Good day, everyone, and welcome to today's Neurocrine Biosciences Report Q1 2020 Results Call. At this time,
you.
Please note this call may be recorded. I'll be standing by should you need assistance. It is my pleasure to turn the program over to Kevin Gorman.
Thank you very much and good afternoon everyone and thank you for joining us today. Here with me at Neurocrine is Todd Tushla, our Head of Investor Relations 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 Officer. Before we get started, Todd, could you read our Safe Harbor statement, please?
Yes, good afternoon. Certain statements made in the course of this conference call that are not historical statements may be forward looking statements, which are subject to risks and uncertainties. Information concerning factors that could cause actual results to differ materially from those contained in or implied by the forward looking statements is contained in the company's SEC filings, including, but not limited to, the company's first quarter 2020 Form 10 Q and in today's press release. Copies may be obtained by visiting the Investor Relations page on the company's website. Any forward looking statements are made only as of today's date, and we disclaim any obligation to update these forward looking statements.
Kevin?
Yeah. Thanks, Todd. We're going to keep our opening statements amongst very brief so that the vast majority of this call, we can take all your questions. I'm sure all of you are dealing with our current situation like we are here your mind and emotions are constantly switching between concern for the safety and well-being of your family, friends, coworkers and then to the well-being of your community and our of how crucial our industry currently is now more than ever. Today we're going to briefly take you through how we've been approaching our work during this time.
Our overriding principles are safety of our employees and their families. Support for the patients we serve and importantly respect and support for the healthcare workers we call upon now and those that we'll be calling on in the future. Neurocrine is in a very fortunate and strong position, not only financially but with our expanding and progressing pipeline. And importantly, as evidenced by last week announcement, we have our 3rd approved medicine on GENTIS for the treatment of Parkinson's disease. You may find throughout our call that our tone may be We're acutely aware of the hardship and sacrifices being felt by many individuals and businesses and we do not take our good fortune lightly.
With that, I would like Matt to take you through our Q1 financials and comment briefly on our April performance.
Matt? Yes, thank you, Kevin, and good afternoon, great hearing from many of you over the last several months. As Kevin said, we feel very fortunate with how Neurocrine is to navigate the challenges created by COVID-nineteen and are grateful to have us all balance sheet, a tremendous medicine like INGREZZA for patients with TD and a growing pipeline with clear opportunities to make a difference in the field of neuroscience in the years to come, including the recent approval of OnGenesis. During the first quarter, our commercial team did an excellent job managing through the payer related seasonal dynamics to ensure patients remained on INGREZZA. In fact, we had strong These results these efforts resulted in $231,000,000 and 500 TRx.
Adjusting for channel inventory, we saw a sequential increase in total scripts, which is a great accomplishment considering the unique first quarter dynamics. On the net revenue per TRx front, the sequential gross to net impact was in line with our expectation. Turning to the P and L, our track record of profitability continued with Q1 GAAP net income of $37,000,000. And non GAAP net income of $79,000,000. On the balance sheet, cash grew to over $1,000,000,000 positioning us well to continue investing in INGREZZA our diversified pipeline and business development opportunities.
We are updating our GAAP and non GAAP SG and A and R and D expense guidance range to $675,000,000 and $550,000,000 to $600,000,000 respectively due to the general delays associated with COVID-nineteen. This compares to previous GAAP and non GAAP expense guidance of $740,000,000 and $6.20 to $650,000,000 respectively. As we look forward to the future of INGREZZA, We remain extremely optimistic In the short term so far through April, we are encouraged by the continued strength of INGREZZA refill rates which are a testimony to the treatment benefits Even with our field teams working remotely, the impact to NRx has actually been less than we originally feared Admittedly, it is still too early to fully understand the ultimate impact of COVID-nineteen, but I am extremely proud of how Era and our commercial team have supported our customers thus far through the crisis. With that, I will now hand the call over to Eric Benevich our Chief Commercial Officer. Eric?
Thanks, Matt. I'm happy to cover the commercial highlights from Q1. I'd like to start off by thanking our entire commercial team for the excellent results delivered in Q1. It's reflective of the caliber of our employees that they were able to keep up the momentum with INGREZZA under very challenging conditions and more importantly help many thousands of patients suffering from tardive dyskinesia. Before I discuss our business results, I'd like to acknowledge 2 important commercial milestones.
The first is the recent 3 year anniversary of INGREZZA's approval. As we sit here for patients since off the long term opportunity to help many thousands more patients with tardive dyskinesia. And second, approximately 2 weeks ago, we received approval from the FDA for our 2nd commercial product called Ongentis. A new medication to help patients strong label granted by the FDA and believe we have a differentiated medication that will be embraced by the Parkinson's community. Irene will elaborate on the benefits of Ongentis for patients later on this call.
You only get one chance to launch a new drug. And we are extremely enthusiastic about the opportunity to bring this new treatment option to patients with Parkinson's disease later this year. Now on to our business results. Once again, this year, Q1 was a tale of two half quarters. During the first half of Q1, our commercial team was laser focused on helping patients and healthcare providers overcome seasonal headwinds These payer related dynamics included calendar year reauthorization requirements, resets for patient out of pocket contributions and re approval for INGREZZA when patients switched health plans.
The combined effect of these factors can potentially delay refills as well as delay new patient starts with extensive planning and collaboration across teams, our field teams did a great job of helping to minimize treatment disruptions for existing patients as evidenced by steady persistency and strong TRx momentum as we move through the quarter. Regarding new patient starts, like last year, we saw a nice uptick in NRx numbers in the second half of the quarter. As we previously communicated in response to COVID-nineteen, we took actions starting in mid March to protect the health of our employees. Including our customer facing field teams by implementing a work from home policy. As this new policy was being implemented, many of the psychiatry in neurology clinics around the country began to severely restrict patient in person visits order to support the productivity of our field teams in a remote manner we pivoted to technologies to enable continued TD education ingressive product presentations and reimbursement assistance.
Despite the current widespread shelter in place directives, our mission remains the same. To help people suffering from TD get effective diagnosis and treatment. At the same time, we realize our customers are struggling to deal with 2 concurrent public health crises, a COVID-nineteen pandemic and a burgeoning mental health catastrophe. We are fortunate to have hired such an experienced field team who have strong relationships with healthcare providers and a dedication to serving patients. Our people have the insight and the flexibility to know when to give a customer some space, when to step in with INGREZZA support and the awareness to know that sometimes the only support they can offer is to listen sympathetically when their customer needs someone to talk to.
Despite our efforts to adapt to this new rapidly evolving environment, we recognize that COVID-nineteen will likely have an impact on our business in the near term especially on new patient starts. The strength of our commercial team Ingres's attractive product profile and the sheer unmet need in TD will likely be key drivers of accelerating momentum when we eventually transition back into the field and re engage with our customers face to face in the hopefully not too distant future. I remain very enthusiastic about our team's mission of delivering on hope for people suffering from TD and soon Parkinson's disease. I'm excited at the opportunity to expand our reach in movement disorders with the launch of Ongensys as we continue to have high conviction in the growth prospects of INGREZZA in the coming months and years. We're ready to help grow Neurocrine from a single commercial product company to a company offering multiple treatments for patients.
So with that, I'll turn the call over to my colleague, Eiry, our Chief Medical Officer.
Thank you, Eric, and good afternoon to everyone on the call. I'm happy to provide healthcare and other service professionals who continue to work so hard on the frontline of this pandemic. I also want to convey my Our team was especially impressed with their partnership as we navigated through the recent regulatory approval process for AngenTus. A little less than 2 weeks ago, on April 24th, the FDA approved once daily on GENTIS as an adjunctive treatment to levodopa, carbidopa for the treatment of patients with Parkinson's disease experiencing off episodes. Ongensys is an oral selective inhibitor of categorical o methyltransferase or comped A key enzyme involved in the breakdown of levodopa in the bloodstream.
Levodopa carvadopa is the current gold standard for treatment of motor symptoms in Parkinson's disease. But as the disease progresses, the therapeutic effect of levodopa, carbidopa can wear off and patients may begin to experience off time between treatment doses during which an increase in their Parkinson's disease motor symptoms such as tremor, slowed movement, and difficulty walking occur. Through its selective inhibition of comped on GENTIS as an adjunctive therapy given once a day administered at bedtime increases and prolongs the therapeutic blood levels of levodopa, carbidopa and therefore results in more consistent motor control for patients with PD including a reduction in OFF time an improvement in on time without troublesome dyskinesia. I'd like to recognize our team who worked diligently living with Parkinson's disease. Shifting gears now, the COVID-nineteen pandemic has impacted many clinical trials across our industry over the past few months including our own.
We announced last month that we temporarily paused enrollment of new patients in 3 ongoing studies: the phase 3 registration study of Valbenazine to treat Korea in Huntington's disease the RESTORE-one registrational study for NBIB-one hundred and seventeen in Parkinson's disease and the phase 2 pediatric study of Carnesophant in congenital adrenal hyperplasia. In managing through these trials, our top priority is to protect the safety of participating patients and to ensure the integrity of To that end, we are working closely with our investigators to adapt assessment measures and trial monitoring as needed to both ensure the safety of all current study participants and to determine when and how to reopen these studies for new enrollment in a safe and effective manner. It is important to note however that while these ongoing studies are temporarily paused to new enrollment, We continue to make progress on all fronts to ensure that we are well positioned to launch We're conducting pre the for our single global registration study of Crenescifant in adults with congenital adrenal hyperplasia and for 2 mid stage studies in rare pediatric epilepsy pending our exercise of the option with Didocia. Regarding crenezophone, following the recent cancellation of the live ENDO meeting, Results of the phase 2 proof of concept study in adult patients with classic CAH will be presented at the ENDO online meeting scheduled for June.
We also registration of crenezafonte in adult patients and we're currently moving ahead to implement this global registrational study design in the second half of the year. We look forward to advancing this In closing, while it is challenging to ultimately predict what kind of impact the pandemic will have on our clinical timelines overall, our plan for 2020 currently remains unchanged to have 3 registrational programs and 4 mid stage programs ongoing by year end. I'll close by thanking all my colleagues at Neurocrine for their truly inspirational efforts and dedication to our company's mission to relieve patients suffering and enhance patients' lives. With that, I'll hand back to Kevin.
Thank you, Eiry, and Matt and Eric So that'll do it for our prepared stations, statements and we're ready to take your questions.
Right at this time, we'll take our first question from Paul Matteis of Stifel. Your line is open.
Great. Thanks so much for taking my questions and congrats on the quarter. Two things from me. I was wondering if you could comment on the average script per patient that you saw in 1Q maybe quantitatively or at least qualitatively relative to that funky dynamic from 1Q 2019 that confounded results And then separately, I was just struck by, by your guys' bullish commentary on NRx in April. You guys usually the kings of kind of being conservative and then maybe and then maybe beating that conservative tone.
So maybe you could just comment a little bit more detail on what you're seeing with INGREZZA thus far in terms of NRx? Thanks so much.
Why don't we start out, Matt, do you want to take the stab and followed by Eric on the first part of Paul's question?
Yeah, sure. Paul, thanks for the question and also for calling us Kings. We appreciate that. From a Rx per patient perspective, as we had flagged heading into the quarter, since we had double the number of patients this year, compared to this time last year, there is a potential for a significant headwind even if we kept the refill rate per patient the same in Q1 as we did last year in Q1. That could have been a significant headwind.
So I think what you can see in our results for this quarter since we actually had a sequential increase in TRx when you normalize for channel inventory. You saw that the teams that were in place actually drove a bit higher refill rate per patient in the first quarter. So it was a heck of a job by the team, and they did an excellent job.
Yeah, Paul, this is Eric. So to answer the second half of your and we feel good about the momentum that we've carried into Q2. As I mentioned in my prepared remarks, Q1 was a really good quarter from an NRx perspective. In fact, it was one of the best quarters that we've had to date. Now obviously going into Q2, the pandemic hit in a widespread basis, shelter in place directives were implemented in states across the country.
And we had to adapt. We implemented a work from home policy and pulled our field teams out. However, despite all this, we saw really good consistent refill rates And we expected that there would be an impact to NRx, but it was less than what we had expected to see given the dynamics. It's early days yet and certainly we're watching things very carefully. And this doesn't affect our long term optimism about the opportunity with INGREZZA in cardiac dyskinesia, but certainly wanted to convey that in terms of our business momentum, we feel good about what we've seen thus far.
Matt, you meant relative to Q1 last year, right, in terms of refill rates, not Q4, is that correct?
Yes, that's correct. And the only thing I would add on NRx for the quarter or sorry for April is that if you read a lot of the different surveys across the industry call volume is down significantly as patient visits have also gone down significantly. I think most say between 65% 75% decline. So our commentary around NRx is those aren't tightly correlated at this point. But as Eric said, and as I mentioned in my prepared remarks, it is still, too early to make a formal call on on Q2 and what it's going to look like.
It really depends on when people start opening back up and patient flow picks back up in person. So, thanks, Paul.
We'll take our next question from Biren Amin. Your line is open.
Hi guys. Thanks for taking my questions. Can you maybe just talk about inventory levels I think you added about $4,000,000 in Q1 and you had, I think, another $11,000,000 in Q4. So I just want to understand where you think typical average is around 4 to 6 weeks. So maybe if you could just address that.
Thanks.
So, Matt, do you want to take that one?
Yes, sure. Thanks. So from a channel inventory perspective, it's very difficult to predict and it can be highly variable. Even based upon the day the quarter ends most of our channel orders on a Monday, for example, or Tuesday. And so depending on the timing, there may be a little bit more stocking at the end of a quarter if it lands on Monday, Tuesday or Wednesday.
So, when you normalize for channel inventory, therein, you know, we really had, you know, 27 of sales results in Q4 and you also normalize to that same place for Q1 around However, since there's such a big gross to net discount period or gross to net discount it leads to a sequential increase in TRx. But from a days on hand perspective within our channel, it's still, it's right around 2 weeks.
Okay. That's helpful. And then I guess on, the new prescription starts that you're seeing Can you maybe describe what percentage what percentage come from switching from existing therapies that patients are on? Versus the treatment naive patient given we've got the COVID epidemic and it's probably harder for treatment naive patient to go in to see a doctor.
Yes. Byron, I'll have Eric start with that.
Yes. The answer is that we don't have that information. It's not clear how much of this has been driven by switching an assume that you're talking about deuterated tetravenazine. In the work that we've done in the past, looking at market research and so on, there's been very little of that kind of activity. The vast majority of new patient starts has been driven by our educational efforts, having providers to identify previously undiagnosed patients and then certainly educating them about the risks and benefits of treatment with INGREZZA.
I assume that that's probably still the case in this current environment. And just to kind of tack on a little bit to what Matt was talking about, certainly there's been a substantial drop in patient visits over the last let's say 6 weeks or so across different sectors of healthcare including in psychiatry and in neurology. But that's been partially offset by an uptick that we've seen in telemedicine. And so Certainly, we've made efforts to understand those dynamics and to help providers in our universe understand how they can continue to assess patients for TD symptoms, how they can monitor patients that are currently on INGREZZA, etcetera. And so that may partially explain why even in these times where there's been a dramatic decrease in patient flow through the clinics It hasn't been, as Kevin said, you know, proportionally impacting our business.
Yeah. And bear and what I'll add on to that is, as Eric just talked about telemedicine, going before COVID psychiatry was the specialty that utilized telemedicine the most. Than any other specialty. That clearly has increased and ramped up from there. And so that's what Eric meant is that we've been looking at this.
We've been in studying telemedicine for a couple of years even prior to this. And so with an experience in talented Salesforce, they were able to plug into that And I think that is, as Eric said, one of the reasons why the treatment, the NRx that we're seeing and area statement as Matt has done and Eric has done, this is still early into this quarter. And so we just need to see and stay on top of and adapt to what is going to continue to happen throughout this quarter and beyond.
Our next question is from Brian Abrahams of RBC Capital Markets.
Hi, this is Leo on for Brian. Thanks for taking my question. I had a question on the CAH program. Just wanted to know what the recent feedback has been, in a regulatory sense on the pivotal trials that you're planning to run? And you potentially looking at something like concomitant steroid use and steroid reduction as an endpoint, compared to normalization of biomarkers?
I might have a quick follow-up as well.
So thanks for the question, Leo, it's Eiry here. And we did meet with the FDA as planned. And In terms of the actual design of the study, as we've said before, I think, on several calls, we do believe that the hormone levels of a 4, a 17 OHP and ACTH are very important and they are used extensively in the management of patients with CAH In addition, we believe it will be important to understand the impact that ACRS 1 antagonist can have on the dose of exogenous glucocorticoids that's required to continue to control the disease. As I mentioned, we are at finally towards implementation of that in the second half of this year. And once that study is posted on clinicaltrials dot gov, obviously there'll be a lot more information about
And if I can just follow-up on maybe more of a broader strategic perspective. I know previously you had mentioned that you were going to go to loan in here, for the global studies. And I just want to know if that thinking has evolved given the global pandemic and the macroeconomic conditions and perhaps how site identification is going?
So I'll take the very first part of that strategic aspect, no, that hasn't changed at all in our thinking. We still plan on
doing the phase 3 trial alone, doing the registration in both territories and commercializing in both territories ourselves. Ira, you want to talk a bit more about how it's gone? Absolutely. I mean, we have external partners we're working within the form contract research organizations that obviously have a very broad reach globally. And we've been working very closely with those teams and also with our investigative sites that are selected and the regulators and FX committees in Europe and in the U.
S, towards the ability to implement in the second half of this year.
Yeah, you know, you do even during this period of time, you do get some pleasant surprises and I'd say one of the pleasant surprises that we have found is that working with the outside partners that throughout all of our programs here whether it's CROs, whether it's the clinical trial sites that we're currently working with the ones that we are signing up for the trials that are all going to be starting in the second half and certainly the regulatory agencies, both EMA and FDA. They have not missed a beat They've all been extremely responsive and we've been able to work highly effectively with all of them telephonically.
Thanks. That was very helpful.
Our next question is from Tazeen Ahmad of Bank of America. Susan, you may wanna check your mute switch. Your line is open. And once again, Tazeen Ahmad, your line is open. Please check your mute switch.
We'll move next to Brian Skorney of Baird. Your line is open.
Hi, thank you. This is Jack on
in for Brian. Thanks for taking our questions. I just had one quick one. I was wondering if you could talk a little the payer mix of INGREZZA and how many of the patients are commercial versus government insurance and how you could see kind of a broader macroeconomic trends in the U. S.
Playing out there? And is there any risk for the business associated with the kind of potential shift to government insurance plans that show unemployment increases as we've seen in the past? Thank you.
Yes. So, Jack, we've not talked about what our actual payer mixes between private and public. As we had said, originally when we had launched looking at the antipsychotics as a proxy for this patient population, we saw a fifty-fifty mix. We said all along that it's actually a bit higher in the public payer arena for this drug not surprising because our patient population is a bit older here. You raise a good point as far as what is happening with COVID and broader issues that are going on.
Right now what we do in through our government relations and both in house and also in Washington throughout state capitals. We keep a pulse on what's happening here. It is evolving continuously. I don't think I can make any intelligent forward looking statements here other than to say that we monitor, we're involved and we will react appropriately. And, Eric, do you have more to say?
Yeah, the only other thing I'll add is that regardless of the patient's insurance status, our commitment to making that they can get
We'll move next to Anupam Rama of JP Morgan. Your line is open.
Hey guys. Thanks for taking the question and congrats on the quarter. Just a quick question on the opicapone launch. So, should be thinking about sort of the resolution of the supply issue and the gaining factors to getting the product launched here in the back half of the year. Thanks so much.
Yeah. Thank you, Anupam. On the, you know, we do have COVID pandemic and that in and of itself makes it impractical for us. And as you've seen with many companies, to launch into this environment. But on top of that as we had discussed back in January, which seems like years ago, at a conference that our partner Beal, who is 100% responsible for supply chain.
Had an incident in a supply chain and they are rectifying that. We stay in close contact with them through each step of the process as that's being rectified and we'll stay tuned. We'll tell you in early we'll probably give you an update early summer about what our what our launch plans are, the timings.
Got
it. Thank you.
We'll take our next question from Jay Olson of Oppenheimer. Your line is open.
Hey, congrats on working through this pandemic and thank you for taking the question. I think you said the unexpected strength in new patient starts for INGREZZA was supported by your transition to online physician education. And I was wondering if you could attribute any of the new patients start to your consumer education program. And then related to that, I was wondering if there's any way you could use your INBRACE program to refer new patients to physicians who practice telemedicine.
Thank you, Jay. Eric, do you want to?
Yes, Jay, thanks for the question. Certainly, I think that the cumulative effect of everything that we've done over the last 3 years is contributing to the sustained momentum that we've seen coming out of Q2 or excuse me out of Q1 into Q2. The talk about PD unbranded disease state education program that you mentioned that's targeted towards patients, we believe is contributing to that as well. Even though there is a lower volume of patients having face to face visits. Many of them are still having the opportunity to talk to their physician and certainly we continue to try and educate them about abnormal movements and the possibility that that it could be TD and to encourage that dialogue.
Ultimately, the strength that we've seen coming out of Q1 into Q2 is really like I said, the cumulative effect of everything that we've been doing and we're really very thankful that we hired such a strong team that they've got the relationships and that they've been able to really pivot very quickly and move from an in person face to face model to remote education and remote customer support. And we've been very pleased with the productivity that we've seen thus far.
Great. Jay, this is Matt.
This is Matt. I also want to just make a couple clarifying comments for everybody. Similar to last year, as we saw in Q1, it was a tale of two quarters where you had a bit slower first half of the first quarter and then the ramp picked back up in the second half of the quarter as patients got back to more normalized refill rates and NRxs were flowing steadily. So we did have, as Eric just mentioned, a nice momentum, nice trajectory, you know, prior to COVID-nineteen, And I just want to make sure, our comments about NRxs in April are not taking out of context I think in how you asked the question. You know, I just want to be clear, we are we're not seeing a sequential increase or growth out of NRx.
We are seeing, like we said, better than we had anticipated NRx given the the changing dynamics, but wanted to make sure, I provided that clarification given a couple other questions.
Great. That's super helpful. Thank you. And are you able to refer TD patients who need doctors practice being telemedicine to a network of doctors local to them?
Yes, sorry, I neglected to answer the last part question. No, not currently. The call to action with the Talk About TD ad is to talk to your doctor. We have certainly discussed and we're evaluating if there's an opportunity to direct patients towards a specific physician in their area that's been educated on TD. So stay tuned.
Super. Thank you very much.
Our next question is from Charles Duncan of Cantor.
Hi guys. Kevin and team congratulations on a good revenue quarter and thank you for taking my questions. I had a commercial question and then a brief pipeline question. Regarding the commercial question, you know, folks are talking about the NRx and kind of just clarified it to the previous question. But I'm really wondering if you think about the interactions that you're having with prescribers say in early April, versus early May versus what may be in early, early tatively discuss that kind of flow.
Was it more, I guess, difficult to get to people in early April than maybe early May? And what would you anticipate for early June?
Yeah, I'll take your question. So I think that as we went through the tail part of March and into early April, there was a lot of adapting that we were doing at that time, both in the field and in the home office to support what our customer facing team was doing. And certainly there was a lot of change happening across the country at different rates and at different times. And we started to see more and more practices essentially restrict access to patients only emergency visits or shut down entirely. Our field team, we needed to pretty quickly equip with new tools and technologies that would allow them to or enable them to have those remote interactions with their customers.
And so there was a period of time where we were very furiously making a lot of changes on the fly so to speak, to be able to support what we are trying to do with our customers and frankly to support what they were trying to do with their patients. I think that over the course of April, we settled into a bit of a rhythm. Certainly, we learned a fair bit about what was working, what was less effective and certainly made some changes in terms of the resources that were available to to our sales and our reimbursement field teams. So at this point, I feel like it's a relatively steady state in terms of what that cadence looks like and the types of interactions that we're having. However, now we're starting to see that as certain states are starting to loosen up the restrictions and so on, we're doing a fair bit of planning in terms of what does re in arrangements in face to face types of interactions with customer looks like.
How can we do so safely etcetera. So I think that the focus is shifting a little bit towards what the future looks like and how we're going to start to have those kinds of engagements with customers like we had in the past where we can do so and at what pace.
That's helpful, Eric, and supportive of our thesis and the use of telemedicine and psychiatry That said, let me ask you if you see psychiatry being a little bit easier not to crack, if you will, versus say neurology and thinking about possibly an impact of a second wave, when you're launching and on on Genesis later on this year?
Yes. I'll comment on that and then perhaps Irae can comment as well. So as Kevin mentioned, pre COVID, there was a higher utilization of telemedicine within psychiatry. And there's a number of factors that drove that. One is that there was a very large gap between the number of patients that need psychiatric support versus the number of providers.
And you see this especially in rural areas. And so many of these mental health clinics had resorted to engaging a telepsychiatrist that could be a county away or across the state to help provide medical services for these patients in their immediate geo area. So that was already utilized to a higher degree than what we saw in other physician specialties. The COVID-nineteen pandemic really just accelerated And what we saw was that some of the restrictions that were put in place and the standards have been relaxed by the government. For example, used to be that the patient had to be in a clinic.
They had to be engaging with the remote psychiatrists via a closed, a closed circuit TV network essentially, etcetera. And now some of these a good portion frankly of these TILA psychiatry consults are via phone. The patients at home the physician could be at home as well. So we're trying to understand those dynamics. What happens once the emergency declaration is lifted to what extent do things go back towards what they were precoded or to what extent will telemedicine remain a core part of psychiatry.
Certainly, we're also trying to understand the impact on neurology. And the potential impact on our launch with on GENTIS. But this is something that we've been keeping an eye on for some time. And certainly, I think we're better prepared probably than many other companies because we have been doing some work to understand how telemedicine could affect TD in our INGREZZA franchise and we're able to leverage that work that we did previously.
Yes. And the only thing I'd add to that Eric is I think it is definitely correct that psychiatry historically has been further ahead in terms of the employment of telemedicine approaches, at least through our interaction with the movement disorder neurology community, both through our Huntington study and also through preparation for the AngenTus launch. It's very clear that that community is acting rapidly in order to that the ongensys population will have is that many of those patients will already be known to then and will be in a relationship with their neurologists already. And so we are seeing in that setting that there's a lot of use of remote technology and assessment techniques that are enabling the clinicians and healthcare professionals to support their their patients very effectively including potentially changing or adding additional treatment options.
Charles, did we answer your question?
Yes, you did. Thank you very much Kevin.
We'll move next to Phil Nadeau of Cowen and Company.
One clarification question on the prescription numbers. I think you're setting 41,500 TRx in Q1. I believe we had in our notes, there were 42,100 TRx in Q4, yet you're calling Q1 a sequential increase. Could you correct our figures if they're wrong or on what basis are you denoted in Q1 as may increase?
Yes. So our Yes. So, our TRX numbers include implied TRX for the channel inventory. So, in Q4, for example, where we had an $11,000,000 inventory build that represented, call it, around a little over 2000 TRx in the quarter. So our reported TRx you would need to reduce by around 2000.
And then this quarter, you had a $4,000,000 channel inventory build, which would represent 600 or 700 type level of implied TRX.
That's helpful. And then, checking on the NRx trends that you've noted in April, in the past, you've suggested that NRx, there can be a lag for when the patient is seen by the physician to when NRx is actually realized and becomes commercial. Is there any chance that the trends you're seeing in April are partially due to a lag and some of those NRx were actually based on patient visits earlier in March or before COVID hit?
Eric, do you want to take that?
Yes. Certainly, there is a bit of a lag time. It depends on the site of care and what pharmacy the patients getting their prescription from. It could be a few days or in some cases a couple of weeks. So prescriptions that were filled on NRxs that were filled at the very beginning of April likely would have been written sometime in the latter part of March.
But as we said, we saw a nice uptick in momentum in the second half of Q1 and that really did continue to carry through into Q2. It's early still and we're monitoring things very carefully, but the impact was not as significant as we feared given the dramatic changes in the external environment.
Take our next question from Vamil Divan of Mizuho Securities.
Great. Thanks so much for taking the question. Maybe just one to clarify and then one extra question. That $4,000,000 that you mentioned was channel inventory So that includes stocking benefit of the patient level, also people maybe just try to fill script before the pandemic picked up, or is that just really in the in the channel. And then my actual question was more on the business development side.
I'm just curious with this pandemic impacting companies differently, is there any way sort of change your priorities or opportunities potentially to pursue business development or maybe some smaller companies that are not able to with getting the pressures as well? Thanks.
Matt, do you want to take the first clarifying aspect?
Yes, the channel inventories act in our channel, so our pharmacy network, it's not, at the patient level. And also, just to note, we did not see any significant change and how patients were getting refills, nothing to note in March. So I would chalk up a very little impact in Q1 associated with anything in connection with COVID-nineteen.
And Kyle, you want to talk about BD?
Yeah. So make sure I captured your question here. A little bit about our interest though. Top of investing for INGREZZA and opicapone in our internal pipeline of course, we continue to be interested in things happening on the outside. There's only so much we can do internally and we're really in an interesting time right now with a lot of people doing some great science outside of our doors.
So we're trying to learn and get smarter on what's going on out there. So of course, we continue to look and see if there are other partnership types of opportunities. I think that if you look across our pipeline at some of the partnerships that we struck recently, Zena and Voyager, you see the type of things that are of interest in Neurocrine strong science platform technology and intellectual property. Those are things that are very important to our current internal programs and that's something that is the cornerstone of our interest to engage in discussions with other companies. So whether they're large or small those are the pieces that we're looking for.
Does that answer your question or do you have a follow-up there?
Yes, I think I guess I was just kind of also curious, have you seen like a change or maybe more conversation starting as smaller company may be struggling to manage their way through the pandemic. Maybe you can comment on valorables?
Yes, we haven't seen that yet. I think most of the people are just trying to and how their business might change and making those adjustments. Not to say that can't happen down the road, but we haven't seen that yet.
We'll take our next question from Carter Gould of Barclays. Your line is open.
Great. Thank you. Good afternoon. Thanks for taking the question and congrats on the INGREZZA performance. I guess First, for Kevin or Eric, just looking for, I guess, a little bit more color as you think about managing the sales force during the reengagement in person, with clinicians and, just sort of, I guess the guiding principles as you think through that and Is your expectation that you'll see sort of an asynchronous kind of re engagement by region or are you going to hold back the entire Salesforce until it's sort of like an all or none type phenomenon.
And then maybe just on opicapone, given the delay here, is our expectation that maybe you'll see, I guess, better access and formulary sort of out of the gate given that you've had some time here to engage with payers maybe a little bit more. Thank you.
So I'll just take briefly the first part of your question. And that is as Eric has said in his opening remarks, we are very fortunate to have such a highly skilled and experienced sales force that has built the relationships that they have that that allows them to even during these times. Bring INGREZZA to our patients. They are they're real skilled even in the close part of this, the most difficult part of this to when that they when they interact and when they engage their, their customers. And that's they're going to be using that that same skill as we reopen, but Eric can probably go into a bit more depth with you.
Yeah. Certainly, this has been a learning opportunity for us we've said that this has been a learning launch and it continues to evolve. Of the way that we've adapted as a company is to really increase our communication, not just with the field sales organization, but really across the entire organization. It's almost as if you can't communicate too much. And so, certainly, with everyone being physically distanced and people having to deal with a lot of personal issues and concerns about the future of the company or the country and their own personal circumstances that communication has been really key and pivotal in terms of helping us as an organization navigate all of these changes.
In terms of that process of going back into the field and reengaging face to face again. You use the term that that I haven't heard before, but I like, which is asynchronous reengagement, And that's I think how it's going to play out. We have a number of different internal planning teams that are helping us to prepare for what going back into the clinics and into the various health care settings looks like as well as bringing our home office team back to our headquarters. Changes are not happening at the same pace in different parts of the country and already we're seeing some states that are lifting restrictions. And so our expectation is that this is going to be a process that occurs over a number of likely weeks to months in terms of individuals in different parts of the country being able to re engage with their customers and what that looks like is probably going to evolve over time as well.
The second or maybe the third part of your question was really related to on Gensys and the fact that we're looking at launching in the latter half of this year Certainly, we want to take advantage of the opportunity. You can always use more time to prepare But with regards to the payers specifically, we've got a plan in place in terms of how we're engaging with payers and how we're introducing on Gensys and now we have a label. So certainly that gives us additional opportunities to engage with plans to understand how they manage the Parkinson's class and to educate them about the labeling and where we see this medication fitting into the current treatment paradigm for those Parkinson's patients. So that and the fact that we're going to continue our efforts to educate neurologists on the importance of comp inhibition as we have been in the months leading up to our PDUFA date.
We'll take our next from Evan
congrats on the progress and I hope you are all staying safe and healthy. So, I know you touched on this, but on ingressa, can you provide more color on the feedback you're getting from physicians on the virtual sales rep interaction model. Are these reps still getting the same level of engagement? I'm really trying to understand if they're as effective now in driving prescription growth versus during normal times? And then just a follow-up on the on Genpys launch.
Yes. Thank you, Evan. I'll just take a first quick and again put it over to, put it over to Eric. This No, the as you can imagine with the sales force working from home and as Eric has talked about with so many of the off of is closed or dramatically reducing the patients they're seeing you and we could not expect our to be as efficient as what they were prior to COVID. But nevertheless they're doing a remarkably better job than what we had anticipated in doing this and they keep they continue to excel as they move along.
So no, I can't say that for structural reasons that they're as efficient as they were with all of their clients. However, with many of their clients, they are as efficient. So With that, I'll turn it over to Eric.
Yes. And I can provide a little bit of additional color, Evan. Calls generally have gone down. And I say calls on HCP customers have gone down across the board, regardless of what therapeutic area you're talking about. However, and I think that's true also in our TD market However, what we have found is that in some instances, we're replacing quantity with quality, meaning that we're getting longer time with the customer, more engagement and more opportunity to go through a full educational presentation.
And so our team, like I said, we pivoted towards the end of March and into early April gave them new tools and resources to be able to conduct these educational programs remotely. We also had to pivot in terms of peer to peer activities. And we've done a nice job thus far I think of leveraging peer to peer educational programs utilizing physician speakers from different parts of the country and being able to make that resource available. So we've adapted to the reality of our customers that are no longer practicing the way that they used to. But we've certainly seen that even though the call volume is less than what it used to be, certainly the quality is very high for those calls that we are able to engage with customers.
How should we think about the total addressable market for this asset? Is it just patients now who are on inhibitor therapy or should we think beyond that to all PD patients on levodopa, carbidopa therapy?
So, if you, if you look at the labeling for on gensetis, it's for patients that are experiencing off time that are currently on levodopa, carbidopa. So there's roughly a million people in the U. S. With Parkinson's disease, about 70% of them are on levodopa, carbidopa preparations and about 2 thirds of those patients are currently on a adjunctive treatment of some sort. So that's really our addressable patient population.
Those patients that are on levodopacarbidopa that are experiencing motor fluctuations and it's a substantial number.
Right. Thank you for that color. Appreciate it. Thanks guys.
Our final question comes from Tazeen Ahmad of Bank of America.
Thanks so much. Sorry about earlier. Thanks for squeezing me in at the end here. Maybe if you haven't already talked about this and I apologize if you have Can you guys talk about what we should be expecting to see on June 8th as it relates to CAH presentation? And I also wanted to follow-up on opicapone and you've talked about really not wanting to launch until the time is right Do you have a better sense of what the environment is going to be for the rest of the year?
Is it something that could get pushed into 2021? Thanks.
Yeah, Tazeen, I'll take the second part of your question first about the Epicaporton launch and then I'll have Eiry talk about the first part of your question. With the opicapone launch the without COVID being involved here as I had said publicly in January that there was an incident at 1 contract manufacturers for our partner, Be Al, who is responsible for the supply chain. And we've been in constant contact with Bial as they move through that incident and make sure that we have resupplies that would come to us in a timely fashion so that we'd never have to worry about patients after our launch. Running short of drug supply and that we will give an update to you about the timing of our launch in early summer. So, Eiry.
Thanks, Pazeen. And so the data that was presented by Doctor. Rich Arcus from University of Michigan on June 8th will be the full data set from our adult proof of concept study, which included 4 cohorts of subjects that were dosed for 14 days. And the data we'll present are the pharmacokinetics, the pharmacodynamic measures in terms of the hormone levels and the tolerability and safety data. I will say we're very encouraged by the data from that study.
And with that in hand, we did meet with the FDA in an end of phase 2 meeting in March and we are moving ahead with our single adult global registration study which we anticipate starting in the second half of this year.
Okay. And then can you give us an idea of how long you were expect enrollment for the adult study to take?
We actually have been working on, as you can imagine, on several different scenarios, particularly in the current situation. And we haven't given any detail around that at point in time, obviously once the study is up and going in the second half of the year, the information will be posted on clinicaltrials dot gov in terms of our sample size and we'll continue to monitor that and adjust our expectations accordingly to the performance
This concludes our question and answer session. I would like to return the call to Kevin Gorman for concluding remarks.
Yeah, thank you. And I really do appreciate, all of you joining the call today. Just a couple of things, you know, while Neurocrine is not a virology or an anti infective company, our efforts therefore don't read directly on SARS CoV-two. However, the impact of this pandemic on on mental health is profound. And we work extensively and deeply with the mental health community in Beth that's where we're putting our efforts and our expertise to work in this.
And it's as Erica mentioned, it's very important to note that May is Mental Health Month. So I'd also like to say that we spent the better part of 2 months quickly adapting to the rapidly changing pandemic. And as you've seen and heard, our people have really come through as they always have. In the past. And I call this 2 months the very early and temporary condition or phase 1.
We're now actively preparing for phase 2, which is returning to work both in the field and in the home office under albeit under very different circumstances when we were last there. But what we've done from the beginning and continuously to work on is what I'll call phase 3 and that is the long term. Our vision for our work, our patience and our company has not changed. Our ultimate goal is and always will be to discover, develop bring life changing medicines to patients and that's unwavering in this pandemic will not change our course So I want to thank you for being here today and I look forward to speaking with you all as time goes by, but probably more importantly, I'm really looking forward to getting together again with you personally. Take care and thank you very much.
This does conclude today's Neurocrine Biosciences Report Q1 2020 results call. You may now disconnect your lines. And everyone have a good evening.