Neurocrine Biosciences Inc

NASDAQ:NBIX

Earnings Call Transcript 2021-Q3

[Operator]

Good day, everyone, and welcome to today's Neurocrine Biosciences reports Second Quarter Results. [Operator Instructions] Please note today's call may be recorded.

It is now my pleasure to turn the conference over to your Vice President of Investor Relations. Todd Tushla. Please go ahead.

[Todd Tushla, Vice President, Investor Relations]

Thanks, Chloe. Good afternoon, and thank you for joining us on our third quarter 2021 earnings call. On today's call, Kevin Gorman, our Chief Executive Officer; Matt Abernethy, our Chief Financial Officer; Eiry Roberts, our Chief Medical Officer; Eric Benevich, our Chief Commercial Officer; and Kyle Gano, our Chief Business Development and Strategy Officer.

During today's call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to review the risk factors discussed in our latest SEC filings. After our prepared remarks, we will then head into question-and-answer session, so please limit yourself to one question so we can get to as many questions as possible.

At this point, I'll hand the call over to Kevin Gorman.

[Kevin Gorman, Chief Executive Officer and Director]

Thanks, Todd. Welcome, everyone. Good afternoon. I am just going to start out with two brief comments. First, I'm very pleased to see INGREZZA's continued growth. This is the second quarter in a row where we see this growth. And I anticipate we're going to have continued growth for the remainder of the year. Now we're not yet back to pre-COVID growth trajectory, but interacts has continued to increase. COVID's impacts are still being experienced in the field and the number of territories is not behind us, but we've adapted well. In addition, telemedicine is still being heavily utilized by healthcare professionals. But again, we are adapting well in growing our business and Eric will talk about how we are investing behind INGREZZA.

Now second, we started the year with an extremely aggressive goal to start a number of Phase 2 and Phase 3 clinical trials. And we are going to meet that goal, growing one of the most robust neuroscience pipelines in the industry. And we will highlight several of these programs. So with that, I'm going to turn it over to Matt.

[Matt Abernethy, Chief Financial Officer]

Thanks Kevin. INGREZZA's momentum continues with Q3 sales of $287 million representing 13% year-over-year growth. We were encouraged to see Q3 new prescriptions approach pre-pandemic record levels, even with telemedicine still representing a large portion of psychiatric patients business. Q4 is off to a solid start and anticipate Q4 sales of just over $300 million reflecting strengthening demand offset slightly by seasonally elevated Q4 gross net discounts. The progress we're seeing with INGREZZA reflects a tremendous medicine, a great team driving strong commercial execution, and most importantly, a significant opportunity to help many more patients with TD. Looking ahead to 2022, we are seeing strong growth from INGREZZA and with INGREZZA being our top capital allocation priority, we will invest an additional $100 million to expand our Field Sales Team and continue our DTC campaign throughout the year.

Behind INGREZZA, we continue to invest in our growing pipeline; we expect to exit this year with 12 clinical programs with many important clinical data readouts coming over the next two years. Fundamental to both growing INGREZZA and advancing our pipeline [Indiscernible]. We continue to invest in our Neurocrine team members and attract top talent in short growing company. Bottom line, we are well positioned for long-term growth, and our people will be the key to executing our strategy of becoming a leading neuroscience company.

With that I will now hand the call over to Eric Benevich. Eric?

[Eric Benevich, Chief Commercial Officer]

Thanks Matt. Let's jump right into it. Our team executed well throughout the quarter driving record in INGREZZA total prescriptions leading to all time high sales of $287 million. From an interact perspective, we continue to see improvements in new patient starts. While interacts levels are not quite back to pre-pandemic levels, we have certainly seen steady improvement since the beginning of the year. I'll note that key performance indicators such as sales call volume, sample distribution; speaker programs were consistently strong throughout Q3, a quarter that historically is a slower growth quarter due to seasonally related challenges. In Q3, persistence and compliance rates bring reservations remained at the historically high level we've come to expect with our medicine.

And as Matt said, we are off to a solid start to Q4. But the pandemic is still having an impact on customer access and patient flow in regions throughout the nation. In addition, psychiatrist in particular is still relying on telemedicine about half the time, which presents a challenge for TD diagnosis. I'd like to shift gears now to provide a bit more insight into the decision to expand our sales team. We have articulated since 2017, that this is a learning watch that we continue to learn and adapt to better meet the needs of patients and healthcare provider customers. For example, you recall in 2018 with strong uptake for INGREZZA and market trends that we saw at that time, we made the decision to upsize our field course to help accelerate TD diagnosis and treatment with INGREZZA.

Last year, the pandemic taught us many lessons including how to better meet the needs of our patients and healthcare provider customers, especially those who rely more heavily on telemedicine. Importantly, it was clear to us that the base of prescribers and high potential prescribers has grown larger over time as we've continued to develop the TD market. The key takeaway was that we needed to evolve our commercial footprint to reach and educate a growing and ever more diverse set of customers. To that end, by Q2 of next year, we will have established two new dedicated sales teams focused on movement disorder neurologists and providers in long-term care respectively.

In total, we will have three dedicated field teams across psychiatry, neurology and long-term care, which we believe will constitute a more focused and effective sales force. When our expansion is complete around Q2 of next year, there will be approximately 350 specialty salespeople across these three teams. Along with the salesforce expansion, we've been taking steps to make it easier for patients to getting revved up by expanding our distribution network. And with this change, we continue to caution you on reliance on third party syndicated data. The salesforce and distribution expansions along with our ongoing branded direct-to-consumer campaign reflect our conviction in the TD market opportunity. While I'm tremendously proud of the collective effort is taken to get TD diagnosis rates up to around 20% today, the fact remains that there is much work ahead. We have a strong belief in the long-term opportunity for INGREZZA and you see that translated into the investments we are making in our people and marketing initiatives to meet the needs of the many patients who still need our help.

Turning to market access, based on the planned formulary designs that have been published thus far, we expect access INGREZZA in 2022 to be similar to this year. And based on what we know today, we expecting INGREZZA net revenue per prescription next year to be similar to 2021 rates. Access for patients remains a critically important priority. Launch to date, greater than 85% of INGREZZA have been fulfilled regardless of formulary status, and we expect to carry forward the success we've had with access and reimbursement into 2022. With regards to ONGENTYS, feedback from the marketplace continues to be positive as more and more patients and prescribers are gaining initial experience with the only ones daily comp inhibitor approved in the US.

In addition, we continue to leverage ONGENTYS and INGREZZA together to main high access levels to our neurology customers. In closing, I'm very pleased with our team's performance under challenging circumstances and the impact that we're making for patients. Q3 was a strong growth quarter and in fact represented all-time highs in total prescriptions and net sales. I'm even more optimistic about where we can go from here in terms of continuing to grow our franchise. So with that, I'll hand the call out to our Chief Medical Officer, Dr. Eiry Roberts. Eiry?

[Eiry Roberts, Chief Medical Officer]

Thank you, Eric. And good afternoon to everyone on the call today. Building on Eric's comments regarding INGREZZA, our medical affairs organization continues to focus on education and key data generation in support of patients living with Tardive Dyskinesia. In fact, we recently expanded the portion of our field team focused on education and support of advanced practice providers, such as nurse practitioners and physician's assistants. Given the critical role that these providers play in the diagnosis and treatment of patients living with TD, we know that the impact TD has on the lives of patients, both functionally and socially, can often be even more important than the movements themselves. And we continue to work to understand this impact through the analysis of data generated from our registrational phase studies, using the Tardive Dyskinesia Impact Scale or TDIS, a Neurocrine developed TD patient reported outcome. At the recent Psych Congress in October, we presented TDIS analyses from the Connect 3 study demonstrating an improvement in patient reported impact of symptoms, both functional and social, in subjects treated with INGREZZA.

Additionally, this analysis shows that questions within TDIS show promise as a potential clinical assessment tool, additional validation of the TDIS as [Indiscernible] is now ongoing. Turning to Valbenazine, I'm pleased to announce that we're currently initiating the registrational study of Valbenazine for the adjunctive treatment of schizophrenia, with enrollment expected to open this month. This Phase 3 randomized, double blind placebo controlled study will enroll approximately 400 patients with schizophrenia who have had an inadequate response to antipsychotics. The primary outcome measure is the change in total pan score from baseline to week 10. Key secondary measures include the change in the Clinical Global Impression Severity score, or CGIS, and change in personal and social performance scales from baseline to week 10. We estimate this study will be complete in late 2023. And thinking about the remainder of the year, there are a number of key milestones and activities to highlight.

Firstly, we remain on track to share top line results from the Connect HD registrational study in Huntington's disease in December. In addition, we're planning to initiate five mid to late stage studies, which include the registrational study about benefits for the treatment of Dyskinesia due to cerebral palsy. And Phase 2 study of Luvadaxistat for the treatment of cognitive impairment associated with schizophrenia. NBI 845, for an adequate response to treatment in major depressive disorder, NBI 846 for an Anhedonia in depression, an MBI 352 for focal seizure onset seizure in adults.

In total, therefore, we anticipate having 12 programs in mid to late stage trials as we enter into 2022. With over 50 ongoing clinical trials and more to come, this is an exciting and potentially transformational time at Neurocrine as we look forward to delivering a number of important clinical data readouts over the coming years. I would like to end by thanking all the teams across our organization and our partners outside the company for their continued hard work in support of our portfolio. Most importantly, I would like to thank the investigators, patients and their families who participate in each of our clinical trials. I'll now turn the call back to Kevin. Kevin?

[Kevin Gorman, Chief Executive Officer and Director]

Thanks Eiry. That sums up all of our prepared remarks. So we are now ready for your questions.

[Operator]

[Operator Instructions]

And we will take our first question from Neena Bitritto-Garg with Citi.

[NeenaGarg]

Hey, guys. Thanks for taking my question. First of all, I want to understand a little bit more about where the growth in new scripts is coming from for INGREZZA because it sounds like you're still seeing kind of 50% telemedicine used in the psychiatry offices and similar 20% diagnosis rate. Can you just talk a little bit more about is that coming from just an increase in the total number of visits regardless of whether telemedicine versus inpatient total number of prescribers overall, is that coming more from psych versus neuro offices? I guess if you could just drill down into some of those dynamics, that'd be great.

[KevinGorman]

Eric?

[EricBenevich]

Yes, thanks for the question, Neena. So it's a little bit of everything. As I mentioned before, we are seeing still significant use of telemedicine within psychiatry, and to a much lesser extent within neurology. It seems as if they have leveled off in terms of volume of patient visits into psychiatry and the rate of telemedicine use. And in terms of, how we've been able to grow, I think that we've adapted to this environment. So it's a combination of things, obviously, our sales people have figured out, who are the providers that they can actually see in person versus those that they would need to see virtually.

Secondly, being adept at identifying new prescribers, those that haven't yet started to utilize the MAT2 inhibitors and have access to our team. And so I think that, overall, we've just adapted to the environment. And we continue to put resources behind helping those providers and especially in psychiatry that are primarily seeing their patients virtually, to remind them of the importance of screening for TD and providing them with resources to help them do so. And in fact, just a reminder, for everyone on this call, if you want to take a look at some of the educational content we've created For providers out there related to TD screening and diagnosis, go to mindtd.com and you'll see a number of different educational resources that we've been utilizing in the field to help providers become better at diagnosing and treating TD remotely. I hope that helps.

[Operator]

And we'll move next to Paul Matteis with Stifel.

[PaulMatteis]

Great, thanks so much for taking the question. Hey, so by my - by our math, for next quarter, the guide that Matt provided would suggest investors' benefits from price and inventory, a greater number of net patients adds and was seen in 3Q even by a small amount. And I would think that just a month into the quarter, you probably guide optimistically but also somewhat conservatively. So maybe can you speak to your level of confidence that demand this quarter could exceed what we just saw in 3Q assuming my maths right, thanks so much.

[MattAbernethy]

Sure, Paul, appreciate the question. I think your math is right. We continue to see great progress and driving interacts, interacts continues to go up. It was right below pre-pandemic level. And I think that's really a testament to what the team has been able to do to engage with the healthcare providers and keeping Tardive Dyskinesia on the radar. So our level of competence, we tried to give you what we're seeing, we've said that a Q4 is off to a good start and what we'd expect throughout the rest of the quarter, and will continue to be transparent as we have in the past. But yes, it's - we're seeing good momentum in the commercial team and medical came in the entire organization is really rallying around helping patients who have TD get treatment with INGREZZA.

[Operator]

We will move next to Carter Gould with Barclays.

[CarterGould]

Great. Good afternoon. Thanks for taking the question. Maybe just the follow up on some of the earlier questions in terms of how you guys are thinking about your expectations for telemedicine dynamics. Looking into next year, given sort of the evolving reimbursement dynamics. Any insight onto that front and how you're thinking about that would be helpful. Thank you.

[KevinGorman]

Yes, sure, Carter. I'll take that. There's going to be new guidelines that are going to be put out by CMS on their reimbursement. We keep saying we anticipate that to come any day or any week now. And we still do. While the public health emergency is still in place, those - the current pricing guidelines will remain in place in all of the current rules associated with the public health emergency are going to stay in place. They'll probably be a transition time after the public health emergency is relieved before everything new starts again or whatever might be new, will start again. But what the construct we work under is that we will be in the same telemedicine environment for basically most if not all next year.

[Operator]

And our next question from Tazeen Ahmad from Bank of America.

[TazeenAhmad]

Hi, good afternoon. Thank you for taking my questions. So, Kevin, as it relates to the decision to make the $100 investment, $100 million investment now for neurologists and providers of long-term care, why do you feel now is the right time because I think at the beginning of the year, you had talked about efforts that you would put into place to try to minimize the effect of doctors, mostly working from home. So do you think that those efforts that you put into place for your current market has been maximized? And you now are looking for additional outlets? Are you going to be trying to work on all of these at the same time?

[KevinGorman]

Yes, Tazeen, it's - you brought up a number of interesting points there. And I'm going to address a couple of them. And then I'll let Eric chime in. The first point that you brought up was do we think we've exhausted the current prescriber base that we have been going into, which is primarily psychiatrist, yes, there's - it is heavily focused on psychiatrist we don't - we do go into neurologist with the salesforce reorganization, the largest of the three teams by far will still be psychiatry, we will be increasing our ability to call on more and go deeper with psychiatrist so no, not at all. Do we think that we fully penetrated? The psychiatrist offices not even close. You are right that at the beginning of the year, because Q1s are so difficult we wanted to do is we kind of like to do no harm here. As we go into Q1. As Eric had said, really, the rollout of these new teams will take place in Q2. So we are leaving intact our territories and our salesforce throughout Q1 so that we don't have that we're not adding to the disruption coming up to Q1. Eric, do you want to?

[EricBenevich]

Yes, I'll piggyback on your comments here. So a couple of things just to clarify, Tazeen, the increased of SG&A by $100 million is driven both by full year spending for DTC, keep in mind this year was only a partial year for advice, as well as the salesforce expansion. So it's a combination of those two initiatives. And then getting back to sort of what's driving it. The bottom line is that we recognize that as we have developed the TD market, there continues to be an expansion of VMAT2 prescribers or INGREZZA prescribers as well as high potential prescribers to treat TD. And we did this analysis, and we believe that there's an opportunity to reach, educate and motivate more neurologists, as well as psychiatrist. And then we had looked at the LTC opportunity, actually, prior to the launch and decided at that time back in 2017, that we didn't have the resources to cover all the different opportunities for INGREZZA TD from day one. And so we deferred our decision to invest in focus on LTC until we got further along and done more to develop the market opportunity and we feel the time is right for us to essentially have dedicated resources to focus on that LTC opportunity. So it's really, the changes to our salesforce size and structure are really driven mostly by the development of the market, and our need to better meet the needs of a growing and more diverse customer base.

[Operator]

And we'll take our next question from Phil Nadeau with Cowen and Company.

[PhilNadeau]

Good afternoon. Thanks for taking our question. We have one on the pipeline; actually, you know that there are 12 programs that are likely to be in clinical trials by the end of the year. And the press release mentions important data events over the next 12 to 24 months. It's a little unclear to us exactly when some of those trials are going to read out. So in particular, which trials are likely to read out next year in 2022? And which ones are more likely to produce data in 2023. Thanks.

[KevinGorman]

So the first trial is going to read out it's going to be in December of this year, and that's going to be the Huntington's study that is going to read out. The next study, after that that's going to read out is going to be the Phase 1b basically in a central tremor. And then the last one is going to CSWS that we'll be reading out later next year

[PhilNadeau]

Great and the others are in 2023.

[KevinGorman]

Yes.

[Operator]

And we move next to Anupam Rama with JPMorgan.

[AnupamRama]

Hey, guys. Thanks so much for taking the question. On Connect HD and Huntington's disease, how are you thinking about the market dynamics there? Like is this a take the share from TD market or based on the profile of INGREZZA, if they've potential to expand the market here for you guys. Thanks so much.

[EricBenevich]

Hi, Anupam, it's Eric. I guess I'll take the question and then Eiry if you want to add on to it. So I think the answer is a little bit of both. We've noticed that there are a significant number of patients with Huntington's and associated Chorea with moderate to severe symptoms that could benefit from treatment with a VMAT2 inhibitor but don't for various reasons, including concerns around tolerability, concerns around safety, or even convenience of multiple times a day dosing. So there is opportunity for us, we believe, to grow the proportion of patients treated with VMAT2 inhibitor. And there's also the opportunity to potentially have some patients switch over if they find the profile that emerges from our Huntington's trial to be attractive, which we believe it will be. So I think it's a combination of those two things. We're excited about the opportunity to complete this trial and unblind the data towards the end of the year, and looking forward to being able to share more about what our commercial thinking is, as we move into 2022. Eiry?

[EiryRoberts]

Yes, no, I think he said it well, Eric, I just build on a couple of things. I mean just to make the point. I mean, there are 30,000 patients in the United States with Huntington's disease, about 90% of them have Chorea and 70% of those have moderate to severe form of Chorea that merits more aggressive treatment. And in spite of that, we know that only 20% of patients get treatment with a VMAT2 inhibitor. And so we really believe there's a lot of room for improvement there. And we particularly think that the simple, flexible once the day treatment with Valbenazine could potentially be very important for patients with Huntington's disease. The reason being that these patients take many, many medications oftentimes, and also may patients have difficulty swallowing. And so the numbers of patients and the complexity of the regimen can be very important. The numbers of tablets needed to be taken. And the complexity can be very important for patients in this space. Also, obviously, currently INGREZZA for the treatment of Tardive Dyskinesia has no black box warning. And so as Eric mentioned, we're very interested to see our results at the end of this year, and to be able to discuss further how we're thinking about going forward to regulators and hopefully, if successful, be able to get approval of a new VMAT2 approach in Valbenazine for the treatment of Huntington's disease.

[Operator]

And we'll take our next question from Josh Schimmer with Evercore.

[JoshSchimmer]

Thanks for taking the question. So it looks like your branded VMAT2 market share this quarter was at the low end of where it's ever been, to what you attribute that and where do you see this evolve? Thanks.

[KevinGorman]

Actually, gosh, I think that it's stayed basically the same. I think that if you take out the competitors Huntington's sales as they describe them, that by dollar amount, it's still a 65:35 market share split, which is what it has been now for quite a while.

[Operator]

And we'll move next to Brian Abrahams with RBC Capital Markets.

[BrianAbrahams]

Hey, there. Thanks so much for taking my question. A pipeline question for me on Valbenazine, schizophrenia. You talk a little bit about that upcoming Phase 3 trial design. I wonder if you talk more about what influenced the design there. I think a 10 week endpoint is a little bit longer than we've seen other - for other schizophrenia studies, wondering if that was guided by some of the anecdotal data you're seeing in terms of time to full effect for Valbenazine or other evidence of activity. And then curious on the 400 patients, what's guided your powering there? What are your expectations and will not be just one dose level? Thanks.

[KevinGorman]

Eiry?

[EiryRoberts]

Yes, along to some of the reasons, some of the information we haven't actually released in the context of the trial. So first of all, to answer the question about the study design and the primary endpoint choice. One thing, just one point just to make right up front, as you see in the Tardive Dyskinesia environment, the onset of effects in terms of Valbenazine impact on the movement, Tardive Dyskinesia is very rapid in many patients. And so we have a rapid onset of effect in that setting. And also, in any preclinical or other data that we've generated, we have seen rapid onset of effects, and so we don't anticipate needing longer and neither do we anticipate needing longer to get to effect in terms of the need for some form of complex titration. And that's certainly not the case in this ATS setting. In terms of the - there are, if you look at the trials that have been done in terms of the duration of treatment, out to the primary endpoint, they are actually quite variable. This is the registration study in many circumstances the agency's seems to see somewhat longer duration of effect out to the primary endpoint. And so in a discussion with the agency, we were able to land upon that primary endpoint timing as being appropriate for evaluation in this setting, particularly of patients who had failed to get adequate treatment from the anti-psychotic alone.

So that's the first piece in terms of the size of the study. The study, I'll say, is power to detect the clinically meaningful reduction in the pans total score, and this we believe this is an appropriate size to allow us to do that very readily if the treatment isn't effective in that setting. And then your final question, we haven't actually talked a great deal about the dosing schedule for this program right now. But as you'll see from the clinical trials.gov posting, it is an active versus placebo, randomized, parallel group study.

[Operator]

And we'll move next to Jeff Hung with Morgan Stanley.

[JeffHung]

Thanks for taking the question. For about Valbenazine and cerebral palsy, you've indicated that about 15% experienced Dyskinesia. How does that rate of Dyskinesia change from diagnosis of cerebral palsy in early childhood versus adulthood? And for the Phase 3 that you're starting this year, can you talk a little bit more about the specific sub population you're focusing on such as a specific age range? And would you split up the adult versus pediatric patients into different studies? Thanks.

[KevinGorman]

Eiry?

[EiryRoberts]

We actually, thanks very much, Jeff. We haven't actually talked about the trial design as yet. Although we have indicated that the trial will includes both pediatric and adult subjects. You're correct that Dyskinesia due to cerebral palsy occurs in about 15% of cerebral palsy and persist into adulthood in a proportion of that population. And so we think it is important given the persistence of cerebral palsy into the adult population that we have the opportunity to establish whether or not Valbenazine can be an important medication or useful medication for individuals who continue to suffer with cerebral palsy Dyskinesia into adulthood.

In terms of the remainder of the trial design, we are intending to start this trial later in Q4. And once the trial is posted on clinicaltrials.gov, we'll obviously be prepared to talk much more about the design.

[Operator]

And we'll move next to Brian Skorney with Baird.

[BrianSkorney]

Hey, good afternoon, everyone. Thanks for taking my question. Just trying to get an idea of what to look for in Huntington's Chorea data that you have upcoming. I know in TD you maintain advantage over steatosis due to both safety dosing, and as well as sort of the perceived advantage on a numerical basis in terms of efficacy, I'm good. Just when I look at a steatosis pivotal, I think they're improvement they showed from a 12.1 to 7.7 improvement from baseline, just how should we be thinking about the outcomes here? In particular, given this drug been on the market for a while, and you're excluding patients who have history with a VMAT2 two inhibitor? Are there any considerations to take in to account in the patient population that's going to be here when we see the efficacy? Or do you think we could be looking at the same sort of accuracy advantage here that we see in PD.

[EiryRoberts]

Thank you, Brian. Very, sorry.

[KevinGorman]

No, go ahead, Eiry.

[EiryRoberts]

Would you like me to go ahead with that? Sorry Kevin. So, Brian thanks for the question. I think the restoration trial MHD that we've designed is designed to fully elucidate the benefit, potential benefit and the tolerability profile of Valbenazine and HD, and we think it will be a combination of both the efficacy that we see and the tolerability and the once a day dosing and flexibility associated with that, that will be important in the overview of the totality of the data. So that's the first point to make.

Secondly, in terms of the trial design, the sizing of the trial is designed in order to be able to detect, and clinically meaningful reduction, similar to the way in which the steatosis program was designed. Just one clarification point, the exclusion of patients who have failed to respond to a VMAT2 inhibitor is done in order to ensure that we don't have patients in the trial who are unresponsive to that VMAT2 mechanism of action. Since there may be a small proportion of patients that are such and previous exposure to VMAT2 inhibitor is a little different. And so I just wanted to clarify that. But we're really looking forward to seeing the totality of the data, which I think includes both the tolerability profile and the efficacy that we're able to generate in this registration study. And if we're successful in reaching our primary endpoint, then we obviously will be going forward to discuss as regulators how we should position this in the treatment of patients with Huntington's disease.

[BrianSkorney]

Thanks, Eiry. Just to clarify, are you saying that you are including patients who have previously established - have previously taken VMAT2 inhibitor just because on clinical trials, it says about exclusion criteria?

[EiryRoberts]

The exclusion criteria is meant to eliminate those who have failed to have adequate response to VMAT2 inhibitor, as you probably are aware, many patients and one of the reasons why with use of deutetrabenazine, many patients fail to get to an outcome that is acceptable for them because of the issues of side effect profile and tolerability associated with the titration and deutetrabenazine. So if people have had a short trial of a VMAT2 inhibitor, then we're not necessarily excluding those individuals, if they meet all other criteria.

[Operator]

And we'll move next to Chris Shibutani with Goldman Sachs.

[ChrisShibutani]

Great, thank you very much for the question. You made reference to a decision by CMS as far as the payment reimbursements for 2022 being quite imminent, can you clarify if you're expecting any particular changes that would have an impact on how you would execute your commercial strategy? In particular, just in reviewing some of the proposals on particularly for Medicare programs? I think within psychiatry, mental health, there is a subdivision between audio only services versus ones that combines video. The point there is being that obviously video would appear to be very important for INGREZZA. Can you just comment about what the scenario is that you're expecting are in the impact? Thank you.

[KevinGorman]

Yes, so I'll start out there, there were a number of changes that were under the Public Health Emergency, one of which is audio only, audio plus video or in person were reimbursed all at the same level and continue to be today. There are the changes that are in there. Also there is release relieved from having a minimum number of in person visits. They've also relieved that it has to be from a secure site that you would be having doing your telemedicine from that there would be another health professional at that other sites and nurse or nurse practitioner. So and also allowed for the practice of medicine across state lines. So we're looking to CMS to really take on all of those and then see what they do come out with. As we alluded to before, we're seeing very good growth with INGREZZA right now, we've adapted to the public health emergency. So I see that as going well for us. But it's really too soon to tell what CMS is going to publish as their final Physician Fee Schedule. All I'm saying is that it appears imminent.

[ChrisShibutani]

Can I just ask do you know what the mix of audio only versus audio and video as far as the telehealth component in psychiatry has been?

[KevinGorman]

Do you have that, Eric?

[EricBenevich]

Yes, I can't report claims data, but I can because it isn't. What I can tell you is from our market research, and then, anecdotally hearing from our customers that, at least in psychiatry, about half of the telehealth visits are audio plus video and about half are video or excuse me audio only. And the audio only tends to be more predominant for patients that are being seen in community mental health settings. And certainly that makes it more challenging to screen for recognize TD and once again, if you go to the mind.td website you'll see a materials that we created to help providers be more adept at screening for TD regardless of whether it's an audio only call, and audio plus video, and how to advance that diagnostic process. So as Kevin said, for 2022, we're expecting status quo because of the extension of the public health emergency into next year. And then at some point, when the public health emergency is lifted, those temporary waivers that Kevin described, will also likely change and the upcoming publication of the CMS physician fee schedule will give us some insight into what the telehealth environment will look like post pandemic and post temporary waiver removal.

[Operator]

And we'll move next to Ami Fadia with Needham.

[Ami Fadia, Needham]

Good evening. Thank you for taking my question. I had a quick follow up on the Huntington's disease Chorea study. Do you anticipate the possibility of superior efficacy to existing treatments with that study? And then with regards to essential tremor, the Phase 2 study readout next year? What should we be looking for as a positive proof-of-concept in Phase 2? Thanks.

[KevinGorman]

Eiry?

[EiryRoberts]

Thanks. So the Huntington trial is not designed as a head to head comparative study. And so in terms of a claim of superiority, we are not held - we haven't designed that trial in order to answer that question, there will be no direct head to head data of ourselves versus any other VMAT2 inhibitor or in a controlled way versus the other treatment. This is a placebo controlled trial. With that said, as I mentioned earlier, we will be particularly interested in the totality of the data, understanding both the efficacy that we're able to generate on the Huntington's Chorea core, but also other functional endpoints that are built into that study and the tolerability profile in the setting of that registration study. And with those data in hand, obviously move forward if we're successful in that trial.

On the Essential Tremor study, this is actually a proof-of-concept study. And so it's a placebo controlled crossover study in individuals with moderate essential tremor and increased 28 patients into with two treatment arms and the primary outcome measure will be the change from baseline to day 28 for each treatment period, amplitude at peak frequency of postural tremor. So with that, in hand, I am looking at the within subject and across subjects, comparison between the active treatment 104 and placebo, we'll be able to determine the next step in terms of whether we go forward for a full registration or quality Phase 2 dose findings to be.

[Operator]

And we'll move next to David Amsellem with Piper Sandler.

[David Amsellem, Piper Sandler]

Hey, thanks. So, given your commentary earlier on call regarding the direction of net revenue per TRx in 2022 versus 2021. Would it stand to reason that you'd be in a position to provide 2022 INGREZZA sales guidance? And I guess, provide a range regarding sales or at least a floor, how do you think about that? Thanks.

[MattAbernethy]

Yes, David, well, the time has definitely come for us to step up and provide an annual guidance. And we do intend to do so in our February call for our Q4 call we will give a 2022 guidance number for INGREZZA and of course, will include a range that would reflect both the environment and also, our latest thinking on the impact and the direct-to-consumer advertising campaign as well as salesforce expansion. So we're continuing to progress and gaining understanding of this market. And that's something that we look forward to having those conversations in February.

[Operator]

And we will move next to Kelly Shi with Jefferies.

[KellyShi]

Thank you for taking my question. So far Connect HD trial in Huntington disease on a primary end of point the total maximum Chorea score from baseline, the previously approved VMAT2 inhibitor showed a two to three point reduction. I wonder if this is the benchmark for the clinical benefit connector trial. What kind of impact it is for including the patients that pre exposed to VMAT2t inhibitor on the trial? And also, how do you think the placebo effect change over time? Thank you.

[EiryRoberts]

So I think as we've previously stated, the primary endpoint for the Connect HD trial is the total Chorea score and what you articulated in terms of the deutetrabenazine impact is indicative of a kind of relevant change in that score. Our study is adequately powered and designed in terms of the sample size, to be able to identify a clinically meaningful change in that score and reduction in that score relative to placebo, we have no reason to believe that the placebo response should change in this disorder over time. Unlike other conditions, such as schizophrenia and elsewhere, where obviously there has been a significant changes in placebo response over time. And I think I clarified a little earlier about the situation for previous exposure to VMAT2 inhibitors, this population we believe will be appropriate for us to be able to detect adequately the effect of Valbenazine in treating the Chorea associated with Huntington's disease. Just to reiterate, again, we're interested in looking at the totality of the data generated from this trial, both in terms of the effectiveness of the medication, and also the tolerability and profiles associated with the ones that they use. We also have functional endpoints for the study, as I think I articulated earlier. And we'll be looking at the totality of that data, as we read out the data at the end of this year, in terms of making the decision to go forward for a potential registration if we're successful.

[Operator]

And we'll move next to Vamil Divan with Mizuho.

[VamilDivan]

Great. Thanks for taking my questions. Maybe just one ONGENTYS. I know it's a smaller product maybe not talked about as much but it's only doing about $2 million or so per quarter year about a year in the launch. I'm just curious kind of what you seemed might be a catalyst to kind of get that product going more whether it's COVID related or, payer access or anything you sort of see going forward, how we should think about that maybe changing its trajectory. Thanks.

[KevinGorman]

Yes. Thanks, Paul. So I think it's a combination of things, obviously, launching a new medicine in the face of a pandemic has been challenging. And certainly we've seen the ups and downs in terms of the surge of especially the Delta variant over the course of this year, impacting our ability to access, especially those important movement disorder specialists. And so, we've seen steady progress in terms of trial and adoption. And certainly the feedback that we've gotten from prescribers has been very positive, in terms of their experience, and the experience that's being read back to them by the patients. And so we're continuing to put our best foot forward in terms of driving initial trial and adoption with ONGENTYS. And I mentioned in my prepared remarks that we believe there is synergy between on ONGENTYS and INGREZZA in terms of being able to access neurology customers going forward. So what's going to drive continued growth with that product? Well, a few things. One, we are building out a dedicated neurology team. And we think that that's going to benefit both INGREZZA and ONGENTYS in those neurology practices.

Secondly, going into next year, we do believe that we will have better access for ONGENTYS. So we will continue to put the resources that we that we built for INGREZZA, the field based reimbursement team, the base for our core programs, and so on behind ONGENTYS and those Parkinson's patients. And then of course, as we continue to learn about the market and where ONGENTYS is fitting into practices, we'll continue to fine tune our approach to the launch. So we feel good about the direction that it's moving, certainly feel like the environment externally, if it gets better, and there's a reduction in the impact of COVID that'll benefit ONGENTYS as well.

[Operator]

And we'll move next to Myles Minter with William Blair.

[MylesMinter]

Thank you for taking the question. Just back on schizophrenia, the pivotal trough INGREZZA, the 10 week endpoint you mentioned that was kind of like a balanced the trend, the FDA wanting to see longer term data in the five to sort of six folks that we might be useful, and is that in the absence of the need for an open label extension with that trial? And also, are you enrolling patients that have extrapyramidal symptoms as part of their therapy? Thanks.

[EiryRoberts]

Yes, so there will be potentially patients with Tardive Dyskinesia and other extra parameters and syndromes included in the trial. There is no exclusion associated with that. And we are looking separately at the long-term safety and tolerability data that would be necessary in the context of a new indication for schizophrenia. One thing I will say is that obviously from our Tardive Dyskinesia program, we have a significant number of patients with schizophrenia and Tardive Dyskinesia, who have been treated for long periods of time with INGREZZA and our safety and tolerability data are very strong. And we - that was one of the things that made us encouraged about going into the schizophrenia invocation.

[Operator]

We will move next to Charles Duncan with Cantor Fitzgerald.

[CharlesDuncan]

Yes, good afternoon, Kevin and team. Thanks for taking the question. Congrats on the new patient adds this quarter. I had a question on the pipeline in Bialbenze seem particularly along the lines of Connect HD. I think that I heard Eiry talking about taking a look at the totality of data, but could we assume that it's possible that you'd be filing an sNDA next year for with positive Connect HD data and then back to kind of Myles' question regarding Valbenazine schizophrenia, I guess I'm wondering if you could provide a little bit more color on what you think modulate the timing to date is that simply enrollment or something else?

[EiryRoberts]

On the first question associated with Huntington's disease, we will read out the data at the end of this year. And then with positive data in hand, if we're successful, we'll go forward to the agency to consider as rapidly as possible, being able to submit the regulatory application in the US for that indication. On the ATF side, can you just repeat the question so make sure I understood what you were asking?

[CharlesDuncan]

Yes, I am just really trying to better understand timing to data. I think it was mentioned '23. And I think you said complete late in '23. And so I'm just trying to wonder, what is the biggest factor that you're considering for that time?

[EiryRoberts]

Yes, I mean, I think we are just starting this trial and opening for enrollment this month, we will obviously be moving as rapidly as possible on this global trial to enroll as rapidly as possible. I think the date is late 2023 is our first guess around enrollment. And we'll clearly update you on that as we go through the trial.

[Operator]

We'll move to our next question Yatin Suneja with Guggenheim.

[EddieHickman]

Hi, guys. Thanks for squeezing me. And this is Eddie on Yatin. And Just a quick follow up on Huntington's, if you are successful, what are the other gating factors? And for filing and sort of how quickly can we see approval here? And then on the Xenon 352 collaboration, which we haven't really talked about? How are you thinking about prioritizing the focal versus sort of pediatric indications in for that asset and sort of what's the optimal regulatory path forward there for both the US and the EU? Thanks.

[EiryRoberts]

So on the HD trial first; I think we haven't really signaled very much about the path to regulatory filing as yet, we've been focused very much on the generation of the data and the release of the data at the end of this year. And obviously after that, once we have shared those data and had the opportunity to interact with regulatory authority will have a much better handle on the timing and path forward there. With respect to approval, obviously, we don't comment on timings of approval at this stage, with respect to 352 - I'm sorry.

[MattAbernethy]

Eiry, yes, just to be specific. If the data were to be positive, our assumption would be we will be filing sNDA sometime next year, just to make sure that's clear.

[EiryRoberts]

Okay, thank you. Thanks for that clarification, Matt. With respect to 352, I think we're excited about the opportunity for this highly selective MAT1.6 inhibitor in both the rare pediatric epilepsy of STMA. And also potentially in focal onset seizures. We, with respect to the design of SCNA trial, we're making every patient in this program count. And so this is a placebo controlled trial from the outset. And our goal is to be able to demonstrate if we're able to demonstrate the effectiveness of this agent, that we have a trial that's appropriately designed to be able to look at efficacy, even in this first setting. And we're hopeful that would provide us a rapid path forward towards interaction with the regulators.

On the focal onset side, obviously, we're initiating a Phase 2 study. And in both cases, I think the unmet need is very significant. And in the focal onset, seizures environment, it's really because of the fact that a lot of patients do not get adequate response to currently available treatments. And so we're excited here as well about the opportunity to bring a more selective agent into this space. And to do it in a way that enables us to be selective, it's successful in delivering efficacy and outcomes for patients. It's a little early on the Phase 2 site for that program, to be able to see how that would stack up against the sNDA indication but, but we're really focused on delivering data as rapidly as possible in both setting.

[KevinGorman]

Thanks, Chloe, we'll take one last quick question.

[Operator]

We'll move lastly to Laura Chico with Wedbush Securities.

[LauraChico]

Hey, thanks very much for fitting me in here. I guess I have one question just with regards to a number, the end of filings that have come through recently, just with respect to not only generic steatosis challengers, but to generic INGREZZA challengers. I'm wondering if you could comment at all upon maybe how you're thinking about not necessarily patent protection, but the longer term pricing strategy for INGREZZA in an environment with generic competition, and it also seems obviously, like you're making a number of investments and future Valbenazine indications. So I'm not sure if you could kind of talk to your confidence at all in terms of navigating that. Thank you.

[KevinGorman]

So, Laura, the end of filings that have been made against both products is basically business as usual. This is nothing unusual; we're handling them in the normal course of business. We have patent protection on INGREZZA that goes many years out, at a minimum, I would say out to about 2032, with some extensions, but we have a number of patents in the green book that can take us longer than that. So we don't see any challenges to our business on near horizons at all.

[Kevin Gorman, Chief Executive Officer and Director]

So, in closing, I would like to thank everyone, for joining us today. We look forward to seeing you as hopefully in person at several of the upcoming meetings in later this year, and early next year. And I think as you can see from today, that we're making very good progress against all our goals and even amid the challenges that have existed out there. This is something that we've adapted to, both with INGREZZA and our pipeline, and we look forward to having even more rapid progress in the future. So thank you, everyone.

[Operator]

This does conclude today's program. Thank you for your participation. You may disconnect at any time.