Q1 2020 Earnings Call

And please press stars zero.

The day, everyone and welcome to today's nor credit Bio Sciences report Q1, 2020 results call. At this time all participants are any listen only mode. Later, you'll have the opportunity to ask questions. During the question and answer session. You May Register to ASCII question by pressing the star in one Keith.

Touch tone telephone excuse me you may withdraw yourself from the Q. by pressing the pound key. Please note. This call may be recorded I'll be standing by should you need assistance. It's my pleasure to turn the program over to Kevin Garnett.

Thank you very much and get afternoon, everyone in thank you for joining us today.

Share with me at American inside <unk> are had the of Investor Relations not Abernathy Art, Chief Financial Officer, I re Roberts, our Chief Medical Officer, Eric benefit, our Chief commercial officer, and Kyle GAINO aren't cheap business development officer before we get started Todd could you read our.

Safe Harbor, stating their place.

Yes. Good afternoon certain statements made in the course of this conference calls that are not historical statements maybe forward looking statements, which are subject to risk and uncertainties.

Formation concerning factors that could cause actual results to different materially from both contain and or implied by the forward. Looking statements is contained in the companies as T.C. filing, including but not limited to the company's first quarter 2024, 10, Q. and in today's <unk>.

You may be obtained by visiting Investor Relations page on the company's website.

He forward looking statements are made only out of today's date.

This claim any obligation to update these forward looking statements Kevin.

Thanks, Todd we're going to keep our opening statements amongst us very brief so that the vast majority of this call. We can take all your questions I'm I'm sure. All of you were dealing with our current situation like we are here your mind and emotions are constantly switching between concerns for the safety in wellbeing of your.

Family Friends coworkers, and then to the wellbeing of your community and and our country.

We've found comfort and motivation to our work and and how I'm very proud of how crucial our industry currently has a now more than ever.

Today, we're we're going to briefly take you through how we've been approaching our work. During this time are overriding principles, our safety of our employees and their families support for the patients we serve and importantly respect and support for the health care workers, we call upon now and the others that will be calling on in the future.

<unk> is in a very fortunate and strong position not only financially, but with our expanding and progressing pipeline and importantly, as evidence by last weekend now announcement, we have our third approved medicine, Punjab test for the treatment of Parkinson's disease.

You may find throughout our calls that are tone, maybe more measured than the numbers and our progress to date deserve.

We're acutely aware of the hardship and sacrifices being self by many individuals and businesses and we do not take our good fortune lightly.

With that I would like map to take you through our Q. when financials and comment briefly on our April performance math.

Yeah. Thank you cabin in good afternoon, great hearing for many of you over the last several months as Kevin said, we feel very fortunate with how nerd printers position to navigate the challenges created by Kobe 19 in our great pulled out a solid balance sheet, a tremendous medicine like INGREZZA for patients with T.V.

And are growing pipeline with clear opportunities to make a difference in the field in neuroscience up in the years to calm.

Including the recent approval of on Jan to.

During the first quarter or commercial team did an excellent job managing three the pay a related seeking old dynamics to ensure patients remained on aggressive.

In fact, we had strong momentum in both total in new prescriptions during the last six weeks at the first quarter.

These result, these efforts resulted in $231 million enough product sales with approximately 41500 T.R. rat.

Adjusting per channel and then Tory we saw sequential increase in total scripts, which is a great accomplishment considering the unique first quarter dynamics.

On the net revenue per T. Rex front, the sequential gross and net impact was in mind with our expectation.

Turning to the P.N.L.R. track record to profitability continued with Q1 gap net income $37 million and non gap that didn't come up to $79 million on the balance sheet cash screwed over $1 billion positioning us well to continue investing in in Gaza.

Diversified pipeline and business development opportunities.

We're updating our gap in non gap S.D.N.A.N.R., and D. expense guidance range to $675 million to $725 million and $550 million to $600 million, respectively. Due to the general delays associated with Kobe 19.

Compared to previous gap in Nongaap expense guidance at $740 million to $770 million and $620 million to $650 million respectively.

As we look forward to the future vinaigrette, we remain extremely optimistic about the long term opportunity to treat many more patients who have tardive disk in Egypt.

In the short term so far through April we're encouraged by the continued strength of big races, refill rates, which are a testimony to the treatment benefit patients derived from an grows up and or specialty pharmacy network.

Even with or feel team's working remotely the impact and Iraq has actually been less than we originally feared.

Admittedly it is still too early to fully understand the ultimate impacted co bid 19, but I am extremely proud of <unk>, Eric and our commercial team have supported our customers that's far through the crisis.

With that I will now in the call over to Eric Bana Bitch, or Chief commercial Officer Eric.

[noise] Thanks man.

I'm happy to cover the commercial highlights from you one.

I'd like to start off by thinking or entire commercial team for the excellent results deliberating C. one.

It's reflective of the caliber of our employees that they were able to keep up the momentum within grass.

Under very challenging conditions and more importantly helped many thousands of patients suffering from tardive just <unk>.

Before I discuss our business results I'd like to acknowledge too important commercial milestones. The first is the recent three year anniversary huffing grabs his approval.

As we sit here today and observed mental health month and tardive disk.

This week.

It's amazing to reflect upon how much we've accomplished per patient since we launched in <unk>, perhaps more importantly, as Matt said, we remain very optimistic about the long term opportunity to help many thousands more patience with part I've discovered Asian.

And second approximately two weeks ago.

We received approval from the F.D.A. for our second commercial product called on Genesis, a new medication to help patients with Parkinson's disease, better managed motor fluctuations.

I'm very pleased with the strong label granted by the F.D.A. and believe we have a differentiated medication that will be embraced by the Parkinson's community.

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I read we'll elaborate on the benefits of on Jan test for patients later on this call.

You only get one chance to launch a new drugs and we are extremely enthusiastic about the opportunity to bring this new treatment option to patients with Parkinson's disease later this year.

Now onto our business results.

Once again this year Q1 was a tale of two half quarters.

During the first half of Q. when our commercial team was laser focused on helping patients and health care providers overcomes seasonal headwinds. These peer related dynamics included calendar year reauthorization requirements resets for patient out of pocket contributions and re approval for INGREZZA when patients switched health plans.

The combined effect of these factors can potentially delay refills as well as delay new patients starts.

With extensive planning and collaboration across teams are field teams did a great job of helping to minimize treatment disruptions preexisting patients as evidenced by steady persistency and strong trx momentum as we moved through the quarter.

Regarding new patients starts like last year.

We saw a nice uptick in interacts numbers in the second half of the quarter.

As we previously communicated in response to cope with 19, we took action starting in mid March to protect the health of our employees.

Including our customer facing field teams by implementing a work from home policy.

As this new policy was being implemented many of the psychiatry neurology clinics around the country began to severely restrict patient in person visits or shut down altogether.

In order to support the productivity of our field teams in <unk> in a remote manner.

Two technologies to enable continued T.D. education.

INGREZZA chronic presentations and reimbursement assistance.

Bite the current widespread sheltering place directives or mission remains the same to help people suffering from T.V. get effective diagnosis and treatment.

At the same time, we realize our customers are struggling to deal with two concurrent public health crises.

19 pandemic.

A burgeoning mental health catastrophe.

We are fortunate to have hired such inexperienced field team, who have strong relationships with health care providers.

Dedication disturbing patients.

Are people have the insight and the flexibility to know when to give a customer some space.

When to step in within grabs a support any awareness to know that sometimes the only support they can offer is to listen sympathetically when their customer need someone to talk to.

Despite her efforts to adapt to this new rapidly evolving environment.

We recognize that covert 19 will likely have an impact on our business in the near term, especially on new patients starts.

The strength of our commercial team.

<unk> attractive product profile and this year unmet need and T.D. will likely be key drivers of accelerating momentum when we eventually transition back into the field. It reengaged with our customers face to face in the hopefully not too distant future.

I remain very enthusiastic about her teams mission of delivering on hope for people suffering from T.D.N. soon Parkinson's disease.

It is the opportunity to expand or reach in movement disorders with the launch of on Genesis as we continue to have high conviction in the growth prospects of in <unk> in the coming months and years.

We're ready to help <unk> from a single commercial product company to accompany offering multiple treatments for patients.

So with that I'll turn the call over to my colleague Ivory, Our Chief Medical Officer.

Q, Eric and good afternoon to everyone on the call.

We could provide an update on a clinical programs.

I would like to add my own Fox.

To all the health care on other service professionals.

To work so hard on the front line if this pandemic.

I also want to convey my thanks to the F.D.A.

Continued high level of engagement with Neurocrine during this challenging time.

Hakim was especially impressed with that partnership.

Regulatory approval process.

Okay.

I was just one less than two weeks ago on April 24th.

F.D.A. approved once daily on gentleness.

Adjunctive treatment to leave it open <unk> for the treatment of patience with Parkinson's disease experiencing.

So.

Chances is an oral selective inhibitor of classical Oh me Oh.

A key ends I'm involved in the breakdown of leave it open in the bloodstream.

Leave it open <unk> gold standard for treatment of notice symptoms in Parkinson's disease.

Disease progressive the therapeutic effect of leave it open <unk>.

Off on patients may begin to experience time between treatment services during which an increasing that Parkinson's disease motives symptoms such as trend slowed movement difficulty walking okay.

Throw it selective in addition of calm on gentleness.

Junk.

Give them once a day administered at bedtime.

Blood levels I believe it <unk>.

Else in more consistent motor control for patients with P.D., including a reduction in off time.

Improvement in on time without troublesome dyskinesias.

I'd like to recognize top team work diligently with the F.D.A. to achieve this timely approval from gentleness.

To to bring this important new treatment option to patients living with Parkinson's disease.

Shifting is now the <unk> 19 pandemic has impacted many clinical trials across our industry over the past few months, including our own.

We announced last month that we temporarily post enrollment of new patients in three ongoing studies.

Three registration study of file band is seen to treat Korea and Huntingtons disease.

<unk> Registrational study for N.B.I.B. 1817 in Parkinson's disease.

The phase two pediatric study of Knesset font and congenital adrenal hype the plays yeah.

In money comes through these trials on top priority is to protect the safety of participant participating patients.

To ensure the integrity of the data generated from the clinical studies doing these challenging times.

And we all working closely with our investigated to adopt assessment measures on trial monitoring off needed to both ensure the safety of all current study participants.

And how to reopen these studies for new enrollment in a safe and effective manner.

It is important to know.

<unk>.

Going studies that temporarily pause to new enrollment we continue to make progress on all fronts to ensure that we are well positioned to launch the new clinical studies plan for the second half of this yeah.

Conducting pretty steady talks on initiation efforts using virtual technologies.

To be ready to initiate these studies as soon as it is safe inappropriate for investigative sites to do so.

These efforts include all pre study initiation preparations for all single Global registration study of Knesset font in adults with congenital adrenal hype plays yeah.

On for two Midstage studies in Red pediatric epilepsy pending are exercise of the option with I don't see.

[noise] regarding current Estefan following the recent cancellation of the life Endo meeting results of the phase two proof of concept studying adult patients just plastic C.H. will be presented at the end do online meeting scheduled for June.

We also recently engaged in in the face to interactions with the F.D.A., which provided clarity on the phase three steady required for registration of <unk>, an adult patients on where currently moving ahead to implement this global Registrational study design and the second half of the yeah.

Look forward to advancing this much needed novel treatment option for adult patients, let's see A.H.

In closing why this is challenging to ultimately predict what kind of impact the pandemic, while hot on our technical timelines overall a plan for Twentytwenty currently remains unchanged to have three registrational programs on full midstage programs ongoing by year end.

How close by thanking all my colleagues at near a <unk>, so that truly inspirational assets and dedication to all companies mission to relieve patients suffering and enhance patients lives with that <unk> to Kevin.

Thank you, Ivory and Matt and Eric So that'll do it for our prepared stations Ah statements and we're ready to take a your questions.

Right at this time, we'll take our first question from Paul Matisse <unk>. Your line is open.

Great banks.

My question grass in the corridor.

You think for me I was one of you could comment on average script per patient that you saw on one q., maybe quantitatively or at least qualitatively relative to that funky dynamic from one q. 2019 that confounded results.

Separately I I was just struck by by your guys Polish commentary on N.R.X. In April you guys are usually the kings of kinda being conservative and then maybe maybe beating beating that conservative town, maybe you could just comment a little bit more detail on what exactly you're seeing within graduated thus far in terms of interaction.

Thanks, so much.

<unk> for your question why don't we started out Matt do you want to take the stab and followed by Eric on the first part of calls question.

Yeah sure appalled. Thanks for the question then also per calling US kings, we appreciate that.

A [laughter] from a or X. crew patient perspective, as as we had flagged heading into the quarter. Since we had doubled the number of patients. This year as compared to this time last year. You know there is a potential for a significant headwind even if we kept the <unk> rate per page.

The same and Q1 as we did last year and and in Q1 that could have been a significant headwind. So I think what you can see in our results for this quarter since we actually had a sequential increase in pure x. When you normalize for channel inventory you saw that the teams that were in place actually drove.

A bit higher refilled rate per patient and me in the first quarter. So it was a heck of a job by the team and they did an excellent job.

Yeah. Paul This is Eric so to to answer the second half of your question you know we feel good about the momentum that we've carried into cue to as I mentioned in my prepared remarks, Q1 was a a really good quarter from an interacts perspective and.

It was one of the best quarters that we've had to date.

Now, obviously going into a cue to the the pandemic kid in a widespread basis.

Sheltering plays directives implemented.

States across the country Huh and you know we had to adapt we implemented a work from home policy and pulled our or feel teams out. However, despite all this we saw.

Good consistent a refill rates.

And we expected that there would be an impact to in Iraq's, but it was less than what we had expected to see given the dynamics.

It's early days, yet and certainly were watching things very carefully.

And just doesn't affect our long term optimism about the opportunity within <unk> hard disk in Asia, but certainly wanted to convey that in terms of our business. When we went you know we feel good about what we've seen thus far.

Thank you.

But <unk> relative to Q1 last year right in terms of refill rates not queue for is that correct.

Yeah that that's that's correct and the only thing I would add on interacts for the corridor or sorry for for April is that if you read a lot of the different surveys across the industry call volume is down significantly as as patient basis.

Also gone down significantly I think most say between you know 65, 75% decline so or commentary around to interact is you know those aren't tightly correlated at this point, but as as Eric said and as I mentioned in my prepared remarks, you know it is still.

Too early to make a a formal call on on two two and what's it going to look like it really depends on when people start opening back up and patient low x. backup in person. So thanks Paul.

Thank you.

Take on next question from.

Buren I mean your line is open.

Hi, guys. Thanks for taking my questions can you may be just talk about inventory levels.

I think you out at about 4 million Q1, and you had if they get another 11 million and Q. for.

I just want to understand where are you you why I think typical averages around four to six weeks. So maybe if you could just didn't cross that thanks.

Oh man you want to take that one.

Yeah sure thing so from a channel women 40 perspective, but it's very difficult for deck and it can be highly variable you been based upon the day the quarter and most of the bar channel orders on a Monday for example, or Tuesday, and so depending on the timing there maybe a little bit more start getting at the end up corridor.

If if it lands on you know Monday, Tuesday, or or or Wednesday. So when you normalize for channel inventory a beer in you know we really had you know 27 sales results in Q4 and you also normalized to that same place for for Q1 around 220.

Oh, however, since there's such a a big grossing out <unk> growth pinette discount period.

Goes to know gross connect discount it needs to a sequential increase in pure x., but from eight days on hand perspective with the nerve channel. It's still it's right around two weeks.

Okay. That's helpful and then I guess on the new prescriptions stars that you're seeing.

Can you maybe describe what precisely what person has come from switching from <unk>. You know you just think there'd be the patients are on versus the treatment you patient given you know we've got to cope with epidemic and it's probably harder for treatment you patient to going to see a doctor.

Yeah beer and I'll have I'll have Eric.

<unk>.

<unk>.

The answer is that we don't have that information, it's I'm not clear how much of this has been driven by switching and I assume that you're.

Talking about Deuterated tetrabenazine.

The in the work that we've done in the past you know looking at market research and someone there's been very little of that kind of activity. The vast majority of new patients starts has been driven by our educational efforts having providers to identify.

Easily undiagnosed patients and then certainly educating them about the risks and benefits of treatment within <unk> I assumed that that's probably still the case in this current environment.

And just to kind of tack on a little bit to what Matt was talking about.

Certainly there's been a substantial drop in patient visits over the last let's say six weeks or so across different ah sectors of healthcare, including in psychiatry and in neurology.

But that's been partially offset by an uptick that we've seen in tele medicine and so.

Certainly we've made efforts to understand those dynamics and to help.

Fighters in in our universe understand how they can continue to assess patients for T.D. symptoms. How they can monitor patients that are currently on INGREZZA et cetera, and so that may partially explain why even in these times, where there's been a dramatic decrease and patient flow through the clinic.

Operator: Good day, everyone, and welcome to today's Neurocrine Biosciences Report Q1 2020 results call. At this time, all participants are in a listen-only mode. Later, you'll have the opportunity to ask questions during the question-and-answer session. You may register to ask a question by pressing the star and one keys on your touchtone telephone. Excuse me.

It hasn't been as Kevin said, you know proportionally impacting our our business, yeah, and bear and went all out onto that as as as Eric just talked about Tele medicine.

You know going before <unk> psychiatry was the specialty that utilized tele medicine, the most than any other specialty that clearly has increased and ramped up from from there.

Operator: You may withdraw yourself from the queue by pressing the pound key. Please note, this call may be recorded. I'll be standing by should you need assistance. Now, it is my pleasure to turn the program over to Kevin Gorman.

And so that's what Eric Meth is that we've been looking at this we've been in studying tele medicine or by you know a couple of years even prior to this.

Kevin C. Gorman: Thank you very much, and good afternoon everyone, and thank you for joining us today. Here with me at Neurocrine is Todd Tushla, our Head of Investor Relations, Matt Abernethy, our Chief Financial Officer, Eiry Roberts, our Chief Medical Officer, Eric Benevich, our Chief Commercial Officer, and Kyle Gano, our Chief Business Development Officer. Before we get started, Todd, could you read our Safe Harbor Statement, please?

And so with an experience and talented sales force they were able to plug into that and I I think that is as Eric said one of the reasons why the <unk>. The the anthrax that we're seeing here is not is not nearly what we had feared.

Todd Tushla: Yes, good afternoon. Certain statements made in the course of this conference call that are not historical statements may be forward-looking statements that are subject to risks and uncertainties. Information concerning factors that could cause actual results to differ materially from those contained in or implied by the forward-looking statements is contained in the company's SEC filings, including, but not limited to, the company's first quarter 2020 Form 10-2 and in today's press release. Copies may be obtained by visiting the Investor Relations page on the company's website. Any forward-looking statements are made only as of today's date, and we disclaim any obligation to update these forward-looking statements.

It would be but I'll always put in the cautionary statement as Matt has done and Eric has done. This is still early into this quarter and so we just need to see and stay on top of and adapt to what is going to continue to happened throughout this quarter and and beyond.

Great. Thank you.

[noise] Oh next question is from Brian Abrams of RBC capital markets.

Hi, This is Leo one for Brian Thanks for taking my question.

Oh I had a question on the C.H. program just wanted to know what the recent feedback has been and then a regulatory sense on the pivotal trials that you're planning to run and are you potentially looking at something like can comment steroid use and stare rate reduction.

Kevin C. Gorman: Yeah, thanks, Todd. We're going to keep our opening statements amongst us very brief so that for the vast majority of this call, we can take all your questions. I'm sure all of you are dealing with our current situation like we are here. Your mind and emotions are constantly switching between concern for the safety and well-being of your family, friends, and co-workers, and then to the well-being of your community and our country. We found comfort and motivation through our work, and I'm very proud of how crucial our industry is now more than ever. Today we're going to briefly take you through how we've been approaching our work during this time. Our overriding principles are the safety of our employees and their families, support for the patients we serve, and importantly, respect and support for the healthcare workers we call upon now and those that we'll be calling on in the future. Neurocrine is in a very fortunate and strong position, not only financially, but with our expanding and progressing pipeline, and importantly, as evidenced by last week's announcement, we have our third approved medicine, Mongentis, for the treatment of Parkinson's disease.

And then point compared to normalization of Biomarkers and I might have a quick follow up as well.

So.

Yeah.

We did meet.

As planned.

In terms of the actual design of the study as we've said before I think on several calls.

The.

Levels of <unk>.

Yeah.

Not very important.

Used extensively in the management of patience with C.H. In addition, we believe it will be important to understand the impact that A.C.R.S. one antagonists.

On the Dos <unk>.

Required to continue to control the disease as I mentioned, we are actually finalizing dot single pivotal phase ones say three study in adults. That's a global study and we'll be moving towards implementation of that in the second half of this.

Matthew C. Abernethy: You may find throughout our call that our tone may be more measured than the numbers and our progress to date deserve. We're acutely aware of the hardship and sacrifices being felt by many individuals and businesses, and we do not take our good fortune lightly. With that, I would like Matt to take you through our Q1 financials and comment briefly on our April performance.

On ones that study is posted on clinical trials dog.

A lot more information about the design of the study.

We're looking at that.

Thanks, and if I can just follow up on maybe more of a broader strategic perspective I know previously you had mentioned that you were going to go it alone in here for the global studies and I just wanted to know that thinking has evolved given the global pandemic in the macro economic condition.

Matthew C. Abernethy: Yeah, thank you, Kevin. And good afternoon.

And perhaps how how slight identification is going.

So I'll I'll take the very the very first part of that from a strategic aspect no that that hasn't changed at all in our thinking we still plan on.

Doing this phase three trial alone doing the registration in both territories and commercializing in both territories ourselves I, where you want to talk a bit more about how it's gone.

Matthew C. Abernethy: Hearing from many of you over the last several months, as Kevin said, we feel very fortunate with how Neurocrine is positioned to navigate the challenges created by COVID-19 and are grateful to have a solid balance sheet, a tremendous medicine like Ingressa for patients with TB, and a growing pipeline with clear opportunities to make a difference in the field of neuroscience in the years to come, including the recent approval of Ongentis. During the first quarter, our commercial team did an excellent job managing through payer-related seasonal dynamics to ensure patients remained on Ingressa. In fact, we had strong momentum in both total and new prescriptions during the last six weeks of the first quarter. These efforts resulted in $231 million in net product sales with approximately 41,500 TRX.

<unk>.

Within the former contract.

Since it obviously have a very broad reach globally and we've been working very closely with those teams and also with our investigative sites that are selected.

The regulators and ethics committees in.

And you are upon in the U.S. towards the ability to implement in the second half of this yeah. Yeah. It you know you do.

Matthew C. Abernethy: Adjusting for channel inventory, we saw a sequential increase in total scripts, which is a great accomplishment considering the unique first quarter dynamics. On the net revenue per TRX front, the sequential growth to net impact was in line with our expectations. Turning to the P&L, our track record of profitability continued with Q1 gap net income of $37 million and non-gap net income of $79 million. On the balance sheet, cash grew to over $1 billion, positioning us well to continue investing in Ingresa, our diversified pipeline, and business development opportunities. We're updating our GAAP and non-GAAP SG&A and R&D expense guidance range to $675 to $725 million and $550 to $600 million, respectively, due to the general delays associated with COVID-19. This compares to previous GAAP and non-GAAP expense guidance of $740 to $770 million and $620 to $650 million, respectively.

Even during this time period of time, you do get some pleasant surprises and I'd say one of the pleasant surprises that we have found is that working with the outside partners that throughout all of our programs here, whether it's C.R. rose whether it's the clinical trials sites.

That we're currently working with the ones that we are signing up for the trials that are all going to be starting in the second half and certainly the regulatory agencies are both E.M.A. and F.D.A. They have not miss the beat they've all been extremely responsive and we've been able to work highly effect.

<unk> with all of them Telephonically.

Thanks, It was very helpful.

Our next question is from Tazeen Ahmad of Bank of America.

Two then you may want to check your mute switch your line is open.

And once again.

He's open please check here mute switch.

Eric S. Benevich: As we look forward to the future of Ingressa, we remain extremely optimistic about the long-term opportunity to treat many more patients who have tardive dyskinesia. In the short term, so far through April, we are encouraged by the continued strength of Ingresa's refill rates, which are a testament to the treatment benefits patients derive from Ingressa and our specialty pharmacy network. Even with our field teams working remotely, the impact on NRX has actually been less than we originally feared. Admittedly, it is still too early to fully understand the ultimate impact of COVID-19. But I am extremely proud of how Eric and our commercial team have supported our customers thus far through this crisis. With that, I will now hand the call over to Eric Benevich, our Chief Commercial Officer. Eric.

We'll move next to Brian <unk> of Baird. Your line is open.

Oh. Thank you. This is Jack Donaghy for Brian Thanks for taking our questions I just had one a quick one I was wondering if you talk a little bit out the pair mixed been grows a and how many of the patients are commercial versus government insurance and tell you could see kind of the broader macro economic trends in the U.S. playing out there and.

Abreast of the business associated with that kind of potential shift the government insurance plans of employment increases as we've seen in the past yeah. So so Jack we've not talked about what our our actual pair mixes between private and public as we've said originally when we had launched looking at looking at the.

Anti psychotic says a proxy for this patient population we saw approximately a 50 50 mix we set all along that it's actually a bit higher in the public pay or Arena war. This drug not surprising because our patient population is a bit older here.

Eric S. Benevich: Thanks, Matt. I'm happy to cover the commercial highlights from Q1. I'd like to start off by thanking our entire commercial team for the excellent results delivered in Q1. It's reflective of the caliber of our employees that they were able to keep up the momentum with Ingresa under very challenging conditions and, more importantly, help many thousands of patients suffering from tardive dyskinesia. Before I discuss our business results, I'd like to acknowledge two important commercial milestones. The first is the recent three-year anniversary of INGRESA's approval.

You raise a good point as far as what is happening with the television and broader issues that are going on.

Right now what we do in through our government relations and both in house and and also in Washington and throughout the state capitals, we keep a pulse on what's happening here. It is evolving continuously I don't think I can make any intelligent forward.

Eric S. Benevich: As we sit here today and observe Mental Health Month and Tardive Dyskinesia Awareness Week, it's amazing to reflect upon how much we've accomplished for patients since we launched Ingresa. But perhaps more importantly, as Matt said, we remain very optimistic about the long-term opportunity to help many thousands more patients with part-eye dyskinesia. And second, approximately two weeks ago, we received approval from the FDA for our second commercial product, called Pongenta, a new medication to help patients with Parkinson's disease better manage motor fluctuations. I'm very pleased with the strong label granted by the FDA and believe we have a differentiated medication that will be embraced by the Parkinson's community. Eiry will elaborate on the benefits of Ongentis for patients later on in this call. You only get one chance to launch a new drug, and we are extremely enthusiastic about the opportunity to bring this new treatment option to patients with Parkinson's disease later this year. Now, on to our business results. Once again this year, Q1 was a tale of two half quarters.

Statements here other than to say that we monitor were involved.

And we will react appropriately.

And Eric do you have more to say yeah. The only other single AD is that regardless of the patients insurance status, you know <unk>, our commitment to making sure that they can get access to and grabs it remains unchanged.

Awesome can do so much.

Thank you.

We'll move next to I don't know Palm Rama of J.P. Morgan Your line is open.

Yeah I, thanks for taking in questioning congrats on the corner.

Quite keen on the and pick up on line so.

Sort of that resolution them to supply issue in indicating factors take <unk> launched here in the in the yeah exactly.

Yeah. Thank you on upon on you know.

We do have the <unk> pandemic and and that in enough itself makes it impractical for us and as you've seen with many companies to launch into this environment, but on top of that as we had discussed back in January which seems like years ago added.

Eric S. Benevich: During the first half of Q1, our commercial team was laser-focused on helping patients and healthcare providers overcome seasonal headwinds. These payer-related dynamics included calendar year reauthorization requirements, resets for patient out-of-pocket contributions, and reapproval for Ingresa when patients switched health plans. The combined effect of these factors can potentially delay refills as well as delay new patients from starting.

Friends that are partner be out who is 100% responsible for supply chain you had an incident in a supply chain and they are wrapped defying that we stay in close contact with them through each step of the processes, that's being rectified and.

We'll stay tuned will tell you a in early will probably give you an update in early summer about what our what are launch plans are the timings.

Eric S. Benevich: With extensive planning and collaboration across teams, our field teams did a great job of helping to minimize treatment disruptions for existing patients, as evidenced by steady persistency and strong TRX momentum as we moved through the quarter. Regarding new patient starts, like last year, we saw a nice uptick in NRX numbers in the second half of the quarter. As we previously communicated in response to COVID-19, we took action starting in mid-March to protect the health of our employees, including our customer-facing field teams, by implementing a work-from-home policy. Meanwhile, as this new policy was being implemented, many psychiatric and neurology clinics around the country began to severely restrict patient in-person visits or shut down altogether.

Thank you.

We'll take on next question from Jane Olson of Oppenheimer.

Caroline is open.

Oh, Hey, congratulations working cruises pandemic and thank you for taking the question I.

The unexpected strengthen mutation starts pouring graduates. According to my your transition to online position education and I was wondering if you could attribute and you get the new patients start to your consumer Education program and then related to that I was wondering if there's any way you could use your embraced.

Eric S. Benevich: In order to support the productivity of our field teams in a remote manner, we pivoted to technologies to enable continued TD education, Ingressive Product Presentations, and Reimbursement Assistance. Despite the current widespread shelter-in-place directives, our mission remains the same, to help people suffering from TD get effective diagnosis and treatment. At the same time, we realize our customers are struggling to deal with two concurrent public health crises. COVID-19 pandemic and a burgeoning mental health catastrophe

Gram to refer new patients to physicians, who practice tele medicine.

Thank you J., Eric you want to.

Yeah, Jay Thanks for the question certainly I think that the cumulative effect of everything that we've done over the last three years is contributing to the sustained momentum that we've seen coming out of Q. too <unk>.

The talk about P.D. unbranded disease State Education program that you mentioned, it's targeted towards patients.

Eric S. Benevich: We are fortunate to have hired such an experienced field team who have strong relationships with health care providers and a dedication to serving patients. Our people have the insight and the flexibility to know when to give a customer some space. When to step in with Ingressa support and the awareness to know that sometimes the only support they can offer is to listen sympathetically when their customer needs someone to talk to. Despite our efforts to adapt to this new, rapidly evolving environment, we recognize that COVID-19 will likely have an impact on our business in the near term, especially among new patients. The strength of our commercial team, Ingresa's attractive product profile, and the sheer unmet need in TD will likely be key drivers of accelerating momentum when we eventually transition back into the field and re-engage with our customers face-to-face in the, hopefully, not too distant future.

We believe is contributing to that as well.

Even though.

There is a lower volume of patients having face to face visits many of them are still having the opportunity to talk to their physician and certainly we continue to try and educate them about abnormal movements and the possibility that that it could be T.D. into encouraged that dialogue.

Ultimately.

The the strength that we've seen coming out of Q. went into cute too is is really.

So the cumulative effect of everything that we've been doing and we're really very thankful that we hired and such a strong team that they've got the relationships and that they've been able to really pivot very quickly and moved from in in person face to face model to remote education in a remote customers support.

And we've been very pleased with the productivity that we've seen thus far.

Eric S. Benevich: I remain very enthusiastic about our team's mission of delivering hope for people suffering from TD and soon Parkinson's. I'm excited at the opportunity to expand our reach in movement disorders with the launch of Ongentis as we continue to have high conviction in the growth prospects of Ingresa in the coming months and years. We're ready to help grow Neurocrine from a single commercial product company to a company offering multiple treatments for patients. So with that, I'll turn the call over to my colleague Eiry, our Chief Medical Officer.

Okay. This is Matt this who's Mad I also want to just make a couple clarifying comments for everybody you know similar to last year as we saw in Q1. It was his tale of two quarters, where do you had a bit slower first stop the first quarter and then the ramp pick back up in the second half.

The quarter as patients got back more normalize refill rates and Iraq says we're flowing steadily. So we did have as a there are just mention a nice no men nice trajectory you know prior to Kobe 19.

Eiry W. Roberts: Thank you, Eric, and good afternoon to everyone on the call. I'm happy to provide an update on our clinical programs, but before I begin, I would like to add my own thanks and gratitude to all the healthcare and other service professionals who continue to work so hard on the front lines of this pandemic. I also want to convey my thanks to the FDA for their continued high level of engagement with Neurocrine during this challenging time. Our team was especially impressed with their partnership as we navigated through the recent regulatory approval process for Ungentis.

I just wanted to make sure or comments about <unk> in April or not taking taken out of context I think in how you ask the question.

You know I just wanted to be clear <unk>. We're in we're not seeing a sequential increase or growth out of pure out of <unk>. We are seeing you know like we said better than we had anticipated interacts given a the changing dynamics, but when do to make sure I provided that clarification given.

A couple other questions.

Eiry W. Roberts: A little less than two weeks ago, on April 24th, the FDA approved once daily Ongentis as an adjunctive treatment to levodopa carbidopa for the treatment of patients with Parkinson's disease experiencing off episodes. Ongentis is an oral selective inhibitor of catechol-O-methyltransferase, or COMPT, a key enzyme involved in the breakdown of levodopa in the bloodstream. Levodopa-carbidopa is the current gold standard for treatment of motor symptoms in Parkinson's disease. But as the disease progresses, the therapeutic effect of levodopa-carbidopa can wear off, and patients may begin to experience off-time between treatment doses, during which an increase in their Parkinson's disease motor symptoms such as tremor, slowed movement, and difficulty walking occurs. Through its selective inhibition of COMPT, Ongentis, as an adjunctive therapy given once a day, administered at bedtime, increases and prolongs the therapeutic blood levels of levodopa carbidopa and therefore results in more consistent motor control for patients with PD, including a reduction in off time and improvement in on time without troublesome dyskinesia.

Right. That's super helpful. Thank you and are you able to refer.

Patients, who <unk> talkers practicing telling medicine to a network of doctors local to them.

Yeah, sorry, I I neglected dance that last part of your question no not currently.

The call to action with the talk about P.D. add is to talk to your doctor.

We have certainly discussed and we're you know evaluating if there's an opportunity to direct patients towards a specific position in their area. That's been educated on T.V. So stay tuned.

Super Thank you very much.

Yeah.

Oh next question is from Charles Duncan of Cantor Your line is open.

Hi, guys, Kevin and team congratulations on a good forever no quarter and thank you for a take my questions I had a commercial question and then a brief pipeline question regarding the commercial question you know folks are talking about that and.

<unk> kind of just clarified it to the previous question, but I'm really wondering if you think about the interactions that you're having with prescribers say in early April versus early may versus like maybe in early early June is there.

Eiry W. Roberts: I'd like to recognize our team who worked diligently with the FDA to achieve this timely approval for Ongentis, and we're excited to bring this important new treatment option to patients living with Parkinson's disease. Shifting gears now, the COVID-19 pandemic has impacted many clinical trials across our industry over the past few months, including our own. Last month, we announced that we had temporarily paused enrollment of new patients in three ongoing studies. The Phase 3 Registration Study of Valbenazine to Treat Chorea in Huntington's Disease The Restore 1 Registrational Study for NBIB1817 in Parkinson's Disease And the Phase 2 Pediatric Study of Chronisophant in Congenital Adrenal Hyperplasia In managing these trials, our top priority is to protect the safety of participating patients and to ensure the integrity of the data generated from the clinical studies during these challenging times.

Any way to quantify or at least qualitatively you know discussed that kind of slow let's say it was it more I guess.

Difficult to get to people in early April then maybe early may and what would you anticipate for late yeah.

Yeah, I'll I'll I'll take your question, so I I think that as we.

Went through the tail part of of March and into early April there was a lot of adapting that we're doing at that time Bowl in the field in in the home office to support what our customer facing a team was doing.

Certainly there was a lot of change happening across the country at different rates and at different times, and we started to see more and more practices essentially restrict access to patients only emergency visits or shut down entirely our field team we needed to pretty.

Eiry W. Roberts: To that end, we are working closely with our investigators to adapt assessment measures and trial monitoring as needed to both ensure the safety of all current study participants and to determine when and how to reopen these studies for new enrollment in a safe and effective manner. It is important to note, however, that while these ongoing studies are temporarily paused for new enrollment, we continue to make progress on all fronts to ensure that we are well positioned to launch the new clinical studies planned for the second half of this year. We are conducting pre-study tasks and initiation efforts using virtual technologies in order to be ready to initiate these studies as soon as it is safe and appropriate for our investigative sites to do so.

Quickly equipped with new tools and technologies that would allow them to.

<unk> able them to have those remote interactions with their customers.

And and so there was a period of time, where we were very furiously.

Making a lot of changes on the fly so to speak to be able to support what we're trying to do with our customers and frankly to support what they were trying to do with their patients I think that over the course of April we settled into a bit of a rhythm certainly we learned a fair bit about what was working what was.

Less effective and you know certainly made some changes in terms of the resources that were available to our to our sales in our reimbursement field teams. So at this point I feel like it's a relatively steady state in terms of what that cadence looks like in the types of interactions that were.

Eiry W. Roberts: These efforts include all pre-study initiation preparations for our single global registration study of chronesophon in adults with congenital adrenal hyperplasia and for two mid-stage studies in rare pediatric epilepsy pending our exercise of the option with eidosia. Regarding Cronosophon, following the recent cancellation of the live ENDO meeting, results of the Phase 2 proof of concept study in adult patients with classic CAH will be presented We also recently engaged in end-of-phase 2 interactions with the FDA, which provided clarity on the phase 3 study required for registration of chronesophon in adult patients, and we're currently moving ahead to implement this global registrational study design in the second half of the year. We look forward to advancing this much-needed novel treatment option for adult patients with CAH.

<unk>.

However, now we're starting to see that as a certain states are starting to loosen up the restrictions and someone we're doing a fair bit of planning in terms of what does reengagement.

Eiry W. Roberts: In closing, while it is challenging to ultimately predict what kind of impact the pandemic will have on our clinical timelines overall, our plan for 2020 currently remains unchanged, to have three registrational programs and four mid-stage programs ongoing by year end. I'll close by thanking all my colleagues at Neurocrine for their truly inspirational efforts and dedication to our company's mission to relieve patient suffering and enhance patients' lives. With that, I'll hand it back to Kevin.

In face to face types of interactions with customer looks look like how can we do so safely et cetera. So I think that the the focus is shifting a little bit towards what the future looks like and how we're going to start to I start to have those kinds of engagements with customers like we had in the past where we can do so.

Oh and at what pace.

Yeah, that's helpful, Eric and and supportive of our thesis in the use of Tele medicine in Psych Psych <unk> Psychiatry that said, let me ask you if you see psychiatry being a little bit easier not to crack if you will versus say neurology in thinking about possibly an impact oh, but.

Wave when you're launching and on on Tonight, I'm I'm I'm Jen. So later on this year.

Yeah, I'll I'll I'll comments on that and then perhaps ivory can comment as well. So is is Kevin mentioned pre co bid.

There was a higher utilization of tele medicine within psychiatry, and there's a number of factors that drove that one is that there was a a a very large gap between the number of patients that need psychiatric support versus a number of providers and you see this especially.

Kevin C. Gorman: Thank you Eiry, Matt, and Eric. So that'll do it for our prepared station statements, and we're ready to take your questions.

In rural areas and so many of these mental health clinics have resorted to engaging tell us psychiatrists that could be a county away or across the state.

Operator: Right at this time, we'll take our first question from Paul Matisse of Stiefel. Your line is open.

Paul Matteis: Great, thanks so much for taking my questions and congrats on the quarter. Two things for me. I was wondering if you could comment on the average script per patient that you saw in 1Q, maybe quantitatively or at least qualitatively relative to that funky dynamic from 1Q 2019 that confounded results. And then separately, I was just struck by your guys' foolish commentary on NRX in April. You guys are usually the kings of kind of being conservative and then maybe and then maybe beating that conservative tone, so maybe you could just comment

To help provide.

Medical services for these for these patients in their in their immediate Geo area.

So that was already utilize to a higher degree than what we saw in other physicians specialties.

The the covert 19 pandemic really just accelerated.

In what we saw was that some of the restrictions that were put in place in the standards have been relax by the government you know as for example used to be that the patient had to be in a clinic they had to be engaging with the remote psychiatrists via a closed a closed circuit.

Paul Matteis: NRX. Thanks so much.

Matthew C. Abernethy: Thanks, Paul, for your question. Why don't we start out, Matt, do you want to take the stab and be followed by Eric on the first part of Paul's question?

T.V. network, essentially et cetera, and now some of these a good portion frankly of these <unk> psychiatry councils are via phone the patients at home the position could be at home as well. So we're trying to understand those dynamics you know what happens once the emerged.

Matthew C. Abernethy: Yeah, sure, Paul. Thanks for the question and also for calling us kings. We appreciate that.

Matthew C. Abernethy: I would say from a RX per patient perspective, as we had flagged heading into the quarter, since we had double the number of patients this year as compared to this time last year, there is a potential for a significant headwind. Even if we kept the refill rate per patient the same in Q1 as we did last year in Q1, that could have been a significant headwind. So I think what you can see in our results for this quarter, since we actually had a sequential increase in TRX when you normalize for channel inventory, you saw that the teams that were in place actually drove a bit higher refill rate per patient in the first quarter. So it was a heck of a job by the team, and they did an excellent job.

Since he declaration is lifted to what extent the things go back towards what they were pre cobot or to what extent well Tele medicine, you remain a court part of of Psychiatry I'm. Certainly you know we're also trying to understand the impact on neurology and the potential.

Impact on our launch with on Gentris, but this is something that we've been keeping an eye on for some time and certainly I think we're better prepared probably than many other companies because we had been doing some work to understand.

How tele medicine could affect P.D.N.R. INGREZZA franchise, and we're able to to leverage that that work that we did previously.

I'm, the only thing I'd add to that because I think it is definitely correct.

Hi entry historically has been so there are hiding tempted employment of Tele medicine approaches at least through 100 interaction with the movement to sorta neurology community both through a Huntington study and also through preparation for the injustice launched it's very key is it not communities.

Eric S. Benevich: Yeah, Paul, this is Eric. So to answer the second half of your question, we feel good about the momentum that we've carried into Q2. As I mentioned in my prepared remarks, Q1 was a really good quarter from an NRX perspective. In fact, it was one of the best quarters that we've had to date. Now, obviously, going into Q2, the pandemic hit on a widespread basis, shelter-in-place directives were implemented in states across the country, and we had to adapt. We implemented a work from home policy and pulled our field teams out. However, despite all this, we saw a really good, consistent refill rate, and we expected that there would be an impact on NRX, but it was less than what we had expected to see given the dynamics. It's early days yet, and certainly we're watching things very carefully, and this doesn't affect our long-term optimism about the opportunity within Graza and Tardive Dyskinesia, but certainly wanted to convey that, in terms of our business momentum, we feel good about what we've seen.

Is adopting rapidly and all just tried to so that patients in a different way in the staffing and one of the advantage is I think that the on <unk> population well hobbies that many of those patients will already be known to that neurologist on will be in a relationship with Evan neurologists already.

So we are seeing it in that setting that there's a lot of use of remote technology and assessment techniques that are enabling the conditions on healthcare professionals to support that that patients very effectively including potentially changing or or adding additional treatment options.

<unk> did we answer your question.

Yes, you did thank you very much Kevin helpful and a color air <unk>. Thank you.

We'll move back to fill in the dough of Cowan than company.

Thanks for took my questions first one clarification question on the prescription numbers I think you're setting 41500 <unk>.

I believe we have no notes. So there were 42100, T. Rex and Q. for your calling Q. wander sequential increase.

Matthew C. Abernethy: Thank you. And Matt, you meant relative to Q1 last year, right, in terms of refill rates, not Q4? Is that correct? Yeah, that's correct.

Did you correct or figures, if they're wrong or or on what basis or you you can only <unk>.

Eric S. Benevich: And the only thing I would add on NRX for the quarter, or sorry, for April, is that if you read a lot of the different surveys across the industry, call volume is down, you know, significantly, as patient visits have also gone down significantly. I think most say between, you know, 65 and 75% decline. So our commentary around NRX is, you know, those aren't tightly correlated at this point. But, as Eric said, and as I mentioned in my prepared remarks, you know, it is still too early to make a formal call on Q2. And what is it going to look like? It really depends on when people start opening back up and patient flow picks back up in person. So, thanks, Paul. Thank you.

Yeah, <unk>, yeah sort t. Rex numbers include implied <unk> for the channel one minutes worries. So in a cue for for example, where we had an 11 million dollar inventory build that represented call it around.

A little over a 2000 trx in the corridor. So are reported tier racks, you would need to reduce by you know around 2000 and then this this quarter you had a 4 million dollar channel import Bill, which would you know rappers that you know six or seven.

100 type.

Level implied T. Rex.

Yeah.

And then.

Checking on the N.R.X. trends you know they can April in the past you've you've <unk> that can be a wag from when the patient.

Biren Amin: We'll take our next question from Biren Amin. Your line is open.

Is seen by the physician to win in our extent should realize and becomes commercial.

Biren Amin: Hi guys, thanks for taking my questions. Can you maybe just talk about inventory levels? I think you added about 4 million in Q1 and you had, I think, another 11 million in Q4. So I just want to understand where you lie. I think the typical average is around 4 to 6 weeks. So maybe if you could just address that. Thanks.

<unk> <unk>, the <unk> or partially due to lag and and some of those in our acts were actually.

Based on.

Because it's.

Earlier in March or before Kobe did.

Eric you want to take that Yeah. You know certainly there is a a bit of a lag time it depends on the the sight of caring what pharmacy.

Matthew C. Abernethy: So Matt, do you want to take that one?

Matthew C. Abernethy: Yeah, sure thing. But from a channel inventory perspective, it's very difficult to predict, and it can be highly variable, even based upon the day the quarter ends. Most of our channel orders on a Monday, for example, or Tuesday. And so depending on the timing, there may be a little bit more stock at the end of a quarter if it lands on, you know, a Monday, Tuesday, or Wednesday. So when you normalize for channel inventory, Baron, you know, we really had, you know, 27 sales results in Q4, and you also normalize to that same place for Q1, around 227. However, since there's such a big gross to net discount period, or gross to net discount, it leads to a sequential increase in TRX.

The patients getting their prescription from.

You know it could be it can be a few days or in some cases a couple of weeks.

So.

Prescriptions that were filled interactions that were filled at the very beginning of of April likely would've been written.

Some time in the latter part of March but as we said you know we saw a a nice uptick and momentum and the second half of Q1 and that really did continue to carry through a into a cute too.

It's early still and you know we're monitoring things very carefully but the impact was not as significant as we feared given the dramatic changes in the external environment.

Matthew C. Abernethy: But from a days on hand perspective within our channel, it's still, it's right around two weeks. Okay, that's helpful. And then I guess on the new prescription starts that you're seeing, can you maybe describe what percentage come from switching from, you know, existing therapies that patients are on versus a treatment IE patient given because we've got the COVID epidemic, and it's probably harder for treatment IE patients to go in to see a doctor?

Okay. Thanks string of course.

<unk>.

Took on next question from Vamil Yvonne of Mizuho Securities.

Thanks, So much on a particular question, maybe just one to clarify <unk> been winning she'll question.

You mentioned a channel inventory does that include stocking benefited the most.

Oh, so people maybe in front of pills cookie quote a pandemic picked up or that just really in in the channel and then my actual question was more on the business development side I'm just curious with this pandemic acting you know company differently.

Anyway. So change your priorities are opportunities simply to do business development, maybe some smaller companies that are not able to withstand the pressure says well. Thanks match you want to take the first clarifying aspect.

Eric S. Benevich: Yeah, Barron. I'll have I'll have Eric. I'll start with that.

Eric S. Benevich: Yeah, the answer is that we don't have that information. It's not clear how much of this has been driven by switching, and I assume that you're talking about deuterated tetrabenazine.

Yeah, the channel inventories actually in our channels or affirmative see a network, it's not at the patient Bible and and also just to know we did not see any significant change in and help patients were were getting refills you know nothing to note in a in March so I would talk.

Kevin C. Gorman: The, in the work that we've done in the past, you know, looking at market research and so on, there's been very little of that kind of activity. The vast majority of new patient starts has been driven by our educational efforts, helping providers to identify previously undiagnosed patients and then certainly educating them about the risks and benefits of treatment within GRESA. I assume that that's probably still the case in this current environment. And just to kind of tack on a little bit to what Matt was talking about, certainly there's been a substantial drop in patient visits over the last, let's say, six weeks or so across different sectors of healthcare, including in psychiatry and in neurology. But that's been partially offset by an uptick that we've seen in telemedicine.

Got a very little impact into one associated with anything in connection with Kobe 19.

And Kyle you want to talk about beauty, yeah. So make sure I captured your question here, a little bit about our our interests though.

No top and investing for <unk> and pick opponent aren't turtle pipeline of course for we continue to be interested in things happening on the outside there's only so much we can do internally and we're really the interesting time right now with a lot of people doing some great science outside of our doors. So we're trying to learn and get smarter on what's going.

Run out there so of course.

<unk> need to look and see if there are other partnership types of opportunities.

Kevin C. Gorman: And so certainly, we've made efforts to understand those dynamics and to help providers in our universe understand how they can continue to assess patients for TD symptoms, how they can monitor patients that are currently on Ingresa, et cetera. And so that may partially explain why, even in these times when there's been a dramatic decrease in patient flow through the clinics, it hasn't been, as Kevin said, you know, proportionally impacting our business. Yeah,

Think that if you look across our pipeline at some of the partnerships that we struck recently xenon Voyager you see the types of things that are of interest to nurse <unk> strong science platform technology and intellectual property. Those are things that are very important to our current internal programs and that.

That is the cornerstone of our interest to engage in discussions with other companies. So what other large or small those are the pieces that we're looking for.

Eric S. Benevich: Yeah, and Barron, what I'll add to that is, as Eric just talked about telemedicine, going before COVID, psychiatry was the specialty that utilized telemedicine the most than any other specialty, and that clearly has increased and ramped up from there. And so that's what Eric meant; we've been looking at this, and we've been studying telemedicine for, you know, a couple of years, even prior to this. And so with an experienced and talented Salesforce team, they were able to plug into that.

Does that answer your question or do you have a follow up there.

I guess I was just got also curious have you too you know like a change or maybe more recovered occasions starting is.

Smaller company they be struggling to manage the way to the pandemic I don't know anything comment on that level.

Yeah, we haven't seen that yet I think most of the people are just trying to understand how their business might change and making those adjustments not to say that cat happened down the road, but we haven't seen that yet.

Kevin C. Gorman: And I think that is, as Eric said, one of the reasons why the treatment, the NRX that we're seeing here is not nearly as bad as we had feared it would be. But I'll always put in the cautionary statement, as Matt has done, and Eric has done, this is still early in this quarter. And so we just need to see and stay on top of and adapt to what is going to continue to happen throughout this quarter and beyond.

Okay. Thanks, so much.

We'll take on next question from.

Gould Barclays. Your line is open.

Great. Thank you good afternoon thinks taken the questioning congrats on the ingress performance like US first for Kevin Eric I'm, just looking for well I guess, a little bit more colors, you think about managing the sales force during the the three engagement in person with quick clinicians and you know just sort of like if the guiding principles <unk>.

Think through that and is your expectation that you'll see sort of in a synchronized kind of reengagement by region or are you going to hold back the entire sales force until it sort of like an all or none type phenomenon and then maybe just.

On a picone given the delay here is our expectation that maybe you'll see I guess better access and formulary sort of out of the gate given that you've had some time here to engage with pairs, maybe it'd be a little bit more thank you.

Biren Amin: Great, thank you.

Brian Abrahams: Our next question is from Brian Abrahams of RBC Capital Markets.

Leo: Hi, this is Leo on behalf of Brian. Thanks for taking my question.

Leo: I don't know.

So I'll just take briefly the first part of your question and that is as Eric has said in his opening remarks. We are we are very fortunate to have such a highly skilled inexperience sales force that has built the relationships that they have that that allows them to even during these.

Leo: Question on the

Leo: and the CAH program.

Leo: Just wanted to know what the recent feedback has been.

Eiry W. Roberts: Unknown Speaker In a regulatory sense on the pivotal trials that you're planning to run, and are you potentially looking at something like concomitant steroid use and steroid reduction as an end point compared to normalization of biomarkers? And I might have a quick follow-up as well.

<unk>.

Bringing grass to our patients.

They are they're real skilled even in the close to part of this the most difficult part of this size two when that they when they interact and when they engage their their customers and and that they're going to be using that that same skill as we reopen but eric and probably go into a bit more depth.

Eiry W. Roberts: So thanks for the question, Leo. It's Eiry here.

Yeah.

Yeah, you know certainly this has been a learning opportunity for US you know we've said that this has been a learning launching that continues to evolve I think one of the sort of the hallmarks of the way that we've adapted as a company is to really increase our communication not just with the field sales organization, but really.

Eiry W. Roberts: And we did meet with the FDA as planned. And in terms of the actual design of the study, as we've said before, I think, on several calls, we do believe that the hormone levels of A4, 17-OHP, and ACTH are very important, and they are used extensively in the management of patients with CAH. As I mentioned, we are actually finalizing that single pivotal phase 3 study in adults. That's a global study, and we'll be moving towards implementation of that in the second half of this year. And once that study is posted on clinicaltrials.gov, obviously, there'll be a lot more information about the design of the study and the endpoints that we're looking at there.

The entire organization, it's almost as if you can't communicate too much and so certainly with everyone being physically distanced and you know people having to deal with a lot of personal issues and concerns about you know the future of the company or the country.

And you know their own personal circumstances.

That communication has been really key and pivotal in terms of helping us as an organization navigate all these changes.

Leo: Thanks.

Leo: If I can just follow up on maybe more of a broader strategic perspective, I know previously you had mentioned that you were going to go it alone here for the global studies, and I just want to know if that thinking has evolved given the global pandemic and the macroeconomic conditions and perhaps how site identification is going.

In terms of of that process of of going back into the field and reengaging face to face again.

You you you use the term that that I haven't heard before but I like which is asynchronous reengagement and that's I think how it's going to play out we have a number of different internal I'm planning teams that are helping us to prepare for what I'm going back into into the clinics and then too.

Kevin C. Gorman: So I'll take the very first part of that from a strategic point of view. No, that hasn't changed at all in our thinking. We still plan on doing this phase 3 trial alone, doing the registration in both territories and commercializing in both territories ourselves. Eiry, do you want to talk a bit more about how it's gone?

The various health care settings looks like as well as you know bringing are are home office team back two or headquarters.

Changes are not happening at the same pace in different parts of the country and already we're seeing some states that are lifting restrictions and so R.X. page expectation is that this is going to be a process that occurs over a number of likely weeks to months in terms of individuals in different parts of the country being able to.

Eiry W. Roberts: We've been working very closely with those teams and also with our selected investigative sites and the regulators and ethics committees in Europe and in the U.S. towards the ability to launch in the second half of this year.

Engage with their customers and what that looks like is probably going to evolve over time as well.

<unk> or maybe the third part of your question was really related to <unk> and the fact that you know we're looking at launching in the latter half of this year certainly we want to take advantage of the opportunity you can always use more time to prepare but with regards to the pairs specifically, we've got a plan in place.

Kevin C. Gorman: Yeah, you know, you do, even during this time, period of time, you do get some pleasant surprises. And I'd say one of the pleasant surprises that we have found is that working with outside partners throughout all of our programs here, whether it's CROs, whether it's the clinical trial sites that we're currently working with, the ones that we are signing up for the trials that are all going to be starting in the second half, and certainly the regulatory agencies, both EMA and FDA, they have not missed a beat. They've all been extremely responsive, and we've been able to work highly effectively with all of them telephonically.

Case in terms of how we're engaging with payers and how we're introducing on Genesis and now we have a label. So certainly that gives us additional opportunities to engage with plans to understand how they manage the Parkinson's class and you know to educate them about the labeling and where we see this medication fitting in.

To the the current treatment paradigm for those Parkinson's patients so that and the fact that we're going to continue our our efforts to educate neurologists on the importance of Compton emission as we have been in the months, leading up to our Purdue for days.

Leo: Thanks, that was very helpful.

Brian P. Skorney: Our next question is from Tazeen Ahmad of Bank of America. Tazeen, you may want to check your mute switch. Your line is open. And once again, Mr. Ahmad, your line is open. Please check your mute switch. We'll move next to Brian Skorney of Baird. Your line is open.

What's it going next question from Evan Suderman Credit Suisse. Your line is open.

Hi, all thank you for taking my questions. Congrats on the progress I Hope you are all staying safe and healthy so I knew tossing that's been on and grabs the can you provide more color on the feedback you're getting from position.

Jack Dongan: Hi, thank you. This is Jack Dongan on behalf of Brian. Thank you for taking our questions. I just have one quick one. I was wondering if you could talk a little bit about the payer mix of Ingresa and how many of the patients are commercial versus government insurance and how you could see kind of the broader macroeconomic trend in the U.S. playing out there and if there are any risks to the business associated with the kind of potential shift to government insurance plans if unemployment increases as we've seen in the past.

<unk> sales rep interaction model or these drip still getting the same level of engagement I'm really trying to understand if they're as effective now and driving prescription growth versus during normal times and then just to follow up on the agenda as launch.

Yeah that thank you haven't I'll just take a a first quick and again put it over to put it over to Eric <unk>. This no. The the as you can imagine with the sales force working from home and as Eric has talked about with so many of the of the.

Kevin C. Gorman: Yeah, Jack, we've not talked about what our actual payer mix is between private and public. As we had said originally when we launched, looking at antipsychotics as a proxy for this patient population, we saw approximately a 50-50 mix. We said all along that it's actually a bit higher in the public payer arena for this drug, which isn't surprising because our patient population is a bit older here.

The offices are closed or dramatically, reducing the the patients. They're seeing you you and we could not expect or wraps to be as efficient as what they were prior prior to coven.

But nevertheless, they're doing a remarkably a better job than what we had anticipated in doing this and they keep they continue to.

Kevin C. Gorman: You raise a good point as far as what is happening with COVID and broader issues that are going on. Right now, what we do through our government relations, both in-house and also in Washington and throughout state capitals, we keep a pulse on what's happening here. It is evolving continuously. I don't think I can make any intelligent, forward-looking statements here, other than to say that...

To excel as they as they move along so no I I can't say that for structural reasons that they're as efficient as they were with all of their clients. However, with many of their clients. They are as efficient so with.

That I'll turn it over to Eric and.

Yeah, and I can provide a little bit of additional color of and.

You know calls generally have gone down and I say calls calls on each C.P. customers have gone down across the board regardless of what their pubic area you're talking about.

Kevin C. Gorman: We monitor, we're involved, and we will react appropriately, and Eric, do you have more to say? Yeah, the only.

Eric S. Benevich: Yeah, the only other thing I'd add is that regardless of the patient's insurance status, our commitment to making sure that they can get access to Ingressa remains unchanged.

However, and you know and I think that's that's true also in in our in our T.D. market. However, well. We have found is that in some instances were replacing a quantity with quality, meaning that we're getting longer time with the customer.

Eric S. Benevich: Awesome. Thank you so much. Thank you.

Anupam Rama: Thank you.

Anupam Rama: We'll move next to Anupam Rama of J.P. Morgan. Your line is open.

Kevin C. Gorman: Hey guys, thanks for taking the question and congrats on the quarter. It's a quick question on the Apicophone launch. So I should be thinking about sort of the resolution of the supply issue and the gaining factors to getting the product launched here in the back half of the year. Thanks so much.

More engagement in more opportunity to go through a full educational presentation and so our team like I said, we pivoted towards the end of March and into early April gave them, new tools and resources to be able to conduct these educational programs remotely. We also had to a pivot <unk>.

Anupam Rama: Yeah, thank you, Anupam. On the other hand, we do have the COVID pandemic, and that, in and of itself, makes it impractical for us, and, as you've seen with many companies, to launch into this environment. But on top of that, as we discussed back in January, which seems like years ago, at a conference, that our partner Bial, who is 100% responsible for the supply chain, had an incident in the supply chain, and they are rectifying that. We stay in close contact with them through each step of the process as that's being rectified. And we'll stay tuned. We'll tell you in early, we'll probably give you an update in early summer about what our launch plans are, the timing.

Terms of peer to peer activities and we've done a nice job best for I think of leveraging.

Peer to peer educational programs utilizing a physician speakers from different parts of the country and being able to make that resource available. So we've adapted to the reality of our customers that are no longer a practicing the way that they use to but we certainly seen that some even though the call volume is less than what it used to be.

Certainly the quality is is very high for those calls that we are able to engage with customers.

Okay, and then just a follow up on the on 10th of launched so how should we think about the total addressable market for the stuff that is it just patient now who are on <unk> <unk> <unk> <unk> inhibitor therapy or should we think beyond that to all P.D. patient I love It opens harbored open therapy.

So if you if you look at the the labeling for <unk>. It's it's for patients that are experiencing off time.

Jay Olson: Cut it. Thank you.

Jay Olson: We'll take our next question from Jay Olson of Oppenheimer. The line is open.

That are currently on leave it up a carpet DARPA.

So there is roughly a million people in the U.S. with Parkinson's disease about 70% of them are on Ah leave adobo Carbidopa preparations in about two thirds of those patients are currently on a a adjunct of treatment of some sort. So that's really are addressable patient population.

Jay Olson: Oh, hey, congratulations on working through this pandemic and thank you for taking the question. I think you said the unexpected strength in new patient starts for Ingreso was supported by your transition to online physician education. And I was wondering if you could attribute any of the new patient starts to your consumer education program. And then, related to that, I was wondering if there's any way you could use your Embrace program to refer new patients to physicians who practice telemedicine.

Those patients that are on leave it up a carbidopa that are experiencing motor fluctuations and it's a substantial number.

Right. Thank you for that Colin appreciate it thinks that.

Eric S. Benevich: Thank you, Jay. Eric, do you want to...

Our final question comes from.

Eric S. Benevich: Yeah, Jay, thanks for the question. Certainly, I think that the cumulative effect of everything that we've done over the last three years is contributing to the sustained momentum that we've seen coming out of Q2, sorry, out of Q1. The talk about TD, and the unbranded disease state education program that you mentioned that's targeted towards patients, we believe is contributing to that as well. Even though there is a lower volume of patients having face-to-face visits, many of them are still having the opportunity to talk to their physicians, and certainly, we continue to try and educate them about abnormal movements and the possibility that it could be TD and encourage that dialogue. The strength that we've seen coming out of Q1 and into Q2 is really, like I said, a cumulative effect of everything that we've been doing. And we're really very thankful that we hired such a strong team, that they've got the relationships, and that they've been able to really pivot very quickly and move from an in-person, face-to-face model to remote education and remote customer support. And we've been very pleased with the productivity that we've seen thus far.

<unk> Ahmad of Bank of America. Your line is open.

Hi, guys think so much sorry about earlier.

And at the end here, maybe if you haven't already talked about that's when I apologize. If you have can you guys talk about what they should be expecting to see <unk> h. presentation.

And I also wanted to follow up on a pickup hone in you've talked about really not wanting to launch until the time is right. Yeah. The better sense you know what the environment is going to be for the rest of the years or something that could get pushed into 2021 thing.

Yeah I'll take the second part of your question first about the effect on lunch and then I'll have Ivory talk about the first part of your question.

Let's see a picnic on launch the <unk> without coded being involved here as I had said publicly in January that there was a a an incident at one of the contract manufacturers for our partner be owl, who is responsible for the supply chain.

And we've been in constant contact with be out as they move through that incident and make sure that we have re supplies.

That we'd come to us in a timely fashion, so that we'd never have to worry about patients. After our launch a running short hub of drug supply and that we will give an update to you about the timing of our launch a in early summer.

Matthew C. Abernethy: Hey Jay, this is Matt. This is Matt.

Matthew C. Abernethy: I also want to just make a couple of clarifying comments for everybody. You know, similar to last year, as we saw in Q1, it was this tale of two quarters where you had a bit slower first half of the first quarter, and then the ramp picked back up in the second half of the quarter as patients got back to more normalized refill rates, and NRXs were flowing steadily. So we did have, as Eric just mentioned, a nice momentum, a nice trajectory, you know, prior to COVID-19. And I just want to make sure our comments about NRXs in April are not taken out of context, I think, in how you asked the question. You know, I just want to be clear. We're not seeing a sequential increase or growth in NRX. We are seeing, you know, like we said, better than we had anticipated NRX given the changing dynamics.

So I read.

Thanks to thing and so the data that was presented a doctor <unk>. Okay from University of Michigan on June eight will be the full data set from our adult proof of concept study, which included full cohorts of subjects that windows for 14 days.

Data will present, the pharmacokinetics the pharmacodynamic measures in terms of the hormone levels and the Tolerability and safety data I will say with very encouraged by the data from that study.

With that in hand, we did meet with the F.D.A. and and and the phase two meeting in March and we I'm moving ahead with off single adult Global registration study, which we anticipate starting in the second half of this yet.

Matthew C. Abernethy: But I wanted to make sure I provided that clarification given a couple of questions. Great, that's super helpful. Thank you. And are you able to refer TD patients who need doctors practicing telemedicine to a network of doctors local to them?

Okay, and then give us an idea of how long you expect enrollment studied a tank.

We actually have been working on as you can imagine on several different scenarios, particularly in the <unk>. The current situation and we haven't given any detail around that at this point in time.

Eric S. Benevich: Yeah, sorry, I neglected to answer the last part of your question. No, not currently. The call to action with the Talk About PD ad is to talk to your doctor. We have certainly discussed, and we're evaluating if there's an opportunity to direct patients toward a specific physician in their area that's been educated on TD.

The ones the study and stuff and going in the second half of the yeah <unk>. The information will be posted on kind of <unk> <unk> sample size on will continue to and monitor that and adjust our expectations. According to the performance.

Eric S. Benevich: So stay tuned. Super. Thank you very much.

Okay. Thank you.

Jay Olson: Super, Thank you very much.

Thank you too.

Just concludes our question and answer session I would like it to return the call to Kevin <unk> for concluding remarks, yeah. Thank you and I really do appreciate all of you are joining the call today.

Charles Duncan: Our next question is from Charles Duncan of Cantor. Your line is open.

Charles Duncan: Hi guys. Kevin and the team, congratulations on a good revenue quarter and thank you for taking my questions. I had a commercial question and then a brief pipeline question. Regarding the commercial question, you know, folks are talking about the NRX, and Matt, you kind of just clarified it for me. But I'm really wondering if you think about the interactions that you're having with prescribers, say, in early April versus early May versus what may be in early June. Is there any way to quantify or at least qualitatively, you know, discuss that kind of flow? Was it more, I guess, difficult to get to people in early April than maybe early May, and what would you anticipate for early June?

Just a couple of things you know <unk> not a virology or an anti in fact of company. Our efforts. Therefore don't read directly on on Sars Cove too.

However, the impact of of this pandemic on on mental health is provide as profound and we work extensively and deeply with the mental health community and that's that's where we are putting our efforts and our expertise to work in this and it's as Eric at mentioned, it's very important to know.

That may as mental health month.

So I'd I'd also like to say that we spent the better part of two months quickly adapting to the rapidly changing pandemic.

And as you've seen and heard our people live really comes through as they always have in the past and I call. This too much the the very early and temporary condition or or phase one.

Eric S. Benevich: Yeah, I'll take your question. So I think that as we went through the latter part of March and into early April, there was a lot of adaptation that we were doing at that time, both in the field and in the home office to support what our customer-facing team was doing. And certainly, there was a lot of change happening across the country, at different rates and at different times. And we started to see more and more practices essentially restrict access to patients, only emergency visits or shut down entirely.

We're now actively preparing for phase two witches returning to work both in the field and then the home office under albeit under very different circumstances. When we were last there.

What what we've done from the beginning and continuously to work on is what I'll call phase three and that is the long term our vision for our work our patients in our company has not changed our ultimate goal is and always will be to discover developing bring life changing medicines to patients and that's on wavering in this pandemic.

Will will not change our course.

Eric S. Benevich: Our field team, we needed to pretty quickly equip them with new tools and technologies that would allow them to, or enable them to have those remote interactions with their customers. And so there was a period of time when we were very furiously making a lot of changes on the fly, so to speak, to be able to support what we were trying to do with our customers and, frankly, to support what they were trying to do with their patients. I think that over the course of April, we settled into a bit of a rhythm. Certainly, we learned a fair bit about what was working, what was less effective, and, you know, certainly made some changes in terms of the resources that were available to our sales and our reimbursement field.

So I want to thank you for being here today and I look forward to speaking with you. All this time goes by but probably more importantly, I'm really looking forward to getting together again with you personally take care and thank you very much.

This does conclude today's no Cringed Bio Sciences report 212020 results call you May now disconnects your lines and everyone have a good evening.

[music].

Eric S. Benevich: So at this point, I feel like it's a relatively stable state in terms of what that cadence looks like and the types of interactions that we're having. However, now we're starting to see that as certain states are starting to loosen up the restrictions and so on, we're doing a fair bit of planning in terms of what re-engagement in face-to-face types of interactions with customers looks like, how can we do so safely, et cetera. So I think that the focus is shifting a little bit towards what the future looks like and how we're going to start to have those kinds of engagements with customers like we had in the past, where we can do so, and at what pace.

Yeah.

[music].

Eric S. Benevich: That's helpful, Eric, and supportive of our thesis and the use of telemedicine in psychiatry. That said, let me ask you if you see psychiatry being a little bit easier nut to crack, if you will, versus, say, neurology, and think about possibly an impact of a second wave when you're launching gensys later this year.

Eric S. Benevich: Yeah, I'll comment on that, and then perhaps Eiry can comment as well. So, as Kevin mentioned, pre-COVID, there was a higher utilization of telemedicine within psychiatry, and there were a number of factors that drove that. One is that there was a very large gap between the number of patients that needed psychiatric services for these patients in their immediate geographical area. So that was already utilized to a higher degree than what we saw in other physician specialties. The COVID-19 pandemic really just accelerated, and what we saw was that some of the restrictions that were put in place, and the standards have been relaxed by the government.

Eric S. Benevich: You know, for example, it used to be that the patient had to be in a clinic, they had to be engaging with the remote psychiatrist via a closed circuit TV network, essentially, et cetera. And now some of these, a good portion, frankly, of these tele-psychiatry consults are via phone. The patient's at home; the physician could be at home as well.

Eric S. Benevich: So we're trying to understand those dynamics. You know, what happens once the emergency declaration is lifted? To what extent do things go back to what they were pre-COVID, or to what extent will telemedicine remain a core part of psychiatry? Certainly, you know, we're also trying to understand the impact on neurology and the potential impact on our launch with Ongentis. But this is something that we've been keeping an eye on for some time. And certainly, I think we're better prepared than many other companies because we had been doing some work to understand how telemedicine could affect TD and our Ingresa franchise, and we were able to leverage that work that we did previously.

Eiry W. Roberts: Yeah, and the only thing I'd add to that, Eric, is that I think it is definitely correct that psychiatry historically has been further ahead in terms of the employment of telemedicine approaches, at least through our interaction with the movement disorder neurology community, both through our Huntington study and also through preparation for the Angentis launch. It's very clear that the community is adapting rapidly in order to try to serve its patients in a different way in this setting. And one of the advantages, I think, that the Angentis population will have is that many of those patients will already be known to their neurologist and will be in a relationship with their neurologist already. And so, we are seeing in that setting that there is a lot of use of remote technology and assessment techniques that are enabling clinicians and healthcare professionals to support their patients very effectively, including potentially changing or adding additional treatment options.

Kevin C. Gorman: Chas, did we answer your question?

Charles Duncan: Yes, you did. Thank you very much, Kevin. Helpful head of color, Eric and Eiry. Thank you.

Kevin C. Gorman: Thank you.

Phil Nadeau: We'll move next to Phil Nadeau of Cowan and Company.

Phil Nadeau: Good afternoon, thanks for taking my questions. First one, clarification question on the prescription numbers. I think you're citing 41,500 TRX and Q1. I believe we had in our notes that there were 42,100 TRX and Q4, yet you're calling Q1 a sequential increase. Could you correct our figures if they're wrong, or on what basis are you denoting Q1 as an increase?

Matthew C. Abernethy: Yeah, so our, our, yeah, so our TRX numbers include implied TRX for the channel inventory. So in Q4, for example, where we had an $11 million inventory bill that represented call it around, you know, a little over 2000 TRX in the quarter. So our reported TRX would need to be reduced by, you know, around 2000. And then this quarter, you had a $4 million channel inventory bill, which would, you know, represent, you know, six or 700 type levels of implied TRX. That's a couple. And then there are some. Second, on the NRX trends that you've noted in April, in the past, you've suggested that NRX, there can be a lag from when the patient. Transcripts provided by Transcription Outsourcing, LLC, patient visits earlier in March or before COVID hits.

Eric S. Benevich: Eric, do you want to take that?

Eric S. Benevich: Yeah, you know, certainly there is a bit of a lag time. It depends on the site of care and what pharmacy the patient is getting their prescription from. You know, it could be a few days or, in some cases, a couple weeks. So, prescriptions that were filled, NRXs that were filled at the very beginning of April likely would have been written sometime in the latter part of March. But, as we said, we saw a nice uptick in momentum in the second half of Q1, and that really did continue to carry through into Q2. It's early still, and we're monitoring things very carefully, but the impact was not as significant as we feared, given the dramatic changes in the external environment.

Phil Nadeau: Great. Thanks for taking my question. Thanks, Phil.

Vamil Devang: We'll take our next question from Vamil Devang of Mizuho Securities.

Vamil Devang: Great, thanks so much for taking the question. Maybe just one question to clarify, and then one actual question. That $4 million that you mentioned with channel inventory, does that include stocking benefits at the patient level? Also, people may be trying to fill scripts before the pandemic.

Vamil Devang: picked up, or is that just really in the channel?

Matthew C. Abernethy: And then my actual question was more on the business development side. I'm just curious, with this pandemic impacting companies differently, are there any ways or changes or priorities or opportunities to pursue business development for maybe some smaller companies that are not able to withstand the pressures as well?

Kyle Gano: Thanks.

Vamil Devang: Matt, do you want to take the first clarifying aspect?

Matthew C. Abernethy: Yeah, the channel inventory is actually in our channel, so our pharmacy network, it's not at the patient level, and also, just to note, we did not see any significant change in how patients were getting refills, you know, nothing to note in March, so I would chalk up a very small impact in Q1 associated with anything in connection with COVID-19.

Kyle Gano: and Kyle, you want to talk about BD? Yeah, so.

Kyle Gano: I want to also make sure I captured your question here. A little bit about our interest, though, you know, it's often investing in Ingresa and Picapone in our internal pipeline. Of course, we continue to be interested in things happening outside. There's only so much we can do internally, and we're really in an interesting time right now with a lot of people doing some great science outside of our doors. Trying to learn and get smarter on what's going on out there.

Kyle Gano: So, of course, we continue to look and see if there are other partnership opportunities. I think that if you look across our pipeline at some of the partnerships that we've struck recently, Xenon, Voyager, you see the types of things that are of interest to Neurocrine. Strong science, platform technology, and intellectual property. Those are things that are very important to our current internal programs, and that's something that is a cornerstone of our interest in engaging in discussions with other companies. So whether they're large or small, those are the pieces that we're looking for. Does that answer your question, or do you have a follow-up question?

Vamil Devang: Yeah, I think I guess I was just gonna go

Kyle Gano: I'm also curious, have you seen a change or maybe more conversations starting as smaller companies may be struggling to manage their way through the pandemic? I don't know if you can comment on that level.

Vamil Devang: Yeah, we haven't seen that yet. I think most people are just trying to understand how their business might change and making those adjustments. Not to say that can't happen down the road, but we haven't seen that yet.

Carter Gould: Okay, thanks so much.

Carter Gould: We'll take our next question from Carter Gould of Barclays. Your line is open.

Carter Gould: Great. Thank you. Good afternoon. Thanks for taking the time to answer the question. And congratulations on the aggressive performance. I guess, first for Kevin or Eric, I'm just looking for, I guess, a little bit more color as you think about managing the sales force during the re-engagement in person with clinicians and just sort of, I guess, the guiding principles as you think through that. And is your expectation that you'll see sort of an asynchronous kind of re-engagement by region, or are you going to hold back the entire sales force until it's sort of like an all or none type phenomenon? And then maybe, on a pick-up tone, given the delay here, is our expectation that maybe you'll see, I guess, better access and formularies sort of out of the gate given that you've had some time here to Thank you.

Kevin C. Gorman: So I'll just take briefly the first part of your question and that is, as Eric said in his opening remarks, we are very fortunate to have such a highly skilled and experienced sales force that has built the relationships that they have that allows them to, even during these times, bring Ingressa to our patients. They are, they're really skilled. Even in the closed part of this, the most difficult part of this is when they interact with, when they engage their customers. And that's, they're gonna be using that same skill as we reopen. But Eric can probably go into a bit more detail with you.

Eric S. Benevich: Yeah, you know, certainly this has been a learning opportunity for us. We've said that this has been a learning launch, and it continues to evolve. I think one of the sort of hallmarks of the way that we've adapted as a company is to really increase our communication, not just with the field sales organization but really across the entire organization. It's almost as if you can't communicate too much.

Eric S. Benevich: And so certainly, with everyone being physically distanced, and people having to deal with a lot of personal issues and concerns about, you know, the future of the company or the country and, you know, their own personal circumstances, communication has been really key and pivotal in terms of helping us as an organization navigate all these changes. In terms of that process of going back into the field and reengaging face-to-face again, you used a term that I haven't heard before but I like, which is asynchronous reengagement, and that's, I think, how it's going to play out. We have a number of different internal planning teams that are helping us to prepare for what going back into the clinics and into the various health care settings will look like, as well as bringing our home office team back to our headquarters.

Eric S. Benevich: Changes are not happening at the same pace in different parts of the country, and already we're seeing some states that are lifting restrictions. And so our expectation is that this is going to be a process that occurs over a number of likely weeks to months in terms of individuals in different parts of the country being able to reengage with their customers. And what that looks like is probably going to evolve over time as well.

Eric S. Benevich: The second or maybe the third part of your question was really related to Ungentis and the fact that, you know, we're looking at launching in the latter half of this year. Certainly, we want to take advantage of the opportunity. You can always use more time to prepare. But with regard to payers specifically, we've got a plan in place in terms of how we're engaging with payers and how we're introducing Ungentis. And now we have a label. So certainly, that gives us additional opportunities to engage with plans to understand how they manage the Parkinson's class and to, you know, educate them about the labeling and where we see this medication fitting into the current treatment paradigm for those Parkinson's patients. So that and the fact that we're going to continue our efforts to educate neurologists on the importance of COMPT inhibition as we have been in the months leading up to our PDUFA date.

Evan David Seigerman: We'll take our next question from Evan Seigerman of Credit Suisse. Your line is open.

Evan David Seigerman: Hi all, thank you for taking my questions, congrats on the progress, and I hope you are all staying safe and healthy. So, I know you touched on this, but on Ingressa, can you provide more color on the feedback you're getting from physicians on the virtual sales rep interaction model? Are these reps still getting the same level of engagement? I'm really trying to understand if they're as effective now in driving prescription growth versus during normal times. And then, just to follow up on the Ongentis launch.

Kevin C. Gorman: Yeah, thank you, Evan. I'll just take a first quick one and again put it over to put it over to Eric.

Kevin C. Gorman: No, as you can imagine, with Salesforce working from home, and as Eric has talked about with so many of the offices closed or dramatically reducing the number of patients seeing you, you, and we could not expect our reps to be as efficient as what they were prior to COVID. But nevertheless, they're doing a remarkably better job than what we had anticipated in doing this. And they keep on, they continue to excel as they move along. So no, I can't say that, for structural reasons, that they're as efficient as they were with all of their clients. However, with many of their clients, they are just as efficient. So with that, I'll turn it over to Eric and

Eric S. Benevich: Yeah, and I can provide a little bit of additional color, Evan. You know, calls generally have gone down, and I say calls, calls on HCP customers have gone down across the board, regardless of what therapeutic area you're talking about. However, and you know, and I think that's true also in our TD market. However, what we have found is that, in some instances, we're replacing quantity with quality, meaning that we get But we've certainly seen that even though the call volume is less than what it used to be, the quality is very high for those calls that we are able to engage with customers.

Evan David Seigerman: Okay, and then just a follow-up on the Ongentis launch. So how should we think about the total addressable market for this asset? Is it just patients now who are on inhibitor therapy, or should we think beyond that to all PD patients on levofopa-carbidopa therapy?

Eric S. Benevich: So, if you look at the labeling for frongentis, it's for patients that are experiencing off time that are currently on levodopa and carbidopa. There are roughly a million people in the US with Parkinson's disease. About 70% of them are on levofopa-carbidopa preparations, and about two-thirds of those patients are currently on adjunctive treatment of some sort. So, that's really our addressable patient population. Those patients that are on levodopa and carbidopa that are experiencing motor fluctuations, and it's a substantial number.

Evan David Seigerman: All right. Thank you for that call. I appreciate it. Thanks, guys.

Tazeen Ahmad: Our final question comes from Tazeen Ahmad of Bank of America. Your line is open.

Tazeen Ahmad: Hi guys, thanks so much. Sorry about earlier. Thanks for squeezing me in at the end here.

Kevin C. Gorman: Maybe if you haven't already talked about this, and I apologize if you have, can you guys talk about what we should be expecting to see on June 8th as it relates to your CAH presentation? And I also wanted to follow up on the pick-a-pone, and you've talked about really not wanting to launch until the time is right. Do you have a better sense of what the environment is going to be like for the rest of the year? Is this something that could get pushed into 2021? Thanks.

Eiry W. Roberts: Yeah, Tazeen, I'll take the second part of your question first about the Epicopone launch, without COVID being involved here, as I had said publicly in January, so that we'd never have to worry about patients after our launch running short of drug supply. And that we will give an update to you about the timing of our launch in early summer.

Kevin C. Gorman: Thanks, Tazeen. And so the data that will be presented by Dr. Rich Auchus from the University of Michigan on June 8th will be the full data set from our adult proof of concept study, which included four cohorts of subjects that were dosed for 14 days. And the data we'll present are the pharmacokinetics, the pharmacodynamic measures in terms of hormone levels, and the tolerability and safety data. I will say we are very encouraged by the data from that study. And with that in hand, we did meet with the FDA in an end-of-phase-2 meeting in March, and we are moving ahead with our single adult global registration study, which we anticipate starting in the second half of this year.

Eiry W. Roberts: Okay, and can you give us an idea of how long you expect enrollment in the adult study to take?

Tazeen Ahmad: We actually have been working on, as you can imagine, several different scenarios, particularly in the current situation, and we haven't given any detail around that at this point in time. Obviously, once the study is up and running in the second half of the year, the information will be posted on clinicaltrials.gov in terms of our sample size, and we'll continue to monitor that and adjust our expectations accordingly to the performance.

Eiry W. Roberts: Okay, thank you.

Tazeen Ahmad: Thank you, Tazeen.

Kevin C. Gorman: This concludes our question and answer session. I would like to return the call to Kevin Gorman for his concluding remarks.

Yeah, thank you. And I really do appreciate all of you joining the call today. Just a couple of things. You know, while Neurocrine is not a virology or an anti-infective company, our efforts, therefore, don't read directly on SARS-CoV-2. However, the impact of this pandemic on mental health is profound, and we work extensively and deeply with the mental health community. And that's where we're putting our efforts and our expertise to work on this. And it's, as Eric mentioned, very important to note that May is Mental Health Month.

So I'd also like to say that we've spent the better part of two months quickly adapting to the rapidly changing pandemic, and as you've seen and heard, our people have really come through as they always have in the past. And I call this two months a very early and temporary condition or phase one.

We're now actively preparing for phase two, which is returning to work both in the field and in the home office, albeit under very different circumstances when we were last there. But what we've done from the beginning and continuously work on is what I'll call phase three, and that is the long term. Our vision for our work, our patients, and our company has not changed. Our ultimate goal is and always will be to discover, develop, and bring life-changing medicines to patients, and that's unwavering in this pandemic will not change our course.

So I want to thank you for being here today. And I look forward to speaking with you all as time goes by. But, probably more importantly, I'm really looking forward to getting together again with you personally. Take care, and thank you very much.

This does conclude today's Neurocrine Biosciences Report Q1 2020 results call. You may now disconnect your lines, and everyone have a good evening.