ACADIA Pharmaceuticals Inc (ACAD) 2012 Q3 法說會逐字稿

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  • Operator

  • Good day, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals' third-quarter 2012 financial results conference call. My name is Keith and I will be your operator for today. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer towards the end of today's call. (Operator Instructions)

  • And I would now like to turn the presentation over to Tom Aasen, Executive Vice President and Chief Financial Officer at ACADIA. Please proceed.

  • Tom Aasen - EVP, CFO and Chief Business Officer

  • Thank you. Good afternoon and welcome to ACADIA's third-quarter 2012 conference call. This call is being recorded, and an archived copy will be available on our website at ACADIA-pharm.com through November 19th.

  • Joining me on the call today from ACADIA are Dr. Uli Hacksell, our Chief Executive Officer; and Dr. Roger Mills, our Executive Vice President of Development. We will begin the call today with some introductory remarks by Uli, and I will briefly comment on our third-quarter financial results. After this, Roger and Uli will provide you with an update on our development programs, 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 and our partners' research and development programs and plans, including the timing, design, and results of clinical trials; the benefits to be derived from and the commercial potential for our product candidates in each case, including pimavanserin; benefits to be derived from changes to clinical trial designs; plans regarding the development of and future commercialization of pimavanserin; the value of pimavanserin; and our future expenses, collaboration, and grant payments, cash position, stock performance 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 with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2011, and on 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, our Chief Executive Officer.

  • Uli Hacksell - CEO

  • Thank you, Tom, and good afternoon. Let me first take this opportunity to thank all of you for joining us on today's conference call. As many of you know, this is an exciting time at ACADIA, as we wait topline results from the pivotal -020 Study in our Phase III program with pimavanserin for Parkinson's Disease Psychosis, or PDP.

  • During the third quarter, we completed patient enrollment in the -020 Study. And I am pleased to report today that we remain on track to report topline results this month. We believe that a successful study should significantly increase the value of pimavanserin. Currently, there is no FDA-approved therapy for PDP. We believe that pimavanserin has the potential to be the first safe and effective drug that will treat PDP without compromising motor control, thereby significantly improving the quality of life for patients with Parkinson's disease.

  • PDP is a large unmet medical need, and we are focused on advancing our Phase III program toward registration for this indication. As Roger will share with you later, while we are finalizing the -020 Study, we are also busy with preparations for the second planned pivotal trial in our PDP program, which we call the -021 Study.

  • Beyond PDP, we believe that pimavanserin has broad potential to address a range of other neurological and psychiatric disorders that are poorly served by existing antipsychotics. Importantly, we hold worldwide commercialization rights to pimavanserin.

  • While pimavanserin provides the foundation of our product pipeline, we have several additional programs in our R&D portfolio. Our pipeline also includes two clinical stage programs in the areas of chronic pain and glaucoma, in collaboration with Allergan, and two programs in advanced preclinical stages directed at Parkinson's disease and other neurological disorders.

  • All of our programs have been generated from internal discoveries, and offer what we believe are innovative approaches that may address large potential commercial market opportunities. Overall, our pipeline of product candidates, led by our Phase III PDP program with pimavanserin, positions ACADIA with multiple product and commercial opportunities, and with significant growth potential.

  • Before we review our programs in a bit more detail, let me ask Tom to briefly comment on our third-quarter results.

  • Tom Aasen - EVP, CFO and Chief Business Officer

  • Thank you, Uli. As expected, we reported a smaller net loss for the third quarter, following the termination of our collaboration with Meiji Seika Pharma, and the resulting recognition of all remaining revenue from that agreement. Our revenues totaled $3.5 million for the third quarter, of which $3 million related to the Meiji collaboration, with the remainder generated from our ongoing collaborations with Allergan as well as other agreements. This compared to total revenues of $584,000 for the third quarter of 2011.

  • Turning to our operating expenses, our R&D expenses were slightly higher in the third quarter relative to the comparable quarter of 2011, reflecting increased pimavanserin clinical costs, while our G&A expenses were consistent quarter-over-quarter.

  • Finally, let's turn to our cash position and guidance. We closed the third quarter of 2012 with $23.1 million in cash and investment securities. During the third quarter, we used approximately $5.3 million in cash to fund our operating activities. At the same time, we raised $7 million in gross proceeds during the third quarter from the sale of 3.49 million shares of common stock under our previously established at-the-market agreement.

  • Following the third quarter raise, we have not used the ATM further. We feel this amount of capital raised was ideal to provide ACADIA with additional financial flexibility. These added resources will enable us to accelerate our preparations for the second planned pivotal trial in our pimavanserin PDP program that Uli mentioned, and to extend our cash runway. We now expect that our existing cash and anticipated payments from our collaborations will be sufficient to fund our operations into the second half of 2013.

  • Let me turn the call over to Roger, we will provide you with an update on our Phase III PDP program with pimavanserin.

  • Roger Mills - EVP of Development

  • Thank you, Tom, and good afternoon. As Uli mentioned, this is an especially exciting time for our team, as we approach topline results from the -020 Study in our Phase III PDP program. -020 is a randomized multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy, tolerability, and safety of pimavanserin patients with PDP.

  • The study incorporates several design enhancements that were guided by previous data in our PDP program, and designed to mitigate placebo response and reduce data variability. This study has been conducted exclusively in North America. Importantly, this geographic focus enabled us to use a small centralized group of highly-trained independent raters to conduct blinded assessments as a primary endpoint at all study sites.

  • In the two-week period between screening and randomization, patients participated in a brief psychosocial therapy program. This was designed to help patients adapt to a clinical trial setting and to pull initial placebo responses ahead of the baseline assessment. To participate in the study, patients were required to have moderate to severe psychosis as measured by the Neuropsychiatric Inventory scale, or NPI, at screening, and the Scale for the Assessment of Positive Symptoms, or SAPS, at the time of the baseline assessment.

  • Criteria for study entry were tightened, based on our observation in previous studies, have a larger placebo response in patients with milder psychotic symptoms. Importantly, the baseline SAPS score was assessed independently from the NPI, which provided an important check and balance. We believe the strength in criteria for enrollment together with the brief psychosocial therapy were effective in filtering out patients with milder psychotic symptoms who, we believe, are more likely to respond to placebo.

  • A total of 199 patients were randomized in the study on a one-to-one basis to receive either 40 milligrams of pimavanserin or a placebo once daily for six weeks. Patients also continued to receive stable doses of their dopamine replacement therapy used to manage the motor symptoms of Parkinson's disease. The primary endpoint of the study is antipsychotic efficacy as measured using nine items from the hallucinations and delusions domains of SAPS that best reflect the expression of the psychosis in patients with Parkinson's disease.

  • This optimized scale, which we refer to as a SAPS PD scale, is supported by data from our previous PDP studies. When we applied this scale to prior studies, we saw a clear reduction in variability, enhanced sensitivity, and an improved effect size relative to use of the larger 20-item SAPS. The -020 Study is designed to be pivotal, and is powered at the standard 90% to provide statistically significant antipsychotic efficacy as measured using the SAPS PD. The toric tolerability is a key secondary endpoint in the trial, and is measured using Part 2 and 3 of the Unified Parkinson's Disease Rating Scale, or UPDRS.

  • Overall, we believe that the optimized -020 Study design has enabled sites to enroll patients with the desired clinical profile, and should significantly improve the likelihood of achieving a successful outcome. We remain on track with a standard closing stage of the study and continue to expect topline results this month. We plan to report these data in the press release, and host a conference call and webcast to discuss the results. We are also planning to follow up with a presentation of the -020 Study data at a future clinical conference.

  • Whilst we have been completing the final stages of the -020 Study, we have also been busy with preparations for the second planned pivotal trial, the -021 Study. Our plan is to use the same optimized design from the -020 Study, and leverage the existing infrastructure, including a core group of clinical sites, to enable us to start up and run the -021 Study in an efficient manner. We will provide more information on timing for this study at a later date.

  • Let me now turn to another ongoing trial in our PDP program, our Phase III open label safety extension study referred to as the -015 Study. This important trial involves patients who completed the -020 Study, as well as patients from previous Phase III PDP trials, and who, in the opinions of treating physicians, may benefit from continued treatment with pimavanserin. I'm pleased to report that 90% of patients who completed the treatment phase in the -020 Study elected to roll over into the -015.

  • This study, along with a similar extension study from our earlier Phase II trial, is allowing us to generate a large amount of valuable long-term safety data regarding the use of pimavanserin in patients with PDP. Importantly, we far exceeded ICH guidelines for required one-year exposure, with over 200 patients having been treated for one year or longer. We also have well over 100 patients that have been treated with pimavanserin for at least two years. And our longest single patient exposure is over seven years.

  • We are encouraged to see that many patients remained on treatment with pimavanserin for long periods of time. And we have continued to receive encouraging feedback from investigators regarding patient's experiences with pimavanserin in these safety extension studies. Our experience to date suggests that long-term administration of pimavanserin appears to be generally safe and well-tolerated in this often fragile elderly patient population. We believe that the favorable safety profile observed to date provides support for the potential of pimavanserin to offer significant advantages, relative to current antipsychotics used off-label for the treatment of PDP.

  • I'll now turn the call over to Uli.

  • Uli Hacksell - CEO

  • Thank you, Roger. We are excited about the upcoming -020 Study results, and believe that a successful trial should provide the opportunity to drive significant value for our stockholders. PDP is a serious disorder that develops in up to 60% of patients with Parkinson's disease. It contributes substantially to the burden of Parkinson's disease, and is the major cause of nursing home placements among Parkinson's patients.

  • We believe pimavanserin, with its innovative and well-tolerated non-dopaminergic profile, has the opportunity to be a first-in-class therapy that will effectively treat psychosis in Parkinson's patients without compromising motor control. While our strategy currently focuses on advancing our Phase III PDP program toward registration, we also intend to use this program as a foundation to develop and commercialize pimavanserin for other neurological and psychiatric disorders that are underserved by currently available antipsychotics.

  • One such neurological disorder is Alzheimer's Disease Psychosis, or ADP, which affects an estimated 25% to 50% of Alzheimer's patients. Similar to PDP, there is currently no therapy approved to treat ADP in the United States. During the third quarter, we published results of studies with pimavanserin in a preclinical model of Alzheimer's disease, which suggests that pimavanserin may be effective in the treatment of ADP.

  • We believe that these findings, together with a favorable safety profile observed to date in elderly patients with Parkinson's disease, suggests that pimavanserin may be ideally suited to address the need for a novel ADP treatment that is safe, effective and well-tolerated. We believe that pimavanserin also has considerable commercial potential in schizophrenia.

  • During the third quarter, data from our earlier Phase II co-therapy trial was published in the journal Schizophrenia Research. This trial demonstrated that co-therapy with pimavanserin and the sub-therapeutic dose of risperidone provided an attractive clinical profile. The treatment's equally effective as a higher standard dose of risperidone, but with a much improved side effect profile and with a faster onset of action.

  • As we continue to advance our Phase III PDP program, we will consider potential opportunities that may allow us to both accelerate development in ex-US regions, and to broaden the program to drive increased value for our stockholders.

  • Let me now touch briefly on the other programs in our pipeline. First, to our long-standing alliance with Allergan, we have two clinical stage product candidates that provide the potential for new treatment options in the areas of chronic pain and glaucoma. We're also continuing joint discovery efforts focused on ophthalmology in a third collaboration with Allergan, which was extended earlier this year.

  • In addition, we have two advanced preclinical programs which may offer new disease modifying approaches to treating Parkinson's disease and other neurological disorders. In our Nurr-1 program, ACADIA scientists discovered a compound that selectively activates Nurr1-RXR complexes, and is effective in restoring motor function and neuronal health in a preclinical model of Parkinson's disease. This program is supported by a grant awarded earlier this year by the Michael J. Fox Foundation.

  • In our ER-beta program, our novel compounds have exhibited neuroprotective and anti-inflammatory properties in preclinical models, and may have the ability to slow down the progression of Parkinson's disease. These compounds may also address symptoms of chronic, inflammatory and neuropathic pain. This program is supported by a grant from the National Institute on Neurological Disorders and Stroke. We expect to advance a compound from at least one of these two preclinical programs into development next year in preparation for future clinical trials.

  • In closing, our pipeline of product candidates, led by our Phase III pimavanserin program, positions ACADIA with multiple product and commercial opportunities, and significant growth potential. With a well-designed Phase III program for pimavanserin, and Phase III data anticipated this month, we believe that we have the foundation in place to drive significant growth for ACADIA and our stockholders.

  • We will now turn to the question-and-answer session. But before we begin, let me mention that, because we expect topline results from our -020 Study this month, and plan to hold a call to discuss these results, you can appreciate that we're not in a position to get into more specifics on the Study at this time.

  • Operator, you may now proceed with the Q&A session.

  • Operator

  • (Operator Instructions) Bert Hazlett, ROTH Capital Partners.

  • Bert Hazlett - Analyst

  • Thank you for taking the questions. And we're all eagerly anticipating the Phase III data release of -020. Just -- if you could remind us, any one of you folks, I guess, with regard to the tolerability of the agent? And what you might expect coming out of -020, based on the prior results or the long-term extension studies? Is there anything -- well, I'll leave that there and I'll follow-up in a second.

  • Roger Mills - EVP of Development

  • Hi, Bert. Thanks for the question. Obviously, as we will be announcing the data this month, we're not actually covering specifics on the -020 Study. But we do have, as mentioned on the -- earlier on the call, we've got fairly extensive experience of using pimavanserin in a range of patients with PDP, across a number of studies. And the tolerability has both in the previous blinded studies, the comparator studies, versus placebo, the -012 and -014, and even the earlier Phase II Study, the tolerability has been really in safety, has been very similar between the active groups and placebo. So it's been very placebo-like in those comparator studies.

  • Obviously, the largest amount of safety data that we have generated have been in the long-term open-label studies, where all patients have received pimavanserin. We've really seen that the drug has been very well-tolerated in that population. And I think it has the potential to very much be an improvement on the atypical agents in this population, where there are really severe safety concerns regarding the off-label use of the existing atypicals in these elderly and neurodegenerative conditions.

  • Bert Hazlett - Analyst

  • Thank you very much for that. And again, if we could just fast-forward, assuming there is a potential positive outcome -- and I know that that's an assumption on my part -- in terms of the acceleration of additional indications with the molecule, or as a result of potential licensing, can you -- could you talk about what a successful outcome might mean in terms of your decision matrix? Would licensing be a part of the next set of decisions? Or would you potentially look to accelerate other indications yourself in the absence of licensing? Just a little bit of additional thought, assuming successful outcomes here in -020.

  • Uli Hacksell - CEO

  • Well, so let me take this. First of all, currently, we are clearly focused on finalizing the -020 Study, which we believe provides great potential to significantly increase the value of pimavanserin. Our next step will be to move on quickly with the -021 Study and the remaining NDA studies, to ensure that we are moving the whole Phase III program towards registration. So -- and that we can build additional value that way.

  • Now, when it comes to partners, we have continued to keep potential partners updated on the progress of the pimavanserin program. And while we are continuing to move forward with the program, we certainly see the opportunity to broaden the specific PDP program into other neurology and psychiatric indications.

  • We, as you know, we have mentioned Alzheimer's disease psychosis and schizophrenia as very tempting kind of avenues to explore pimavanserin in. We think those indications provide great opportunities to further expand the value of pimavanserin.

  • Also, which is very important for us, is to accelerate development in other geographic regions outside of the US. And the most important thing, perhaps, is that we have worldwide rights for pimavanserin. Now that means that all options are open to us.

  • Bert Hazlett - Analyst

  • I guess my question is more on the lines of, would you expect to pursue those yourself? Or would you expect those to pursue either other geographies or other indications with partners? Any sense of that at this point?

  • Uli Hacksell - CEO

  • Well, clearly, we see the options to do either of them in the future. And we will look at the opportunities and then take them right when they appear. But the important thing is that we can move forward with pimavanserin on our own. But we also have opportunities for other scenarios, since we have kept the worldwide rights for pimavanserin.

  • Bert Hazlett - Analyst

  • I appreciate that. Thank you very much.

  • Operator

  • Brian Lian, SunTrust.

  • Brian Lian - Analyst

  • Thanks for taking the questions. I have a question on the -- on minimizing the placebo response. Can you give us any sort of a historical perspective on how the brief psychosocial therapy has impacted placebo response rates in other trials? Has this been an effective sort of validated approach?

  • Roger Mills - EVP of Development

  • Yes, so it has actually been used. Primarily, it came from the Alzheimer field, where there was a very similar -- or remains a very similar challenge with regards to placebo response. So, it's developed for use in Alzheimer patients. And therefore, it was quite a nice transition to be able to move it through into this similar population with psychosis in PD.

  • And it clearly showed therapeutic utility in that Alzheimer population. And it's really from advisers who'd used it effectively in that field that we adopted it for purpose with the -020 Study. The aim is essentially to try and draw the placebo response ahead of the randomized portion of the study.

  • You can -- in terms of looking at that, you may think that you can continue the study out for a long time; but that's very difficult to manage these patients for long periods in a placebo-controlled study. And it wouldn't be very attractive to patients that come in nor to investigators.

  • By using the brief psychosocial therapy, it really offers a couple of things. It offers us the ability to pull that placebo response, as I say, ahead of the randomized portion. But it also offers patients -- and we're looking for patients with more severe disease -- it offers patients and caregivers and the investigators something to be able to use with patients during the period -- of the screening period when they're really -- they're not in the study and don't have access to any therapeutic.

  • Brian Lian - Analyst

  • Okay, thanks very much. That's really helpful. And with the -021 Study, can you talk about any key structural differences that might be incorporated in that trial? You talked about a core group of sites that will be used. Will the overall number of sites be the same? And are there any other changes planned?

  • Roger Mills - EVP of Development

  • We're not giving specifics at the moment, but we really do intend that the Study will be essentially the same as the -020 Study. So, we intend the Study to be North American-based. We intend to use the same centralized rating that we've used in the -020. We'll continue to use the upfront -- the brief psychosocial therapy. So it'd be very, very similar, if not exactly the same, to the -020 Study.

  • Brian Lian - Analyst

  • Okay, thanks very much.

  • Operator

  • Jason Butler, JMP Securities.

  • Jason Butler - Analyst

  • Thanks for taking the question. The first one, can you just remind me of what the new definition of enrollment for severity of disease is? I know you're trying to exclude patients with milder disease here.

  • Roger Mills - EVP of Development

  • Yes, so we base -- there are two elements to enrollment. Well, there's actually three elements. There are two structural elements, and then there is the -- really relying on the investigator to really determine which patients would be ideal for the study.

  • The two structural hurdles to get into the study really are screening and at baseline. So, the screening takes place initially; two weeks later, the patient comes in for their baseline visit. And prior to them being randomized, they actually have a further assessment. The assessment at screening is the NPI, the Neuropsychiatric Index. And the assessment at the baseline is using the SAPS.

  • Now, the NPI is performed by the investigator. The SAPS is performed by the independent raters. So not only do we have two hurdles, but in fact, those two assessments are done by different groups. So that provides an important check and balance in terms of bringing patients in.

  • What we did based on the data that we saw from the previous study, the -012, where we saw that patients with milder disease tended to respond to placebo. We actually looked at the MPI, and we increased the score for patients to come into the study. And also, we did a very similar increase with the SAPS at the baseline. So, both the screening and at baseline, we increased the hurdle of severities of patients to come into the study.

  • Jason Butler - Analyst

  • Okay, great, thanks. And then can you give us an idea, if any, what additional efficacy information you'll be able to get from the open-label safety study?

  • Roger Mills - EVP of Development

  • So the open-label safety study, I think, in its definition is based around safety. We don't have specific measures of efficacy in that study -- save the obvious surrogate of patients who remain on the study, because the criteria for that is that patients remain on the study in the opinion of their investigator, who feels that the patients are deriving benefit from being on the study. But it is primarily a safety study; that's what we are looking at in the trial.

  • Jason Butler - Analyst

  • Okay, great. Thank you very much.

  • Operator

  • Juan Sanchez, Ladenburg Thalmann.

  • Juan Sanchez - Analyst

  • Just a couple of reminders. Could you remind me on the assumptions on dropout that you had when you put together a trial? And the second question would be -- I understand that you have 80% powered to show a difference, assuming there is a 3-point delta. What if you have a 2.5-point delta, assuming all the variables remain the same, what kind of power are we talking about in this case?

  • Roger Mills - EVP of Development

  • Thanks. And just so, in terms of the -- so, the first (multiple speakers) --

  • Uli Hacksell - CEO

  • The first one was the dropout rate.

  • Roger Mills - EVP of Development

  • -- was the dropout rate. (multiple speakers) So we haven't given specifics on the dropouts here, but we actually -- what is very interesting is that the -- in terms of patients going through with PDP, traditionally in the psychiatric area, dropouts have been very, very high. Schizophrenia, sometimes over 50% of patients will drop.

  • In PDP, it's absolutely the opposite. Very few patients actually drop out of the study. And even if they do drop out, the analysis is able to take that into account, unless the patient is completely unevaluable. So if they only have one reading at baseline with no follow-up reading.

  • This is an incredibly compliant population. It's just this elderly population who -- they take their drugs on time, they go through the study and complete. So we don't actually have and we've not seen in previous studies, and we don't expect in this study, that there is any form of excessive dropouts. And the power intakes all that into account. It's based on a standard Phase III 90% powering.

  • With respect to the margins of improvement, I think it's premature to discuss what the point difference will be. And obviously, they're very close to actually being able to look at the data. So I think we'll look at it in the light of actually having the data in front of us. But I think this study is very well-powered to show a clinical effect of the drug.

  • Juan Sanchez - Analyst

  • Thank you, guys. And good luck, okay?

  • Operator

  • George Zavoico, MLV and Company.

  • George Zavoico - Analyst

  • Hi, Tom, Uli and Roger. Looking forward to the results later this month, as everyone else is. A couple of questions. With the long-term -015 Study, I mean, clearly, some of these patients have stayed on a very long time. You've talked a little bit about dropouts. Would this longer-term study -- have there been any specific AEs that might have caused some patients to drop out? Or, as you mentioned, Roger, it's a very compliant group that just stays on.

  • Roger Mills - EVP of Development

  • I think the study is -- the nice thing about this study in many respects is it's a very real-world study. It -- given the duration that we are interacting with these patients, there's a lot of things going on in their lives. And people move; there's all sorts of things, which is what you'd expect. As I say, it's a very real-world study.

  • We have not seen any safety signals in this population which would suggest there is any safety concern, nor any safety reasons that patients would drop out because of a safety signals. And it -- there are many, many -- as I say, there are many, many events occurring in these patients' lives during the period on the study, but we've not seen any signal which causes us concerns.

  • George Zavoico - Analyst

  • And in the -015 Study, there's no end to it. I mean, there's no, like, a 10-year limit or a 7-year limit. It's just going to go on until the patient decides to stop?

  • Uli Hacksell - CEO

  • Until we are on the market.

  • George Zavoico - Analyst

  • Until you're on the market. (laughter) Of course. Great. A question about the Nurr1 and ER-beta programs. I'm glad you're guiding to bringing at least one of these up to clinical trials perhaps next year. In that regard -- and both are funded partly or perhaps in full by grants. Do these grants cover the beginning of clinical development? Or is that going to have to be coming out of your pocket eventually?

  • Uli Hacksell - CEO

  • So, let me first say now that what I tried to say earlier on, what was that we will move at least one of these programs into development next year. I didn't say that we would move into the clinic necessarily.

  • So, but currently, these programs are essentially completely supported by external grants; something that we're very proud of, because we have been able to compete with academic and other commercial applications for money, and done so very successfully. We cannot really speculate on how grants may be -- possible to covering clinical expenses. We will see in the future. We don't not -- it's too early to speculate on that simply, I think. One thing is certain, and that it is more difficult to get grant support for clinical studies than for preclinical studies.

  • George Zavoico - Analyst

  • Yes, yes. That's what I was wondering about. That's what I thought. Okay, well, I look forward to some of the preclinical data coming out, hopefully, that you've worked on with a grant. I imagine those are going to be submitted to the usual medical or research conferences sometime in the next year or two?

  • Uli Hacksell - CEO

  • Yes, absolutely. So, in fact, we do intend to present those [two] and we have done that before as well. And we will most likely have applications coming up as well.

  • George Zavoico - Analyst

  • Thank you very much.

  • Operator

  • (Operator Instructions) Alan Carr, Needham.

  • Alan Carr - Analyst

  • Thanks for taking my questions. Wondering if you'd give us a couple of things -- one of them, can you give us any updates on the baseline data that you've seen in -020 versus the previous Phase III trials? And then also, an update on the work with Allergan, when we might see some of that progressing. Thanks.

  • Uli Hacksell - CEO

  • Say, you start, Roger.

  • Roger Mills - EVP of Development

  • Yes, thanks, Uli. So Alan, I think we -- as we've -- on previous calls, we've indicated that the baseline scores have been really demonstrated that I think we've seen that the structural design we put into the -020 study has resulted in patients with milder disease being screened out of the study. And in the complete enrollment in the study, I think that has been consistent. So we've not seen any changes in the later stages of the study.

  • So we -- the design changes that we made really do seem to have been effective in screening out patients with milder symptoms. And of course, that's important, because those are the ones who are most likely to respond to placebo in the previous study.

  • Uli Hacksell - CEO

  • So, when it comes to the Allergan collaboration, I can take that. So, as you know, we have two clinical state programs in collaboration with Allergan, and one discovery collaboration.

  • When it comes to the adrenergic pain program, Allergan has conducted several Phase II studies. And we have communicated previously, and are still doing that, that they are seeking a partner for further development, that can also -- and they hope to find a partner that can also help them to commercialize such a product in an area that gets predominantly served by general practitioners. They have indicated also that this particular strategy relates to their focus on specialty pharmaceutical markets.

  • The second program, which is the muscarinic glaucoma program, that is in Phase I clinical development. And then the third program, as I indicated previously, that's a muscarinic collaboration, which is focused on ophthalmological applications. And that's what we can say today about the Allergan collaboration.

  • Alan Carr - Analyst

  • All right. Thanks very much.

  • Operator

  • And ladies and gentlemen, we have no other questions at this time. Dr. Hacksell, please proceed with your closing remarks.

  • Uli Hacksell - CEO

  • 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 near future. Thank you.

  • Operator

  • Thank you for your participation in today's conference call. This concludes the presentation and you may now disconnect. Have a good day.