Neurocrine Biosciences Inc (NBIX) 2017 Q3 法說會逐字稿

Good day, everyone, and welcome to Neurocrine Biosciences Reports Third Quarter 2017 Results.

(Operator Instructions) Please note, today's call is being recorded. (Operator Instructions)

It is now my pleasure to turn the conference over to Kevin Gorman, CEO. Please go ahead, Sir.

Thank you very much, and welcome, everyone, to our Q3 call. Before I get started, I will be making forward-looking statements.

So Jane, could you please read our Safe Harbor statement?

Yes. Of course, certain statements made in the course of this conference call that are not historical statements, may be forward-looking statements, which are subject to risks and uncertainties. Information concerning factors that could cause actual results to differ materially from those contained in or implied by the forward-looking statements is contained in the company's SEC filings, including but not limited to the company's annual report on Form 10-K, quarterly reports on Form 10-Q and in today's press release.

Copies of these filings may be obtained by visiting the Investor Relations page on the company's website.

Any forward-looking statements are made only as of today's date, and we disclaim any obligation to update these forward-looking statements.

Kevin?

Thank you very much, Jane. I'm joined here today on this call with Tim Coughlin, VP of Finance; Chris O'Brien, Chief Medical Officer; Eric Benevich, Chief Commercial Officer.

I trust you've all seen our press release that has gone out and leave it to say that we continue to be very pleased with the launch of INGREZZA.

I'd say by far the most satisfying aspect of this launch of INGREZZA has been our ability to meet with patients who have been treated with INGREZZA and seeing the impact this has made on their -- the positive impact it has made on their lives. And then obviously, it is very nice to see how the drug is being received out there in the marketplace. And Eric is going to go into that in some detail.

Just a couple of things that I'd like to say at the outset, it's still early days in this launch. And I know that many of you, you'd love to have a lot of data around this new patient -- the new Rxs versus total Rxs, length of time to refill the patient mix and it goes on and on and on. Unfortunately, we're not going to be sharing those as of a yet. It's still way too early in the launch for us to be drawing any conclusions from any of this, other than to say we're very happy with how this is going. So I ask you to be patient and hang onto those because at some point in the future, we will be answering those questions.

The other caution that I want like to give you is, is that, we've been on the market now. It's just over 6 months, going on month 7. So we're getting more and more data, and you now have 2 numbers to work with: the number that we gave you, approximately $6.3 million in net sales at the end of the first 2 months; and then, now north of $45 million in Q3 here, which is our first full quarter.

I just want to caution you, don't draw a straight line now that you have 2 data points on this. While the launch is going really nicely, there's a number of moving parts that are going here, not the least of which, as you are well aware of, we just introduced the 80-milligram dosage form. And we only took a very slight price increase of the 80 above the 40-milligram dosage form. And it is the recommended dose, and it does give substantially more efficacy without any -- a hit to safety as the dose is doubled, and yet, it's only priced about 18% above the 40-milligram. But what that means now, as the patients are transitioning, as the scripts are all transitioning from 2 40-milligram scripts to 1 80-milligram script, is that the speaking broadly, each script is -- going forward is worth approximately half as much as it has been in this first 6 months of the launch.

Now the other aspect going forward is that this quarter, the fourth quarter, this is going to be where the full impact of Teva entering the market is -- we're going to realize. And Teva is a very good company, and they've got a lot of resources. So we need to be able to see how the 2 of us out there in this marketplace, how that's going to play out.

And then the third thing that I would add is in this quarter, our sales force is out of the field for approximately 1 week while I have -- while we have our national sales meeting and put extra tools in their tool bag to be able to work with.

And so those 3 things together, I would caution you as while we anticipate having month to month more patients on therapy, that's not going to translate directly into an increase that one would expect with net sales because of these things.

So that is the cautionary statement I'll put out there. But I'll reiterate obviously, we're very happy with the way the launch is going and all the feedback that we've been getting from patients, from healthcare practitioners, and that means psychiatrists, neurologists, nurse practitioners, nurses and medical assistants.

Also, as Eric will be going into a bit more detail on, I continue to be pleased with the reimbursement and how that is moving along.

So in addition, we're going to go over our development programs. And again, I really have to take our hat off to our partner, AbbVie, where, you can see by their 2 releases that have gone out over just the last week or so, on elagolix, they've gotten priority review, and they've got multiple important presentations. It was at ASRSM yesterday and today. So Chris will be going through that, and he's going to update you on the significant progress that we've been making with the rest of our pipeline.

So what I'm going to do right now is turn it over to Tim to go into more details on the financials.

Good afternoon. I'd also like to thank you for joining us on today's call.

As Kevin stated, the third quarter of 2017 is very productive on both the commercial and R&D fronts. And the fourth quarter is continuing this positive trend.

Since our launch on May 1, 2017, INGREZZA has shown strong, continual month-over-month of growth in prescription volume over the initial next 6 months.

During the initial 2 months of sales recorded net revenue of just over $6.3 million or the equivalent of approximately 745 prescriptions filled. During the third quarter of 2017, our first full quarter of INGREZZA sales, there are the equivalent of approximately 5,100 total prescriptions filled, representing net revenue for the first full quarter of sales of $45.8 million.

We're using a sell-in methodology for revenue recognition. This means that we recognize product sale revenue when the drug arrives at the select pharmacy or select distributor's warehouse. The other revenue recognition method, typically employed by pharma companies, is called sell-through, where a company records revenue upon the fulfillment of a prescription to a patient.

Beginning on January 1, 2018, the accounting rules are changing for revenue recognition, and all companies selling pharmaceuticals will no longer be permitted to use a sell-through model and will migrate to a sell-in method of revenue recognition. We, as a company, made the election to early adopt this change in accounting rules. We determined it was easier for both the company and investors to understand an early adoption of the new accounting rules for revenue recognition rather than switch from a sell-through model to a sell-in model, a short 8 months after launch.

I would also note that the difference between revenue recognized using the sell-in versus sell-through methodology is quite small. This difference arises from inventory that has been shipped to distributors or pharmacies but not yet used to fill a prescription. The amount of drug in this shipment of our supply channel, i.e. the shipped -- drug shipped to a distributor but not yet sent to the patient is less than 1 week of scripts.

Research and development expenses increased to $22.5 million during the quarter compared to $20.9 million in the same period in 2016, principally due to an increase in headcount in R&D.

For the 9 months ended September 30, 2017, R&D expenses were $96.2 million compared to $71.7 million for the same period last year. This increase is primarily due to a $30 million payment in the first quarter related to our exclusive licensing agreement with -- for the development and commercialization of opicapone in the United States and Canada. This was expensed in early 2017 as in-process R&D.

SG&A expenses increased to $43.9 million for the third quarter of 2017, up from $17.5 million for the third quarter of 2016. For the 9 months ended September 30, SG&A expenses were $113.6 million compared to $44.4 million. This increase in SG&A is almost entirely due to commercialization activities for INGREZZA.

Our loss for the quarter was $11.1 million or $0.13 per share compared to the net loss of $36.9 million or $0.43 per share for the same period in 2016. For the 9 months ended September 30, 2017, the company reported a net loss of $149.4 million or $1.70 loss per share as compared to a net loss of $96.4 million or $1.11 loss per share for the first 3 quarters of last year.

As Kevin mentioned, we are very pleased with the company's performance for the first 9 months of 2017.

And now looking forward to the next quarter, starting with revenues. In terms of milestones from our partners, we have earned a $30 million milestone payment from AbbVie due to the acceptance of the elagolix NDA for endometriosis for priority review. The NDA was submitted in the third quarter, and acceptance by the FDA occurred in October, which is generating this milestone. We expect payment from AbbVie later this month.

Pharmaceutical sales of INGREZZA continue to progress with continuous month-over-month script increase. In addition, we have added the 80-milligram dose to the mix in mid-October. The 80-milligram capsule, as Kevin mentioned, is at a price point that's approximately 18% higher than the 40-milligram dose.

Regarding expenses, our cost of product sales should remain at approximately 1% of net sales for the next quarter and into the middle of next year.

All of the active pharmaceutical ingredient utilized thus far in the production of INGREZZA commercial product was produced prior to FDA approval and was appropriately expensed at the time of manufacture. This also limits the value of our inventory on our balance sheet at September 30.

SG&A and R&D should remain relatively stable at third quarter levels as we move into the final quarter of 2017.

Finally, we ended the third quarter with total assets of $772 million, including cash, investments and receivables of $754 million, a strong cash position to continue to drive our launch of INGREZZA.

I'll conclude all of my prepared remarks here, but for those looking for additional details, our 10-Q is on file with the SEC.

And with that, I'll turn it over to Eric.

Thanks, Tim.

Q3 was our first full quarter on the market following our INGREZZA launch midway through Q2, and I'm pleased with both the execution by our team and the results they achieved as we continue to build the TD market and customer preference for our products.

As I stated on our previous earning call back in August, it's still very early in our launch process. We're executing on a commercial plan that is focused on several key strategic imperatives: educating healthcare providers or ACPs to help them better recognize and diagnose TD, building awareness of INGREZZA as a new breakthrough treatment for TD and supporting patient access through our patient services hub, and engagement with payers to support broad reimbursement.

So let me provide some color on some important initiatives. Our efforts to educate ACPs on tardive dyskinesia are primarily driven to our specialty sales team. And key resources for them to educate on differential diagnosis include a series of video vignettes showing TD patients with a range of uncontrolled movements across multiple body regions, including the face, neck, trunk, hands and feet. In addition, we are investing in peer-to-peer programming, presence at key medical meetings and other initiatives to reach our target audience with our TD educational messages.

Our promotional efforts are focused on private practice and community mental health psychiatrists as well as a strategically important subset of neurologists that specialize in movement disorders. In addition, we have increased call activity to advance practice registered nurses and other allied health professionals that are critical providers of care to patients with TD.

In Q3, we invested in a significant commercial presence at important medical meetings, including the U.S. Psychiatric & Mental Health Congress and the American Psychiatric Nurse Association annual conference, where we hosted exhibits with strong boot traffic and organized product symposia that drew very large crowds.

In addition, we conducted a series of well-attended national broadcast webinars featuring thought leaders talking about TD and INGREZZA. And we've expanded our speaker's bureau to support increased peer-to-peer speaker program activity.

These programs serve as educational forums for healthcare professionals, who wish to learn more about TD and INGREZZA and critically serve as a mechanism to allow HCPs to discuss their initial experience with the product.

Throughout the launch, we have been very pleased with the early feedback from those that have treated their first cohort of patients. Psychiatrists, movement disorders neurologists and allied health professionals have been very receptive to our educational focus on TD and our messages about INGREZZA as the first FDA-approved treatment for TD.

Key product attributes, such as significant efficacy seen as soon as 2 weeks; long-term, sustained efficacy demonstrated out to 48 weeks; lack of language in the prescribing information that limits patient candidates such as contraindications or a box warning; the clean tolerability profile; compatibility with common psychiatric medication regimens; and simple, once-daily dosing are differentiating and motivating for initial product trial.

As treated patients start to flow back through the practices, the significant improvements in TD symptoms that HCPs observe and the feedback they hear from patients serve as drivers for expanded use within those practices.

Most importantly, the many patient success stories we are hearing from prescribers across the country serves as validation that INGREZZA is performing in the real world as good as it did in clinical trials, and that's highly motivating to our team who are committed to helping patients get better.

Most recently, we received FDA approval for our 80-milligram capsule. 80-milligrams daily is the recommended dose, but from the time of launch until a few weeks ago, we only had a 40-milligram capsule available. So patients being treated were taking 2 40-milligram capsules once a day.

Now with the availability of our 80-milligram capsule, we can offer the benefit of 1 capsule, once-daily dosing, the only VMAT2 inhibitor that can make that claim. The new, even simpler dosing has been embraced by our prescribers, and our network pharmacies are dispensing the 80-milligram capsule to both new and existing patients as their refill.

With regards to market access, we continue to see reimbursement of INGREZZA across all segments of the payer landscape, including commercial Medicare Part D and Medicaid plans. Our national account team has been engaged with payers to ensure that they develop coverage policies that are medically appropriate and consistent with our data and labeling.

In most instances, when INGREZZA is prescribed, the requirement from the health plan is simply that the HCP submit a prior authorization form confirming the patient's diagnosis of TD. The pharmacies and our network provide assistance to the HCPs with any administrative requirements from the plan as well as exploring financial assistance options for the patients to ensure that their treatment is affordable.

And for those patients without insurance, we have a patient assistance program that provides medication free of charge.

In addition to the affordability and other support services we offer through our program, we also recently rolled out a 37-day free trial offer. Essentially, we are allowing patients a trial of INGREZZA for 1 week at the initial 40-milligram dose, and then 4 weeks at the recommended 80-milligrams dose to determine if INGREZZA is improving their TD symptoms and is tolerable. HCPs typically choose to submit a prescription along with the free trial requests, so in effect, the free trial usually occurs in parallel while reimbursement is being secured from the patient's health plan.

Our commitment is to help ensure that patients that need access to INGREZZA get access to INGREZZA, and all our programs and systems are set up to do just that.

So in summary, we had a great Q3 and accelerated the momentum of our early launch. We are excited to be providing a true, breakthrough treatment for patients living with TD. Our sales team has introduced INGREZZA to their target customers in neurology and psychiatry, and we are seeing adoption across all sites of care, specialties in TD patient types as well as across all geographic regions. Our payer accounts team continues to proactively work with formulary decision makers, and they have been successful in securing coverage.

Tardive dyskinesia is a brand-new market, and we are introducing a whole new treatment paradigm. We recognize that it will take some time to educate the many thousands of HCPs and change the ingrained behaviors that they have developed over decades. But we have a highly differentiated product, a highly motivated team, and we are committed to making a difference for people living with TD along with their loved ones.

So with that, I'll turn it over to Chris.

Well, thanks, Eric -- echo the comments. Thanks for the participants in the call this afternoon.

As Kevin mentioned, I'll provide some clinical updates on our pipeline, specifically 5 programs, which are all moving along well. So let's start with the 2 valbenazine programs.

First up, tardive dyskinesia. You just heard about the commercial aspects of the INGREZZA launch from Eric. We are also very pleased with the engagement that our medical affairs team has been having with scientific leaders, both in psychiatry and neurology. The medical affairs group has been successful with multiple manuscripts recently submitted for publication, including the connect 3 long-term extension data, which has been accepted, and specific subtype patient analyses, psychiatric stability and other topics of clinical importance.

We do anticipate sharing more data at upcoming scientific meetings, including the American College of Psychoneuropharmacology coming up later this year, and a steady flow of data is planned in 2018.

For Tourette's syndrome, we are very pleased that the FDA recently granted us orphan disease designation for valbenazine for pediatric patients with Tourette's. The clinical team is currently very busy with wrapping up the T-Force/Fusion study, which was that open-label extension study, which followed T-Force GREEN. And the data from that Fusion study is important because in conjunction with our exposure-response modeling that we got from the T-Force GREEN study, we were able to come up with a sufficient set of data to design the T-Force GOLD study.

So following the investigator meeting, which was held just is in October, a couple of weeks ago, the T-Force GOLD study is now enrolling pediatric patients. You can see it on clinicaltrials.gov. And as we noted in our press release last week, this new trial is a randomized, double-blind, placebo-controlled trial with 1-to-1 randomization of valbenazine and placebo.

The control treatment period is for 12 weeks, and it is being conducted all in the United States. The trial will randomize approximately 120 patients with Tourette's syndrome, and these are kids aged 6 through 18 years of age.

The design of the trial includes a dose optimization strategy and includes higher doses that were used in the prior Phase II study. Like our other trials, this also will offer an open-label extension trial for those subjects who complete the placebo-controlled portion. We anticipate top line data from the T-Force GOLD study in late 2018. Obviously, that's dependent on the rate of recruitment for that trial.

So huge progress on that. Very excited about those patients beginning to enroll.

Turning to congenital adrenal hyperplasia. This Phase II clinical study with the molecule that we call NBI-74788 is about to begin. We're initiating sites as we speak, and we expect top line data in the first half of 2018.

If you'll recall, based on prior descriptions, our goal with this trial is to confirm proof of concept in adult patients with CAH. With that data in hand, we will then request a meeting with the FDA to discuss study design details for the pediatric study that we hope will follow. So we will have data readout in -- early in the first half of 2018 and keep you updated.

And now turning to our opicapone program for Parkinson's disease. We requested and were granted a meeting with the FDA in January 2018, and this meeting is designed to confirm plans for the submission of the NDA of opicapone for the treatment of Parkinson's disease. As usual with these meetings, the FDA would then provide formal meeting minutes approximately 1 month after the face-to-face meeting. So we'll keep you updated on that.

As Kevin mentioned, we are really happy with the progress with elagolix that has been made by our partners, AbbVie. They have done a tremendous job in not only generating high-quality data, but now beginning to share that data across a range of scientific meetings and publications.

So after the really pivotal publication in the New England Journal Medicine recently, they're now rolling out additional long-term safety and efficacy data out to 12 months of treatment. And I won't go into all of the details about the abstracts. You can read them for yourself from the American Society for Reproductive Medicine going on this week.

But let me point out 3 key things that I take away when I look at these data. Number one, when you look at the efficacy of elagolix for the treatment of endometriosis in patients who have taken elagolix for a year, what you see is a remarkable persistence or maintenance of benefit, such that with the primary end points of dysmenorrhea and non-menstrual pelvic pain in these 2 large extension trials, it's remarkable to see this 70 to 80 -- sorry, 50% to 80% responder rate for both dysmenorrhea and non-menstrual pain. That's remarkable. With a chronic pain syndrome that has been extremely difficult to treat, often requiring surgeries, opiates and other forms of aggressive intervention to have this kind of responder rate is remarkable. And this will resonate well with clinicians who take care of these patients.

As important, or maybe more important, is how patients feel. And the tool used to assess this has been the Patient Global Impression of Change or the PGIC. After 12 months of treatment, the responder rates in these 2 long-term trials range from 70% to 90% responders who described their response as much improved or very much improved. So this is a robust response as judged by the patients, and really speaks to the potential impact that elagolix will have for -- in women suffering with endometriosis

The flip side of the question that I'm always asked is, "Yes, but at what cost? What's the safety profile?" AbbVie has done a really done a good job talking about that. I would point out there are some very interesting data about bone mineral density in their presentations. And if you look at, for example, the z-scores that are used to describe whether women's bone mineral density is in the normal range or not, you see remarkable numbers. And that women on chronic therapy with elagolix for up to a year are all in the normal range with their z-scores. It's quite remarkable data, very, very encouraging for the drug.

For the 200-milligram BID, without add-back, there is a slight widening of the confidence intervals around the z-score that is suggesting that there are a few more patients with more measurable reduction in BMD on the higher dose. But in their follow-up data, after stopping drug, you seen that the BMD tends to progressively return towards baseline in the post-treatment period for those high-dose individuals.

Lastly, the only other comment I'd make is some remarkable data has been generated in the uterine fibroid studies. As you know, there are 2 replicate trials currently being conducted with top line data from those Phase III studies expected at the end of this year. The data presented by AbbVie at ASRM includes some really powerful data on the impact of elagolix on health-related quality of life for women suffering with heavy menstrual bleeding and uterine fibroids. And again, the data here has really not been seen before in programs like this. This is a remarkable impact across all areas of the quality of life domains, including activities, self-consciousness, sexual function, energy levels, et cetera. So the kind of data that is important, not just to physicians and patients, but also to payers. So congrats to our colleagues at AbbVie for such outstanding work.

So with that, that's an update on the 5 programs that are currently active in the clinic.

I'll turn it back to Kevin, and look forward to your questions.

Thanks, Chris.

There's a lot of very good data that we've just shared with you, financially, commercially and from our pipeline.

So at this point, I would like to open it up for questions.

(Operator Instructions) Our first question comes from Charles Duncan with Piper Jaffray.

First of all, thanks for taking my questions. I just have one commercial question, one pipeline question, and maybe a question for Tim. So on the commercial question, I know you're not really going to talk about number of prescribers or scripts per prescriber or even patients on drug. But now that you've had, call it, 6 months of some experience, and some of those patients may have been on the drug for a while, I'm wondering if you have a sense for percentage of patients that have come off the drug using the 40-milligram tablet, and if you think that, that percentage is going to contract or reduce or you might be able to pick up those patients again with the 80-milligram tablet going forward.

Charles, I guess, you're asking us, if I can paraphrase is what is the persistence of each patient in taking the drug. And again, while we're pleased with what we're seeing, we don't feel comfortable in putting this out there because it is such a short period of time, still. And part of this goes to the fact that the physicians that will start only a very small number of their patients on drug, and then they will wait usually about 3 months later to see their patient. Again, see how they're doing, get their input as well as making an evaluation themselves into this. So as you could imagine, being out about 6 months, that's still a very small number. So we're not going to draw a whole lot of conclusions based on that small number now. So give us more time. And when we feel comfortable that what we see is real and we -- it really reflects how the market's going, then we'll be happy to share that.

So you feel good about persistence, but is it logical for me to assume that 80-milligram tablet may actually be slightly better than 2 40s?

As far as an 80-milligram tablet being better, they're bioequivalent. And as a matter of fact, in our clinical studies, the patients were given 2 40s throughout that. That was our 80-milligram dose, 2 40s given at the same time once a day. So there's no reason to believe that a single 80-milligram tablet behaves pharmacologically any different than taking 2 40s simultaneously.

It's just easier to take. So moving on to my pipeline question for Chris. I guess I'm wondering with regard to the GOLD study, you're changing a little bit, the end point. And I'm just wondering how you feel the Premonitory Urge for Tics Scale compares to the Yale Global, and if you feel good about using that one in that study, and how the previous study informs the use of that.

Charles, I'm taken aback here, just a second, and I hope something didn't happen that you're describing. We did not change anything about the primary endpoint. It's the Yale Global Tic Severity Scale that's used, not the Premonitory Urge. The Premonitory Urge is an exploratory or secondary endpoint, and we've had that in every study.

Okay, my mistake. We read it wrong. And then on opicapone, you suggested that you might be filing an NDA. But I guess, we're assuming that you would still need to do a Phase III. Is that still the going-in assumption?

I mean, our base case has always been -- and what we said publicly is we assume we'll have to do a Phase III study, but we'd really rather not do a Phase III study. So that's the question that we're going to bring up with the FDA.

Okay, last question is for Tim. Quick question for you on inventory. I think you said it's about a week. So really, is that the case? And has it been shifting over the course of the last 6 months?

No, I think what we have, we have plenty of inventory to basically fill the pipeline. What we have sitting in inventory basically at our select pharmacies and select distributors is somewhere a little less than a week sitting on their shelves. So that's drug that's been shipped to them. We've recognized the revenue on that because it's been shipped to them, but they have not distributed to them. That's probably more like 3 days. They order, on average, every 2 to 3 days.

We'll go next to Paul Matteis with Leerink.

Just a few questions for you. First, I was wondering if you could quantify the difference in what revenues would have been on the sell-in method versus the sell-through method and whether or not any change in inventory in the quarter could have had an impact.

This is Tim. So we use sell-in. Sell-through, as I described, is when you recognize revenue when it's prescribed to patients. So we actually did a back-of-the-envelope calculation, and the $52 million we've recognized in revenues so far under sell-in. Had we been recognizing under sell-through, it would be about $3 million to $4 million less. It's a rough estimate because we don't know exactly the fill of all the scripts on the other side and the timing of that. But that's about what it would be. So not a huge difference at all. And as I just told Chaz, we're talking about roughly a little less than a week's worth of inventory there, so that all lines up. It's somewhere in the neighborhood of 6% would come off the top.

Okay, okay, that's helpful. And then could I just ask about gross-to-net adjustment dynamics? So right now the drug's not on formulary largely? Once you get on formularies and get into the whole contracting element of the strategy, do you expect gross to net to go up over time? I guess I don't have a great understanding of what the gross to net should be at this stage from the launch versus, say, 1 year from now.

Yes, I guess, without -- as we said, we're not going to be giving specific guidance on gross to net, so I'll take a first stab at this. Is that, there are no plans for us to do contracting with this product even in the near future. So that's not going to be something that will be changing our gross to net from that standpoint.

And the thing I'll add, and I'll let Eric chime in, too, is that our gross to net has been pretty steady over the first, let's call it, 5 months, so Q2 and Q3. We're happy with it. Our estimate and the bills that came in Q2 were pretty much spot on, so we're also happy with that. And again, as Kevin said, contracting is really where you see the compression in gross to net as well as, as you pick up more Medicaid business, that will also impact your gross to net. If you'll recall, we were just getting on the Medicaid listings. We did have Medicaid business in Q2, but obviously, picked up in Q3.

Okay. Okay, fair enough. So just to clarify, you guys expect formularies and PBMs to carry both VMAT2s and reimburse both, and it's not going to be a contracting battle?

What we anticipate is that the formularies will be carrying our drug. I can't speak for the -- anything about Teva's drug.

Okay. And if I just -- if you don't mind me just having one last question, which you probably won't answer. So far what are you observing -- we did a physician survey and we found that 30% of patients from our survey were taking the 40-mg dose as their maintenance dose. And I'm not sure if this was just a sampling error or if this is accurate. So what are you seeing in the channel?

Paul, it's Eric. What I can say is that the vast majority of prescriptions that are written are for 80-milligrams a day at maintenance. And I think that there may be some patients that are inadvertently taking 1 40 instead of 2 a day. As we transition over to the 80-milligram capsule, as new patients are starting and refills are happening, I would expect that dynamic would decrease. But certainly, I think what you saw in your research was a little different than what we're seeing in terms of the pattern.

We'll go next to Ian Somaiya with BMO Capital.

First, would love to get your take on the recently published ISR report, the draft evidence report, just the analysis and the conclusions they reached. And then separately, I don't know if you have any updated thoughts on the development of valbenazine in Europe?

Ian, Chris here. With the ISR report, obviously, we've seen the draft and we applaud that ISR has reached out to other companies and patient groups to seek input on this draft. They have a formal meeting coming up in December where input from various groups will be taken into account. The fundamental question that we would raise is for an indication like tardive dyskinesia, where we have evidence of efficacy as measured by rating scales and a clinical trial. You don't have what ISR normally wants to do to create an economic and utility impact model because there are no monetary assessments of burden of illness and things like that. So its very nature is, you end up making just how much does this drug costs to change the name scale. And they don't have the other pieces that they'd like to incorporate in their model. So it becomes somewhat an unbalanced position. So obviously, we're working hard to try to generate data about the impact of treating tardive dyskinesia through some of our clinical trials and our HEOR research. And over the next couple of years, we may be able to get closer to understanding that impact from a utilization and HEOR point of view. But right now, we think they're in a difficult position because they don't have the data they need to come up with a -- really a meaningful position. And some of the key aspects of why it's important to tardive dyskinesia, as stated quite eloquently by patients and patient advocacy groups, they don't incorporate those things into their model. So as such, it is what it is, but can't really do much more about it.

And Ian, as far as your second question goes, specifically, in Europe. Right now with INGREZZA, our focus is totally on our launch here in the United States and getting the education and this drug to patients here in the United States, and that is our first priority. Secondly, from a business development aspect, we have other priorities with business development right now other than INGREZZA in Europe.

Would this be something you would consider potentially partnering out? I don't know if you've had any sort of inbound interest in the asset outside.

No, we've had a number -- we've had a lot of inbound interest from Europe, it's just not the right timing for us to be able to entertain that.

Okay. And if I just may add one more question. Just trying to understand the importance of the elagolix study in endometriosis where you're looking at add-back, just given you've only had 1 patient that surpassed a Z-Score of 2 based on the data that's released most recently. Just do we need add-back in endometriosis, I guess, is the question.

I can't really speak for AbbVie. But from my perspective, we've always felt that for the majority of patients with endometriosis-related pain, 150-milligram once-a-day dose is a very effective intervention with a great safety and tolerability profile. I think from AbbVie's perspective, what they're looking at is really the full range of potential opportunities for elagolix in the marketplace, and there may be situations clinically where women might be more appropriately managed with high dose elagolix for a much longer period of time, at which point, add-back may be useful but that would be a good question for you to add them. Base on the data that we have today, do you need add-back for getting elagolix to market in helping patients, No.

And also just to reiterate with Chris said, the 150-milligram dose. The difference in efficacy between the 150 and the higher dose is not that great and it continues as it was in AbbVie's hands as it was in our hands, really looks quite neutral on both.

We'll go next to Geoff Meacham with Barclays.

The first on commercial, I know, Kevin, you probably want to answer this. But I want to get your perspective. What you see today, do you feel like the number of patients with TD is more than you thought or do you feel you're reaching that number quicker? And maybe just help us qualitatively with some of the prescriber bases, namely the psychiatrists, that you feel like who are initially going to be lagging adapters and maybe need to come up the learning curve on the signs and symptoms of TD and maybe your -- just any sort of metrics that you could give us with that patient or that physician subset and then one follow up for, Chris.

Share. So thanks for the question, Geoff. What I will say is that, we've only just scratched the surface of this patient population. As I've said for nearly 2 years, expect a slow but progressive growth month over month, quarter-over-quarter as we launch this drug. But somewhere around quarters 4, 5 or 6, that's when you're going to start -- the market will start truly revealing itself. So we're quite pleased, we've done very well to date, but we have just barely scratched the surface of this marketplace. And we have lots of data that leads us to believe that. And when it comes to the prescriber base, as we've said before, and this has held true and now through the launch, that about 75% or so of our effort, our promotional effort is with psychiatrists and maybe 20% to 25% with neurologists. We -- so you're seeing that the way that, the scripts are breaking out is approximately the same with both of them based on that and that was based on who sees the patients. So the vast majority of TD patients are seen by psychiatrists. The -- having said that, most of our sales force time is still spent on education to the health care practitioner. Whether we're talking about a neurologist or whether we're talking about a psychiatrist, they'll recognize TD when it isn't above the neck I will say, the oral-facial TD. Where a lot of the education comes is the TD in the other body areas, that's what they miss attribute to other things, and that's where a lot of that education is, and then the most appropriate way to treat that is where the education is going. So that, that's -- I hope I answered your question. And Eric, do you have anything to add?

Yes. I mentioned in my prepared comments, that we're focusing on TD education. We're helping various kinds of HCPs, whether it's a psychiatrist or an allied health professional. Whether it's other nursing staff working in these facilities to -- it really help them identify patients that are suffering from TD. And to distinguish it from, especially in psychiatry, this isn't so much issue in neurology, but in psychiatry sort of this paradigm of EPS or extrapyramidal symptoms. And EPS is sort of an umbrella term that used to describe really anything unusual that's happening with these patients after they initiate treatment from a movement perspective. And certainly, it can include things like akatisha and the acute dystonic reaction, parkinsonian tremor and so on and part of our effort here around differential diagnosis is to help those professionals really distinguish TD, which is by default a late-occurring issue versus some of these acute movement disorders that can occur when a patient's initiated on treatment or when their psychiatric regimens are adjusted. So we're helping them to sort of separate TD from EPS. And I think that, that's a big part of, as we continue to develop the market and grow the market is to continue that educational effort in psychiatry.

Geoff, you have a question for Chris?

Yes. So the follow-up and it's just one not 4. It's just that in Tourette's syndrome, if you were to -- if this were to form the basis for filing, I know for the last study, you guys were a little nervous about moving up the dose curve in pediatric patients. But just wondering what gating factors are left and do you have to do, for example, a separate safety, tolerability or any kind of toxicity study? I guess, the potential filing package is the question.

So you've asked 2 separate kinds of questions, Geoff. So from a -- do we have enough data on the -- what is the right dose for the right population, we should get that all from this T-Force GOLD study, but that, in and of itself, would not constitute normally what was necessary for a full data safety package for an NDA. That package wouldn't generally include long-term exposure. And so we have a number of initiatives, obviously, the T-Fusion study was a 6-month study. Remarkably, we had very high persistence of Tourette's patients in that 2 -- T-Fusion study and we actually saw increasing tic reduction or improvement in the long-term study. So it showed us that for -- particularly for those patients that were at the high-end of slightly under-dosed that were doing well. If you just waited another month or 2, they continued to get better. So hence, we now have a 12-week study for T-Force GOLD. Secondly, after T-Force GOLD, we will have an open-label extension study. So we will have now considerable longer-term exposure in pediatric population. And the question then becomes, is that enough data to submit as an NDA and what does the FDA require? Right now, it's way premature for me to answer that, because I don't have a positive study to take to them. I need to have the T-Force GOLD study work well, and then I need to sit down and have a discussion with the psychiatry division about what they would then require for a supplemental NDA. Because we do get to piggyback a lot of the long-term safety data that we have from our tardive dyskinesia program even though it's in a different population, it is useful. And we have completed all the necessary preclinical safety work, including juvenile toxicology studies to support a pediatric NDA.

Our next question comes from Andrew Peters with Deutsche Bank.

I guess, I just wanted to come back to the competitive landscape in TD. And in particular, the formulary front. So I know you guys mentioned that you're not planning to go down the contracting and formulary routes. But I just wanted to get a sense of what your plans are if Teva does decide to be a bit more aggressive on that front. And if any of your initial conversations on the payer side, have suggested that they are waiting to figure out what Teva is going to do before kind of figuring out the formulary positioning for INGREZZA?

Andrew, it's Eric. So there are couple of things. One, we've been focus on educating payers about TD, what it is, who are the appropriate patient types for treatment with INGREZZA and who are the appropriate prescribers. And I think in this early phase of the launch, they've put interim policies in place that allowed them to get visibility on who's receiving prescriptions, who are the doctors that are writing it and so on because they want to get comfort that this drug is going to be used appropriately, consistent with the clinical studies and the label. Second thing is, when we do have conversations with payers, we're not bringing Teva and their tetrabenazine products into the conversation, and typically, payers aren't bringing it in to the conversation either. So far I'd say that we're seeing favorable coverage. And I'm very pleased with where we are in terms of the coverage policies and the way they are being enacted. Obviously, we're continuing to monitor the competitive landscape. We haven't seen any signal of any sort of aggressiveness on the part of our competitor. And keep in mind, that they need to manage their franchise, not just for the TD indication, but also for their other indication in Tourette's. So to sum it up, we're -- excuse me, in Huntington's. But to sum it up, I -- we feel good about where we are with the process and maybe a little ahead of what we're expected to be at this point from a coverage perspective. We are going to continue to work with payers to be sure they understand that INGREZZA is being used appropriately with the right patients and being prescribed by the right doctors.

Our next question comes from Brian Skorney with Robert Baird.

I guess, I heard your comments at the beginning of the call, and not wanting to give too much details around prescriptions. But I guess just to kind of your general thoughts. I think it's surprising to all of us how well this is doing off the bat considering the view and the discussions we've had. This is really kind of a building a market that needs a lot of education, a lot of building. So do you have any changed thoughts on what you think the addressable market for TD in the United States? And then just in terms of next quarter, it seems like there will be a lot of choppiness in terms of what to expect for revenues? Are there any nuances that we should expect there, or if we just assume that there's no growth within new patients, would -- the patients from the last quarter just essentially be revenue cut in half from those patients for next quarter?

Okay, Brian. So yes, a number of things there. I'll take first stab at it. As far as, yes, it's been a nice launch. The launch is going actually to plan. The launch is going pretty much current with our expectations with it. As I've said all along, it's going to be a launch that is going to continue to grow, but over 4 to 6 quarters, you're not going to see a real dramatic growth until after that period of time. So where are we? I'm happy with the launch and I think that our commercial team has done the job, a very good job. But the job that we expected them to do in this patient population. It hasn't changed what we think the size of the market is or what the opportunity of the market is. We've always been very confident about that and we continue to be. Now when it's next quarter, I've kind of laid out for you what I thought are going to impact next quarter, but I'll give it to Eric, to kind of give his views on what he sees next quarter as being.

Yes, so Brian, we are very pleased with the receptivity we've gotten really from a different audiences. Psychiatry and neurology and different sites of care from private practice to community mental health. TD's been a problem for a long time and this is the first category that I worked in where not only was there nothing improved, but there was actually nothing effective. No real viable off-label treatment strategies. And for many people, the choice was either trying to adjust their anti-psychotic regimen or more commonly, do nothing. And so we've brought a real breakthrough therapy. And I think the initial reception that we've gotten is consistent with that. And I did mentioned that the feedback that we're getting from customers is that it's performing in the real world as it did in the clinical trials, which is something that often, there's a little disappointment factor when drugs come to market and the initial experience is not as good as what you expect it to be based on the clinical data sets. We ran our trials in a manner with real patients, very complex patients, with a variety of underlying psychiatric illnesses, a lot of concomitant medications. So these are the patients that are out there that are being treated with INGREZZA. The other thing that I mentioned was that, a lot of our customers have really just treated the initial cohort of patients in their practice. So they think about -- I've got a patient or a few patients that I want to try this on and then I want to see how it does when they come back. And that's what's really driving where do I go next with this medication and how do I sort of proceed in getting that initial experience. Chris?

One other comment I would make is that, I think Brian, I heard you say that something to the effect of no new patients in the fourth quarter, and that is not the expectation. We expect to continued prescribing for new patients going into the quarter. I think Kevin was talking more about revenues rather than new patients.

Yes. I do want to clarify that. We're going to continue to see growth in prescriptions, both in terms of new patient starts and refills. But I think what Kevin was getting at, with his comments is that, there are couple of factors that are unique to this quarter that impact that net sales number. Obviously, introducing the 80-milligram capsule at a price that is -- even though it's at a premium to the 40, it's still substantially less than getting 2 bottles of 40 per month. We are getting patients that are on maintenance that will be getting 1 bottle of 80-milligram capsules per month, so that's about 60% of what that revenue would be previously. Obviously, having a new competitor in the market, there will be some initial trial of that product from our customers that want to get some experience with both drugs. And then I mentioned earlier that we've rolled out a new free trial offer, which is 5 weeks of treatment. And so that may have some impact in terms of timing of prescription fills or refills. So all of these things are events that are occurring over the fourth quarter and as you've said that could lead to some of choppiness. But I do want to reiterate that we expect to see continued month over month growth in terms of new prescriptions and returning patients.

Very clear. No, you were clear on that. I just meant that purely from a modeling perspective, if there are 100 patients on at the end of the quarter, would the expectations be for fourth quarter, the revenue recognized from a full quarter last quarter would be 40% less for those.

Yes. the other challenge with this, Brian. This is Tim, is that you'd expect insurers would want to flip patients from the 2 40s's to the 80s and the timing of that is really dependent by insurer, and dependent by patients. Some patients have a 90-day script, and they're going to let those 2 40s's roll for the next month, where other insurers will flip them more quickly. Those are things out of our control and makes it difficult for us to model it as well.

We'll go next to Anupam Rama with JPMorgan.

Just one from me. I know there's a lot of -- you guys are getting a lot of data in and there are going to be some various factors in the market with Teva being introduced and the 80-milligram dose for you guys. But when you might have enough data and be comfortable with providing some forward yield type of guidance for INGREZZA?

Yes, I would -- Anupam thanks for the question. I would just, right now, say that's something that we'll look at from quarter-to-quarter. But my feel right now is that probably about a year out is where I see that.

We'll go next to Phil Nadeau with Cowen and Company.

First, a question on the impact of Teva. I know you really mention that as a risk factor for Q4 -- a factor to consider for Q4. Teva has been in the market for 2 months. Can you call qualitatively give us any assessment of the impact that you've seen on you patient starts since its launch?

Honestly, no, at this point in time, with them being on the market for such a short period of time. And we believe they have kind of a free goods start to get the patients through the 2 months of titration that they go through. That's why I said that, I don't feel comfortable in saying anything about Teva for this first period of time of the 2 months that they've been on. I really think it's going to be in Q4 where we get our first hint of what it's like with both of us on the market. And as Eric said, it would be reasonable to assume that our customers are going to want to try the Teva drug also.

Yes. One other thing that I would point out Phil is that there is a sort of silver lining to have a second product in the market and that is another team out there talking about TD and making noise and increasing the education level across these different practices. So I've certainly seen this in other therapeutic areas with the addition of second and sometimes third products to market, it really does accelerate the development of the category.

Great. And then second question on Teva. It seems like there's not perfect clarity on the dose that patients are getting on tardive dyskinesia and what translates -- how that translates to a price. Do you have an estimation for what the relative pricing difference is between your 80-milligram pill and the average dose that Teva would be giving to patients, and the price of that dose in tardive dyskinesia?

It's obviously, very early and I don't know that we have better information than you do about what the real world utilization of that product looks like. But from their pivotal trial, the mean dose was 38.5 milligrams per day. And that's, that's a dose that's a little bit above one of the doses within the range which is 36 milligrams per day. And at 36 milligrams per day, their [WACC] price would be approximately $90,000 annually. If you look at our pricing for maintenance therapy at the 80-milligram dose, that's a substantial price differential. But our focus isn't on selling INGREZZA based on the price, it's based on the clinical profile and the benefit that we've been able to demonstrate with our data. And we're focusing on that and letting doctors pick what they think is the best treatment for the patients.

That's helpful. One last commercial question. And that's on the idea of a bolus of patients. It sounds like from most of your prepared remarks where you expect continued growth and new patient starts, you're not seeing any evidence of a bolus but one thing I think you just said in the response to another question was physicians do sort of have cohorts of patients and maybe they've gone through the first cohort now and will wait to see how those patients respond before moving on to other patients. Is there some idea that there could be a small bolus that we've just seen, that new patient adds could slow down over the next couple of months or would that be just too early to tell, hard to say?

I think yes. I wouldn't describe it as a bolus. I would say, generally speaking, when our people have gone into these offices and introduced INGREZZA, doctors immediately think about a patient or several patients that they would like to try it on. And usually they are thinking about who's going to be coming in over the next few weeks, that would be a good candidate here. And then they like to get a few patients started, see how they are doing and get some feedback from them before they determine where do they go next in terms of expanding their utilization within the practice. So that component of the known patients that are immediately available in sort of the next short period of time. But also, our effort is working with staff and other clinicians to help with identifying additional patients that could benefit from treatment. And as I mentioned earlier, also helping to sort of clear up some confusion that may be out there around TD versus other types of drug-induced movement disorders.

Cohort may have been the wrong -- some people think cohort being a group, and it's initial trial.

So it's not -- you still haven't seen any evidence of patients having -- of physicians having put warehouse patients or having a set of...

No, So new much education, that it's real eye-opening. That's not warehousing.

Yes. I would, just qualify, a lot of the education, the key education is on the psych side of our franchise. The movement disorder neurologists, they're well aware of the differences between TD and other types of movement disorders. However, their patient opportunity is really driven by referral whereas going into these private psych offices, these community mental health centers, it's more about identifying patients that are flowing through over the course of time.

Got it. Then just one development question, on 74788. As far as I can recall, you've never disclosed the mechanism for that compound. I'm curious if I'm wrong and you have disclosed it, and if so, could you remind us what it is. Or if you haven't disclosed it, would you care to disclose it.

Just to be clear, that is our CRF 1 antagonist. We've been -- we've absolutely disclosed the mechanism and we even published on it. This is for CAH.

We'll go next to Alan Carr with Needham & Company.

I think Phil might have been thinking 756 for Essential Tremor. Can you give us an update on the Essential Tremor program and if Phil was thinking of that, what was the mechanism for that? Was there any update on that? And then also coming back to your Tourette's program. Jeff had some questions around, what your plans in terms of whether or not this trial might be suitable for registration. Can you give us an update on the last set of discussions you've had with the FDA around what they want in Tourette's and some background on that?

So for the Tourette's response, no detailed information. Obviously, we collaborate closely with the FDA. They see all of our protocols and all the details. And we're not treating new paths here, Tourette's syndrome trials, their primary endpoints et cetera. Those things are pretty much sorted out. So there's no new precedent that has to be established unlike what we had to do with tardive dyskinesia. So no other details, obviously. The next stage of our interactions really depends on whether we can bring in some compelling data from the T-Force GOLD study. With respect to our Essential Tremor program, as you know, we took one of our ET compounds out of the lab and put it into healthy volunteers in a single ascending dose and multiple ascending dose trials. And what we've learned just recently after completing those and some additional preclinical toxicology studies, is that the variability of exposure to the compound in healthy volunteers was more than we had thought. And because of the kind of relative safety margins with the preclinical tox data, it made us decide to shelve that molecule, keep the ET program going and go back into the lab and bring forward an alternative molecule, so. And we have not disclosed the mechanism of action of those.

Is this something that might move back into the clinic next year? How much preclinical work do you need to do here? Do you have candidates ready, back up candidates ready?

Our general policy is, not to provide any detail into that until we have an IND open. Because every time I have done that, something happens. I mean this is a tough business with getting molecules out of to the lab into the clinic, lots of surprises along the way. And as you know, most molecules don't succeed in getting into the clinics. Until it's an IND open, you probably not hear anything from us on that one.

We'll go next to Jay Olson with Oppenheimer.

I have just one question, kind of a big picture question. But with $750 million in cash on your balance sheet, can you comment on your priorities for cash or deployment and whether or not your vision for business development has changed at all based on the remarkable early success of the INGREZZA TD launch?

Thanks, Jay. Obviously, for cash deployment, first and foremost is whatever it takes in order to make INGREZZA into the product that we believe it's going to be. So Eric gets first-hand into the bucket, as I will say. Next, what we have is, as I say, dance with the girl who brought you. And that means, that when you look at our compound here, with only the exception of opicapone, but when you look at elagolix, when you look at INGREZZA, discovered here at Neurocrine. And so that would mean that in our research in our preclinical groups,that's where the next amount of money goes because they are quite productive and they do an excellent job. Third is, there is that -- we're always very active out on the business development front. And being a larger company, having more resources, having a franchise with INGREZZA now where we can see continued growth, we're obviously looking vigorously outside for the right opportunities that will -- that we believe bringing them in house is going to add substantial value to that -- to those compounds or projects out there. And that we can truly enhance shareholder value as we do that. So we -- we're in a really nice position right now. And I'd say for the first time in the company's history to have this strong commercial arm going and to have the financial resources to be an active player out there.

We'll go next to Biren Amin with Jefferies.

Kevin, how many of the 1,500 prescriptions in the third quarter were repeat consumers and I guess objectively, are the vast majority of these moderate to severe in severity versus mild?

So I'll answer some of what you've asked. First off, it wasn't 1,500 total scripts, it's 5,100 total scripts that we had in the second quarter. As far as how many of those are repeat scripts versus new scripts, as I've said, we're not going to be giving that information here. The third question that you basically asked was the fact that, well say it again.

Moderate to severe versus...

Oh yes, Moderate to severe versus -- actually, what we're seeing out there, feedback from the sales force feedback coming from our MSL and other teams out there is that the physicians are prescribing them overall to a wide variety of patients that are -- as far as severity of their TD goes. It's really a holistic determination that the physicians are making, is how troublesome this to the patients and/or their loved ones or caregivers, and that's how they are making this determination of who to prescribe to. And Tim is reminding me of a couple of things is that, number one, in Q2, that first 2 months of commercialization, we had 745 scripts written. And as I've said in Q3, our first full quarter, it's 5,100 scripts written in that quarter. And the last thing that I will tell you is that, we -- I met a patient just a day before yesterday who came into the office with their husband. This was just them on their own dime, coming from where they live because she wanted to meet the people in the company that developed the drug that change her life so dramatically. And she wanted to thank us. Here's a situation that's interesting. This is -- I don't know how we can say it more, patients had nothing for this condition prior to INGREZZA being there. And doctors, regardless of who their physician was, hesitated or did not have the knowledge base to be able to adequately diagnose it. She was actually diagnosed by her orthodontist in all the biting and chewing on her tongue and the problems that she was having with her teeth and she fortunately went to an orthodontist that was at a teaching hospital. Her orthodontist she brought in students and she diagnosed her with having TD. She then went back to her treating psychiatrist. It took a while to get that referral and in that period of time, she really educated herself now on hearing the words, tardive dyskinesia. She was able to then track us down, knew her psychiatrist had told her that we were done with our trial, the drug is under review, she found our PDUFA date, called us on April 11, and said, "Okay what's going on?" And then she actually called us about 15 minutes before the FDA contacted us, 9 days on 40-milligram dose and this woman got her life back. I -- it is those kinds of -- not stories, I don't want to diminish it by that -- it is those people that we've now been all exposed to that really show us what the value of INGREZZA really is.

That's great. Maybe just a question for Chris. On opicapone. Are you planning to submit a briefing document on FDA ahead of your meeting with them?

Yes.

And I guess, should we expect a clear resolution on a go, no-go filing from the minutes? Is that when we should expect to hear from the company.

I hope so, as I mentioned in my prepared remarks, if we meet with them in a January, normally it's about a month later, we get the formal FDA-generated meeting minutes. And I'm looking forward to having that discussion with the neurology division. Very straightforward set of questions we're asking and hopefully we'll get a very straightforward answer.

It appears we have no further questions at this time. I'll turn it back to you, Mr. Gorman for any closing remarks.

Thank you very much. I really do appreciate all the questions that were asked. I think you went to the heart of the matter with everything and the heart of the matter is that, we've got -- we're very pleased with the way the launch is going. As I said, it is going as to our plan. Our commercial team is doing an outstanding job. But again, while I've said we've only scratched the surface of the potential of this drug, it is still just going to be steady growth is what you're going to see over the next several quarters. And then, I would say by -- towards the end of next year, that's when we're going to really -- the drug and the patient population will truly start revealing itself. I'm also extremely pleased with the progress that we have with our internal pipeline and also with the outstanding job that Chris has talked about, with what AbbVie is doing with elagolix, both in endometriosis and with a uterine fibroids. And the uterine fibroid Phase III data is still due to be released top line by AbbVie, somewhere around the turn of the year, either very late of this year, if it runs into the holidays, then it will be early next year. But I would really encourage you to take a look at these ASRM abstracts because the data that AbbVie has generated on the drug is a very compelling. So with that, I thank you all, for your attention and we look forward to catching up with you in the meetings that are coming up later this year, starting next week. Take care.

This does concludes today's conference. We appreciate your participation. You may disconnect at any time, and have a great day.