Hey, everyone, and welcome to today's Neurocrine Biosciences Reports First Quarter Results. At this time, all participants are in a listen only mode. Later, you will have the opportunity to ask questions during the question and answer session. Please note this call may be recorded. It is now my pleasure to turn the conference over to Vice President of Investor Relations, Todd Tushla.
Please go ahead.
Thanks, Chloe. Good afternoon and thank you for joining us on our Q1 2021 earnings call. Here with me today is Kevin Gorman, our Chief Executive Officer Matt Abernethy, our Chief Financial Officer Eiry Roberts, our Chief Medical Officer Eric Benovich, our Chief Commercial Officer and Kyle Gano, our Chief Business Development and Strategy Officer. I'll remind everyone that 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 and our latest SEC filings. Following our prepared remarks, we'll then head into Q and A. With that, I'll turn the call over to Kevin.
Thanks, Todd. It's good talking to you all today. Our remarks will be very brief, so we have plenty of time for questions This afternoon. As we've discussed for 4 years now, Q1 has always been a challenging quarter with many TD sufferers needing reauthorizations. Each year we've learned from the previous year and have improved our ability to prepare prescribers and our specialty network of pharmacies for the onslaught of these prior authorizations.
However, this year despite our best efforts, the lack of direct access and communication between prescribers, patients and pharmacies led to a much more protracted delay in refills than what we normally see. Now while that's the bad news, the very good news is Patients did receive their refills and we did not lose them. Now we traditionally see looking forward That Q2 as a stronger quarter and we expect Q2 versus Q1 sales growth will be in the range of what we saw last year, not quite as strong, but certainly there will be a great deal of growth. Now both Eric and Matt will discuss our Q1 experience in more detail in a moment. Importantly, We've made considerable progress in the number of our clinical programs.
If you recall at the beginning of the year, I told you about our ambitious goal of starting 8 new mid to late stage clinical programs this year and Eiry is going to take you through our pipeline on this call. So without any further comments, I'd like to the call over to Matt.
Thanks, Kevin. Good afternoon, everyone. 1st quarter INGREZZA sales were $230,000,000 reflecting the payer related seasonal dynamics Kevin just mentioned and also the seasonal impact from gross to net. Importantly, the team did an excellent job ensuring patients remained on INGREZZA. However, the extended insurance reauthorization process due to the pandemic resulted in a lower than normal refill rate per patient.
As the quarter progressed, we saw strengthening NRx performance and commercial activity. Although encouraged, lack of in person care continues to impact the growth trajectory of the TD market, given greater than 50% of patient visits are still being conducted virtually. As physicians and patients return to visits in person, we expect TD diagnosis rates will increase leading to improved INGREZZA performance. Based
upon what
we've seen so far in April, we would expect on an inventory adjusted basis We have a strong financial position with over $1,100,000,000 in cash and are deploying our capital towards growing INGREZZA and advancing our pipeline. We increased our 2021 operating expense guidance to reflect our INGREZZA branded DTC campaign called TD Spotlight, which Eric will cover next. With that, I hand the call over to Eric Benovich, our Chief Commercial Officer. Eric?
Yes. Thanks, Matt. I'm happy to provide additional commercial insight into our Q1 performance. And today, I'll keep my prepared remarks focused on INGREZZA. First off, There has already been discussion of our Q1 business dynamics during Kevin's and Matt's prepared remarks.
But it's important to note right upfront that we exited the quarter with more patients on INGREZZA treatment than when we entered the quarter. In many ways, Q1 represented the most challenging quarter we've had since launching INGREZZA just 4 years ago. Typically, Q1 performance is characterized by the first portion of the quarter being impacted by seasonal payer dynamics and then an increase in new patient starts occurs over the latter part of the quarter. Over the past few years, our field teams have done a great job helping patients, healthcare providers and their office staff manage through this annual process where many continuing patients need insurance reauthorization to get their INGREZZA refills. However, the external environment was different this year.
The surge in COVID-nineteen pandemic in January made it especially difficult to support our HCP customers and the TD patients they care for. With many clinics restricting access or even closed altogether, this limited our ability to mitigate the typical Q1 payer dynamics. In short, the pandemic exacerbated the impact of seasonal payer reauthorization requirements causing higher than normal delayed refills and treatment interruptions for many INGREZZA patients. However, it was encouraging to see continued strong persistence rates throughout Q1 and that we finished the quarter with more patients treated with INGREZZA than when we started the quarter. In addition to these payer and pandemic related external factors, We saw a tick down in gross to net price as additional health plans added INGREZZA to their formularies as Matt noted.
During the latter part of Q1, as COVID cases waned and the HCP practices started to open up again, Our field teams did an excellent job of reengaging with customers and we saw improved With key initiatives including launching our first ever INGREZZA branded direct to consumer campaign, which we call TD Spotlight later this month. In addition, we will be introducing a new INGREZZA 60 milligram dose strength, which provides healthcare providers and their TD patients with increased flexibility by offering 3 effective dosing options, while maintaining the simplicity of 1 pill, once a day dosing with no mandatory or complex titration required. We believe this will be a meaningful enhancement to our INGREZZA franchise and we're excited to roll out the new 60 milligram dose to HCPs later this quarter. In reflecting back on where we were at this time last year, much has changed, but there are some things that remain the same. INGREZZA with its attractive product profile is still the most preferred and most prescribed VMAT2 inhibitor for TD.
Our commercial team remains strong, energized and as committed as ever. And there remains a huge unmet need to diagnose and treat the roughly 600,000 patients in the U. S. Who suffer from tardive dyskinesia. We're firmly committed to continuing to shining a spotlight on the substantial impact TD has on patients and their care partners and the meaningful benefits of treatment with INGREZZA.
So with that, I'll look forward to answering your questions during the Q and A portion. And I'll go ahead and turn the call over to my colleague, Eiry Roberts, our Chief Medical Officer.
Thank you, Eric, and good afternoon to everyone on the call. I'm happy to provide a quick update on recent progress with our clinical portfolio. At the beginning of the year, I indicated that we plan to initiate a total of 8 new mid to late stage clinical programs in 2021. We're making good progress and continue to be on track with this plan with the potential to add a 9th new program start by the end of the year for lubidaxastat in the treatment of cognitive impairment associated with schizophrenia. Since our last earnings call, We have initiated 2 important programs, namely the pediatric registrational study of crenesafont for the treatment of classic congenital adrenal hyperplasia and a Phase 2 study evaluating the efficacy and safety of the T type calcium channel antagonist NBI-one hundred and four for the treatment of essential tremor.
Essential Tremor or ET represents the 2nd potential indication for NBI-one hundred and four acquired through our partnership with Idorsia. T type calcium channels have been identified as having a critical physiological and pathological role in ET where abnormal oscillatory activity occurs in the brain. As background, ET is the most common neurological movement disorder and is associated with physical and cognitive impairments, avoidance of social settings and related difficulties that negatively impact the lives of patients. Ity affects approximately 2.5% of the population worldwide with a prevalence of more than 5% in adults aged in addition to the potential tremor, the Phase 2 study for NBI-one hundred and four in the rare pediatric epilepsy indication of continuous spike and wave during sleep continues to progress in the clinic. Shifting gears now, I'll provide an update on our luvodaxastat program, formerly known as NBI-eight forty four.
Following a thorough review of the clinical data from the recently completed Phase 2 INTERACT study, we are moving forward to initiate a Phase 2 study for the treatment of cognitive impairment associated with schizophrenia with the goal of replicating the potential signal of cognitive improvement that we saw within the INTERACT study. Cognitive impairment is an area of significant unmet need in schizophrenia with no currently approved treatments in the United States. We're currently on track to initiate this new study by the end of the year. In closing, I want to thank the many teams who are helping advance our large, growing and diverse pipeline. With 2 new mid to late stage programs now ongoing in patients and an additional 7 more planned this year, The momentum for our pipeline is strong.
So with that, I'll turn things back to you, Kevin.
Thank you, Eiry. So while the operator is getting the questions to that teed up right now, I'd be remiss if I didn't note that this month is Mental Health Month. And this week is Tardive Dyskinesia Awareness Week or TDOF for short. This year Marks the 4th year we've partnered with the mental health community to recognize TIDA by spurring conversations about TD and the importance of seeking a diagnosis and treatment. This year, 48 states and Washington, D.
C. Have formally declared this 1st week in May as TD Awareness Week, and I'm very happy that our hometown here San Diego has done the same. So Chloe, I think we're ready for the questions now.
And we will take our first question from Brian Abrahams with RBC Capital. Please go ahead.
Hey, guys. Thanks so much for taking my question. So Unpacking the INGREZZA dynamics a little bit more, by our rough math, it looks like inventory adjusted TRx were down about 7% sequentially, which will imply about 5% to 6% lower revenue per script. And so I'm wondering if you could give us a sense of the degree of seasonality to this gross to net change versus How much of this change we should expect to persist throughout the rest of the year with additional formulary access? And then along these lines, I'm just curious How quickly and meaningfully you'd expect to see pull through from the DTC investment to TD diagnosis and new patient starts and whether that's baked into your 2nd quarter dollar growth expectations?
Thanks.
Hi, Brian, this is Matt. Thank you for the question. As it relates to gross to net dynamics, we did see an increase in discount during the quarter and that's largely seasonal driven by the Medicare Part D Donut Hole as well as co pay assistance programs on the commercial side. We did have some incremental discounts come from contracting, but I would say, by and large, the majority of that gross to net discount increase should recover throughout this year. I believe I had guided last quarter, we would expect a sequential down A sequential increase in gross to net discount of around 5%.
It landed just north of that around 6% during the quarter. So hopefully that gives you the right line of sight there. On the DTC investment, Big aspect here is to accelerate TD diagnosis and ultimately allow more patients to have benefits with INGREZZA. As you know, there's a lag time between when you do a direct to consumer advertising campaign and when it actually translates to patients receiving medicine. So you would expect some level of a return later this year, but more meaningfully, in 2022.
Next question from Paul Matteis with Stifel. Please go ahead.
Great. Thanks so much. I wanted to ask a little bit more about the 2Q
Kind of
sort of guide, I'm a little bit confused by it because historically you've talked about average script per patient Fluctuating in 1Q, maybe decreasing by 0.1 or 0.2. And so let's say it decreased by 0.2, that's It's about a $20,000,000 headwind. So even right there with the reversion of that, you can get close to what you're implying for 2Q based on last year and Adjusting for inventory, so I guess maybe you could just respond to that. And then in terms of this Q2 number kind of guide you provided, What's
behind it
in terms of actual organic patient growth? Thanks.
Yes, Paul, this is Matt. Happy to answer that question for you. If you look back at what occurred last Dear, we had a tremendous Q1. We did a great job keeping patients on medicine. And then we also actually had a record number of new patients, Great trajectory entering out of or exiting Q1 and heading into Q2.
So the benefits that we saw in Q2 were really reflective of how our performance was in Q1 of last year and just to reiterate the record on number of new patients. When you adjust for inventories sequentially last year, I believe that was around a $28,000,000 $29,000,000 increase. When you think about the different dynamics this year, as you said, we did have a bit more of an impact on refill rate per patient. But on the NRx front, we're still operating in a market where patients aren't going physically into And so that does mute the NRXs that we're able to generate. So We would expect to have decent growth, but getting New patient additions back up to historical pre pandemic levels is really what's going to allow us to kick in growth.
On the patient side, We actually had a bit more patients exiting the quarter than we entered, and I think that was a really positive sign, and we expect something similar to that when you exit Q2. However, our growth will be somewhat capped Based upon the patients not going into the office, however, we have many tactics that Eric can illuminate that we're working on to both drive commercial activity as well as you can see in the DTC engaging patients in this process. Eric, anything you want to add there on the commercial side?
Probably the only thing that I would add and mentioned this in my prepared remarks, that normally we do see the first portion of the Q1 with A lot of focused effort around reauthorizations and getting patients going on refills. And Typically, we see the 2nd part of the quarter more focused on new patient starts and we did see that I'm here this year as well, but with more interruption in those refills than what we've In the years past because of the challenges related to communication caused by the pandemic. And therefore, The pickup in the lift from NRx is kicking in a little bit later in the quarter than maybe what we've seen in prior years. So Similar kinds of dynamics happening, but the pattern was a little bit different this year because of the And the timing of new patient starts makes a big difference when you think about how many potential refills you might get over the course of the quarter.
Phil Nadeau with Cowen and Company. Please go ahead.
Good afternoon. Thanks for taking my question. I'm also going to ask about the Q2 dynamics. I apologize. But Matt, I just want to make sure I understood what you just said.
So last year, it looks like the revenue actually went up by $35,000,000 $36,000,000 but there were inventory effects in both Q1 and Q2 of last year. Based on the comments you just made, It seems like you're saying back out the inventory effects when we determine what the quarter over quarter growth is was last year and therefore will be in Q2. Is that correct? And if so, can you just repeat what that number is? And I guess the broader question is, Why not just give a specific guidance for Q2 with the revenue range?
It seems like this is much more complicated than it needs to be.
Yes. Thanks, Phil. Yes, you have the numbers correct. Last year, there was an increase on an inventory adjusted basis. We had $227,000,000 in Q1 and we went up to about $255,000,000 So that's a $28,000,000 increase on an inventory adjusted basis.
We felt it important to be really direct this quarter as to what we would be expecting out of the Q2 given the dynamics we saw in Q1 and the evolving Landscape of the pandemic, we're going to continue to think about providing a more formal guide. It would likely be and annual guide if and when we ever provide that guidance. But for right now, Phil, we just wanted to give as much clarity as
Question from Brian Skorney with Baird. Please go ahead.
Hey, good afternoon, guys. I'm going to depart from the Q2 dynamic question for a second here and just ask a little bit about ET. We've seen some recent results on competitive Phase 2 programs In ET, that showed some interesting efficacy, but seems to have had a very lukewarm investor response due to some of the safety signals seen there. I guess maybe you could just kind of try and help characterize in terms of what you're looking for in Phase II, what you want to see out of 104 and how to really think about an appropriate therapeutic index
Sure. Thanks very much. That's great. I'm happy to answer that. So in terms you're right, in terms of the recent readouts in essential tremor, I think given the prevalence of the disorder and The age of the population as well, the therapeutic index and the safety profile for new medications is very important in this realm.
What I can say is with 104 up to this point, we're very pleased with the profile that we saw in terms of tolerability in the healthy subject data that was generated in the Phase 1 environment. So that is encouraging for us as we enter into the this first Phase 2 study. The study itself is a study a proof of concept study, actually which it will be taking place in 14 of those subjects are under the age of 65 and 14 will be over 65. And that study is being conducted currently in Europe, just started. What we thought was important was to get some Objective efficacy and tolerability data in that older population as early as possible.
And so from that point of view, we will have good information exiting The other element of the design, which we believe is powerful is this is a crossover study. So there will be an opportunity to look at it within Subject change comparing 104 to placebo in that setting. And we are looking at in addition to Obviously, more quality of life type outcomes. We are looking at objective measure in terms of the amplitude of tremor at the end of the 28 day period. And so we'll have both objective and more subjective measures of efficacy in the study in addition to, obviously an initial look at tolerability.
Question from Josh Schimmer from Evercore ISI. Please go ahead.
Thanks very much. With regard to your comment that 50% of psychiatry visits are still Telehealth, it feels like that number has been bouncing around a little bit. Have there been any recent trends or updates into the second quarter to start to normalize that. And then just separately for your for the DTC campaign that you're planning, have you Tried any pilot approaches to gauge what kind of an impact the DTC campaign might have on INGREZZA adoption? Thanks very much.
Yes. So I'll tackle both those questions. And so yes, there are different syndicated data sources out there That give estimates for the use of telehealth across different physician Specialties, what we've seen from the data and what we hear directly from our customers and through our field sales team is that use of telehealth and psychiatry substantially higher than it is in other specialties, including neurology. And even though it's not as high as what it was, Let's say last summer or fall, more than half of all patient visits in psychiatry still are via telehealth either Video plus voice or voice only. And so to that end, we've certainly made great strides in adapting Our business model and our educational content to accommodate providers that are seeing their patients remotely.
And in fact, I would encourage you if you Want to learn more to visit mindtd.com, mindtdtd.com. And you'll see some of the tools and Resources that have been developed in conjunction with thought leaders in neurology and psychiatry to help them become more comfortable and adept at Recognizing and diagnosing TD in virtual patient visits. So Telehealth is certainly prominent today. We think it will continue to be prominent in the future. And We've made great strides in terms of our ability to adapt to that into that new mode of delivering healthcare.
And then with regards To the TD Spotlight campaign, the way that we're thinking about it is that this is a Process of really developing the market over time. Early on in the launch, a lot of the educational focus that we had with And their care partners was via outreach through the patient advocacy organizations. And then as we progressed, You may recall that we launched an unbranded disease state educational TV campaign called Talk about TD that's been on the air for about 2 years. And we are very pleased with the response to it in terms of website visits, registrations to receive more information, etcetera. And importantly, we've been monitoring all along, how we're doing in terms of raising awareness with the target population of patients that are on antipsychotics experiencing these abnormal movements.
And we've seen over time That awareness has increased of TD and the understanding of TD and its relationship to their underlying psychiatric illness and the medications that treat their psychiatric illness. And so we felt like it was we were at the point where it made sense to transition into a broader campaign that incorporated not only the TD educational component, but also introducing the idea of treatment. And in fact, our market research indicates the number one reason that patients don't pursue treatment for their TD is they're unaware that there are treatment So we're excited about the opportunity to launch the TD Spotlight campaign later this month. And we're very optimistic based on the Testing and the work that we did to show it to thought leaders in The psychiatric and neurology community as well as the patient advocacy groups that it will be an effective way of helping to once again allow TD sufferers to get effective treatment.
Question from Nina Beatriz Garg from Citi. Please go ahead.
Hey guys, thanks for taking my question and I apologize if somebody already asked about this earlier. But just on the creneser front, the pediatric Study for CAH, I thought that was posted and so the primary endpoint there is change from baseline and serum androstenedione versus the glucocorticoid burden reduction in the adult study. So I guess can you just walk us through kind of the rationale there in terms of the different endpoints?
Yes. Thanks very much for the question. We were very excited to launch the crenecifon pediatric registrational trial and in doing so, we gained insight into the design and background of That trial globally from many of our key stakeholders, including regulators, patients, clinicians, payers. And as a result of that and in determining the primary and secondary endpoints, I think it's important to note that both the hormone levels, particularly androgen levels and the glucocorticoid dose remain very important in pediatric patients in the treatment of their crenecephont of their congenital adrenal hyperplasia. However, in pediatric patients, The androgen levels are a very significant importance because of, issues such as growth and other developmental aspects of the development of patients in that pediatric age group.
And so with that in mind, the primary endpoint The study is the 4 week androgen level and other hormone levels. In addition, you'll see from the design of the study though that we are still interested Very much in the 6 month glucocorticoid dosing level for these pediatric patients. And we will be Similarly, following the ability to reduce the overall glucocorticoid dosing for patients in the context of treatment with crenecifant. So the endpoints overall align very closely with those within the pediatric the adult program. It's just that in
Question from Jay Olson with Oppenheimer. Please go ahead.
Thanks for taking the question. Since you grew INGREZZA pretty rapidly to $1,000,000,000 nearly $1,000,000,000 in annual revenues last year, just on TD and just in the U. S. And now you have Another indication on the way potentially in Huntington's Korea and potentially new market in Japan. And you've got 2 other new indications you'll be studying in neurology and psychiatry.
Can you talk about how important those are for The future growth of INGREZZA and how long it might take to get to $2,000,000,000 And can you get to $2,000,000,000 On TD alone in the U. S. Or do you need the new geographies and the new indications? Thank you.
Yes. So Jay, thanks for the question. We haven't talked about what we believe is the ultimate market revenue that can be attained here. TD, as Eric said, the vast majority of patients have yet to be diagnosed, let alone be treated Appropriately. As a matter of fact, with the 20% or so that have been diagnosed, only half of them are being treated with a VMAT2 antagonist At this point, so even within the diagnosed population right now, that small fraction of the total population, You should have a doubling of the amount of patients who are on medication.
One of the things that we had talked about Early on, and you'll remember, you've been covering us for quite a while here, was that there we believe that there were going to be a number of indications for the VMAT2 mechanism and that's coming to fruition at this point. And so we look to constantly Stand to the number of different patient types that this mechanism is going to be important in managing the diseases and disorders. And I think we've got several very important ones here. And the last Thing that I would say here is that that actually extends to almost everything in our franchise That when we go after a target, we're generally going after it not just for a single disease state, But we're going after it because we think it's a very important biological system for a number of disease states. And that's both with our internal programs and with the ones that we do with partnering.
So Eric, you have anything to add?
No, I mean other than just reinforcing that TD market alone Represent significant potential for us. It's an as yet mostly undeveloped market. There are many patients that are Undiagnosed and untreated. And we're certainly excited about the mechanism of VMAT2 and its potential utility in additional disease areas in neurology and psychiatry and the potential to help many more patients. And so that's what gives us a lot of
To Anupam Rama from JPMorgan. Please go ahead.
Hey, guys. Thanks so much for taking the question. Maybe I'd just like I asked a little bit more of a clarifying ish type of question sort of in regards to 2Q pandemic. With everything, Matt, that you've kind of said about How we should be thinking about 2Q and then relative to last year. You're essentially guiding to like a mid-250s kind of Hi, 250 is kind of range for 2.5% if you could confirm that.
And then why wouldn't it be greater Then what you saw last year of the script trends that you're seeing exiting 1Q like what's holding you back from saying, you know what, The quarter is going to be better than what we observed last year.
Yes. You're breaking up a little bit, Anupam, but I think I made my way through what you were asking. In general, Yes. In the 250s is mid-250s is what we would be anticipating based upon what we're Seeing right now, the piece that I know it's difficult to understand, But our performance last year, for example, in Q1 is what drove our Q2 results. Q2 was a derivative of Q1 activity.
And in Q1, we had record numbers of new patients last year. So you added the new patients, Heavily concentrated in the back half of the quarter last year and then you get a full quarter's of refill rates from those patients. Now when you think forward into what happened last year in Q3, that's when the impact from The patients not going in person into the offices really kicked in. And so Those were activities that were being done in Q2 and that showed up in our Q3 revenue more in a more pronounced way. So similarly this year, what we saw in Q1, we did see nice growing new patient additions.
We also saw record levels of commercial activity. So our expectation is, yes, we performed pretty well in Q1. Our NRXs should continue to improve in Q2 and that should set you up for a much better Q3 or Q4
And all of that is with the assumption that this improving environment for COVID continues in the direction that it has been going, which we all hope.
We'll move Next to Carter Gould with Barclays. Please go ahead.
Great. Thanks for taking the questions. I guess first on the DTC campaign, I just wanted to it sounds like you're kind of characterizing this as a sort of a natural evolution of your broader awareness and education campaign. But I guess why now In terms of just specifically on timing and is this going to does this come with sort of like a predetermined or a finite magnitude or length or should we just Consider this sort of business as usual going forward as we think about your SG and A spend. Thank you.
Yes. So, I guess, I would agree that it makes the way that we're thinking about it is a We've been trying and piloting different types of initiatives over the last 4 years And we felt like we were at the point where it made sense to transition into a broader campaign That introduced the concept of INGREZZA directly to patients. And this was a decision that we made some time ago, but we're just rolling it out Now, in terms of is there going to be sort of a finite cycle for this? The way that we're looking at is we're going to be carefully monitoring the effectiveness of the ad campaign, looking at key performance metrics, etcetera, and then making adjustments as we go forward. Normally when you look at the lifecycle of a branded Ad campaign, it's effective for a few years.
And so I wouldn't expect TD Spotlight to be any different. Sometimes They could be extended and refreshed, but ultimately, we're going to be looking at this as an important lever for educating and motivating patients to talk to their doctor. And certainly we're very optimistic about The way that we developed the campaign and the way that the testing results came out and we look forward to rolling it out later this month.
Next to Myles Mentor with William Blair. Please go ahead.
Hey, thanks for taking the questions. Just a question on lividadaxastatin cognitive impairment for schizophrenia. I'm very curious about the type of patients you're going to be enrolling in that trial. Are they stable on all other Symptoms and predominantly have cognitive symptoms. And are you going to be meeting with regulators before you That trial, I just understand there's a little bit of conjecture around that matrix endpoint, what are talking academic circles about whether The right one to use and there's no formal FDA guidance here to my knowledge.
So any color you can provide there would be great.
Yes. Thanks for the question. So yes, we have been obviously had a lot of spent a lot of effort analyzing the information coming out of the INTERACT study. And just as a reminder, the cognitive measures included in the INTERACT study, which were responsible for the positive signals that we saw there were secondary endpoints and it was the backs, the brief assessment of cognitive symptoms and the scores. And those two measures measure something a little different.
1 is actually a kind of a pure score that's generated by the patient themselves and the clinician. And the scores is more of a functional interpretation of the cognitive impairment and includes the caregiver as well. And so what we were most struck by in the finding from the INTERACT study, which encouraged us to move forward into the next generation of testing here was the fact that we saw the signal in both of those measures. And to our knowledge, that has not been demonstrated in the context of a clinical trial before. As you quite rightly said, the data in this field has been very mixed with negative and few, very few positive signals on the matrix or the BACs historically.
So with that in mind, we are designing a study essentially to replicate an attempt to replicate that finding using those appropriate endpoints. And at an appropriate time, we will then engage with the agency then to understand if successful, The path forward into registration plan. And so I think the key goal in our minds right now is that we're intrigued by the signal we saw. We recognize the very significant unmet medical need in cognitive impairment within schizophrenia, And we're seeking to as rapidly as possible replicate that finding and work out whether it's really a real finding.
Question from Vamil Divan with Mizuho Securities. Please go ahead.
Great. Thanks for taking the questions and the color that you provided so far on the 2Q dynamics. I guess maybe one other topic, which I think has maybe covered as much as Ingenitus has been approved for about a year. I know you didn't launch until Thanks. Kemper, so can you maybe just share any details there around kind of the progress you had with that product?
I don't think you had great formulary position 3 months ago, I'm just curious if you made progress there and sort of how the initial sort of reception has been to that product in the market? Thank you.
Yes, I'll give some insight there and then perhaps Eiry, you might want to add Some color. So yes, from a timing perspective, we launched Ongentis Right at the end of Q3, really effectively the beginning of Q4. And we recognized that launching a product During a pandemic environment was less than optimal, but we also felt obligated. We had an improved product. We had sufficient commercial Supply and patients that could benefit.
And so we press forward. The fact that so many of these practices are limited in terms of Their ability to see patients in person does hamper the initial trial and adoption of OnGenesis, It's not unexpected and certainly we recognize that it would be challenging to introduce OnGenesis in this environment. The feedback that we're getting from neurologists and from Parkinson's specialists is very favorable. The feedback that I'm hearing is that they really Are pleased with the convenience with the once daily dosing. In many instances, the efficacy is stronger than What they might have expected.
And certainly, we continue to see steady growth week from week in terms of the number of new patient starts. Importantly for us, Ongentis also creates an opportunity for us to get additional time with neurologists For INGREZZA and TD. And so we're leveraging both products when we are in front of neurologists. So We're now 2 quarters into the launch. And as with all new branded products, they don't have coverage From a payer perspective, Wendy Watts, so our payer team has been very busy presenting Ongentest to the various Medicare and commercial and Medicaid formulary committees.
From a Medicare perspective, We launched right after the bid cycle and so for 2021. So Effectively, the expectation is that you would see OnGenesis added to Medicare formularies in 2022 for commercial and for Medicaid that would occur throughout the year of 2021. So near term, we're continuing to help our In terms of securing approval for those prescriptions through the formulary exceptions process. And then as we move through the year and into next We'll see what that pattern looks like for coverage from especially a Medicare perspective. Irene, do you have anything to add?
Yes. What I would just add is just to echo what Eric said in terms of for our medical affairs organization out in the field. Certainly, as we've engaged with neurologists around their first set of experiences with Ongentis, we are hearing Feedback consistent with what we might have anticipated from what we'd learned from BL in Europe when Ongentis was launched The efficacy profile that clinicians are experiencing for their patients tends to be maybe better than was experienced in the clinical trial setting and in terms of tolerability that the patient experience is evolving in a reasonable way. And in that regard, we also have a trial that we have ongoing now to generate real world data and evidence for patients within the United Receiving Ongenis, that's called the OPTION study, it's currently enrolling. And the enrollment in that program is going very well, which I think also reflects The interest in for patients and for clinicians and experience with the medication.
We'll move next to Paul Choi with Goldman Sachs. Please go ahead.
Hi, everyone. This is Charlie on for Paul. Thank you so much for taking our questions. Just a quick one from us going back to NBI-one hundred and four. You say with enrollment progressing, we were just wondering how that enrollment is progressing, what rates are you seeing currently And when we might be able to see some pediatric epilepsy data from that study in 104?
Thank you.
Yes. So that study is ongoing. We have centers open in the United States and a couple of centers in Europe as well. We have guided that the data from that study, which is a 24 patient study would be available sometime next year. And as we continue to progress with that study, we can give updates as required.
Chloe, I think you cut out. I know We're moving to David, if you're on.
Hi. Can you hear me?
Yes. Hi.
Okay. Sorry about that. I didn't hear the operator. Okay. All right.
Well, all right. I thought it wasn't me then. Okay. Well, just real quick, Just looking at the trajectory of INGREZZA and then just looking at the trajectory of Teva's AUSTEDO, It kind of struck me that it seems just looking at the volume trajectory that INGREZZA has struggled a little more amid the pandemic compared to AUSTEDO. It's not lost on me that AUSTEDO, of course, is approved in Huntington's Chorea.
But is there an For that, is it simply just that AUSTEDO has Huntington's in the label and INGREZZA doesn't? Or is there another reason why it seems that INGREZZA has seemed to struggle more over the past year, whereas that perhaps hasn't?
So I would say that there is the dynamic that they do have the Huntington's What also I would state is that neurologists came back into the office seeing patients full time Actually a while ago. So there's better than 90% of the patients visits in the neurology offices are in person. And as we talked about, that's not been the case with the psychiatrists. Basically, I think that may account for the differences that we've seen during the pandemic. We've always been the market leader.
We continue to be the market leader and everything that we do here is to retain that dominant position.
Question from Mark Goodman with SVB Leerink. Please go ahead.
Yes. Hi. Matt, can you give us a sense of how we should be thinking about net Price per Rx for the full year, obviously, there's a big step up in the quarter. But and I don't know, Kevin, maybe just Since I'm kind of nearing the end of the call here, can you talk about elagolix a little bit and whether you're just comfortable with everything that AbbVie Doing and what's going on there? It just seems like that product is not really doing much.
Thank you.
Yes, I'll take the first one. Yes, the last question first is that, I think that we all have expected and we continue to expect to see much better performance out of Elagolix for the indications now, the 2 indications that it's approved for. That has been taking Longer than what any of us would have thought for that to start picking up. It is completely in AbbVie's hands. They continue to invest in it.
We're just unfortunately much like you. We're waiting to see what happens with that drug. I do have to say that it is addressing 2 very important disorders in endometriosis and uterine fibroids. And I do have to say that we still have a lot of belief in that drug. It's a very good medication.
Matt?
Yes. On the net revenue per TRx, what I would expect is something, like I said earlier, similar to last year, last year was around $5,600 I would expect this year would shake out around, call it, 5,500 to 5,600. So somewhere in the 5,500 Our range is what we would be anticipating right now based upon what we saw in the quarter as well as contracts that we have with payers
from Yatin Suneja with Guggenheim. Please go ahead.
Hi, everyone. This is Evan Tadeo on for Yatin. Congrats on the quarter and thanks for taking our question. If you get positive data in the Korea in Huntington study, would this be enough to support filing? And what else, if anything, would you need from this program to file?
Thanks.
Thanks. It's Eiry here. So our goal is To complete this study and read out the results and to your point if positive and if we're successful there, we plan to go forward to the agency with Supplemental NDA submission for Huntington's Korea. In addition, we do have an open label longer term tolerability study ongoing in parallel, which would and that additional safety information would be added to the package.
Question from Laura Chico with Wedbush Securities. Please go ahead.
Thanks very much for taking the question. I just wanted to follow-up. I don't think I heard this asked, but what is the typical duration For folks on treatment now, I guess relative to what it was pre pandemic, it sounded like there were a lot of efforts made to keep folks on therapy during this quarter. And then you've kind of answered this question a little bit throughout the call, but I just wanted to maybe more explicitly ask what gives you confidence in the size of the addressable TD market as it stands now? Thanks very much.
So I'll take a first crack at this, Laura, then Eric can chime in. We have always seen great Persistence and adherence to our drug back when we launched it, we had looked at these patients and The psychiatric patients and set up all the medications they're on, what's the average duration that they're on? They And I'll use a rough shorthand that they would take them about 50% to 60% of the time. So that means 6 A little over 7 months out of the year, they're on their medications. And that doesn't mean just their antidepressants, anxiolytics, antipsychotics, not just their mental health Meds, but all of their meds, whether it be diabetes meds, cardiovascular meds or whatnot.
These in our clinical trials, these patients were on an average of 7 daily medications. So we didn't expect INGREZZA to perform any better than that. We just thought this was a feature of this patient population. However, we were very pleased to see that the adherence and persistence of patients right from the get go was much, much better than that. I would say that probably for the first 2 years of our launch, I said this isn't going to last.
It is maybe just The fact that it's a new drug and there's so few new drugs that are introduced into this patient population. But then after years 3 and 4 where it has continued like that, it truly is the fact that This is a very simple drug for a very complicated set of patients. And I think that's very much appreciated by the patients And their caregivers and the physicians and the other advanced practice practitioners. So yes, there was a blip in Q2 of last year just as the pandemic hit, just as we put Our sales force had to go totally virtual. And as we had discussed in previous calls, They then did the only thing that they could do at that moment in time is make sure that the patients who are on Drug that continuity of care stayed and they did an excellent job of that.
So we did even above an extremely high baseline Here it saw a bit of an increase there. That increase I said is not sustainable because Our efforts had to go back into generating new patients to the drug. And so we saw that go back to what the very high historical norm was in Q3 and Q4. Q1 was a completely different situation. You did have an interruption in the number of refills there.
It just took longer than what it normally takes. But there's no reason for us to believe that now and as we've said, we exited with more patients on Ingress and then what we exited Q4 on. So there's no reason to expect that we're not going to continue with that Extremely high rate of adherence and persistence.
Yes. I'll tackle the second part of your question, but I do want to tack on To Kevin's comment here, really two things. 1, the persistence numbers that we saw in Q1 were consistent with what we've seen in prior quarters and remain very high. And one of the things that we've looked at is, we've tracked the persistence of various cohorts of patients really from the very beginning of the launch. And so looking at patients that might have started In 2018 versus patients that started in 2019, haven't seen any meaningful differences in terms of the expected duration of treatment, and that continues really all the way to the present.
In terms of what gives us confidence around Market size, you might have heard me mention that we're estimating currently that the TD market is around 600,000 prevalent patients. How do we get to that number? Well, there's a number of different things. Certainly, we continue to look at the various prevalence publications in the peer reviewed literature that all point towards numbers in that range or even higher. We continue to do market research with healthcare providers.
And importantly, we're seeing an increasing trend in terms of the number of TD patients they think they have in their practices. We look at claims databases and we're certainly seeing an trend in terms of the claims related to TD treatment. And really what's the underlying driver here? There continues to be an increased use of antipsychotics, which are associated with causing TD. So these are all indicators for us that give us confidence that the size of the prevalent population is At least as big as we think it is.
And importantly, for us, our near term focus remains to drive recognition and diagnosis and bridge the gap between the diagnosed population and the TD treated Excuse me, the prevalent population. And as Kevin mentioned, of those that are diagnosed today, only about half even get offered of VMAT2 inhibitors. So there's a lot of upside potential for us to not only improve diagnosis, but to improve the rate of people that are treated for their TD and that's really the core part of our mission.
So that brings us to the end of our call. I think what you've heard this afternoon is the fact that we have a total belief and it's based in data that we have A growing market here that we have a patient population that is Needlessly suffering, probably 80% at least of TD patients are needlessly suffering. So that is where our mission lies. That is what we're going to work on and we're using every avenue that we have at our disposal in order to do that. You've seen a lot of that efforts that we put in place over the last 4 years.
You've seen us treat take this marketplace from something that physicians 4 years ago denied that even TD existed. To now, there are a great number of TD patients that are on treatment And being helped in every aspect of their life. That is going to continue and that will only grow over time. And that's what we're dedicated to and we're going to keep going with that. So with that, I would like to thank you all for your attention today and we look forward to talking in the near future.
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