're not currently providing specific guidance for either study at this time. However, as I just said, looking at the 104 study, we'd expect that to be round about, total 12 to 18 months in terms of completion. For PDP is small the size of patient population relative to the number of Schizophrenics out there. Furthermore, this is a pivotal trial whereas the 104 isn't. So we would anticipate it will take a degree longer to conduct and report this trial. But as we progress through the studies, we'll be providing more information relative to this.

  • - Analyst

  • The PDP will take a little longer than the Schizophrenia, is that what you said?

  • - EVP, Development

  • Yes. Smaller population the Schizophrenia is a much larger population.

  • - Analyst

  • Okay, sure.

  • - CEO

  • So when it comes to the other aspect of your question, when we expect to start the second pivotal study, we have said that we will start it in a staggered fashion and that we will do that from the first the study is up and running full speed.

  • - Analyst

  • When you finish enrollment, is that when you said before?

  • - EVP, Development

  • No.

  • - Analyst

  • No, not when you finish enrollment on the first one, oh, just--?

  • - EVP, Development

  • The two studies will be parallel studies, just a staggered start.

  • - Analyst

  • Okay, okay. And how about the earlier stage pipelines? Can we expect any movement from -- any movement from them from the preclinical stage to the clinical stage?

  • - CEO

  • We haven't provided any specific guidance on when we will move these earlier programs into the cleaning. What we just reported was that Allergan is going to start a clinical exploratory study with the muscarinic program that we have together with them. We also have two preclinical programs, ACP-105 and ACP-106. We haven't provided guidance when these will move into clinical trials, but I can say is that we are moving them forward and that we are also continuing with the earlier stage discovery efforts in several different areas.

  • - Analyst

  • Okay. Well, thanks very much and congratulations on a good quarter.

  • - CEO

  • Thank you.

  • Operator

  • Your next question comes from the line of David Amsellem with Friedman Billings Ramsey. Please proceed.

  • - Analyst

  • Thanks for taking my question. Talking about your cash guidance, I wanted to get a little more color on the assumptions underlying your cash burn guidance and does that contemplate you conducting a Phase III study for 104 on your own or a Phase III in Schizophrenia for pimavanserin on your own or additional studies in sleep maintenance insomnia. Just give us a sense of what additional large scale studies your assumptions might entail?

  • - CFO

  • Sure, we'll be happy to provide a little color. What we've said consistently is that with respect to our immediate plans, we're moving forward aggressively in Parkinson's Disease Psychosis, so it has a full scale Phase III program there and as Uli mentioned earlier, many of those enabling and safety studies do leverage into the other development programs with pimavanserin. The particular guidance that we've put forth in terms of our cash position and outlook does not include the impact of a major Phase III program in schizophrenia, because our strategy, again, has been consistently to explore potential alliances and to conduct such a program in conjunction with a partner. I will say that also the flip side there does not include any potential cash infusion from such an alliance. So we have not factored in one in either direction.

  • - Analyst

  • Okay, that's helpful. Thank you.

  • - CFO

  • Thanks.

  • Operator

  • Your next question comes from the line of Ajim Tamboli with Lehman Brothers. Please proceed.

  • - Analyst

  • Hi, guys. With the completed analysis for the Phase II data for pimavanserin and schizophrenia, will we hear from you when that data has been accepted for presentation at a conference and then what are the most likely venues that you're targeting for that presentation? Finally, are you able to at this time, now that it's completed, share that data in confidentiality and partnership discussions? Thanks.

  • - EVP, Development

  • This is Roger. We've obviously completed the data now and we will submit to present at a meeting and when we gain acceptance in that meeting, we'll notify where it is and which meeting. Second part of the question was regarding the--?

  • - CEO

  • Yes. We should be clearly able to use the full analysis data in confidential discussions with potential partners. That's the impact, the reason why we wanted to complete the full analysis before we moved into the exploration of potential partnerships?

  • - Analyst

  • And then just in terms of the venues in the second half of the year, which ones should we be marking on our calendars?

  • - CEO

  • I think just to give you one example, it could be the [ECMP] meeting, for example.

  • - Analyst

  • Thanks.

  • - CEO

  • Sure.

  • Operator

  • You have a follow-up question from the line of Mike King with Rodman & Renshaw. Please proceed.

  • - Analyst

  • Thank you for taking the follow-up questions. Further to Alan Carr's question about early stage pipeline, Uli, can we get -- or Roger -- an update on the Sepracor muscarinic program any advancements there expected in '07?

  • - CEO

  • I can give you a very brief update on that. What we are doing there is that we are exploring our specific muscarinic agonist for both neuropsychiatric and pain conditions. We have made a lot of progress in the Sepracor collaboration. I think it has and is a very interesting collaboration where we pull from the strengths of both Sepracor and Acadia. We are excited about the progress and we have not announced any kind of nomination of a clinical candidate yet, but time will tell when we get there. What I can say is we have made lots of progress in the collaboration.

  • - Analyst

  • Okay. When will we see further tangible evidence of that?

  • - CEO

  • I will not provide guidance about that today.

  • - Analyst

  • Okay. Thank you.

  • - CEO

  • Sure.

  • Operator

  • You have no other questions at this time. This concludes our Q&A session. I would now like to turn it back over to -- I'm sorry, Dr. Uli Hacksell. Please proceed.

  • - CEO

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

  • Operator

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