Good day, everyone, and welcome to today's Neurocrine Biosciences Reports Second Quarter 2020 Results. At this time And it is now my pleasure to turn today's conference over to Todd Tushla, VP of Investor Relations. Please go ahead.
Thank you, Ryland. Afternoon, everyone, and thank you for joining our Q2 2020 earnings call. Joining me on the call is Kevin Gorman, our Chief Executive Officer Matt Abernathy, our Chief Financial Officer, Irene Roberts, our Chief Medical Officer, Eric Benevich, our Chief Commercial Officer and Kyle Gano, our Chief Business Development And Strategy Officer. During today's call, we'll be making forward looking statements. These statements are subject to certain risks and uncertainties and our actual results may differ materially.
I encourage you to review the risk factors discussed in our latest SEC filings. With that, I now turn the call over to Kevin.
Thank you, Todd, and good afternoon, everyone. I am beginning to sound a little bit like a broken record, but here I like sounding like a broken record is this quarter by any measure has been remarkable. The impressive achievements across the entire organization is a great display of the resilience of our company, in this first full quarter that we've been living with COVID. This resilience is evident, in our regulatory approvals, the advancement of our clinical programs continued success of INGREZZA and the growth of our pipeline. No, I'm certain the tenacity of our employees and that of all of our external, partners will allow us to fulfill our mission throughout this pandemic.
We are presented with the same challenges that COVID has presented to the entire, biopharmaceutical industry. And yes, the fits and starts the openings and closings in health care and the economy. It just adds to the fatigue everyone is experiencing. However, this is temporary. And we have shown that we are adaptable, but perhaps most importantly, the fundamentals of INGREZZA's importance to patients, their caregivers and healthcare professionals now is objectively demonstrated by the continued high compliance rates of this past quarter.
This unique environment where nearly 90% of patients interact with their physicians by telemedicine will moderate back to a more balanced mix of in person and telemedicine. While we are certainly encouraged with INGREZZA's impressive growth. Until more patients are seen in the doctor's office, we expect to see this continued impact on Prior to this call, I I looked back, on the company. I actually went back about 2 years ago, from this time. And at that time, we were talking about the unique position, we were in.
We had 2 approved medicines and 4 compounds in clinical development. But today, we find ourselves with 4 approved medicines and 10 compounds in the clinic. I want to touch on that actually later at the end of our call. There's more to it than just that. As always, we try to keep our opening remarks here, to a minimum so we can get through as many of your questions as possible.
So now I'm going to be turning the call over to I REMAT and Eric, and they'll go into more depth, in brief on each of the aspects of the business, starting with Matt.
Thank you, Kevin, and good afternoon. We're really proud of what our team has accomplished with another great quarter for INGREZZA. 2 FDA approvals on GENTIS for Parkinson's disease in Orion for uterine fibroids and expanding our psychiatry pipeline with the Takeda collaboration. We are preparing to make on Gensys available to patients in the third quarter, and we formally initiated a registrational Phase III trial in CAA. With our commercial growth opportunities for our FDA approved medicines, our expanding R and D pipeline and our strong financial profile, We are well positioned to execute on our strategy Regarding the financial results for the second quarter, INGREZZA sales were $268,000,000, which equates approximately 46,400 TRx.
Adjusting for channel inventory, we had approximately 250 $1,000,000 of underlying sales reflecting continued strong demand from existing patients. On the NRx run, although in person patient visitations were very low across the industry, the impact to Enerx was less than initially feared. The step down we saw in April helped steady through the majority of Q2 and continued through July. Turning to the P and L, we had another strong quarter of profitability with Q2 GAAP net income of $80,000,000 and non GAAP net income of $139,000,000. We ended the quarter with $1,100,000,000 in cash on our balance sheet.
This sequential increase includes approximately $50,000,000 paid to Adorca for the in licensing of MBI 827104, but does not include the $120,000,000 upfront payment associated with the Cata transaction, which closed in the 3rd quarter. Looking forward with the estimated diagnosis rates for TD at what we think is around 20%. We remain extremely optimistic We expect there'll be many ups and downs across the entire industry for Neurocrine getting in person patient visitation flow back near historical level is an important aspect needed to both make a meaningful difference for patients with TD and to advance our pipeline. What we saw in July is very similar to what we experienced in Q2 regarding NRx trends and acknowledge the longer pandemic related disruptions continue the more the impact will be on INGREZZA in the short term. These challenges are not unique to Neurocrine or INGREZZA, But as I said at the outset, we are quite proud of what our team has been able to accomplish in these circumstances.
I will now hand the call over to Eric Benevich, our Chief Commercial Officer, add further
performance and insight into what we have seen so far in Q3. I'll start off by saying that Q2 of 2020 may have been our best quarter ever demonstrating, as Kevin said, the resilience of our entire team to continue our mission of ensuring that nobody with Tardive Dyskinesia suffers longer than they need to. We saw strong INGREZZA sales momentum in Q1 carry through into the 2nd quarter. And the strength of our With great execution from our home office and field teams, combined with the support of our select pharmacy network, The refill and persistency rates for existing patients were at record levels for Q2. Across the biopharmaceutical industry, it is important to note that because of COVID-nineteen, new to brand patient starts declined, due to an estimated trend and saw a decline in new patient starts in Q2.
But as, as Matt noted, and as I note, the impact was not proportional our team adapted from in office education to remote engagements. Although overall customer call volume decreased, we found that remote engagements resulted in generally higher quality, lengthier interactions with healthcare providers. Just as we went to a remote engagement model, the psychiatry and neurology provider communities also pivoted to telehealth platforms helping to stay as connected as possible with their patients. While this is somewhat encouraging, nothing can truly replace in office face to face interaction, between a healthcare provider and a patient, especially as it relates to diagnosing a movement disorder like tardive dyskinesia. The vast majority of people suffering from TD remain undiagnosed.
In person clinic visits are important to improve TD diagnosis and treatment rates and get back onto our historical patient growth are now back in the field interacting with customers Healthcare provider access remains highly variable dependent on region and care setting, and we expect to continue to see a stop start pattern as the pandemic continues. However, the majority of the time we are still relying on virtual methods to connect with our customers. It's worth reiterating that during these challenging times, we are fortunate to have hired such experience and exceptional field teams. Who have strong relationships with healthcare providers and a true dedication to serving patients. Historically, Q3 has typically been a slower quarter for INGREZZA sales growth due to HCP summer vacation and patient compliance dynamics, And now we are also addressing the COVID-nineteen situation.
While we expect refill rates to carry over for existing patients into Q3, We do expect a continued impact on new patient starts and may see channel inventory pull back a bit. Now, I'd like to switch gears and talk about on GENTIS. Our newly approved medication for movement disorders, which we believe has a tremendous opportunity to help a lot of patients with Parkinson's disease suffering from motor fluctuations. I'm very pleased with the label our clinical and regulatory teams were able to secure, and we are now planning to make on GENTIS available to patients in the United States by the end of this quarter. Our launch efforts with Ongensys is the 1st and only FDA approved once daily COMT inhibitor for people with Parkinson's disease, to help patients achieve more consistent motor, motor symptom control.
It's one capsule taken once a day, which is convenient for patients and may lessen daily pill burden levels for Parkinson's patients. It also has a demonstrated safety and tolerability profile that's attractive. It's our belief that Ongensys can deliver on the broken promise of previously launched COMT medications. Which failed to live up side effects. We're excited to bring this new therapy to our Movement Disorder Neurology customers.
We believe Ongensys will be well received by the Parkinson's community and will benefit our efforts with INGREZZA in TD as well. Having 2 phenomenal products to promote will give us more FaceTime and opportunity in neurology practices, and burnished our reputation as a leader in movement disorders. Despite the many challenges brought on by the pandemic in the near term, The long term opportunity in treating movement disorders with both INGREZZA and Ongentes remains extremely compelling. Now I'll turn the call over to my colleague, Ivory Roberts. Will provide an update on our progress with the pipeline.
Irene?
Thank you, Eric and good afternoon to everyone on the call. I'm happy to excellent partner organizations who continue to work with passion on all research and development efforts across the portfolio at this time. It's amazing to reflect that since the beginning of 2019 in just over 1.5 years, we have doubled the size of our designed to address patient needs across a diverse range within neurology, neuroendocrinology, and psychiatry. We know that COVID-nineteen has significantly impacted clinical trial execution across our industry. And as extensively in approaches to progress our clinical trials in a safe and responsible manner for trial participants and health care professionals.
These approaches include the remote qualification and startup of investigative sites, remote monitoring of safety and other data, home health care visits and the adaptation of endpoints in clinical trials to enable telemedicine assessments where appropriate. These changes have led to the successful re initiation of screening in all previously paused clinical trials over the past few weeks. I'm pleased to announce that in July, we achieved the exciting milestone of the first patient screening in the single global registrational study of crenezafonte for adults with classical form of congenital adrenal hyperplasia or CAH. The results from our phase 2 study presented in June at ENDO online informed a productive dialogue with regulatory authorities in the U. S.
And Europe resulting in the approval of The catalyst study is a phase 3 randomized, double blind, placebo controlled study to evaluate the safety and efficacy of Crenesca font in adult subjects with classical congenital adrenal hyperplasia, followed by an open label treatment period. Approximately 165 subjects from North America and Europe will be enrolled in the study and will participate in a 6 month, randomized, double blind, placebo controlled period followed by 1 year of treatment with crenezafone. The primary outcome measure for the study is the Secondary outcome measures include change from baseline in Androstenedione at week 4, the proportion subjects able to achieve physiologic levels of daily glucocorticoid dosing at week 24 together with a variety of clinical outcomes related to metabolic health, including body weight and fat mass. We're excited to begin this important study with the hope that crenezifant will provide a valuable and differentiated treatment option for patients in the control of their underlying congenital adrenal hyperplasia, with the much needed added benefit of enabling patient to significantly reduce the amount of glucocorticoid they need to take everyday over the course of their lifetime. In parallel with screening in the phase 2 proof of concept study in pediatric CAH and continue to progress our discussions with regulators in Europe and the U.
S. In support of the initiation of a single global registration Beyond Crenescifant, the Phase III registration study of Valbenazine to treat Korea in patients with Huntington's disease is now also reenrolling patients. Regarding our expanding mid stage pipeline, we continue to make good progress in part of the initiation of phase 2 studies for the treatment of 2 distinct rare pediatric epilepsies by year end. For NBI-three fifty two and NBI-one hundred and four, the novel precision medicine assets in license from xenon and iDosea, respectively. In addition, our partner AbbVie continues to develop elagolix for the treatment of poly to Gophery Syndrome.
Finally, our newest phase 2 program, NBI-six forty four formerly known as TAC-eight thirty one continues to enroll patients in the global proof of concept study designed to assess tolerability and efficacy in the control of negative symptoms from this study are expected in the second half of next year. You'll notice today on our pipeline chart that we've removed the VMAT 2 follow on molecule previously in phase 1 development. The time spent with this molecule was very instructive and taught us a lot more II inhibition can bring to patients across a broad range of neurological and psychiatric conditions. We remain firmly committed to bringing forward additional clinical candidates for this target, and we'll keep you posted on our progress. In thinking about the remainder of the year, it continues to be difficult to predict what impact the pandemic will have on our R and D programs.
But despite these current challenges, let me reiterate that our plan for 2020 remains unchanged. By year end 2020, we intend to have 3 registrational programs ongoing. And with the addition of NBI-six forty four to have 5 mid stage programs in the clinic. Search and development at Neurocrine as we continue to build a world class neuroscience pipeline. I'll close once again by thanking all my colleagues for their truly inspirational efforts and dedication to Neurocrine's mission to relieve patient suffering and enhance patients' lives With that, back to you, Kevin.
Thank you, Eiry. Before I open it up with questions, I'd first like to highlight Neurocrine's corporate sustainability efforts. As Iris said, our mission is to relieve suffering and enhance lives and fundamental to this is responsibility we have to our patients, customers, partners, shareholders and society at large. And in that light, we really simply issued our first corporate sustainability report that can be found on Neurocrine's website, which highlights the connection between our mission and the environmental, social and governance programs we believe to be most impactful to our company and society. The disclosure of this report just marks the first step in communicating our ESG strategy As this strategy evolves, we look forward to engaging with you on the sustainability issues that matter most to ensuring we continue to develop on our to deliver on our mission and to help patients and drive long term shareholder value.
So With that said, I'd like to open it up for
We will take our first question from Paul Matteis Please go ahead your line is open.
Hey, Paul, if you're there, we can't hear you.
Hey, can you hear me now?
It's taken you 4 months to learn this through COVID, Paul. It's good to hear your voice.
Can you hear me now, Matt?
That's the way it's going to go.
I love it. I love it.
I can hear you. All right. Hey, I'm going to try to couple of questions now and hoping my funds still works. I'm trying to get a better understanding of how many patients you guys added this quarter and there's a lot of moving parts. I guess Maybe just for 1, can you quantify a little bit more of the increases in compliance and refill rates and how that should inform our sequential patient add estimate And then second, what's going on with inventory?
And where are you relative to steady state and how much of a drawdown do you foresee happening over, say, the next 3 to 6 months? Thanks.
Yes, sure, Paul. So for the second quarter, a couple of dynamics low led to the sales increase. First, gross to net came back from where we were at in the donut hole in the first quarter The second element as we experienced last year, we did have a step up in level of patients staying on drug as well as as refill rates. And that was an incredible effort by the team and our specialty pharmacy network to ensure that patients state on medicine in the quarter. And I think is really a testament to the value that patients ultimately get from taking INGREZZA.
On the new patient front, we're not going to get into the ultimate quantification there as we described coming out Q1, we did have a step down in NRx in April due to COVID, but it wasn't anywhere near the seventy percent drop that you saw in patient or in person patient visitation. So that NRx rate stayed very steady throughout the quarter. We weren't to a point where because when you're a big brand like INGREZZA, you do have your natural discontinuations. We weren't at a place where, NRX with less than discontinuations. But as Kevin and I both said in our prepared remarks, We know for INGREZZA to reach its long term potential, and we're very confident in the ability for INGREZZA to reach its long term potential we have to see in person patient visits get back near historical levels.
And I think that many other companies are dealing with this in a very similar way, and it's not unique to Neurocrine. Then I think the last piece your question relates to channel inventory and it is something that's very difficult to predict. We've had 3 straight quarters of bill And we tried to disclose that number so that you can normalize our sales to reflect an adjusted sales number that more represents the underlying sales results, the $8.256 is the right baseline last quarter. It was around $2.27 I do, we would expect there to be a drawdown in inventory, Paul. It's hard to get into want to get into the nuances of why stocking occurs.
Sometimes it's because your distribution channel sets up another site for distribution for example, but over the long run, I think that our inventory levels should be around 2 weeks on hand. And I would expect at some point to be there to be a drawdown in inventory.
Thank you. That's helpful. And can I just ask one quick follow-up, Matt? Last year, you saw a pretty big snapback on average script per patient in 2Q relative to 1Q. And in 1Q, this year, you said the seasonality issues weren't as significant.
Is there anything you can say about any sort of reversion benefit you on average script per patient in this quarter against sort of understanding the broader context here is trying to figure out, what the underlying patient, that number is. Thanks a lot.
Yes, like you said, last year, we had a big step back up in average script per patient from Q1 to Q2 as people went through the authorization or reauthorization process in Q1. And this year, our team did a great job and actually was better year on year from a net revenue or a revenue script per patient. So you're right, you wouldn't have seen as significant of a step up from Q1 to Q2 this year in that script per patient.
All right. Thank you so much.
Marillyn, we'll take the next question.
Our next question comes from Phil Nadeau. Please go ahead. Your line is open.
Good afternoon. Thanks for taking my questions. And let me add my congratulations on a great performance, in tough circumstances. Matt, maybe first one for you. Looking at the disruptions that you're calling out into Q3, just qualitatively, I'm trying to understand, is the 1st 4 or 5 weeks of Q3, are they looking better than what you experienced in Q2?
Is it more of the same? Can you just qualitatively give us some help, as we project into Q3 and we try to come up with a revenue number as to what you're seeing in the field?
Yes, yes. Good question and good to hear from you. What we saw in July, from an NRx perspective was very similar to what we would have seen April, May, June. So we had seen a step down going into COVID. And then it's pretty much stabilized.
And I think we were all in hope as a society when things started looking a bit better, from the economy opening up. But then once it's shut back down again, I would say that we're at a very similar level of NRx, which is absolutely a testament to our field sales team, the medical professionals that are helping us here, that, people with tardive dyskinesia, new people are still getting access to INGREZZA and existing patients are remaining very, very compliant. So, I think the cautious statements that you hear forward looking, the team is doing a great job and we expect them to continue to do a great job. But for us to have an NRx level that's significantly above discontinuation that naturally occur, on any medication, we need to see, in person, patient visits, get back up to, to higher levels. Eric or Kevin, any other insights?
Yes. Phil, I guess I just want to add one thing is that there's a, as I said in my opening statement, with the snapping, you know, open close, things like that, and I hope we don't you know, for society's sake, we don't keep getting whipsawed back and forth like that. But as it does that, you know, there I'm sure you feel it. Everyone does. There's a certain fatigue as in there and patients and caregivers are no different.
And so, it, again, is a testament to just what a terrific job, that our field sales team is doing that they keep at it and they keep delivering each and every quarter. But that's where you see a bit of a caution in our voices coming off of again, two really nice quarters that we've had thus far is you just don't know what to expect in front of you. As things open or close. And I we don't want to lose sight of that because while Eric and his team adapts amazingly well, to these things, this we seem to get curveballs, almost weekly, right?
Right, right. That helps a lot. If I could just follow-up with 2 pipeline questions. The first on AgenTus, do you have a sense of when buyout will be ready to resupply the market or they'll be ready to tell you, when they'll be ready to resupplied market? And then second, on the CH Phase III study, currentclinicaltrials dotgov, the primary completion is February 2023.
Is, should we expect results therefore from the primary endpoint in the first half of twenty twenty three? Is that reasonable or is there something I'm missing in the clinical trials dot co posting? Thanks.
So, Phil, I'm going to take the first part there. B. Al did a great job of, of getting the good job. We're confident that we will be launching this drug and supply chain is not an issue at this point.
With respect to the CAH question, I mean, we're, I'm really proud of how the team has worked with our external partner enabling this trial to get up and started. I mean, obviously, like all of our research efforts, there is impact around the world from the COVID-nineteen pandemic, as soon as we kind of get a few months into the trial and understand enrollment relative to our current expectations, be able to give you a much better update. But on the with respect to the enrollment estimates that we took into the trial, those dates that are in CT.gov consistent.
Perfect. Thanks for taking my questions.
We will take our next question from Bryan Abrams. Please go ahead. Your line is open.
Hey, guys. My congrats on the quarter as well. Thanks for taking my questions. On INGREZZA, I'm curious if you can talk a little bit about how telemedicine and your detailing approach maybe has evolved over the course of the pandemic. You're seeing shifts in regional utilization.
And Are there ways that you can improve comfort, diagnosing movement disorders via telemedicine to maybe help drive some new patient growth if the pandemic continues to linger?
Yes, absolutely.
As I mentioned in my prepared remarks, we've had to adapt to this new environment. And as our neurology and psychiatry customers have, moved to a, remote engagement model with their patients via telehealth platforms, we too move to a remote engagement model with those prescribers. And what that looked like, early on was essentially taking a lot of the existing educational content and adapting it to, remote engagement platforms like zoom, GoToMeeting, even FaceTime, And as we went forward, through Q2, we became a lot more proficient in terms of understanding how to reach people that were no longer necessarily in the clinic and how to engage them either in discussions about TD and INGREZZA or really supporting existing patients, as Matt talked about, for refills. Going forward, I certainly believe that there's an opportunity to develop new tools and resources to assist in diagnosing TD remotely. And of course, as we've done in the past, we're going to have to blaze a new trail here.
This isn't something that's been done on a widespread basis. We've been learning a lot from, from thought leaders and from prescribers in the community about how they're assessing, movements remotely in their patients. And we're capturing those best practices and we're, integrating them into educational content that we've been more recently rolling out to our customers. So I think that, you know, telehealth is here to stay in many ways. Certainly it's somewhat offset a steep decline in patient interactions, between HCPs and patients.
But, ultimately even after we get past this, this, health crisis and return to a more normal posture. Ultimately, telehealth is going to be at a higher level than what it was previously. And just as we've continued to adapt with this learning launch, we're going to adapt to this new environment and make sure that regardless of whether a provider is seeing a patient in person or remotely, we've got, relevant, credible educational that will help them make that diagnosis and of course, when appropriate choose INGREZZA.
Got it. That's really helpful. And then The pricing for, on Genentis was recently announced. I was wondering if you could give us a little bit more color on your engagement with payers thus far as you prepare for the launch later this quarter. Expectations for access, would you expect any step at through other classes like MAOB inhibitors or other COMT inhibitors?
Thanks.
Sure. Yes. So we announced price, I want to say like 2 or 3 weeks ago. That's about right. And, our WACC price is 5.90 per month, which is below the threshold for specialty tier on, Medicare plans.
So, we made that choice with patient access in mind. As we've said previously, patient access is critically important, for us as a company. Price isn't the only element of our access plan. Obviously, we have, our field reimbursement team in place. We have built out our patient support program and or other elements, that will be available at the time of launch.
But ultimately, we want to make sure that patients that need access to on gensetis can get it. With the announcement of price, we've actually started to engage with payers ahead of our commercial launch. And the goal there is to introduce them to the product the labeling and to understand how they're currently managing adjunctive treatments in the Parkinson's category and to start to make sure they understand that, step edits through, other comp inhibitors or other classes of adjunctive treatments may not be beneficial for patients. And so initially, as we get out the gate at the end of Q3 and into Q4, on genset is going to be a non formulary drug. And it's going to have to be approved on a formulary exceptions process.
And we're very good at this. Obviously, we had to go through this with INGREZZA. As we get into 2021, certainly we'll start to see formulary decisions made and those will be publicly available for you as well. But initially out of the gate, it's going to be a formulary exceptions process, and we're currently engaging with payers to make sure the and the value that we're bringing with Vungentes.
Thanks again for all the color.
And we will take our next question from David Ancillin. Please go ahead, David. Your line is open.
Thanks. So couple of crewness or font, question. So, I'm sure it's not lost on anyone that there are other, CRF type 1 receptor antagonist that are in development. So with that in mind, I'm specifically alluding to Tildasser Font, the Spruce product. What's your take and commercially on the market's ability to accommodate more than one anti CRF1 products.
So that's number 1. And then secondly, appreciate all the color. On the global phase 3 study. I guess my question here is, what's your take on which endpoints you think are the most commercially relevant? I mean, is it indeed steroid burden?
Is it something along the lines of more direct clinical endpoints like, like, body mass or, bone density. Help us understand how you're thinking about that in terms commercially relevant endpoints? Thanks.
Yes, thanks for the question, David. So a few questions in there actually. So let me just start with the first question. First thing that's absolutely clear is there is a very significant global unmet medical need in congenital adrenal hyperplasia Patients really only treatment option right now is steroids glucocorticoids, often at very high supraphysiologic doses which in and of themselves lead to a lot of issues, over the course of a lifetime in terms of side effects. With respect to, our Crenescifon program, I mean, we're absolutely delighted that we're now entering what will hopefully be the last stage of clinical development in the registration study that we just initiated.
And so I think we find ourselves in a little bit of a different situation from potentially the competition With respect to the design of the study itself and our overall program, we really designed this study based on a lot of our learning previously from our valbenazine programs from elagolix involvement. And it's really very holistic in terms of how we're looking at the endpoints within that trial. Obviously, we know that managing the steroid hormone levels in patients with CAH is important and that that is many times how they manage their disease day to day. But when we look at the clinical relevance of that, it really becomes much more important for us to think about endpoints like the ability to reduce the glucocorticoid dosing. So we designed our program with the 6 months endpoint, focused on steroid reduction in order to gain a very important set of efficacy and tolerability and safety data that we believe will then serve many stakeholders, including the patients, the caregivers, the health care professionals, regulators and ultimately payers around the world.
And so, I think in doing so, as we come to the completion of this study, we believe we will have a very robust set of data, combining this and the previous clinical data that exists cranesophant in order to support the registration of this medicine and ultimately the ability for patients to get access to the medicine.
Thank you.
Great, thanks. We'll take the next question please.
Our next question comes from Paul Choi. Please go ahead.
Thank you. Good afternoon everyone and congratulations on the quarter and all the progress. I think, during the earlier prepared remarks, you talked about maybe a 20% diagnosis right now for TD was wondering if you can maybe just sort of comment on, are you seeing a step up just in physician recognition or do you think this is being driven by any particular factors such as your advertising, if you can maybe just elaborate on that. And just as you think about the diagnosis right here over the short intermediate term. Is this the sort of rate of increase we should think about in terms of our modeling?
And then I had a follow-up.
Well, I think as a hey, Paul, this is Matt. And then Eric will give you a little bit more insight as to what he's seeing from a customer perspective and where we're generating new demand. For modeling purposes, I just want to flag the movement from Q1 to Q2 the growth there was largely driven by the gross to net change and then patient compliance and persistency And then also some level of growth out of the net new patients left that discontinuation. So Going forward, Q2 to Q3 sequentially, what we've been talking about is that our NRx levels have remained very steady which is good because relative to the drop in person patient visits, it's much higher than that. However, to have sustained, growth similar to what we've seen historically, we, we need in person patient visits to get back closer to normal, which none of us can predict when going to occur.
But, Eric can talk through what he's seeing on the customer front, our insight to that 20% diagnosis rate and where we go from here with that.
Yes, Paul. So I think it's important to note that that estimate of about 20% of patients in the prevalent population that have now been diagnosed
with TD. That's after about 4 years of
effort. An educational push on the part of the company. When we started developing this market, there was, we estimate low single digit percentage of patients that had actually been diagnosed with tardive dyskinesia. And so over time, we've seen that percentage of patients increase. And, as we get to the middle of this year, our estimate is around 20% of now been given a diagnosis.
As Matt said, diagnosis is largely a function of education and also HCP interaction with patients, with the dramatic decrease in patients flowing through clinics and hospitals. That decreases the likelihood of TD being diagnosed. And I've spoken about, the pivot that we've made to help providers, be more comfortable and confident in making that diagnosis remotely. Obviously, that diagnosis is happening has, is, remotely, as Matt said, the decrease in new patient starts that we've seen with INGREZZA has not been proportional or commensurate with the decrease in patient foot traffic through these clinics. So, the takeaway here is that this is a short term disruption in our belief in terms of, what that diagnosis rate will be and what the impact is on new patient starts.
The vast majority of people with TD remain undiagnosed and it's our commitment to continue our educational efforts, whether it be in person or, remote engagement, to help providers make that diagnosis and get those patients started on INGREZZA. So I hope that provides a little bit more context for you.
Yes, that's great. Thank you for that color. And one quick one for Erie, with regard to the phase 3 in Huntington's, which you mentioned has resumed enrollment there. As you think about the clinical outcomes, given that you'll technically be potentially second to market here versus the competition, Have you thought about any other incremental data points that you'd be gathering from a trial that might help with potentially with with formulate, formulary positioning with regard to Huntington. Thank you.
Thanks, Paul. So the trial is designed as a registrational trial. The primary endpoint is the career score as part of the UHP DRS score. And that is the a obviously an important endpoint in terms of determining the impact of Valbenazine on the important career outcomes.
We have other
quality of life measures included in that which we believe are important as we seek to support the Huntington's career patient most appropriately moving forward. In addition though, I would say that, in terms of the context of differentiation for Balbanazine in this study, we're very encouraged by the profile that we've seen up to this point of INGREZZA. The differences in the label with respect to black box warning relative the absence of a black box warning relative to our competition. And obviously being a once a day therapy with a straight forward dose escalation and titration, we believe all of those are differentiating. And in fact, we've designed the study in order give us the best opportunity to address any differences if they as they occur.
Great. Thank you for taking our questions.
Great. We'll go to the next question, please.
Our next question comes from Mark Goodman.
Hi. First question is about inventories. You mentioned that you believe inventories will come back down to 2 week levels Can you just tell us where do you think they are right now? 2nd question is on SG And A, which seemed a little lighter than I would have expected in the quarter. And can you just talk about, why that was?
And will you be adding sales reps, for the launch of your new Parkinson's product? And then I guess 3rd, tardive dyskinesia relative to all these other therapies out there, it's just I guess, amazing to me why, you're having such success, in such a tough environment relative to everybody else and I just was wondering if it's just, you know, I mean, obviously, you've attributed to a lot of different things, but is there mean, is there anything special about tardive dyskinesia that you could figure out, or is it really just, you know, just this persistence of the patients and stuff? Cause we're seeing new patients down, you're telling us. So I was just curious if you give us some more color on that. Thanks.
Yes. Hi, Mark. I'll take the first two questions and then hand it off for the Tardive Dyskinesia. On the inventory front, this is the first time we've ever been over 3 weeks on hand. And like I said earlier, I think it has to do with a little bit of a phenomenon of one of our partners, actually stocking up a new warehouse And I'd expect that they will normalize that.
Historically, we've tried to keep our inventory levels below 2 weeks, but now they're actually over 2 weeks. So, and what I've even seen on ordering pattern so far this quarter, in July relative to the underlying TRx demand, it looks like there has been some slight bleed down. But like I said, I think the best way to measure our sales results is to look at us on an inventory adjusted basis. And that's something that, we're going to continue to disclose every quarter so that people can see what true underlying demand is. On the SG and A front, there's really 2 aspects that led to the sequential decline from Q1.
Number 1 is that you typically have a seasonal spend that's concentrated in Q1. And then that recovers in Q2. The second piece is that we do have some spend that was slowed down as it relates to COVID nineteen, some of the field based activities that we would have normally been spending behind aren't necessarily, weren't being done at the same level as what they were. We aren't in a place where we're trying to squeeze out as much profit here in the near term as possible. It's just how things shook out on the SG and A front as well as the slowdown in R&D spending.
I would just flag as people want to think about R&D investment going forward. We do have We did have a lot of trials pause. We have more getting back up and running now. And when you think about the Takeda collaboration, the Dorisia, product, as well as Xenon and then all the other programs I already mentioned, we're so excited about what we have ahead of from the number of clinical programs that we'll have up and running. And from a spend perspective, that's going to lead to a big step up in spending in 2021.
But believe it really positions us well for the future. So I'm going to hand the next part of the question about, what makes are what drives our ability to diagnose PD or our position to diagnose PD in this environment over to, to air Kevin?
Yes, it's a good question. What is it about TD? Was it about INGREZZA that's allowed us to be so successful despite the circumstances? I think there's a few external factors and then there's a few internal factors. It starts off with, the, aspect of TD that many people don't really appreciate is that there's a real significant disease burden here.
People that are living with TD experience it every day, and it affects their lives in many different ways, functionally, emotionally, in terms of their willingness to engage with others in the community. The second thing is that INGREZZA offers a really meaningful benefit. And that's been seen not only in the clinical trials where we saw significant improvements as quickly as 2 weeks, but also based on, the trial and adoption that many providers have gone through over the last several years. They try it in a few patients. They see that it offers a meaningful benefit and that motivates them to treat, diagnose and treat additional patients.
And then the 3rd external factor, which is important to note is that, the HCPs that are out there, the psychiatrists the allied health professionals, they're very passionate about caring for these patients and they recognize that these are individuals in our society that are often overlooked and frankly stigmatized. From an internal perspective, we talked about the the high quality people that we've hired both in the field and in the home office that are very committed to helping these patients get access to INGREZZA. And in addition, I think, you know, frankly, having a really strong, select pharmacy network has, benefited us as well. In terms of patients being able to get refills, despite the disruptions caused by the pandemic. So all of those things together, I think, have added up to the success that we've seen, certainly with, very favorable refill and persistency rates in Q2.
As we've mentioned before, the longer that this pandemic goes on, especially with this stop start pattern that we're seeing in different states and even at the county level around the country, it makes it more challenging, to help patients get started on treatment. But despite all this, we remain committed to helping our providers, whether it's an in face or, remote interaction with the patient and Certainly, we expect to continue to be successful in the near term and over the long haul.
Great. Let's take the next question, please. Riley?
We will take our next question from Biren Amin. Please go ahead. Your line is open.
Hi guys. Thanks for taking my questions. Maybe I could just start on INGREZZA. I know you've discouraged us from using IMS script data But in the second quarter, there was a 7% sequential decline in TRx data from IMS compared to what you reported today, which is 12% sequential growth. What do you think is the reason why IMS is failing to capture the script trend at the sites where they collect data?
Yes. Biren, definitely understand your question. And, you know, our conversations around IMS data have been not to use it as a proxy for our sales results. I think it captures different of our specialty pharmacies or closed door pharmacies data and it sometimes can't be as representative as other periods. So hard to determine why it was different than what our results were, but Like we've said, inventory adjusted, we had a sequential increase of about 8%, I think, TRx, which was very strong in this environment
Got it. And then on OgenTus, I know you've had some peer discussions that are engaging with payers. Should we be expecting a step edit through entekapone?
So, Biren, our base expectation is that we wouldn't, just based upon the value that we have that we see in Ongentis relative to intactopone, but payer conversations are still very early. And that's something that we're hoping to get more insight on over the next 3 or 4 months, but we have a very good, as Eric said earlier, a very good payer account team that is currently meeting with payers as we be?
Yes, the only other thing I'll throw in there is, is that, initially this is going to be a non formulary product and we're going to have to go through a formulary exceptions process Majority of these patients are Medicare Part D, and, Medicare Part D plans have up to 6 months to, review new products. Part of our message to the payers is that it wouldn't be medically appropriate to force patients to step through Tacopone. And certainly, we're bringing our payer account team and the medical science liaisons into those conversations. We'll see how the, how the, our coverage policies shape up over the next year or so. But our position is that, that that's not medically appropriate or necessary to, to manage this class in this product.
And certainly, our pricing decision wouldn't be one that would make that, something that pairs would necessarily rush towards.
And then maybe if I could have a pipeline question on the phase 3 CH trial with the primary endpoint being steroid reduction at week 24, How are you setting up the algorithm for the steroid taper? Is it based on, I guess, improvements on certain biomarkers like androstenedione? And is it on improvements to the upper limit of normal, or is it based on reductions of baseline, that, that patients come in with? On these biomarkers.
Yes. You ask a very important question, Bern, not one that I'm going to be able to talk very much about on this call. I mean, obviously, as you can imagine, we spent a huge amount of appropriate trial design here to give the most robust set of data. And from a competitive perspective and from just ensuring that we can do the right thing by patients here. We're really not talking about the how we're actually doing that steroid reduction at this point.
Ryan, let's see. Great.
Thanks for taking my questions.
Let's see if we can sneak 2 more in here.
Okay. We will take our next question from Charles Duncan. Please go ahead. Your line is open.
Yeah. Thanks for taking my questions. Kevin and team, congrats on a great, quarter of progress. Particularly in terms of pipeline build and progress. It is notable in the last couple of years how this has expanded Most of my commercial questions have been asked.
So I did wanna just ask a couple of pipeline questions. When you consider the kind of timing to, data, with the Velbenazine program versus the SIR Font, program in CAH. What would you anticipate to read out first? And can you help us to understand kind of the pacing of patient enrollment in those 2, programs?
Yes, thanks very much. So we're we were very pleased initially that we were able to reopen safely and responsibly the HD trial enrollment and obviously see the significant unmet need in Huntington's disease still because so few people are currently treated with the VMAT2 inhibitor. And so, we are seeing good signs of, screening and enrollment in that study and we anticipate that that will hopefully, given the if the COVID-nineteen situations kind of stays relatively stable that we will be able to move forward effectively there. With Carnesa Fund, we are just initiating the phase 3 registration trial. That is a global trial.
And as I mentioned, I think in response to a previous question, We our estimates that we see in clinicaltrials dotgov are our initial estimates of enrollment. We will need to see how things progress in the next few months as that trial gets up and running to understand the overall timing. So it's really difficult to predict at the moment.
That's helpful, Irene. I appreciate that. And then perhaps either for you or for Eric or whoever wants to take it when you when you think about Velbenazine in Huntington's, Korea. You mentioned, differentiation of Velbenazine or INGREZZA in tardive dyskinesia, which is obvious to me relative to the competition, but Help me understand Velbenazine in Huntington's versus a tardive dyskinesia. What what are the strategies that you're contemplating to really differentiate the two products?
Or or could you see parity parity pricing? Help me understand, is there a dosing thing? How how will this be a different drug? Or does it need to be?
Yes. So, Jess, I'll take that question. I think it starts with our perspective that, that there's still significant unmet medical need in Huntington's Korea. The majority of patients that, exhibit moderate severe, Korea movements, still or as yet untreated with a VMAT2 inhibitor. And there are varying reasons for that, relating to, for example, safety concerns or, tolerability issues, challenges with those titration things like that that may, give us an advantage in that particular market.
But the reality is the majority of people that could benefit from treatment with an approved, option are not currently being treated. So we certainly feel like there's room for another treatment option, one that, we'll have to see what the data look like. But based on, the target profile, we think there'll be multiple points of differentiation that perhaps are similar to the way that we differentiated in the TD market. So we're excited about the opportunity, to complete the study and to see what the profile, that emerges looks like here. But based on what we know about INGREZZA, in TD, we're confident that there's a meaningful opportunity for us in the Huntington's Korea market.
Rila, let's take one last question,
We will take our last question from Jay Olson. Please go ahead. Your line is open.
Hey, congrats on the quarter and thank you for taking my questions. I'm curious about the impact of discontinuing your second gen VMAT inhibitor. And I was wondering if that decision might lead you to increase your focus on additional indications for aldenazine and or any other lifecycle management strategies? I had one quick follow on if I could.
Hi, Jay. Thanks for the question. So as I mentioned, I think we learned a great deal from the experience of the VMAT 2 follow on molecule that we had in phase 1 development And we're looking to apply all of that learning as we bring forward next generation research candidates into the clinic because we do think that there is a significant opportunity for VMAT 2 inhibition across a broad range of different neurological and psychiatric disorders in beyond what valbenazine would be able to bring to patients. And so we're very focused on that. And then also, obviously, in parallel, we continue be very focused on understanding potential new indications for valbenazine.
And, as we move forward and get any of those into the clinic, we'll be sure to update you.
Okay, great. Thank you for that. And then since your business development team has emerged as an important competitive advantage, as you add innovative new assets to your portfolio. Can you talk about the appetite for more deals and any potential gaps in your portfolio where you may like to add new molecules?
That's a great question. This is Kyle. Yes, I think that we're going to continue to focus on our, commercial success with INGREZZA and then taking that to Ongentis here shortly. And we're focused on funding those as well as the pipeline. But in terms of our interest in business development, we're quite pleased with the way things have transpired over the past 12, 18 months.
If you look at the portfolio, it's been diversified by stage and by modality and by disease state. So a lot of the things that are attractive to us in neuroscience have played out nicely for us. We need to execute on the clinical studies to get those off and running. But we continue to also look at building the pipeline over time. If it makes sense to bring additional assets, we'll find a ways to make it happen.
Thanks.
And I will turn it back over to Kevin Gorman.
We've said this before, but sincerely, we feel very fortunate to be in the position that we're in. And the way that this year is shaping, up for us. We have an outstanding medicine in INGREZZA. And as all of you have pointed out here, it's it just it is just a medicine that is so appreciated and so needed in this patient population. And that is going to go on for years.
Driving our company. And now we get to add yet another important medicine that's coming through in on GENTIS. And so we're really looking forward to bringing that to patients. And I do appreciate all the questions that you've had, today in particular in the last part too, about our pipeline. As I said at the beginning, we, we have 10 pipeline programs, but it's not just the number of those programs when you look at it.
Our pipeline consists of 3 pivotal programs, and 5 more will be in mid stage development by the year end. And then 2 in early stage. So it's a really well balanced pipeline right now. Our medicines offer the hope for significant symptomatic treatments, disease modification and we're in precision medicine. And as Kyle said, we're not constrained by a single modality.
Currently, we're developing small molecules and we're developing gene therapy. The therapeutic areas that we're in as neurology, neuroendocrinology and neuropsychiatry, we started out with an audacious goal a number of years ago and we have stuck with that and we've said it out loud and that's we're dedicated to being the world's leading neuroscience company. And what you're seeing now is just the beginning. So I really do thank you for your questions and your participation today. Take care.
This concludes today's program. Thank you for your participation and you may