ACADIA Pharmaceuticals Inc
NASDAQ:ACAD
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ACADIA Pharmaceuticals Inc
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Good day, ladies and gentlemen. And welcome to the ACADIA Pharmaceuticals Third Quarter 2020 Financial Results Conference Call. My name is Giji, and I will be your coordinator for today. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session toward the end of today’s call. [Operator Instructions]
I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at ACADIA. Please proceed.
Thank you. Good afternoon. And thank you for joining us on today’s call to discuss ACADIA’s third quarter 2020 financial results. Joining me on the call today from ACADIA are Steve Davis, our Chief Executive Officer, who will provide an overview of our Q3 2020 financial performance and a review of our business. Also joining us on today’s call Michael Yang, our Chief Commercial Officer, who will provide updates on our commercial initiatives; and Dr. Serge Stankovic, our President, who will discuss our pipeline progress. Our Chief Financial Officer, Elena Ridloff, will then discuss our financial results in more detail, before turning it back to Steve for final remarks and opening the call up for your questions.
I would also like to point out that we are using supplement slides, which are available on the Events & Presentations section of our website.
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 within the meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements including goals, expectations, plans, prospects, growth potential, timing of events or future results, 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.
These factors and other risks associated with our business can be found in our filings made with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of today’s date.
I will now turn the call over to Steve.
Thank you, Mark. Good afternoon, everyone, and thank you for joining us today. Please turn to slide five. We have made important and significant progress on our three strategic pillars. First, we are driving the growth of NUPLAZID for patients with Parkinson’s Disease psychosis or PDP through a combination of best-in-class virtual engagement and in-person activities.
Our second pillar is delivering on the dementia-related psychosis or DRP opportunity, a potential second indication representing a 10-fold increase in the addressable market size for NUPLAZID.
And third, we are developing innovative new treatments by advancing our development pipeline and acquiring new assets.
Let’s review in greater detail starting on slide six. For the third quarter of 2020, NUPLAZID achieved $120.6 million in net sales, a 27% year-over-year increase, driven by strong commercial execution. This is a direct result of our ability to successfully pivot and execute in these uncertain times, as well as a testament to the importance of treating PDP.
As a result of our continued performance in 2020, we are reiterating our full year net sales guidance to be between $430 million to $450 million, representing 30% year-over-year growth at the midpoint of the range. We are well-prepared to achieve the long-term market opportunity for NUPLAZID in PDP and look forward to the addition of the DRP indication.
Let’s move to the DRP opportunity on slide seven. We are excited that pimavanserin could be the first and only FDA approved medicine for the treatment of Dementia-related psychosis. Psychosis is associated with serious consequences in patients with dementia, such as repeated hospital admissions and increased likelihood of nursing home placement, progression of dementia and increased risk of morbidity and mortality.
Dementia-related hallucinations and delusions represent a high burden for patients and for caregivers. We are confident in both the efficacy and safety data supporting our supplemental NDA and we will continue to work with the FDA to facilitate their review with a PDUFA date of April 3, 2021.
We continue to make important progress in our late stage development pipeline as shown on slide eight, with but ongoing Phase 3 studies with pimavanserin for the treatment of negative symptoms of schizophrenia and with trofinetide for the treartment of Rett Syndrome.
As part of our third strategic pillar, we remain focused on expanding and diversifying our development pipeline by investing in new treatments. Earlier this year, we brought in two very exciting investigational programs with the potential to bring differentiated approaches to areas of significant unmet need.
In the spring we in-licensed a muscarinic receptor program including ACP-319 from Vanderbilt University. In this program, we are focused on improving cognition and neuropsychiatric symptoms through an ongoing research collaboration with Vanderbilt.
Over the summer we acquired CerSci Therapeutics, which is advancing first in class non-opioid candidates for the treatment of acute and chronic pain and a portfolio of earlier stage molecules focused on neurodegenerative disorders.
Finally, I’d like to share one more positive update, which will be disclosed in the 10-Q we are following later this afternoon. We are pleased to report that the Department of Justice notified us recently that it has concluded its investigation of the company and will not be taking any further action.
With that, I will now turn it over to Michael to discuss our commercial performance and highlights.
Thank you, Steve. Today I would like to review our third quarter performance, which highlights a fundamental strength of our business and gives us confidence in the long-term expectations for the new NUPLAZID franchise.
Please turn to slide 10. We have driven positive momentum this quarter, growing our base of new prescribers and new patients in both channels. In the third quarter, we delivered net sales of $120.6 million, driven by a year-over-year volume growth of 14%.
This quarter’s growth was a result of our best-in-class virtual tactics layered with a mix of opportunistic and COVID appropriate in-person interactions. We have been able to return to offices in several instances for physician visits, as well as an in office promotional programs, all of which have been received well.
Our commercial foundation is solid as we continue to leverage our digital platforms to stimulate patient and caregiver conversations with their physicians about PDP and treatment with NUPLAZID. Importantly we continue to invest in the ability to prescribe NUPLAZID remotely.
Especially pharmacy channel contributed to the strong overall performance as new patient growth has remained at pre-COIVD expectations. In addition, monthly fulfillment rates for both new and continuing patients in the quarter remained consistently high.
As we mentioned on the last call, we observed a temporary COVID related impact to our growth in the long-term care channel. In the third quarter long-term care facilities were able to get back on track from an operational standpoint and we open their doors for new admissions. And now we have seen that over the past couple of months NUPLAZID prescriptions in the LTC channel have stabilized.
We continue to build a broad range of partnerships with professional organizations and national electronic health records systems and pharmacies. As a result, NUPLAZID continues to perform well on a relative basis, outperforming a basket of other LTC promoted products according to IQVIA. Overall we are well-positioned to serve the needs of PDP patients with NUPLAZID wherever they are located.
Let’s discuss our dementia related psychosis initiatives on slide 11. Our DRP launch preparations including disease awareness and talent recruitment are on track. We are focused on preparing the market through disease stated education initiatives and platforms.
For example, we have generated over a 0.25 million views since we launched our disease education website MoreThanCognition.com, with several exciting updates including enhanced capabilities for our lives, virtual expert panel webinars. The introduction of a dementia-related psychosis, MDIQ quiz and new key opinion leader videos focused on the neurobiology and unmet need in DRP.
We are also syndicating our content from more than cognition on third-party sites such as Doximity, SERMO, Health Casts and Medscape. We continue to be very active at Medical Congresses with several disease education theatres and presentations on PDP and DRP.
In addition, we are generating evidence to better understand the impact of dementia-related psychosis from the perspectives of patients, providers and payers. We recently completed an analysis of Medicare administrative claims data that showed that the average annual all cause costs for a newly diagnosed DRP patient compared to a dementia-patient without psychosis nearly doubles reaching almost $90,000 during their first year with psychosis. These results were presented in a poster at the Academy of Managed Care Pharmacies Nexus Conference last month.
Additional awareness opportunities include a disease education film we sponsored in partnership with a Lewy Body Dementia association titled SPARK-Robin Williams and his Battle with Lewy Body Dementia. SPARK is adapted from the full length film released this summer Robin’s Wish and will be available to major academic research institutions and Center of Excellence to drive awareness and education on dementia and its symptoms.
I will now turn it over to Serge who will provide an update on our development pipeline.
Thank you, Michael, and good afternoon. Please turn to slide 13. First, I am pleased to report that the review of our supplemental NDA for dementia-related psychosis is going well and progressing as we would expect. We are working with the FDA to facilitate the review in a timely fashion and are on track for the April 3rd PDUFA date.
Our Phase 3 studies are also progressing well. The ADVANCE 2 study for the treatment of negative symptoms of schizophrenia is bringing on site and enrolling patients. The Lavender study for the treatment of Rett Syndrome is enrolling well and remains on track for topline results in the second half of next year.
We acquired two new promising clinical assets earlier this year, ACP-044 from CerSci and ACP-319 from Vanderbilt and are working diligently to advance them in the clinic next year. Consistent with our strategy we remain focused on developing innovative new treatments with high unmet need and that is reflected in our growing and advancing pipeline.
Now I would like to discuss ACP-044, which is the compound we brought in with the CerSci Therapeutic acquisition on slide 14. ACP-044 is reactive species decomposition accelerant or RSDA which represents a first-in-class non-opioid mechanism being about for the treatment of acute and chronic pain.
Chronic pain is a major problem and the CDC estimates that it affects approximately 20% of the U.S. adult population and has significant health and economic consequences. Furthermore, moderate to severe acute pain is prevalent following the vast majority of surgeries in the United States with more severe or extreme pain present in about one-third of the cases.
ACP-044 have shown compelling and promising results in several animal models of both acute and chronic pain. In Phase 1 clinical testing we have seen favorable tolerability and pharmacokinetics and in the first half of next year we will initiate our Phase 2 program with clinical studies in models of both acute and chronic pain.
Slide 15 highlights some of the exciting new scientific data on team of ancillary being presented at this week’s clinical trial on Alzheimer’s Disease Conference or CTAD. This Friday, Dr. Clive Boller from the University of Exeter Medical School will present new analysis of pimavanserin in clinical data from four placebo-controlled studies, investigating pimavanserin impact on cognition in patients with neuropsychiatric symptoms related to neurodegenerative disease including dementia-related psychosis.
In addition, Dr. Daniel Weintraub from the Pearlman’s School of Medicine at the University of Pennsylvania will present a poster analyzing the impact on motor function in patients treated with pimavanserin in across multiple clinical studies.
The presentations at CTAD continue to support the overall safety profile of pimavanserin in these vulnerable patient populations. We remained encouraged with the breadth of clinical data, which supports the potential role of pimavanserin especially in elderly patients with dementia-related psychosis.
Finally, I would like to mention an interesting and encouraging poster that was presented during this year’s International Parkinson and Movement Disorders Society’s Virtual Congress in September on slide 16.
It describe described the retrospective cohort study conducted in Medicare Parkinson’s disease patients treated with either pimavanserin or a group of atypical antipsychotics primarily before therapy [ph].
The outers which includes members of the U.S. FDA, the Centers for Medicare and Medicaid Services and Stanford University concluded that pimavanserin treatment was associated with reduced all-cause mortality compared to treatment with atypical antipsychotics.
The figure you see on the slide is the Kaplan-Meier survival curve for the pimavanserin and atypical antipsychotics cohort. The key takeaway from this graph is that pimavanserin exhibited a higher survival probability through one year of treatment compared to atypical antipsychotics.
This separation was specifically exhibited in the 180 days of treatment in among the 85% of patients who were not in nursing homes. These findings are in line with the way we view pimavanserin and is another contribution to the growing body of data supporting pimavanserin safety profile.
With that, I will now turn the call over to Elena to discuss our financial performance.
Thank you, Serge. Today I will discuss our third quarter results and our updated 2020 financial outlook. Please turn to slide 18. In the quarter, we recorded $120.6 million in net sales. That’s an increase of approximately 27%, compared to $94.6 million of net sales in Q3 of 2019. This is driven by approximately 40% volume growth year-over-year. The gross to net adjustment for Q3 2020 was 13.2%. Weeks of inventory in the channel at the end of the third quarter were consistent with previous quarters.
Moving down the P&L, GAAP R&D expenses increased to $120.1 million in the quarter, compared to $62.6 million in Q3, 2019. GAAP R&D expense included $52.8 million upfront consideration and transaction expenses related to the acquisition of CerSci Therapeutics in August of 2020.
GAAP SG&A expenses increased to $81.6 million in the third quarter from $72.7 million in the third quarter of last year. This is largely due to increased advertising and promotional costs, as well as an increase in personnel and related costs.
Non-cash stock-based compensation expense during the quarter were $21.4 million, compared to $22 million for the same period in 2019. Cash used in operations during the quarter were $22.8 million, compared to $18.9 million for Q3 2019. Our cash balance at the end of the quarter was $644.4 million.
Please turn to slide 19. For the full year 2020, we are reiterating our 2020 net sales guidance to be between $430 million and $450 million. At the midpoint of this guidance range this represents approximately 30% growth in revenue year-over-year. As a reminder, gross to net is sequentially higher in the fourth quarter as a result of accruing for the donut holes obligation associated with year-end inventory in the channel.
On the expense side for 2020, we have increased our GAAP R&D guidance to be between $325 million to $340 million from a previous range of $265 million to $280 million. This increase is primarily a result of the upfront and transaction expenses associated with the acquisition of CerSci Therapeutics.
We are reducing our GAAP SG&A guidance to $385 million to $400 million from the previous range of $400 million to $420 million. Non-cash stock-based compensation expense is now anticipated to be between $80 million to $90 million in 2020. We will end 20 with a strong balance sheet and our reiterating of our year-end cash guidance of $570 million to $590 million.
And with that, I will turn the call back over to Steve.
Thank you, Elena. Please turn to slide 21. At Acadia we have built a strong organization in neuroscience with best-in-class R&D and commercial capabilities to fully leverage the advancement opportunities.
Today we are executing on our promise to deliver NUPLAZID patients with PDP. We continue to grow the opportunity in PDP, while preparing for a potential second indication in DRP and the ability to help a much larger magnitude of patients and their caregivers.
We will look forward to keeping you updated on our progress, we are continuing momentum of our NUPLAZID franchise, and breadth and depth of our brand position of ACADIA for long-term growth.
In closing, I would like to thank our employees for their continued commitment and passion as we advance the business.
I will now open up the call for questions. Operator?
[Operator Instructions] Your first question comes from the line of Ritu Baral from Cowen. Your line is now open.
Hi guys. Thanks for taking the question. I wanted to just ask about unit growth. You guys noted that year-over-year you have had 14% volume growth. Can you give us quarter-over-quarter what you are seeing in unit growth? And also if you could just separate the unit growth by the retail channel and the long-term care channel? Thanks.
Sure. Thanks Ritu. Elena, you want to take that question?
Sure. Thanks, Ritu. So sequential volume growth in the quarter was approximately 3% and that was driven largely by growth in the SP channel, as Michael mentioned in his remarks. We have seen stabilization in SP channel in the third quarter sequentially.
Got it. Thanks for taking the question. I will hop back into queue.
Thanks.
Thank you. Our next question comes from the line of Neena Bitritto-Garg from Citi. Your line is now open.
Hey, guys. Thanks for taking the question. I just wanted to ask a quick question about the DRP review. Based on the timelines that you discussed previously is that kind of safe to say that we are at the point now where the FDA is probably not going to change their mind on holding an AdCom? Thanks.
Serge, do you want to start. Serge, are you mute? Let me go ahead answer that, Serge you may jump up in a second. I wouldn’t say that, just as a reminder, when the FDA indicated they accepted the submission for filing, they indicated to us at that time that they do not plan to have an AdCom and we don’t have any information to the contrary at this juncture.
But it is possible they could change their mind. And if you kind of work backward from the PDUFA date and think about when an AdCom could be and then how much advance notice they need to give us the advance of that, we are not at the point yet where I would say, we could rule out that they could change their mind. But at this juncture we do not anticipate having an AdCom.
Great. Thanks.
Thank you. Our next question comes in the line of Cory Kasimov from JPMorgan. Your line is now open.
Hey. Good afternoon guys. This question is probably for Michael. I appreciate the comments you made on the disease education you are doing in preparation for the potential DRP launch. I guess I am curious what you are learning from all this? I mean, what is your outreach in market research suggest about the level of disease awareness and kind of like anticipation or even pent-up demand for new plasmid in DRP at this time?
Hey, Cory.
Michael, go ahead.
Okay. Thanks Steve. Hey, Cory. Great question. So I think the market research that we see is there’s great healthcare practitioner enthusiasm, in part because there is a understanding that the disease treatments that they have all have some compromise associated with them particularly in areas of cognition, surprisingly more on the motor side, EPS, other things.
So the safety profile -- well, rather the efficacy and safety profile together are really knocking the socks off the physicians in regards to the potential of deposit. And that’s fits into well into our platform that we are trying to do to really establish with new plans, which is efficacy without impairment. We were able to do that with PDP, as you know, without impacting motor function and then I think cognition is important safety mechanism that that they don’t have that ability today.
So we are reaching I think a good audience. I think the Spark Film will help a lot in terms of the consumer side. But on the on the physicians I think we are doing really well in engaging with their awareness.
Okay. Good to hear. Appreciate you taking the question.
Thank you. Our next question comes from the line of Jeff Hung from Morgan Stanley. Your line is now open.
Thanks for taking the question. I was wondering if you can talk about what you have seen over the last month or so on new patient starts and persistence and if you have seen any changes in trend as we hear of cases of COVID increasing? Thanks.
Michael, do you want to take that?
Sure. Yeah. No. As I mentioned in my prepared remarks on our office based neuroscience side, where add new patients starts a pre-COVID level and we have not see any impact to fulfillment or persistence and if we have seen a consistently high performance there.
Long-term care as we mentioned stabilizing. We are outperforming a basket of products, as I mentioned. I think it’s important that I think the pandemic really hasn’t obviated the symptoms of PDP and thus I think they become even more vocal to treat and we have been able to provide a wide variety of mechanisms to prescribe NUPLAZID and start NUPLAZID for patients in a remote digital environment.
So we actually think we are catching patients whether they are in the nursing home or in the office or even on the remote side. So from our standpoint, I think, we are feeling really good about the potential to capture the patients.
All right. Just to clarify, so then was that strictly 3Q or did that also pertain to last month as well?
Well, I would say, for long-term care we have seen the market stabilize there in the last few months. I think persistence at fulfillment and new starts were for the third quarter on the neuroscience side of the retail side.
Thank you.
Thank you. Our next question comes from the line of Marc Goodman from SVB Leerink. Your line is now open.
Serge, can you talk about ACP-044, what kind of proof of concept data did you look at, what you have seen, I mean RSDAx first in class, so maybe you could just give us a little sense of how confident we have something here.
Yes. Happy to do so. ACP-044 has shown promising results in the animal models evaluating a variety of different pain models in seasonal pain, inflammatory pain or robotic pain. And also what we saw in the Phase 1 clinical pharmacology studies, displayed a favorable tolerability and pharmacokinectic properties.
So we are fairly confident that as one can be based on the animal models, and particularly, variety of animal models addressing both acute pain, as well as chronic pain that -- and as well as the properties of the drug in our Phase 1 studies. We are very confident to move into a Phase 2 development.
And as it is right now, we are planning to initiate our Phase 2 study program in the first half of next year and current plans include both acute and chronic human pain models in -- for the next stage of development.
And these animal models I assume these are standard pain models and so I am sure that…
Yeah.
… you have a lot of animal model data from what opioids do, so I was just kind of curious, is the…
Absolutely.
Is the play here we are better than opioids or we are just as good, but obviously what an opioid that’s a huge advantage?
Yeah. The mechanism of action of ACP-044 is such that it acts in periphery in a very different manner than the opioids obviously, but has a strong analgesic properties that are primarily based in its ability to interfere with multiple pain pathways.
And based on the animal data obviously you will do comparative studies. Well, we compared with the opioids and it displays impressive -- impressing analgesic potential that we saw in the preclinical study.
So that that gives us a level of confidence and optimism to move forward. So no opioid properties, but a stronger analgesic properties and mode of action that actually interfere with multiple pain pathways.
Thank you.
Mark, I would just echo Serge’s thoughts. I’d say, one of the things that we found very compelling is the consistency of the results in the animal models. Now we all know that animal model, because the animal models and you try to get predictive information for what happens in humans and in some disease states those are more predictive than others.
But in the models that we looked at, one, they were very consistent, two, I would say, the results that we saw running against comparators in those models when they run against opioids were produced results that were equal to or better than the opioid comparators and the other models were at least equivalent to other pain relieving agents.
So I think it’s too early to say whether the ultimate play would be better pain relief than you get with an opioid or just a pain relief that does not have the opioid addictive qualities. But I would just simply say that the consistency of the data in the animal models that we saw was very compelling and gives us very high hopes as we now launch into Phase 2.
Thanks, Steve.
Thank you. Our next question comes from the line of Charles Duncan from Cantor. Your line is now open.
Super. Thanks to Steve and team. Congrats on a good quarter and thanks for taking my question. I will try to be brief here and respect the rule. For Michael, perhaps, do you have any estimate of market penetration? And I think you mentioned consistently high fulfillment rates. Any color on what that means? And then perhaps for Elena, you guided for $430 million to $450 million for year-end revenue. I guess I am wondering what triggers have to happen for the aspirational side of that guide?
Michael, do you want to take the first question then we will go to Elena.
Yeah. Sure. Hey, Charles. The first part of your question is in terms of PDP, I would say, that our share in the market is in the high-teens, which is great. And in regards to fulfillment, you know there is obviously for the patients that are taking the product patients get close to three bottles a month and that’s a full fulfillment rate.
And so it gives you some sense of what we are seeing. We are seeing very high fulfillment rates based on the potential of the number that we want to call it take rate bottles per patient per quarter and we track that. So that’s been very consistent and very high throughout the past really year since the 34-milligram launch that we have seen that.
And with regards to your guidance question around what would need to occur to for us to achieve the high end of our guidance. At the high end of our guidance we would -- that would require us seeing improvements on the LTC channel, as Michael mentioned, in his prepared remarks we are seeing stabilization there and we are outperforming a basket of peer products seeing improvement in the trends in LTC we will beat us to the higher end of the range. And just a reminder when you think about Q4 revenue and the full year guidance range, we do have higher growth to net sequentially in Q4. So that is a headwind in the fourth quarter.
Thanks for added color. Congrats.
Thanks.
Thank you. Our next question comes from the line of Tazeen Ahmad from Bank of America. Your line is now open.
Hi. Thanks for taking my questions. First one maybe for Elena, can you give us a little bit of color on SG&A. You weren’t picking up higher in 4Q. Should we expect that trend in general to continue going forward as you are prepping for the DRP launch? And then secondly a question maybe for Michael about the updated information you have about targeted physicians for DRP. How much overlap is there going to be with the physicians that you target for PDD? Thanks.
Okay. Elena do you want to go first and then Michael.
Sure. So, yes, that is right, Tazeen. We will see an increase in SG&A in the fourth quarter. There’s a few drivers there. As you mentioned, we are investing ahead of the DRP launch and on both our commercial and medical affairs side.
And we are -- as Michael mentioned more recently shifted to more in-person field activities which has higher costs associated with it. In addition we are on air currently with our DTC campaign and so that that investment is in the fourth quarter as well.
And as you look towards next year we will provide guidance on our year end call, but to qualitatively talk about a few things. We will be expanding the field team for DRP in the first part of next year and we will also be increasing our marketing investments for a launch both with these education, as well as brand investments including DTC next year, as well as our medical affairs investments to support the launch.
And then -- hey Tazeen. The way I’d answer that question on targeting is a couple of ways. In many ways we already have a fairly good footprint. For an example in the Parkinson’s disease area and in long-term care. And mostly in long-term care we also call geriatric psychiatry and we will have to go deeper obviously with some physicians for example with their highly and Lewy Body as an example. That would be an expansion within neurology.
And then there are going to be physicians that we are going to be expanding into psychiatry and what we call dementia care specialists, which are pseudo specialists physicians who are treating a lot of elderly patients and act like the de facto specialist dementia care specialist in their general location.
I would also say from a facility and academic perspective, we have a good coverage of the key academic centers and the LTT facilities, obviously, there will be more patients on a magnitude basis that are DRP versus PDP. So the audience and the patient opportunities are going to be larger.
But we already do have a group focused on these key academic centers and those LTC facilities and we will have to expand a bit in terms of long-term care, specifically around memory care units that they are within long-term care facilities.
Okay. Thank you.
Thank you. Our next question comes from the line of Salveen Richter from Goldman Sachs. Your line is now open.
Hi, everyone. Thanks for taking the question. This is Andrea on for Salveen. Maybe a question for Steve a big picture. Just as you think about the PDP transactions you outlined, how are you thinking about additional ones on this forward and is it likely to be similar first or last stage asset?
Yeah. Great. Thanks for the question. I am going to -- I will start take a little bit of running start at it. So going to kind of transactionally is an important part of our strategies. I think we have been really clear.
It’s important for a couple of reasons. One is we built I think a really highly competitive capability in both the R&D space and in the commercial space in the CNS therapeutic area. So we want to make certain we take advantage of opportunities to further leverage those capabilities and that infrastructure that we have.
We started early, we started early for a reason. We wanted to be able to be strategic and judicious and that’s what we have done. But I have been very clear that you will see more deals coming from us. You know sometimes we don’t always have the luxury of being able to pick the precise profile for a deal and match it up with timing that that precise timing.
And so I can’t tell you whether the next deal will be early-stage deal or late-stage deal, but I will simply say, we have done both so far. Obviously with Trofinetide, we have bought a Phase 3 -- program in Phase 3. With the Vanderbilt collaboration we have got a program in Phase 1 and with CerSci we have bought a program in Phase 2 already.
So I will just simply say there will be more deals and the same criteria that have driven our deal decision so far will continue to drive additional deals. One is, we start with science. So it has to be compelling scientific and medical case.
Two, we do a very good job I think of doing a cradle to grave analysis of assessing assets all the way through a projected lifecycle of products that we do a very full commercial assessment even when we are looking at very early-stage assets, and then, of course, there has to be a good fit for our infrastructure and strategy.
Thank you. Our next question comes from the line of Paul Matteis from Stifel. Your line is now open.
Hey. Great. Thanks so much for taking my question. I thought that pimavanserin all-cause mortality poster comparing the drug to a typical was super interesting. Are any of the FDA authors on that poster also involved in the DRPS and DA review? I know David Graham is a senior pharmacovigilance guy. Have you spoken to any of these authors and do you still kind of correspond with them? Thanks.
Serge, do you want to take that question?
Yeah. To our understanding, people from the FDA involved in the result would come from the drug safety and pharmacovigilance, their group. We are not aware of anybody from the division being involved in these.
But obviously this group is involved in any review of the applications. So they certainly did and this group has been involved as well in the reviews on the safety of pimavanserin as is involved on the ongoing basis.
And to your second question, no, we did not have any direct communication. We are looking forward. We are obviously encouraged and find it very interesting and it’s in line with how we understand the safety of pimavanserin.
But certainly looking forward to maybe a manuscript or publication where we would have a little better insight into the data and methodology apply for this. So at this point all our knowledge comes from simple poster presentation.
Got it. Great. That’s very helpful. Thanks so much.
Thank you. Our next question comes from the line of Jason Butler from JMP. Your line is now open.
Hey. It’s Roy in for Jason. Thanks for taking our questions. Just hoping, maybe I missed it but you could characterize a bit your current level of in-person interactions with healthcare providers? And how do you think it compares to the broader field, we have heard that offices have opened up for patients, but not necessarily for reps. So, can you just give a little characterization around that? Thanks.
Michael, do you want to speak to that?
Sure. Yeah. Thanks for the question. Obviously, it is a hybrid patch of different conditions throughout the country. So we leverage a sophisticated algorithm with our medical team to look at the COVID exposures. We look at local practices that are going on with these facilities in offices.
And so I would only be allowed to answer that question in general by it varies by region and by channel. And I would say that long-term care facilities is one channel and then physician offices as another channel. And I would just characterize it ranges I would say, between, probably, 25% to 75%, depending on the territory region channel situation that we look at.
Okay. Great. Thank you.
Thank you. Our next question comes from the line of Yatin Suneja from Guggenheim Partners. Your line is now open.
Hey, guys. Thank you for taking my question. Just wanted to refresh some of the harmony data with you guys, I think one of the pushback or things that we consistently hear is that, if you look at the 12-week data I think some might say that not all dementia subset performed equally well and then we have not really seen the double-blinded portion. So perhaps could you maybe talk about the consistency of effect among different dementia subtype that you see in both the open-label and randomize that gives you confidence for a broader label for this a particular subset? Thank you.
Serge, do you want to take that.
Oh! Yeah. Absolutely. Well, the data that we presented, particularly, when you look at the open-label data with the simplest or subset of different dementia subtypes are larger and we see over 12 weeks of fairly consistent actually a response to pimavanserin treatment.
The overall response rate, as well as individual subtype response rates are very cohesive and consistent and we presented that data the last year’s sheet head meetings. So, obviously, some subtypes are represented with fewer patients just based on the pure epidemiology of the disorders and that may affect a little bit of the variability.
But the overall there is a high level of consistency in terms of the strong response, as well as whether you look that on the proportion of responders or you look that based on the overall decrease on the subs H&D score over the 12-week period. In both aspects we do a sequence consistency.
In terms of the double-blind stage, first of all, the analysis is prospectively defined for the overall dementia related psychosis. But when you look at the subtypes obviously the numbers rapidly becomes very small and it’s very difficult to actually on spar some subtypes to draw conclusions.
But the -- but those that are represented better we do see a fairly consistent response in that -- in the double-blind section as well. So I would little bit disagree with the characterization that there is a variability in the response that we are seeing.
Got it. Very helpful. Thank you.
Thank you. Our next question comes from the line is Alan Carr from Needham & Company. Your line is now open.
Yeah. Thanks for taking now open. Coming back to marketing, so your SG&A budgeted, is this going upon 4Q, which is still bringing your guidance down for spent for the year. I am wondering what -- to what extent that’s related to COVID-19. And Michael I am curious about your perspective on how much COVID-19 has changed marketing in specialty drug and or some of the changes permanent? Thanks.
So, Elena do you want to go first then Michael?
Yeah. So the extremely are largely due our flatted the current operating environment and while we are returning to in-person engagement in the fields as when possible Congresses and speaker programs and other engagements continue to be virtual. Michael, do you think the second piece of the question?
Yeah. Thanks, Alan. I think the opportunities the way I would describe it in a COVID environment is really shore up the muscle digital and remote engagement and so I think from standpoint ACAD and many other companies are building capabilities that I think are going to sustainable and leverageble in a future environment. So I think that’s a benefit.
I am certainly pleased that we have seen a response in our -- to our marketing tactics and getting back to pre-COVID expectations and in part I think that speaks to the value of the drug and the brand loyalty and exposure that we have and we will be using that I think to leverage and expand upon when we get to DRP.
But I think that is without question a commercial organization is stronger in a face-to-face environment. I think that’s clear. And so we are I think all of us or looking forward to getting back into face-to-face interactions. But I think the mix will be enhanced with digital and remote tactics and to leverage telemedicine to leverage virtual engagements more on the web and through other tactics.
So I think the mix is going to shift. But I think I don’t think going away from face-to-face tactics. I don’t think that is -- I don’t think that’s not where our best promotional commercial foot is put. I think we are better off with a face-to-face interactions.
Sure. Great. Thanks for taking my questions.
Thank you. Our next question comes from the line of Gregory Renza from RBC Capital Markets. Your line is now open.
Hey, Steve and team. Thank you for taking the question and congrats on the quarter. Steve, just wanted to focus on Europe for a moment and perhaps you could just provide your latest refresh views on the plan to unlock value with pimavanserin now that we are getting closer to 2021 and the potential DRP approval here state side? And perhaps just analogously just thinking about the schizophrenia trial that launched this quarter, just curious if you had any thoughts about how that is progressing given that it’s in Europe and the foresight of any potential impact with cases of COVID-19 there? Thank you very much.
Yeah. Sure. I will let Serge answer the second part. So as it relates to -- I always like to say, when this topic comes up, that the value pie for the pimavanserin is heavily weighted to the U.S. There is value outside the U.S. and we want to make sure that we leverage every element of value that exists.
And as it relates to launching in Europe, I will start there, our view has been that we made a decision a couple of years ago to frame ship things to try to get a better opportunity to get more indications within the same period of exclusivity.
We have a global launch strategy that expands beyond Europe and with a certain sequencing that we anticipate going through. And at this juncture, I would just simply say that, we are not quite yet at a point where ready to reveal more and to talk more specific timelines for submissions outside of the U.S.
But I would just simply say that we have a global -- coordinated global plan for doing that and as we progress in this frame shipment strategy that are described we will come back and speak more to it. Serge, do you want to take this schizophrenia question?
Yeah. Sure. Our second pivotal trial in negative symptoms schizophrenia ADVANCE 2 is progressing well. Now it’s early in the study. We initiated it in the mid-summer. So these are early months. But we are seeing very good interest than initial involvement, as well as scaling up the sites or the trial. It is done in Europe.
And to your question related to COVID, obviously, it’s -- although it’s very difficult to make any generalization, because there is a certain level of variability from country-to-country, how they are approaching COVID and to what extent.
I think overall -- in some countries obviously it’s slowed down, but overall in the trial, we are so far pleased how things are progressing and the progress we are making. So that’s generally the situation with the study.
That’s great. Thanks guys.
Yeah. Thank you.
Thank you.
Thank you. Our next question comes from the line of Danielle Brill from Raymond James. Your line is now open.
Hi, guys. Good evening. Thanks for the question. So I was just wondering if you could provide some color on any discussions that you have had with the agency and how the Black Box warning might be addressed for the DRP label or if those haven’t been initiated yet at what point during the review process do you think those conversations might start taking place? Thanks.
Serge, do you want to address that?
Yes. Hi, Danielle. The -- we -- it’s early in the review process to -- for that sort of a discussion, usually that, of course, toward the end of the review process when the labeling is discussed. So there is -- there were no any specific discussions with the FDA related to the Box warning other than us and them discussing the overall extent of the safety data that we will be including in our supplemental NDA.
And then I do want to repeat here that we feel very comfortable and confident in both efficacy and safety package that we included in the supplemental NDA and definitely it’s the largest database -- safety database in this patient population that we are aware of. So we are comfortable with that. But it’s too early and obviously mature for those kinds of discussions. So we didn’t expect that, but expect that towards the end of the video.
Understood. Thanks for the question.
Thank you. We have time for one more question. Sumant Kulkarni from Canaccord. Your line is now open.
Thanks for taking my question. So from a commercial perspective if a disease modifying product is approved for Alzheimer’s disease and is on the market, do you foresee any competitive impact at all for allocation of the payer reimbursement dollar pipe for symptom management products such as pimavanserin when you hit the market next year for DRP?
Yeah. Thanks for the question. Michael you want to start?
Sure. Thanks for the question. I think stepping back it’s really important to remember that in the dementia space caregivers and patients have been waiting for some innovation for a very long time. It’s important to note that dementia related psychosis today is an unmet need with no approved medication.
And so frankly we take the view that both pimavanserin and the Biogen products are treating different indications. But the increased attention on available treatments for caregivers and patients in this space would be a very good thing. And so, I think, we don’t view this as a take away. We view it as a net positive to market attention of a disease state that has been underserved for a long time.
Got it. Thanks.
Thank you. Mr. Davis, please proceed to closing remarks.
Great. Thank you, Operator. Just want to say thanks again everyone for joining us today. We very much appreciate your time and look forward to updating you on our progress next quarter.
Thank you for your participation in today’s conference call. This concludes the presentation. You may now disconnect. Good day.