Q2 2020 Neurocrine Biosciences Inc Earnings Call

Good day, everyone and welcome to todays Neurocrine Biosciences reports second quarter 2020 <unk>.

Operator: Good day, everyone, and welcome to today's Neurocrine Biosciences Reports second quarter 2020 results. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing the star and one on your touchtone phone.

All participants are in listen only mode. Later, you will have the opportunity to ask questions. During the question and answer session. You may registered to ask a question not any time by pressing the star and one on your Touchtone phone.

These standing by if you should need audio assistance and it is now my pleasure to turn todays conference Ritu, Todd <unk> VP of Investor Relations. Please go ahead.

Operator: I will be standing by if you should need audio assistance, and it is now my pleasure to turn today's conference over to Todd Tushla, VP of Investor Relations. Please go ahead. Thank you, Rylan. Good 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, Irie 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.

Thank you Ryan.

Everyone and thank you for joining our Q2 2020 earnings call. Joining me on the call is Kevin Gorman or Chief Executive Officer met Abernathy, Our Chief Financial Officer, I Roberts, our Chief Medical Officer, Eric Deleverage, our Chief Commercial officer called you know, our chief business development and strategy Officer.

During today's call will be making forward looking statements. These statements are subject to certain risks and uncertainties and our actual results may differ materially I encourage you to review the risk factors discussed in our latest FCC filings with that I now turn the call over to Kevin. Thank you Todd and good afternoon, everyone.

Todd Tushla: 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. You know, I'm beginning to sound a little bit like a broken record. But here I like sounding like a broken record.

You know I I I'm, beginning to sounded a little bit of like the broken record, but here I like sounding like a broken record is this quarter by any measure has been remarkable.

Todd Tushla: And this quarter, by any measure, has been remarkable. The impressive achievements across the entire organization are 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, the continued success of INGRESA, and the growth of our pipeline. Now, 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 just add 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 all aspects of our business are stronger than at any time in the history of NERC.

The impressive achievements across the entire organization is a great display of the resilience of our company.

In this first quarter that we've been living with Covance.

This resilience is evident in our regulatory approvals the advancement of our clinical programs continued success of ingress.

And the growth of our pipeline.

No I'm I'm certain that tenacity of our employees and out of all of our external partners will allow us to fulfill our mission throughout this pandemic.

We are presented with the same challenge has the covered as presented to the entire biopharmaceutical industry and yes, the fits and starts the openings and closings in health care in the economy.

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 all aspects of our business are stronger than at any time in the history of dark rent.

In grasses importance to patients their caregivers in health care professionals now is objectively demonstrated by the continued high compliance rates of this past quarter.

Kevin C. Gorman: Ingress'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 Ingresa's impressive growth, until more patients are seen in the doctor's office, we expect to see this continued impact on new patient starts as we discussed in our last quarterly call. Prior to this call, I looked back on the company. I actually went back about two years ago from this time, and at that time we were talking about the unique position uh we were in we had two approved medicines and four compounds in clinical development, But today we find ourselves with four approved medicines and 10 compounds in the clinic. I want to touch on that actually later at the at the end of our call. There's more to it than just that.

This unique environment, where nearly 90% of patience interact with their physicians by Tele medicine will moderate back to a more balanced mix of in person and and Tele medicine.

While we are certainly encouraged.

Within grass is impressive growth until more patients are seen in the Doctor's office, we expect to see this continued impact on new patient starts says we discussed in our in our last quarterly call.

Prior to this call I looked back.

On the company actually went back about two years ago from this time.

And at that time, we're talking about the unique position.

We were in Oh, we had two approved medicines and for compounds in clinical development.

But today, we find ourselves with four approved medicines and Ken compounds in the clinic.

I want to touch on that actually later at the at the end of our call there there's more to it than just that.

As always we tried to keep our opening remarks here to a minimum so we can get to do as many of your questions as possible. So now I'm going to be turning the call over the I remain generic and they'll go into more daps in brief on each of the aspects of the business starting with math.

Kevin C. Gorman: 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 Eiry, Matt, and Eric, who will 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 ingress.

Thank you Kevin and good afternoon, we're really proud of what her team has accomplished with another great quarter for INGREZZA.

Two ASCII approvals on justice for Parkinsons disease, and already on for uterine fibroid and expanding or psychiatry pipeline with the Takeda collaboration.

Kevin C. Gorman: Two FDA approvals for Jentis for Parkinson's disease and Orion for uterine fibroids, and expanding our psychiatry pipeline with the Takeda collaboration. We are preparing to make Ongentis available to patients in the third quarter. We formally initiated a Registrational Phase III trial in CAA, and with our commercial growth opportunities for FDA-approved medicine, our expanding R&D pipeline, and our strong financial profile, we are well positioned to execute on our strategy to become a leading neuroscience-focused biopharmaceutical company. Regarding the financial results for the second quarter, Ingress's sales were $268 million, which equates to approximately 46,400 TRX.

We are preparing to make on justice available to patients in or in the third quarter, and we formally initiated or Registrational phase three trial and see.

With their commercial growth opportunities for FDA approved medicines are expanding R&D pipeline and our strong financial profile.

We're well positioned to execute on our strategy to become a leading are assigned focused biopharmaceutical company.

Regarding the financial results for the second quarter, Congress' sales were $268 million, which equates to approximately 46400 Kara.

Adjusting for channel inventory, we had approximately $256 million at the underlying sales, reflecting continued strong demand from existing.

Matthew C. Abernethy: Adjusting for channel inventory, we had approximately... On the NRX front, although in-person patient visitations were very low across, the impact to NRX is less than initially feared. The stuck down we saw in April helped steady through the majority of Q2. Turning to the P&L, we had another strong quarter of profitability with Q2 gap net income of $80 million and non-gap net income of $139 million. We ended the quarter with $1.1 billion in cash on our balance. This sequential increase includes approximately $50 million paid to Adorcia for the in-licensing of MBI-827104 but does not include the $120 million up-front payment associated with the Decatur transaction, which closed in the third quarter.

On the interacts front, although in person patient visitations were very low across the industry the impact to interact with less than initially fear the step down we saw on April held steady through the majority of Q2 and continues through July.

Turning to the piano, we had another strong quarter profitability with Q2, GAAP net income of $80 million and non-GAAP net income of $139 million.

We ended the quarter with $1.1 billion in cash on our balance sheet.

Sequential increase includes approximately $15 million paid to endorse here for the in licensing of MD 87, 104, but does not include the 120 million dollar upfront payment associated with the Decatur transaction, which closed in the third quarter.

Looking forward with estimated diagnosis rates for TD, what we think it's around 20%.

Matthew C. Abernethy: Looking forward with an estimated diagnosis rate of around 20%, we remain extremely optimistic about the long-term opportunity for... in the near term with COVID-19. We expect there'll be many ups and downs across the entire Neurocrine getting in-person patient visitation flow back to near historical levels is an important aspect Transcribed by https://otter.ai and to Advance Our Pipeline. What we saw in July is very similar to what we experienced in July, regarding NRX trends, and acknowledge the longer pandemic-related disruptions continue. The more the impact will be on Ingrid in the short term, These challenges are not unique to Neurocrine or Ingressa, but as I said at the outset, we are quite proud of what our team has been able to accomplish. I will now hand the call over to Eric Benevich, our Chief Commercial Officer, to add further insight to our ongoing commercial efforts.

Remain extremely optimistic about the long term opportunity for INGREZZA in the near term with Cobiz 19, we expect they'll be many ups and downs across the entire industry.

For Neurocrine getting in person patient visitation flow back near historical levels is an important aspect needed to both make a meaningful differences for patients with TD into advanced or pipeline. What we saw in July is very similar to what we experienced in Q2 regarding interacts trends and acknowledge the longer pandemic.

Related disruptions continue the more the impact will be on ingrained in the short term.

These challenges are not unique to neurocrine oren groza, but as I said at the outset, we're quite proud of what our team has been able to accomplish in these circumstances I.

Ill now hand, the call over the air benefit or Chief commercial officer that further insight to our ongoing commercial effort.

Yeah.

Thanks, Matt I'm happy to provide a commercial update on our Q2 performance and insight into what we have seen so far in Q3.

Eric S. Benevich: Thanks Matt. I'm happy to provide a commercial update on our Q2 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. We saw strong Ingressive Sales momentum in Q1 carry through into the second quarter, and the strength of our results in the first half of 2020 reflects the value of Ingresa to patients and healthcare providers

I'll start off by saying that Q2, 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 would tardive dyskinesia suffers longer than they need to.

We saw strong INGREZZA sales momentum in Q1 carry through into the second quarter.

And the strength of our results in the first half of 2020 reflects the value of INGREZZA to patients and health care providers with great execution from her home office and feel teams combined with the support of our select pharmacy network.

Eric S. Benevich: 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-19, new-to-brand patient starts declined due to an estimated 70% reduction in in-office patient visits. We were not immune to this trend and saw a decline in new patient starts in Q2. However, as Matt noted, and as I note, the impact was not proportional to the reduction seen nationally in in-office patient visits.

The refill in persistency rates for existing patients were at record levels for Q2.

Across the biopharmaceutical industry. It is important to note that because of cobot 19.

New to brand patient starts declined due to an estimated 70% reduction in in office patient visits.

We were not immune to this trend in saw a decline in new patient starts in Q2.

But as as Matt noted and as I note the impact was not proportional to the reduction seen nationally and in office patient visits.

With the advent of stay at home orders our team adapted from in office education to remote engagements.

Eric S. Benevich: With the advent of stay-at-home orders, our team adapted from in-office education to remote engagement. 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 jumped on the telehealth platform, 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 cardiac dyskinesia. The vast majority of people suffering from TD go undiagnosed.

Although overall customer call volume decrease we found that remote engagements resulted in generally higher quality lengthier interactions with health care providers.

Just as we went to a remote engagement model the psychiatry endourology provider of Humidity's also pivoted to tele health platforms, helping to stay as connected as possible with their patients.

Well this is somewhat encouraging nothing can truly replaced in office face to face interaction between the healthcare provider in 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 trend.

Eric S. Benevich: In-person clinic visits are important to improve TD diagnosis and treatment rates and get back on to our historical patient growth rate. As we enter into Q3, many of our field representatives are now back in the field interacting with customers, wearing personal protection, and following appropriate safety guidelines. 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.

As we enter into Q3 many of our field Representatives are now back in the field interacting with customers with personal protection and following appropriate safety guidelines.

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're still relying on virtual methods to connect with their customers.

It's worth reiterating that during these challenging times, we are fortunate to have hired such experienced an exceptional feel teams who have strong relationships with health care providers and a true dedication to serving patients.

Eric S. Benevich: It's worth reiterating that during these challenging times, we are fortunate to have hired such experienced 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 Ingresa sales growth due to HCP summer vacation and patient compliance dynamics. And now we are also addressing the COVID-19 situation. While we expect refill rates to carry over for existing patients into Q3, we do expect the continued impact on new patient starts and may see channel inventory pull back. Now, I'd like to switch gears and talk about Ungentis, 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.

Historically Q3 has typically been a slower quarter four INGREZZA sales growth due to H.C. peak summer vacation and patient compliance dynamics and now we're also addressing the cobot 19 situation, while we expect refill rates to carry over from for existing patients into Q3, we do expect to continue to impact.

A new patient starts it may see channel inventory pull back a bit.

Now I'd like to switch gears and talk about on Genesis, 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're now planning to make on gensets available to patients in the United States by the end of this quarter.

Eric S. Benevich: I'm very pleased with the label our clinical and regulatory teams were able to secure, and we are now planning to make Ongentis available to patients in the United States by the end of this quarter. Our launch efforts with Ongentis will focus on education, something that our entire commercial and medical affairs teams excel at, as witnessed by the continued success of Ingressive. Ongentis is the first and only FDA-approved once-daily COMPT inhibitor for people with Parkinson's disease to help patients achieve more consistent motor symptom control.

Our launch efforts with on Genesis will focus on education, something that our entire commercial and medical affairs teams excel at as witnessed by the continued success of INGREZZA.

On gents, just as the first and only ft approved once daily comps 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 Parkinsons patients.

It also has a demonstrated safety and tolerability profile that's attractive.

It's our belief that on Gensets can deliver on the broken promise of previously launched C. O M T medications.

Eric S. Benevich: 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 Ongentis can deliver on the broken promise of previously launched COMT medications, which failed to live up to the expectations of the Parkinson's community due to the need for frequent dosing, perceived weak efficacy, and or rate-limiting side effects. We're excited to bring this new therapy to our Movement Disorder Neurology customers. We believe Ongentis will be well received by the Parkinson's community and will benefit our efforts with Ingresa NTD as well. Having two phenomenal products to promote will give us more face time and opportunity in neurology practice and burnish 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 for treating movement disorders with both Ingresa and Ongentis remains extremely compelling. Now I'll turn the call over to my colleague Eiry Roberts, who will provide an update on our progress with the pipeline. Eiry?

Which failed to live up to the expectations of the Parkinsons community due to the need for frequent dosing perceived week efficacy and or rate limiting side effects.

Excited to bring this new therapy to our movement disorder neurology customers. We believe on Genesis will be well received by the Parkinsons community and will benefit our efforts within Graz NTT as well.

Having to phenomenal products to promote will give us more face time, an opportunity in neurology practices and burnish 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 bolting, President and on Gentris remains extremely compelling.

Now I'll turn the call over to my colleague every Roberts, who will provide an update on our progress with the pipeline Irene.

[noise], Thank you, Eric and good afternoon to everyone on the call.

I'm happy to provide an update on our clinical programs.

Before I begin now I want to thank the many people at Neurocrine I'm not our 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 one and a half years, we have doubled the size of our R&D pipeline, which now includes potential first in class all best in class clinical candidates designed to address patient needs across a diverse range of Sears.

Eiry W. Roberts: Thank you, Eric. And good afternoon to everyone on the call. I'm happy to provide an update on our clinical program. Before I begin, though, I want to thank the many people at Neurocrine and at our 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 one and a half years, we have doubled the size of our R&D pipeline, which now includes potential first-in-class or best-in-class clinical candidates designed to address patient needs across a diverse range of serious and underserved conditions within neurology, neuroendocrinology, and psychiatry. We know that COVID-19 has significantly impacted clinical trial execution across our industry.

Yes, and I'm, just said conditions within urology Euro endocrinology and psychiatry.

We know that covert 19 has significantly impacted clinical trial execution across our industry and ask the impact of the virus continues to evolve you couldn't has invested extensively in approaches to progress our clinical trials in a safe and responsible manner. The trial participants on health care.

Professionals.

These approaches include the remote qualification stocks of investigative sites remote monitoring of safety. Another data home health care visits I mean 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 poets clinical trials over the past few weeks.

Eiry W. Roberts: And as the impact of the virus continues to evolve, Neurocrine has invested extensively in approaches to progress our clinical trials in a safe and responsible manner for trial participants and healthcare professionals. These approaches include the remote qualification and start-up 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.

I'm pleased to announce that in July we achieved the exciting milestone if the first patient screening in the single Global Registrational study of Knesset font <unk> adults with classical form of congenital adrenal hyperplasia or C. H.

The results from our Phase two 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 final design said this global single Registrational study now called the catalyst study.

Eiry W. Roberts: These changes have led to the successful reinitiation 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 Chronesophon for adults with the 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 final design for this global, single, registrational study, now called the Catalyst Study. The Catalyst Study is a Phase III randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of chronesophon in adult subjects with classical congenital adrenal hyperplasia, followed by an open-label treatment period.

The catalyst studies the phase three randomized double blind placebo controlled study to evaluate the safety and efficacy of Knesset font in adult subjects with classical congenital adrenal hyperplasia yet.

Hi, an open label treatment period.

Approximately 165 subjects from North America, and Europe will be enrolled in this study animal participate in a six month randomized double blind placebo control period.

By one yes treatment with Knesset font.

The primary outcome measure for this study is the percent change from baseline in glucocorticoid daily dose at week 24.

Secondary outcome measures include change from baseline in understanding die on at week four.

The proportion of subjects able to achieve physiologic levels of daily two quick quoted dosing at week 24, together with a variety of clinical outcomes related to metabolic health, including body weight in fact nice.

Eiry W. Roberts: Approximately 165 subjects from North America and Europe will be enrolled in the study and will participate in a six-month randomized double-blind placebo-controlled period, followed by one year of treatment with crinesophon. The primary outcome measure for the study is the percent change from baseline in glucocorticoid daily dose at week 24. Secondary outcome measures include change from baseline in Andrestein-Dyon at week four, the proportion of 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 CronessaFont will provide a valuable and differentiated treatment option for patients in the control of their underlying congenital adrenal hyperplasia.

Were excited to begin this important study with the hope that current estefan, well provide a valuable and differentiated treatment option for patients in the control of their underlying congenital adrenal hyperplasia.

With a much needed I did benefit of enabling patients to significantly reduce the amount of glucocorticoid they need to take every day over the course of their lifetime.

In parallel with the initiation of this pivotal adult study, we recently successfully reinstated screening in the phase two proof of concept study in pediatric C. H.

Continue to progress our discussions with regulators in Europe on the U.S. in support of the initiation of a single global registration study in pediatric subjects.

Beyond kind of used to fund the phase three registration study about managing to treat Korea in patients with Huntingtons disease is now also re enrolling patients.

Regarding our expanding mid stage pipeline, we continue to make good progress in support of the initiation of phase two studies for the treatment of two distinct rare pediatric epilepsy by yearend.

Eiry W. Roberts: With the much needed added benefit of enabling patients to significantly reduce the amount of glucocorticoids they need to take every day over the course of their lifetime. In parallel with the initiation of this Pivotal Adult Study, we recently successfully reinstated 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 Study in Pediatric Patients. Beyond Chromosomes, the phase three registration study of valbenazine to treat chorea in patients with Huntington's disease is now also re-enrolling patients.

<unk> N.B. I three five too.

N.B. I one no for the novel precision medicine assets in license from Xenon and I don't see a respectively.

In addition, our partner Abbvie continues to develop elagolix for the treatment of polycystic ovary syndrome.

Finally, our newest phase two program N.B. I six full full formerly known as Todd 831 continues to enroll patients in the global proof of concept study designed to assess tolerability and efficacy in the control of negative symptoms of schizophrenia.

Results from this study are expected in the second half of next yet.

You will notice today on our pipeline shot that we've removed the female to follow on molecule previously in phase one development. The time spent with this molecule was very instructive until it has a lot more about the v. Matt to mechanism.

Eiry W. Roberts: Regarding our expanding mid-stage pipeline, we continue to make good progress in support of the initiation of Phase II studies for the treatment of two distinct rare pediatric epilepsies by year-end, for NBI 352 and NBI 104, the novel precision medicine assets in license from Xenon and Eidosia, respectively. In addition, our partner AbbVie continues to develop L-egolix for the treatment of polycystic Finally, our newest Phase II program, NBI 644, formerly known as TAC 831, continues to enroll patients in the Global Proof of Concept Study designed to assess tolerability and efficacy in the control of negative symptoms of schizophrenia. Results from this study are expected in the second half of next year. You'll notice on our pipeline chart that we've removed the VMAT2 follow-on molecule previously in Phase 1 development. The time spent with this molecule was very instructive and taught us a lot more about the VMAT2 mechanism.

With this knowledge, we remain excited about the potential value that we believe the Matt to inhibition can bring to patients across a broad range of neurologic 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 yeah. It continues to be difficult to predict what impact upon dynamic well have on our R&D programs.

But despite these current challenges let me reiterate that our plan for Twentytwenty remained unchanged by year end Twentytwenty, we intend to have three registrational programs ongoing.

With the addition of NB Isix full fall to have five mid stage programs in the clinic.

It's an incredibly exciting time for research and development at Neurocrine as we continue to build a world class neuroscience pipeline.

Okay. It was once again by thanking all my colleagues, so that truly inspirational assets and dedication to neurotransmission to relieve patient suffering on enhanced patients' lives with that back to you Kevin.

Eiry W. Roberts: With this knowledge, we remain excited about the potential value that we believe VMAT2 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 will 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&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 three registrational programs ongoing and, with the addition of NBI 644, to have five mid-stage programs in the clinic. It's an incredibly exciting time for research 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 very before I open it up with questions I'd first like to highlight NERC runs a corporate sustainability efforts.

As I reset our mission is to relieve suffering and enhance lives and fundamental to this is our responsibility we have to our patience customers partners shareholders and society at large.

And in that light, we really simply issued our first corporate sustainability report that can be found a nerve surgeons website, which highlights the connection between our our mission and the in environmental social and governance programs. We believed to be most impactful to our company in society.

The disclosure. This reserve report just marks the first step in communicating our yesterday strategy. As this strategy involves we look forward to engaging with you on the sustainability issues that matter most to ensuring we continue to develop the on our mission.

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 questions. Please.

As a reminder, if he would like to ask a question. Please press the star and one.

We will take our first question from Paul Matisse. Please go ahead. Your line is open.

Kevin C. Gorman: Thank you, Eiry. Before I open it up for 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 our responsibility we have to our patients, customers, partners, shareholders, and society at large. And in that light, we have simply issued our first corporate sustainability report, which 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.

Hey, Paul if you if you're if you're there we can't area.

Hey can you hear me.

It's taken your four months to learn this through coded ball good to hear your voice.

Can you hear me now Matt.

[laughter], that's the way it's going to go.

[laughter], Iberia, Alright, Hey, I'm going to turn out to a couple of questions around open my phone. So it 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 one can you quantify a little bit more of the increases in compliance in refill rates and how that.

Should inform our sequential occasion that estimate and then second what's going on with inventory and where are you relative to steady state and how much of a draw down do you foresee happening over say the next three to six months. Thanks, Yeah sure Paul So for the second quarter, a couple of dynamics low led to the sales increase.

Kevin C. Gorman: 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 our mission, deliver on our mission, and help patients and drive long-term shareholder value. So, with that said, I'd like to open it up for questions, please. As a reminder, if you would like to ask a question, please press the star and one. We will take our first question from Paul Matthews. Please go ahead. Your line is open. Hey, Paul, if you're if you're not there, we can't hear you.

First gross to net came back from where we were at and the donut hole in the in the first quarter.

Second element as as we experienced last year, we did have a step up in level of patients staying on drug as well as a as refill rates and that was an incredible effort by the team and our specialty pharmacy network to ensure that patients stayed on on medicine in the quarter I think is really a testament to.

ER to the value that agents ultimately.

Front, taking a INGREZZA on the new patient front, we're not going to get into the ultimate quantification. There as we described coming out of Q1, you did we did have a step down in enter acts in April due to cogan, but it wasn't anywhere near the 70% dropped that you saw on inpatient or in person.

Paul Matthews: Hey, can you hear me now? It took you four months to learn this through COVID, Paul. Good to hear your voice. Can you hear me now, Matt?

Paul Matthews: Is that the way it's going to go? I love it!

Matthew C. Abernethy: I can hear you. All right. Hey, I'm going to try to ask a couple of questions now, and hopefully, my phone still works. I'm trying to get a better understanding of how many patients you guys added this quarter, and there are a lot of moving parts. I guess maybe just for one, 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 you are relative to steady state, and how much of a drawdown do you foresee happening over, say, the next three to six months? Thanks. Yeah, sure, Paul.

Patient.

Visitation, so that and Irex rate stayed very steady throughout the quarter, we weren't to a point, where you can because when you're a big brand like INGREZZA you do have your natural Discontinuations, we were not a place where.

Interacts what was then discontinuations, but as Kevin and I.

Both said in our prepared remarks, we know foreign grows it or reach its long term a potential and we're very confident and the ability for and grow the to reach a as long term potential we have to see a in person patient visits get back near historical levels and I think that many other companies are doing.

Matthew C. Abernethy: So for the second quarter, a couple of dynamics led to the sales increase. First, gross PNET 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 the level of patients staying on the drug as well as refill rates, and that was an incredible effort by the team and our specialty pharmacy network to ensure that patients stayed on medicine in the quarter. And I think that is really a testament to the value that patients ultimately get from taking Ingreza. On the new patient front, we're not going to get into the ultimate quantification there. As we described coming out of Q1, we did have a step down in NRX in April due to COVID, but it wasn't anywhere near the 70% drop that you saw in in-person patient visitation. So that NRX rate stayed very steady throughout the quarter.

Dealing with this in a very similar way and it's not unique to NERC right.

Then I think the last piece your question or relates to channel inventory and it is something that's very difficult to predict we've had three straight quarters of build and we tried to disclose that number. So that you can normalize or sales to reflect an adjusted sales number that more represent the underlying sales results.

For for the company. So in this quarter for example, although reported to 68 to 56 is the is the right baseline last quarter. You know it was it was around 227 I do I, we would expect there to be a drawdown and inventory Paul.

It it's hard to get into that want to get into the nuances of why stocking occurs sometimes it's because your distribution channel sets out than another.

<unk> for distribution for example, but over the long run I think that are our inventory levels should be around a two weeks on hand, and and I would expect at some point to be a there to be a a drawdown and and the inventory.

Matthew C. Abernethy: We weren't to a point where, because when you're a big brand like Ingreza, you do have your natural discontinuations. We weren't at a place where NRX was less than discontinuations, but as Kevin and I both said in our prepared remarks, we know for Ingreza to reach its long-term potential, and we're very confident in the ability for Ingreza to reach its long-term potential. We have to see in-person patient visits get back to 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 NuroGren. Then I think the last piece of your question relates to channel inventory, and that is something that's very difficult to predict. We've had three straight quarters of build, 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 for the company.

Thank you that's helpful and can I just ask one quick follow what Matt.

Last year, you saw a pretty big snapped back on average script per patient you relative to one Q1 Q. This year you said the seasonality issues weren't as significant is there anything you can say about any sort of reversion benefit you saw on average script per patient and this quarter I guess sort of understanding the broader context here is trying.

<unk> figure out what's your underlying patient that number as thanks, a lot yeah. Let 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 the authorization or reauthorization process in Q1, and this year team did a great job in AG.

Actually was better year on year from a a from a net revenue or revenue a script for patient so.

Matthew C. Abernethy: So in this quarter, for example, although reported 268, 256 is the right baseline, last quarter, you know, it was around 227. 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 two weeks on hand, and I would expect at some point to be, there to be a drawdown in inventory.

You're right you wouldn't have seen as significant enough of a step up from Q1 to Q2, this year and ER and ER scripts per patient.

Alright, thank you so much.

Berlin will take another question.

Our next question comes from Phil Ned You. Please go ahead your line is open.

Good afternoon, Thanks for taking my questions and let me add my congratulations on a great performance and circumstances.

Maybe first one for you looking at the disruption so you're calling out into Q3, just qualitatively I'm trying to understand is the first four or five weeks of Q3 are they looking better than what you experienced in Q2 is it is it more the same can you just qualitatively give us.

Paul Matthews: Thank you. That's helpful. And can I just ask one quick follow-up question, Matt? Last year, you saw a pretty big snapback on average script per patient in QQ relative to 1Q. And in 1Q this year, you said the seasonality issues weren't as significant.

Some help.

As we project into Q3, and we try to come up with the revenue number as to what you're seeing in the field.

Yeah, Yeah. Good good question and good to hear from you.

What we saw in July Oh from an interactive perspective is very similar to what we would have seen April may and June. So we had seen a step down going into coated and then it's pretty much stabilized and I think we were on one hope or as a society when things started looking a bit a bit better from a.

Paul Matthews: Is there anything you can say about any sort of reversion benefit you saw in the average script per patient in this quarter? Again, sort of understanding the broader context here is trying to figure out what the underlying patient ad number is. Thanks a lot.

The economy opening up but then you know once its shot back down again, I would say that.

Matthew C. Abernethy: Yeah, 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 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.

We're at a very similar level of interacts which was which was actually absolutely a testament.

To our field sales team to medical professionals that are helping us here that people with tardive dyskinesia, new people are still getting access to INGREZZA an existing patients are remaining very very compliant. So I think the cautious statements that you hear.

Your forward booking the team is doing a great job and we expect them to continue to do a great job, but for us to have an interacts level that significantly above discontinuations that naturally occur on any medication you know we need to see a in person patient visits.

Operator: Marilyn, we'll take the next question. Our next question comes from Phil Nadeau. Please go ahead. Your line is open. Good afternoon.

Phil Nadeau: Thanks for taking my questions. And let me add my congratulations on a great performance in tough circumstances. Matt, maybe the first one for you, looking at the disruptions that you're calling out into Q3, just qualitatively, I'm trying to understand, are the first four or five weeks of Q3 looking better than what you experienced in Q2? Or is it more the same?

It get back up to two Oh higher levels, Eric or Kevin any any other insight yeah, Phil I guess I just want to add one thing is is that they said it as I said in my opening statement with this snapping you know opening close and things like that and I Hope we don't you know for society.

Sake, we don't keep getting website 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 that goes in there and patients and caregivers there are no different and so it again as a testament to just what a terrific job.

Matthew C. Abernethy: 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? Yeah, yeah, good, 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 in April, May, and June. So we saw a step down going into COVID, and then it's pretty much stabilized.

That that our field sales team is doing that they keep at it and they keep delivering each and every quarter, but a that that's where you see a bit of a caution in our voices coming off of again, you know to really nice quarters that we've had thus far is you just don't know what to expect inside of you as things open or close and.

Matthew C. Abernethy: And you know, I think we were all in hope as a society when things started looking a bit better from an economic point of view. But then, you know, once it's shut back down, again, I would say that we're at a very similar level of NRX, which is, which is actually, 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 Engraza, and existing patients are remaining very, very compliant. So I think the cautious statements that you hear are 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 the discontinuations that naturally occur on any medication. You know, we need to see in-person patient visits get back up to higher levels. Eric or Kevin, any other insights?

And I, we don't want to lose sight of that because while Eric and his team adapts amazingly well.

So these things.

Yes. This we seem to get curve balls, you know almost weekly right.

Right right that helps a lot if I could just follow up with too.

My questions.

First on contracts is to have a sense of win.

Yeah, we'll be ready to respond to market or when it will be ready to tell you when they'll be ready to reverse supply market and then second on the seats phase three study clearing the clinical trials that drove the primary completion is February 2023 is should we expect results there for from the primary endpoint in the first half a 2020 threes that is.

Reasonable or is there something I'm missing in the clinical trial stucco posting thanks, So Phil I'm going to take that the first part there be al did a great job of getting the whole supply chain in order.

Kevin C. Gorman: Yeah, Phil, I guess I just want to add one thing, as I said in my opening statement, with this snapping, you know, open-close, things like that. And I hope we don't, for society's sake, keep getting whipsawed back and forth like that. But as it does, you know, I'm sure you feel it. Everyone does.

And because they've done such a good job, we're confident that we will be launching this drug and and supply chain is is not an issue at this point.

With respect to the C. H question I mean, when I'm really proud of how the team has worked with our external partners in enabling this trial to get up and started.

Obviously, you like all of our research efforts their eyes impact around the world from the Cold 19, and a pandemic as soon as we kind of get a few months into the trial and understand enrollment relative to our current expectations would be able to give you a much better uptake but.

Kevin C. Gorman: There's a certain fatigue that goes into it, and patients and caregivers are no different. And so it is, again, a testament to just what a terrific job that our field sales team is doing, that they keep going, 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, you know, two really nice quarters that we've had thus far. You just don't know what to expect in front of you as things open or close. And we don't want to lose sight of that because while Eric and his team adapt amazingly well to these things, we seem to get curveballs, you know, almost weekly, right? Right, right. That helps a lot.

With respect to the enrollment estimates that we took into the trial.

Dates that are MCT dot dot dot consistent.

Perfect. Thanks for taking my questions.

[noise] Brown will take the next question please.

We will take our next question from Brian Abrahams. Please go ahead. Your line is open.

Hey, guys my congrats on the on the quarter as well thanks for taking my questions.

On aggressive I'm curious if you could 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, maybe help drive some new patient growth.

Phil Nadeau: If I could just follow up with two pipeline questions. The first, on Gentis, do you have a sense of when Biow will be ready to resupply the market, or when they'll be ready to tell you when they will be ready to resupply the market? And then second, on the CH phase three study, according to clinicaltrials.gov, the primary completion date is February 2023. Should we therefore expect results, therefore, from the primary endpoint in the first half of 2023? Is that reasonable?

It depends that continues to linger.

Yeah, absolutely you know as as I mentioned in my prepared remarks, you know 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. We tele health platforms are we to move to a remote engagement model with those prescribers.

And what that looks like early on was essentially taking a lot of the existing educational content and adapting it to a remote engagement platforms like zoom go to meeting I, even face time and as we went forward through Q2, we became a lot more proficient.

Kevin C. Gorman: Or is there something I'm missing in the clinicaltrials.gov posting? Thanks. So, Phil, I'm going to take the first part there. Biow did a great job of getting the whole supply chain in order. And because they've done such a good job, we're confident that we will be launching this drug, and the supply chain is not an issue at this point. With respect to the CAH question, I mean, I'm really proud of how the team has worked with our external partners in enabling this trial to get up and running. I mean, obviously, like all of our research efforts, there is impact around the world from the COVID-19 pandemic. As soon as we kind of get a few months into the trial and understand enrollment relative to our current expectations, we'll be able to give you a much better update. But with respect to the enrollment estimates that we took into the trial, those dates that are in ct.gov are correct. Perfect.

In terms of understanding how to reach people.

That were not no longer necessarily in the clinic.

And how to engage them either in discussions about TV and INGREZZA or really supporting existing patients as Matt talked about a four 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, you know as we've done in the past we're gonna have to blazing new trails here on 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 are assessing movements remotely and their patients.

And we're capturing those best practices, and we're integrating them into educational content.

Operator: Thanks for taking my questions. Great, Ryland, we'll take the next question, please. We will take our next question from Brian Abrahams. Please go ahead, your line is open. Hey guys, my congratulations on the quarter as well.

That we've been more recently rolling out.

To our customers. So I think that you know tele health is here to stay in many ways.

Certainly, it's somewhat offset the steep decline in patient interactions.

Brian Abrahams: Thanks for taking my questions. On Ingresa, I'm curious if you could talk a little bit about how telemedicine and your detailing approach maybe have 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? Yeah, absolutely.

Between Cps and patients.

But ultimately even after we get passed as a this health crisis and returned to a more normal posture ultimately tele health is gonna 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.

Make sure that regardless of whether a provider is seeing a patient in person or remotely they've got relevant credible educational content that will help them make that diagnosis and of course.

Eric S. Benevich: You know, as I mentioned in my prepared remarks, we've had to adapt to this new environment, and as our neurology and psychiatry customers have. We have moved to a remote engagement model with their patients via telehealth platforms. We, too, have moved 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, and even FaceTime.

When appropriate choose INGREZZA.

Got it that's really helpful and then the pricing for.

Consensus was recently announced it 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 edits through other classes like I know, you'll be inhibitors or other see on t. inhibitor specs.

Sure, Yes, so we announced price I want to say like two or three weeks ago, but right.

Eric S. Benevich: And as we went forward through Q2, we became a lot more proficient in terms of understanding how to reach people that were not necessarily in the clinic and how to engage them either in discussions about TD and Ingresa or really supporting existing patients, as Matt talked about for refilling prescriptions. Going forward, I certainly believe that there is an opportunity to develop new tools and resources to assist in diagnosing TD remotely. And of course, you know, 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.

And our whack price is 590 per month, which is below the threshold for specialty tier on Medicare plans.

So you know, we we made that choice with patient access in mind and 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 are our field reimbursement team in place.

We have built out our patient support program.

And our other elements that you know that will be available at the time of watch, but ultimately you know we want to make sure that patients that that need access to on Gensets can get it.

Eric S. Benevich: We've been learning a lot 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.

With the announcement of a price we've actually started to engage with payers ahead of our commercial watch.

And the goal there isn't to introduce them to the products into the labeling and to understand how that currently managing adjunct to.

Treatments in the park since category and to start to make sure they understand that step edits through or other comped inhibitors or other classes of adjunct of treatments may not be beneficial for patients and so initially as we get out the gate at the end of Q3 and.

Eric S. Benevich: Certainly, it's somewhat offset the steep decline in patient interaction between the HCPs and patients. But, you know, ultimately, even after we get past this Health Crisis and return to a more normal posture. Ultimately, telehealth is gonna 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 content that will help them make that diagnosis. And, of course, when appropriate, I got it.

For a on Genesis is going to be in on formulary drug and it's gonna have to be approved on a formulary exceptions process and were very good at this obviously we had to go through this with the INGREZZA.

As we get into 2021.

Certainly we will start to see formulary decisions made and those will be a publicly available for you as well, but initially out of the gate, it's gonna be a formulary exceptions process and we're currently engaging with payers to make sure they understand the value that we're bringing with agendas.

Thanks again for all the color.

Brian Abrahams: That's really helpful. And then the pricing for Ongentis 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, and whether you expect any step edits through other classes like MAOB inhibitors or other COMP inhibitors. Thanks.

And we will take our next question from David Amsellem. Please go ahead, David Your line is open.

Think so couple of Christmas or fun.

Question so.

It's not lost than anyone that there are other Crs Oh type one receptor antagonist that are in development, so with that in mind them, specifically alluding to till that surface.

Eric S. Benevich: Sir, yes, so we announced the price. I want to say, like, [inaudible] 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 there are other elements that will be available at the time of launch. But ultimately, you know, we want to make sure that patients that need access to Ongentis can get it.

Screws CRADA, what's your take and commercially on the.

The market's ability to accommodate.

More than one entity CRF one.

Products. So that's number one and then secondly, appreciate all the color on the global Phase three study I guess my question here is what's your take on which endpoints. You think are the most commercially relevant I mean is is it indeed steroid burden.

Eric S. Benevich: 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 and to 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, Ongensis is going to be a non-formulary drug, and it's going to have to be approved through a formulary exceptions process, and we're very good at this, obviously we had to go through this with Ingress. As we get into 2021, certainly we'll start to see formulary decisions made, and, you know, 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 they understand the value that we're bringing with on-chain. Thanks again for all the color.

Is it something.

Along the lines of or direct clinical endpoints like like.

Body mass or a bone density help us understand how you're thinking about that in terms of commercially relevant and points. Thanks.

Thanks to the question David So few questions in there actually so let me just not but the first question.

First thing that's absolutely clear is there is very significant global unmet medical need and congenital adrenal hyperplasia patients. We only treatment option right now is steroids glucocorticoid, often very high superficially logic doses, which ended of themselves lead to a lot of issues.

Over the course of a lifetime in terms of side effects.

With respect to Knesset Funk program I mean, we're absolutely delighted that when now entering what well hopefully be the last stage 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.

David A. Amsellem: And we will take our next question from David Anselm. Please go ahead, David, your line is open. Thanks. So, a couple of questions about the chronesophant.

With respect to the design of the study itself and our overall profile on we really designed the study based on lot of all learnings previously from off L band as impose on some elagolix involvement and it's really very realistic in terms of how we're looking at the end points within not trial, obviously, we know that managing.

David A. Amsellem: So I'm sure it's not lost on anyone that there are other CRF type one receptor antagonists that are in development. So with that in mind, specifically alluding to tildesophant, the spruce product, what's your take commercially on the market's ability to accommodate more than one anti-CRF1 product? So that's number one.

David A. Amsellem: And then secondly, appreciate all the color on the global phase three 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 the steroid burden? Is it something along the lines of more direct clinical endpoints like body mass or bone density?

The whole steroids hormone levels in patients with C. H is important and that that is many times, how they manage their disease day today, but when we look at the clinical relevance if not 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 six month.

And.

I'm focused on steroids reduction in order to gain a very important set of efficacy and Tolerability and safety data that we believe will then said many stakeholders, including the patients. They can't give it is the health care professionals regulators and ultimately pay is around the world and so.

Eiry W. Roberts: Help us understand how you're thinking about that in terms of commercially relevant endpoints. Thanks. Thanks for the question, David. There are quite a few questions in there, actually. So let me just start with the first question. The first thing that's absolutely clear is that there is a very significant global unmet medical need for congenital adrenal hyperplasia.

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 and combining this on the previous clinical data that exist. Knesset fund you know to support the registration of this medicine and ultimately the ability for patients to get access to the medicine.

Eiry W. Roberts: 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 for Cronethafond in order to support the registration of this medicine and ultimately the ability for patients to get access to the medicine. Thank you.

Thank you.

Great. Thanks, we'll take the next question please.

Operator: We'll take the next question, please. Our next question comes from Paul Choi. Please go ahead. Your line is open.

Our next question comes from Paul Kelly. Please go ahead your line is open.

Thank you good afternoon, everyone I'm in congratulations on the quarter and all the progress.

Paul Choi: Thank you. Good afternoon, everyone, and congratulations on the quarter and all the progress. I think during your earlier prepared remarks, you talked about maybe a 20 percent diagnosis right now for T.D. And I was wondering if you could maybe just sort of comment on whether you are seeing a step up just in physician recognition, or do you think this is being driven by any particular factor, such as your advertising? If you can, maybe just elaborate on that.

I think I'm starting to earlier prepared remarks, you talked about maybe a 20% diagnosis right now for <unk> for TD I was wondering if maybe just sort of comment on you know are you seeing a step up just in physician recognition or do you think this is being driven by any particular factors such as Youre right Youre. Your advertising if you can make.

He just elaborate on that and just as you think about the diagnosis right here over the short to intermediate term is this the sort of rate of increase we should think about in terms of our modeling that I had a problem.

Eric S. Benevich: And just, you know, as you think about the diagnosis right here in the short to intermediate term, is this the sort of, you know, rate of increase we should think about in terms of our modeling? 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, you know, I just want to flag, you know, the movement from Q1 to Q2, the growth there was largely driven by, you know, the gross net change and then patient compliance and then also, you know, some level of growth out of the net new patients, less discontinuation.

Well I think does it Paul this is Matt and then Eric will give you a little bit more insight as to what you're seeing from a a customer perspective, and where we're generating a new new demand.

For modeling purposes, you know I just want to flag the movement from Q1 to Q2 the growth there was largely driven by you know the gross to net change and then patient compliance and persistency and then also you know some level of growth out of the net new patients.

Discontinuation, so going forward Q2 to Q3 sequentially. What we've been talking about is that are in or eggs levels have remained very study.

Eric S. Benevich: 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 in-person patient visits, they are much higher than that. However, to have sustained growth, similar to what we've seen historically, we need in-person patient visits to get back closer to normal, which none of us can predict when that's going to occur. But Eric can talk through what he's seeing on the customer front, you know, our insight into that 20% diagnosis rate and where we go from here with that. Yeah, 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 four years of effort and educational push on the part of the company. When we started developing this market, there was, we estimate, a low single-digit percentage of patients that had actually been diagnosed with CARDI-B.

Which is good because relative to the drop in person patient visits a it's much higher than that.

However to have sustained.

Growth similar to what we've seen historically, we are we need in person patient visits to get back closer to normal which none of us can predict when that's 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 from here with that.

Yes, so I think it's important to note that that estimate of about 20% of.

Patients and the prevalent population that have now been diagnosed with TD.

That's after about four years of of effort.

And educational push on the part of the company. When we started developing this market. There was a we estimate low single digit percentage of patients that have actually been diagnosed with tardive dyskinesia.

And so you know over time, we've seen that percentage of patients increase and as we get to the middle of this year or estimate is around 20% have now been given a diagnosis as Matt said diagnosis is largely a function of education in also.

Eric S. Benevich: And so, you know, over time, we've seen that percentage of patients increase, and as we get to the middle of this year, our estimate is that around 20% have 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 T.D.

So HCP interaction with patients.

With the a 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 and be more comfortable and confident in making that diagnosis remotely.

Eiry W. Roberts: 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 as remotely as Matt said, and the decrease in new patient starts that we've seen with Ingresa has not been, [inaudible] So, you know, the takeaway here is that this is a short-term disruption to our belief. In terms of what that diagnosis rate will be and what the impact is on new patients, 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 Ingressa. So I hope that provides a little bit more context. Yes, that's great. Thank you for that color!

Obviously that diagnosis is happening has is at remotely as Matt said.

The decrease in new patient starts that we've seen with INGREZZA has not been.

A portion or commensurate with the decrease in patient foot traffic through these clinics. So you know the takeaway here is that a this is a short term disruption aren't in our belief in terms of what that diagnosis rate will be and what the impact is on on new patient starts.

We already have people with TD remain on diagnosed and that's our commitment to continue our educational efforts whether it be.

In person or a remote engagement to help providers make that diagnosis and get them those patients started on INGREZZA.

So I hope that provides a little bit more context for you.

Yes, that's great. Thank you for for her that color and one quick one for Erie with regard to these to the phase three Huntingtons, which you mentioned has resumed enrollment there as you think about the.

Paul Choi: And one quick one for Eiry, with regard to the phase three Huntington's, which you mentioned has resumed enrollment there. As you think about the clinical outcomes, given that you will technically be, you know, 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 formulae, formulary positioning with regard to Huntington's? Thank you. Thanks, Paul.

The clinical outcomes, given that youre technically be out potentially it's not going to market here I personally, but competition, how do you I'm talking about any other incremental data points that you'd be gathering from a trial that might help wet potentially with was formulation formulary positioning with regard to huntingtons. Thank you.

Thanks, Paul and so the trial is designed to that Registrational trial. The primary endpoint is actually the Korea school as part of the U.S.P. Drs School and Dot is the a obviously an important endpoint intensive determining the impact of valbenazine on the input.

Eiry W. Roberts: So the trial is designed as a registrational trial. The primary endpoint is actually the career score as part of the UHPDRS score, and that is obviously an important endpoint in terms of determining the impact of valbenazine on important career outcomes. There are some differences in the label with respect to the absence of a black box warning relative to our competition, and obviously, being a once-a-day therapy with a straightforward dose escalation and titration, we believe all of those are differentiating, and, in fact, we've designed the study in order to give us the best opportunity to address any differences as they occur. Thank you for taking our questions. Great.

Korea outcomes, we have other quality of life measures included in that study, which we believe are important as we seek to support the a hunting gets create a patient most appropriately and moving forward.

In addition, though I would say that I intend to the context of differentiation for Valbenazine. In this study you know we're very encouraged by the profiles that we've seen up to this point I think rise doesn't differences in the label with respect to a black box warning relative the absence of a box books wanting relative to.

Competition, and obviously being a once a day therapy with a straight full what dose escalation and Tightrail version and we believe all of those are differentiating and a in fact, we've designed the study in order to give us the best.

Operator: We'll go to the next question, please. Our next question comes from Mark Goodman. Please go ahead. Your line is open. Hi.

Community to address any any differences if they are saying.

Great. Thank you for taking my questions.

Great well go to the next question please.

Our next question comes from Marc Goodman. Please go ahead your line is open.

Marc Goodman: The first question is about inventories. You mentioned that you believe inventories will come back down to two-week levels. Can you just tell us where you think they are right now?

[laughter] Hi, a first question. It's about inventories you mentioned that you believe inventories will come back down to two week levels can you just tell us where do you think they are right now.

My question is on SGN day, which seemed a little lighter than I would've expected in the quarter.

Matthew C. Abernethy: The second question is on SG&A, which seemed a little lighter than I would have expected in the quarter. Can you talk about why that was, and will you be adding a sales rep? for the launch of your new Parkinson's, And then, I guess, third... 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. 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, I mean, is there anything special about TARDIP dyskinesia that you could figure out, or is it really?

He's talking about why that was and will you be adding sales reps or for the launch of your new Parkinsons product.

And then I guess third.

It's hard at this can easier relative to.

All these other therapies out there, it's just I guess amazing to me why.

You are 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 youve attributed to a lot of different things, but is there I mean is there anything special about tardive dyskinesia that you could figure out or is it really just you know just the persistence of the patients and stuff because were sandy patients down you're telling us. So I was just curious if you give us some more color that thanks.

Matthew C. Abernethy: You know, just this persistence of the patients and stuff because we're seeing new patients down, you're telling us, so I was just curious if you'd give us some more color. Yeah, 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 three weeks behind. 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 a new warehouse. I'd expect that they will normalize that. Historically, we've tried to keep our inventory levels below two weeks, but now they're actually over.

Yes, Hi, Mark I'll take the first two questions and then he ended up for the for the Tardive dyskinesia on inventory front. This is the first time, we've ever been over three weeks on hand, and like I said earlier I think it has to do it a little bit of phenomenon of one of our partners are 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 two weeks, but but now they're actually over two weeks, so and what I've, even seen on ordering pattern. So far this this quarter.

Matthew C. Abernethy: So, and what I've even seen in the 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 the true underlying demand is. On the SG&A front, there were really two aspects that led to the sequential decline from Q1. Number one is that you typically have seasonal spend that's concentrated in Q1, and then that recovers in Q2.

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 Arps ourselves results is to look at us on and inventory adjusted basis, and that's something that.

We're going to continue to disclose every every quarter. So that people can see what true underlying demand is.

On the screen a front, there's really two aspects that led to the sequential decline from Q1 number. One is that you typically have a seasonal spend that's concentrated in Q1, and then that recovers in Q2 or the second piece is that we do have some spend that was slowed down as it relates.

Matthew C. Abernethy: The second piece is that we do have some spend that was slowed down as it relates to COVID-19. Some of the field-based activities that we would normally be 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.

To to coded 19, some of the field based activities that we would have normally been spending behind a aren't necessarily.

Aren'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 you're in the near term as possible. It just how things shook out on the S. DNA front as well as the slowed down in R&D.

Matthew C. Abernethy: It's just how things shook out on the SG&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 paused. We have more getting back up and running now. When you think about the Takeda collaboration, the Dorsia product, as well as Xenon and then all of the other programs I've already mentioned, we're so excited about what we have ahead of us with the number of clinical programs that we'll have up and running. From a spend perspective, that's going to lead to a big step up in spending in 2021, but I believe it really positions us well for the future. I'm going to hand the next part of the question about what makes or what drives our ability to diagnose PD or our position to diagnose PD in this environment over to Eric or Kevin. Yeah, it's a good question.

Spending I would just flag as people want to think about R&D investment going forward. We do 'em. 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 Dorsey product as well as xenon and then all the other programs I remain.

And we're we're so excited about what we have ahead of us from the number of clinical programs that will have up and running and premise 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 the next part of the question about what makes.

Or what drugs or ability to diagnose Pee dee ER physicians to diagnose TD in this environment over to the Eric or Kevin.

Yeah I have a it's a good question you know what is it about TD was it about congrats it that's allowed us to be so successful despite the circumstances.

Eric S. Benevich: What is it about TD? What is it about Ingressive that's allowed us to be so successful despite the circumstances? I think there are a few external factors, and then there are a few internal factors. It starts off with the aspect of TD that many people don't really appreciate, which is that there's a real significant disease burden. People that are living with T.D. experience it every day, and it affects their lives in many different ways, functionally, and emotionally, in terms of their willingness to engage with others in the community.

I think it's just a few external factors and then there's a few internal factors.

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 are really meaningful benefit and that's been seen not only in the clinical trials, where we saw significant improvements as quickly as two weeks.

Eric S. Benevich: The second thing is that Ingresa offers a really meaningful benefit, and that's been seen not only in the clinical trials, where we saw significant improvements as quickly as two weeks. But also, based on the trial and adoption that many providers have gone through over the last several years, they try it on 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 third 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, you know, frankly stigmatized.

But also based on the trial in adoption that many providers have gone through over the last several years. They tried and a few patients. They see that it offers a meaningful benefit and that motivates them to treat.

Listen treat additional patients.

And then the third external factor, which is important to note is that the HCP is 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 you know frankly stigmatized.

From an internal perspective, you know we talked about the the high quality people that we've hired bolt in the field and in the home office that are very committed.

Eric S. Benevich: From an internal perspective, you know, we talked about the high-quality people that we've hired both in the field and in the home office who are very committed to helping these patients get access to Ingresa. 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, you know, 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, you know, we remain committed to helping our providers, whether it's an in-person or remote interaction with the patient, and certainly, you know, we expect to continue to be successful in the near term and over the long haul. Thanks.

To helping these patients get access to INGREZZA.

And in addition, I think you know frankly, I'm, having a really strong.

So let pharmacy network has benefited us as well in terms of patients being able to get refills.

Despite the the doctors 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 you know very favorable refill it 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 you know we remain committed to helping our providers, whether it's in phase or a remote interaction with the patients and certainly you know we expect to continue to be successful the near term and in over the long haul.

Okay.

Thanks.

Great Let's take the next question please.

Operator: Great. Let's take the next question, please. We will take our next question from Byron Amin. Please go ahead. Your line is open. Yeah, hi guys, thanks for taking my questions. Maybe I can just start on Ingreso.

We'll take our next question from.

Ivan Aman. Please go ahead your line is open.

Hi, guys. Thanks for taking my questions and then he just started on INGREZZA I know I'm, you've discouraged best friend using IMS script data.

Byron Amin: I know you've discouraged us from using IMS script data, but in the second quarter, there was a 10% 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? Yeah, Barron, I 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. You know, I think it captures different aspects of our specialty pharmacies or closed door pharmacies data. And it sometimes can't be as representative as other periods.

During the second quarter or there was a 7% sequential decline and Trx data from my math compared to what you reported today, which is 12% sequential growth.

What do you think is the reason why I missed this feeling to capture in the script trends at the sites, where they collect data.

Yeah beer and.

Definitely a understand your question and you know our conversations around Imus data have been not to use it as a proxy for for ourselves results. You know I think it captures different of our specialty pharmacies or closed or pharmacies data and it sometimes king.

It is representative as other periods, so hard to determine why it was different.

Matthew C. Abernethy: So, It's 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 Ogentis, I know you've had some PAIR discussions or engaged with PAIRs. Should we be expecting a step-edit through Antecapone?

And then what our results were but like like we've said inventory adjusted we had a sequential increase of about 8% I think trx, which was which was very strong in this environment.

Got it and then on no Gentris I know you've had some pair discussions are engaging with payers should we be expecting a step through hunt and peck upon.

So beer and our base expectation is that we wouldn't just based upon the value that we have that we see and on juntas relative to a intact the bone to pay or conversations are still very early and that's something that we're hoping to get more in.

Matthew C. Abernethy: So, Biren, our base expectation is that we wouldn't, just based upon the value that we have in Ongentis relative to Tacapone. But payer conversations are still very early, and that's something that we're hoping to get more insight on over the next three or four months. But we have a very good, as Eric said earlier, a very good payer account team that is currently meeting with payers as, Yeah, the only other thing I'd throw in there 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. The majority of these patients are Medicare Part D patients, and Medicare Part D plans have up to six months to review Part of our message to payers is that it wouldn't be medically appropriate to force patients to step through to tacapone.

Side on over the next three or four months, but we have a very good as Eric said or earlier, a very good payer account team that is currently meeting with payers as we speak.

Yeah. The only other thing I'll throw in there is that initially this is going to bring on formulary product and we're gonna have to go through formulary exceptions process. Jordi. These patients are in Medicare part D.

And Medicare part D plans have up to six 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 attacked compound.

As you know certainly we're bringing our payer account team and the medical science liaisons into those conversations we'll see how the how they have a coverage policies shape up over the next year. So but our position is that that does not have medically appropriate are necessary to demand.

Eric S. Benevich: And certainly, we're bringing our payer account team and the medical science liaisons into those conversations. We'll see how the coverage policies shape up over the next year or so, but our position is that it's not medically appropriate or necessary to manage this class and this product, and certainly, our pricing decision wouldn't be one that would make that something that payers would necessarily rush. And then, maybe, I could have a pipeline question on the phase three CH trial with the primary endpoint being steroid reduction at week 24. How are you setting up the algorithm for the steroid tape?

There's a this class in <unk> and this product in certainly our pricing decision wouldn't be one that would make that or something that pairs with necessarily rush towards.

And then maybe if I could have a pipeline question on the phase three C. H trial with the primary endpoint being served reduction at week 24.

How are you setting up the algorithm for the stairway papers that based on I guess improvements on certain biomarkers like Syndros to die on and is it on improvements to the upper limit of normal or is that based on reductions of baseline.

Byron Amin: Or is it based on, I guess, improvements in certain biomarkers like androsodione? And is it on improvements to the upper limit of normal? Or is it based on reductions in baseline that patients come in with on these biomarkers?

That that patients come in with on these biomarkers.

Got you you asking very important question burn I'm, 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 have spent a huge amount of time with external experts in the field on the regulators and everybody else defining the most appropriate trial design hedge against the most robust set of data on you know from a competitive suspect.

Eiry W. Roberts: 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 have spent a huge amount of time with external experts in the field and the regulators and everybody else defining the most appropriate trial design here to give the most robust set of data. And, you know, from a competitive perspective and from just ensuring that we can do the right thing by patients here, we're really not talking about how we're actually doing that steroid reduction at this point. Great, thanks for taking my questions. Okay, we will take our next question from Charles Duncan. Please go ahead. Your line is open.

Live on from just ensuring that we can do the right thing by patients here will be not talking about the at the how we're actually doing not salary reduction at this point.

Right and let's say thanks for taking my questions.

If we can speak to 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.

Charles Duncan: Thanks for taking my questions, Kevin and team. Congratulations 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 want to just ask a couple of pipeline questions. When you consider the kind of timing for data with the Velbenazine program versus the Cranisterfant program in CAH, what would you anticipate to read out first? And can you help us understand kind of the pacing of patient enrollment in those two programs? Yeah, thanks very much.

Grants and a great.

Quarter progress, particularly in terms of pipeline build and progress. It is notable in the last a couple of years held this has expanded most my commercial question's been asked so I did want to just to ask a couple of pipeline questions. When you consider the kinda tiny.

Who data, we said failed Ben and seen program versus the Korean NIS or find a program you'd see age what would you anticipate to read out first and can you help us understand kind of the pacing of patient enrollment in those two.

Programs.

Yes, thanks, very much and so when we were very pleased initially that we were able to reopen safely and responsibly. The H T trial enrollment and obviously see the significant unmet need and Huntingtons disease does that because so few people I currently treated with if he not to inhibit and so.

Eiry W. Roberts: 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 a 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-19 situation kind of stays relatively stable, that we will be able to move forward effectively there. With CronessaFont, we are just initiating the phase three registration trial, that is a global trial.

We are seeing good signs of screening and enrollment and non study and we anticipate that that well hopefully give then the if the cope with 19 situation kind of stays relatively stable that we wouldn't be evident move forward effectively that with Knesset font. We are just initiating the.

Yeah. The phase three registration trial that is a global trial and as I mentioned I think in response to previous question on we are estimates that we see in clinical trials Dot Gov. Our initial estimates of enrollment we will need to see how things progressed in the next few months, that's as dot targets.

Eiry W. Roberts: And as I mentioned in response to a previous question, our estimates that we see in clinicaltrials.gov 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.

And running to understand the overall timing, so it's really difficult to predict at the moment.

It's helpful. I read I appreciate that and then perhaps say there for you or for Eric or whoever wants to take it when you. When you think about they'll Ben is seen in Huntingtons Korea, you mentioned, a differentiation of they'll Bennett seen ARINC, whereas in tardive dyskinesia.

Eric S. Benevich: It's helpful, Eiry. I appreciate that. And then, perhaps either for you or for Eric or whoever wants to take it. When you think about Velbenazine in Huntington's Korea, you mentioned differentiation of Velbenazine or Ingriza in Tardive Dyskinesia, which is obvious to me relative to the competition. But help me understand Velbenazine in Huntington's versus tardive dysskinesia. What are the strategies that you're contemplating to really differentiate the two products? Or could you explain parity pricing? Help me understand. Is there a dosing thing?

Which is obvious to me relative to the competition, but help me understand Bell then is seen in Huntingtons versus say tardive dyskinesia, what one or the strategies say you're contemplating to.

Really differentiate the two products or could you see paired parity pricing help me understand is there a dosing thing I will this be a different truck.

Eric S. Benevich: How will this be a different drug? Or does it need to be? Yeah, so, Chas, I'll take that question. I think it starts with our perspective that there's still a significant unmet medical need in Huntington's Korea. The majority of patients that exhibit moderate to severe Korea movement are still as yet untreated with a VMAT2 inhibitor, and there are varying reasons for that, you know, relating to, for example, safety concerns or tolerability issues, challenges with those titrations, 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, you know, we certainly feel like there's room for another treatment option, one that, you know, we'll have to see what the data look like.

Because they need to be.

Yes, so chez I'll take that question I think it starts with our perspective that.

But there's still significant unmet medical need in Huntingtons Korea.

The majority of patients that exhibit moderate severe Korea movements.

Still are as yet and treated with BMS, two inhibitor and their varying reasons for that.

Relating to for example.

You know us safety concerns or.

Tolerability issues.

Challenges with those titration and things like that that me or give us an advantage in that particular market, but the reality is the majority of people that could benefit from from treatment with an improved option or not currently being treated so we certainly feel like there's room for another treat.

Mint option, one that will have to see what the data look like but based on the target product profile, we think there'll be multiple points of differentiation that perhaps.

Eric S. Benevich: But based on the target product profile, you know, we think there'll be multiple points of differentiation that are perhaps 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, you know, based on what we know about Ingresa in TD, we're confident that there's a meaningful opportunity for us in Huntington's Korea. Rylan, let's take one last question. We will take our last question from Jay Olson. Please go ahead. Your line is open.

Our similar to the way that we differentiated in the TV market. So we're excited about the opportunity to.

Completes the study and to see what was the profile that emerges looks like here, but based on what we know about.

INGREZZA in TD, we're confident that theres, a a meaningful opportunity for us and the Huntingtons chorea market.

Right Okay.

Well take one last question or Ireland.

We'll take our last question from gay Olson. Please go ahead. Your line is open.

Oh, Hey, congrats on the quarter and thank you for taking my question I'm curious about the impact is discontinuing. Your your second Gen V met inhibitor and I was wondering if that decision might lead you to increase your focus on additional indications for valves anything and or any other lifecycle management strategies I had one quick follow on if I could.

Jay Olson: 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 valdenazine and or any other lifecycle management strategies. I had one quick follow-on, if I could. Hi Jay, thanks for the question. So we, as I mentioned, I think we learned a great deal from the experience of, that to follow on molecule that we had in phase one 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 VMAT2 inhibition across a broad range of different neurological and psychiatric disorders even beyond what valbenazine would be able to bring to patients so we're very focused on that and then it also obviously in parallel we continue to 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.

Hi, Jay Thanks to the question and so we as I mentioned I think we learned a great deal from the experience of thought.

Not to follow on molecule that we had in phase one development and were looking to apply all about learning as we bring forward next generation research candidates into the clinic I because we do think that there is a significant opportunity.

Not to inhibition across a broad range of different neurological and psychiatric disorders I, even beyond what follow up anything would be able to TEP bring to patients and so we're very focused on that and then also obviously in parallel we continued to be very focused on understanding potential new indications football benefiting and as.

We move forward and get any of those into the clinic I will be shown to update you.

Okay, great. Thank you for that and then since your business development team has emerged as an important competitive advantage and you add a innovative new assets to your portfolio can you talk about the appetite for more deals in any potential gaps in your portfolio, where you may like to add new molecules.

Eiry W. Roberts: 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.

So that's a great question a this is Kyle.

I think that's ever going to continue to focus on our commercial success with INGREZZA and then taking that to on Genesis you're sort of shortly.

Kyle Gano: You know, I think that we're going to continue to focus on our commercial success with Ingresa and then take 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, by modality, and by disease state.

We're focused on funding those as well as the pipeline, but in terms of our or interest in business development. We're quite pleased with the way things of 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 attracted to us in neuroscience.

Kyle Gano: 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 ways to make it happen. Sounds great.

I 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 overtime. If it makes sense to bring additional assets will find ways to make it happen.

Oh.

Sounds great. Congrats again, thanks for taking the questions.

Thanks.

Kevin C. Gorman: Congratulations again. Thanks for taking the question. Thanks. And I will turn it back over to Kevin Gorman. Thank you very much. You know, 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.

And I will turn it back over to Kevin Gorman.

Thank you very much.

No.

We've said this before but but sincerely oh, we feel very fortunate to be in the position that we're in and the way that this year is shaping.

For US you know we have we have an outstanding medicine in INGREZZA and as all of you have have pointed out here it's <unk>.

Kevin C. Gorman: You know, we have an outstanding medicine in Ingresa. And as all of you have pointed out here, 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.

It just it is just a a medicine that is so appreciate it 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 medicines.

Kevin C. Gorman: And now we get to add yet another important medicine that's coming through and 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 the last part, too, about our pipeline. As I said at the beginning, we have 10 pipeline programs, but it's not just the number of those programs when you look at it. Our pipeline consists of three pivotal programs and five more that will be in mid-stage development by the year end, and then two in early stage, so it's a really well-balanced pipeline right now. Our medicines offer 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.

Thats coming through and on Gen tests, and so we're really looking forward to bringing that to patients.

And and I do appreciate all the questions like that you've had a today in particular in the last part to 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 our pipeline consists.

The three pivotal programs.

In five more they'll be in mid stage development by the yearend and then to an early stage. So it's it's a really well balanced pipeline right now.

Our medicines offer the hope for significant symptomatic treatments disease modification and wherein precision medicine.

And is as Kyle said, we're not constrained by a single modality currently we're developing small molecules and we're developing gene therapy.

Kevin C. Gorman: Currently, we're developing small molecules, and we're developing gene therapy. The therapeutic areas that we're in are 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 we're dedicated to being the world's leading neuroscience company. And what you're seeing now is just the beginning.

The the therapeutic areas that we're in this neurology neuroendocrinology and nurse psychiatry.

We started out with an eye nations call a number of years ago, and we we we have stuck with that and we've set it out loud and that's where 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.

Operator: 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 disconnect at any time.

This concludes today's program. Thank you for your participation and you may disconnect at anytime.

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