Q4 2019 Earnings Call

Good day, everyone and welcome to the Neurocrine Biosciences fourth quarter and year end 2019 results call. All participants are any listen only mode leaders, you'll have a chance to ask questions during the <unk>.

Operator: Good day, everyone, and welcome to the Neurocrine Biosciences fourth quarter and year-end 2019 results call. All participants are in a listen-only mode. Later, you'll have a chance to ask questions during the Q&A session. Please note today's call will be recorded, and I will be standing by if you should need any assistance.

Please note today's call will be recorded and I will be standing by the she need any assistance.

And it's now my pleasure to turn the program over to Kevin Gorman CEO of Neurocrine Biosciences. Please go ahead. There. Thank you very much operator I. Thank you everyone for joining us here this afternoon.

Operator: It is now my pleasure to turn the program over to Kevin Gorman, CEO of Neurocrine Biosciences. Please go ahead.

Kevin C. Gorman: Thank you very much, Operator, and thank you, everyone, for joining us here this afternoon. Today, I have Eiry Roberts, our Chief Medical Officer, Eric Benevich, Chief Commercial Officer, Matt Abernethy, CFO, Kyle Gano, our Head of BD and Strategy, and Todd Tushla, our Head of IR, with me. Before we start out, Todd, could you read our safe harbor statement? Yeah, good afternoon, everyone

Today I have I re Roberts, our Chief Medical Officer, Eric benefits, Chief Commercial Officer, Matt Abernathy, CFO, Kyle GAINO or how to BB and strategy and Todd titular head of IR with me before we start out Todd could you read our safe Harbor said, yeah. Good afternoon, everyone. Certain statements made in the course of this copper gold or not historically.

Todd Tushla: Certain statements made in the course of this conference call that are not historical statements may be forward-looking statements, which are subject to risk of uncertainty. 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 third quarter 2019 Form 10-Q and in today's press release. Copies may be obtained by visiting the investor relations page on the company's website. Any forward-looking statements are made only as of today's date, and we disclaim any obligation to update these forward-looking statements. Kevin

Statements, maybe forward looking statements, which are subject to risks and uncertainties information concerning factors that could cause actual results could differ material Lee from those contain and or implied by the forward looking statements contained in the company that you see filings, including but not limited to the company's third quarter point I'd seen form 10-Q and in today's press release.

Copies may be obtained by visiting 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.

Thank you Todd I'm I'm going to keep my remarks brief so we can get to your questions.

Kevin C. Gorman: Thank you, Todd. I'm going to keep my remarks brief so we can get to your questions.

First and foremost 2019 was a year, we continued to make progress in our primary focus of educating healthcare providers caregivers and patients about tardive dyskinesia. These efforts will continue in 2020 and beyond because the vast majority of tardive dyskinesia suffers are still struggling.

Kevin C. Gorman: First and foremost, 2019 was a year where we continued to make progress in our primary focus of educating healthcare providers, caregivers, and patients about tardive dyskinesia. These efforts will continue in 2020 and beyond because the vast majority of tardive dyskinesia sufferers are still struggling while waiting for a diagnosis and appropriate treatment. We believe 2020 will be another year of significant growth for Ingressa. Now, having said that, we're fortunate not to be a single product company. In 2009, we also took important steps to build the leading neuroscience biopharmaceutical company by nearly doubling our pipeline of important medicines. This year, we will have three compounds in pivotal clinical trials, five compounds in phase two studies, and the real possibility of having three medicines approved in four indications. Now that's a powerful foundation from which we'll build. With that said, I would like to turn the call over to Matt and Eiry.

While waiting for a diagnosis and appropriate treatment. We believe 2020 will be another year of significant growth foreign graph that.

Now, having said that we're fortunate not to be a single product company.

In 2009, we also took important steps to build the leading neuroscience biopharmaceutical company by nearly doubling our pipeline of important medicines. This year, we will have three compounds and pivotal clinical trials five compounds in phase two studies and the real possibility of having three medicines approved.

And for indications.

Now that's a powerful foundation from which will build.

With that said I would like to turn the call over the mountain Irene.

Good afternoon, and thank you for joining our fourth quarter earnings Conference call I'll keep my comments brief since we provided a lot of information over the past month.

Matthew C. Abernethy: Good afternoon, and thank you for joining our fourth quarter earnings conference call. I will keep my comments brief since we have provided a lot of information over the past month.

Overall, INGREZZA demonstrated another strong quarter with $238 million enough products sales, putting sales over $750 million in 2019.

Matthew C. Abernethy: Overall, Ingresa demonstrated another strong quarter with $238 million in net product sales, putting sales over $750 million in 2019. This was just our second full calendar year on the market. Given our increased business development activity and non-cash P&L items, we will begin reporting our financial performance on a GAAP and non-GAAP basis. Full reconciliations are included in the tables of our press release.

Just a second full calendar year on the market.

Given our increased business development activity in non Caspian L. items will begin reporting our financial performance on a GAAP and non-GAAP basis.

Well reconciliations are included in the tables of our press release.

Our sales results translated into increasing profit would Q4 net income of $34 million in non-GAAP net income of $102 million.

Matthew C. Abernethy: Our sales results translated into increasing profit with Q4 net income of $34 million and non-GAAP net income of $102 million. For the full year 2019, we finished with net income of $37 million and non-GAAP net income of $284 million. We exited the year with $970 million in cash and marketable security.

For the full year 2019, we finished with that income at $37 million in non-GAAP net income $284 million.

We exited the year with $970 million in cash and marketable securities.

Regarding 2020, S. DNA in R&D expense guidance, we expect a range of $740 million to $770 million on a GAAP basis.

$620 million to $650 million on a non-GAAP basis.

Matthew C. Abernethy: Regarding 2020 SG&A and R&D expense guidance, we expect a range of $740 to $770 million on a gap basis and $620 to $650 million on a non-gap basis. This compares to $469 million of non-GAAP R&D and SG&A expenses in 2019. The increase for 2020 reflects our increased investment in R&D, including our three registrational programs and meaningful investments in our Voyager and Xenon collaboration. For SG&A, our guidance reflects continued investment in Ingresa and marketing costs associated with the anticipated launch of a pickup home. Please note that our GAAP guidance reflects approximately $100 million of share-based compensation and a $20 million expected milestone payment to be out connected with the expected approval of a pickup home by the FDA during the second quarter. No other future potential milestones or IPR&D associated with current collaborations or future business development activities are included in our GAAP guidance.

This compares to $469 million of non-GAAP, R&D, NFC and <unk> expenses in 2019.

The increase for 2020 reflects our increased investment in R&D.

R&D, including our three registrational programs and meaningful investments in our Voyager and xenon collaboration.

Yes, DNA or guidance reflects continued investment in INGREZZA.

And marketing costs associated with the anticipated launch of the pickup on.

Please note that our GAAP guidance reflects approximately $100 million share based compensation under 20 million dollar expected milestone payment to be out connected with the expected approval of the pickup phone by the FDA during the second quarter.

No other future potential milestones or IP R&D associated with current collaborations or future business development activities are included in our GAAP guidance.

Regarding INGREZZA well, we've made tremendous progress developing the tardive dyskinesia market diagnosis rates for TD are still only in the mid teen we'll continue our educational efforts to remain confident in our ability to help many more patients struggling with T D.

Health care providers patrons and insurers continue to understand the value of INGREZZA and we expect accessible remained strong with similar net revenue per script in 2020 as what was realized in 2019.

As we think about Q1, the first quarter of every year as challenging for any company with a special teacher drug due to payer related seasonal dynamics, we're working diligently to mitigate the impact from these headwinds.

Although the first quarter poses unique seasonal challenges are long term focus is ensuring new patients receive help with their TV.

And existing patients then INGREZZA throughout the year.

Matthew C. Abernethy: Regarding Ingresa, while we've made tremendous progress developing the Tardive Dyskinesia market, diagnosis rates for TD are still only in the mid-teens. We'll continue our educational efforts to remain confident in our ability to help many more patients struggling with TD. Healthcare providers, patients, and insurers continue to understand the value of Ingresa, and we expect access will remain strong with similar net revenue per script in 2020 as what was realized in 2019. As we think about Q1, the first quarter of every year is challenging for any company with a specialty-tier drug due to payer-related seasonal dynamics. We are working diligently to mitigate the impact from these headwinds. Although the first quarter poses unique seasonal challenges, our long-term focus is ensuring new patients receive help with their TD and existing patients Stan and Greta throughout the year. Overall, 2020 signifies an important year of increased investment in Neurocrine as we continue to grow GRESA, advance our existing programs, and expand our pipeline. With that, I will now hand the call over to our Chief Medical Officer, Eiry Roberts.

Overall 2020 signifies an important year of increased investment into Neurocrine as we continue to grow and Rosa advance or existing programs and expand our pipeline with that I'll now hand, the call over to our Chief Medical Officer every Roberts.

Thank you, Matt and good afternoon to everyone on the call I will also keep my comments brief today.

We remain on track with all kinda called program timelines across the portfolio, including the anticipated midyear start of the Registrational trial for connects the fog in adult patients with congenital adrenal hyperplasia.

Hi, This we will present the adult proof of concept data for NASA Fund I'd be Endo meeting in San Francisco on March that yet.

By the end of this yeah, we plan to have a diversified portfolio of multi stage programs in clinical development at near accretive.

Including three registration study stage studies each in a different clinical indication I'm fall early to mid phase Neurocrine clinical programs.

In the me Tim the most important program in the newer can clinical portfolio for patients is a pickup with a PDUFA date of April 26.

I think in Poland has the potential to significantly help patients impacted by moved to fluctuations in Parkinson's disease, who need better adjunctive treatment options.

We look forward to bringing a pick up on to patients in the U.S. and educating physicians patients and pay is on the impact that this well tolerated differentiated pumped inhibitor can have an improving motor functioning for parkinsons patients.

Eiry W. Roberts: Thank you, Matt, and good afternoon to everyone on the call. I will also keep my comments brief today.

So my remaining remarks I'll review, our two most recently announced collaborations which highlight neurocrine entry into the field of precision medicine through I'll focus on rare pediatric epilepsy.

Eiry W. Roberts: We remain on track with all clinical program timelines across the portfolio, including the anticipated mid-year start of the registrational trial for Cronesifont in adult patients with congenital adrenal hyperplasia. Ahead of this, we will present the adult proof of concept data for Cronesifont at the ENDO meeting in San Francisco on March 30th. By the end of this year, we plan to have a diversified portfolio of multi-stage programs in clinical development at Neurocrine, including three registration stage studies, each in a different clinical indication, and four early to mid-phase Neurocrine clinical programs. In the near term, the most important program in the Neurocrine clinical portfolio for patients is picapone with a PDUFA date of April 26. Picapone has the potential to significantly help patients impacted by motor fluctuations in Parkinson's disease who need better adjunctive treatment options.

Firstly in December we announced an important collaboration xenon Pharmaceuticals Guinea exclusive rights to N.B. I nine to 135 to a promising first in class molecule, which potently and selectively inhibits the NAV one point.

Six sodium channel.

We believe this molecule could have great promise in the treatment, but see an eight a. developmental encephalopathy or eight eight for short I rare and devastating type of pediatric epilepsy, specifically related to a gain of function genetic mutation of the not 1.6.

So Jim channel.

AJ very often present in the first few months of light on causes a chronic and complex seizure disorder with developmental delays.

In addition, sudden unexpected that can occur in 10% to 20% of patients with a.

So the first time with NBC <unk> nine to 135 to on its selective mechanism of action, we plan to precisely target the ion channel implicated in AJ and offer the opportunity to provide a significantly improved benefit risk profile for these patients relative to <unk>.

Eiry W. Roberts: We look forward to bringing picapone to patients in the US and to educating physicians, patients, and payers on the impact that this well-tolerated, differentiated COMPT inhibitor can have on improving motor functioning for Parkinson's patients. For my remaining remarks, I'll review our two most recently announced collaborations, which highlight Neurocrine's entry into the field of precision medicine through our focus on rare pediatric epilepsy. Firstly, in December, we announced an important collaboration with Xenon Pharmaceuticals, gaining exclusive rights to NBI-921352, a promising first-in-class molecule which potently and selectively inhibits the NAV1.6 sodium channel. We believe this molecule could have great promise in the treatment for SCN8A developmental encephalopathy, or 8A for short, a rare and devastating type of pediatric epileptic disorder, specifically 8A very often presents in the first few months of life and causes a chronic and complex seizure disorder with developmental delays. In addition, sudden unexpected death can occur in 10 to 20% of patients with 8A.

Currently available treatments.

Beyond day to day NB <unk> nine to 135 to also has great potential in a range of seizure disorders, including adult focal epilepsy.

We plan to file an I.M.D. application for this molecule with the FDA in the middle of Twentytwenty in order to start a phase two trial in 80 patients in the second half of this yet.

Secondly in January we disclose that we entered into an agreement with I don't see a which includes the option to exclusively licensed 87.9478.

A potent selective orally active and brain penetrant t. tight calcium channel blockers, which is completed phase one clinical studies as a potential treatments for rare pediatric epilepsy.

Pending approval of the I N. D. Later this year, we plan to initiate a phase two study in a rare pediatric epilepsy, starting in the second half of this year.

In addition to the treatment of epilepsy. This mechanism has potential application across a broad range of important neurological disorders, including essential tremor and pain.

Our collaboration but I don't see and xenon.

Kevin C. Gorman: For the first time, with NBI 921352 and its Selective Mechanism of Action, we plan to precisely target the ion channel implicated in 8A and offer the opportunity to provide a significantly improved benefit-risk profile for these patients relative to currently available treatment. Beyond 8a, NBI 921352 also has great potential in a range of seizure disorders, including adult focal epilepsy. We plan to file an IND application for this molecule with the FDA in the middle of 2020 in order to start a phase 2 trial in 8A patients in the second half of this year. Secondly, in January, we disclosed that we had entered into an agreement with Eidosia, which includes the option to exclusively license ACT709478, a potent, selective, orally active, and brain-penetrant T-type calcium channel blocker, which has completed Phase I clinical studies as a potential treatment for rare pediatric epilepsy.

Competitive in fact, they are highly complementary and reinforced our commitment to addressing the needs of patients Bowen with rare and devastating forms of epilepsy <unk> currently available treatment options are largely inadequate.

It is our expectation to have these two molecules in phase two in rare pediatric epilepsy by the end of this yet.

Through our internal research efforts and through collaboration agreements with the xenon idols, Yeah, I'm Dod gene therapy programs with Voyager, we've nearly doubled in Europe cranes pipeline over the last 12 month.

Programming, all growing pipeline has the potential to make a dramatic impact on the lives of patients and their families and I'd like to close by thanking the many cross functional teams that neurocrine and that's our partner companies for their hard work to advance. These important molecules Kevin. Thank you I agree so we're a ready to take.

Your questions at this time.

And if he'd like to ask a question today. Please press Star then one I'm not touchtone telephone you need withdraw your question not anytime bypassing the top key to ensure because everyone's questions. Today, all participants will be allowed one question and one follow up question only once again.

Star then one for questions and we'll take our first question at the day some disease Ahmad from Bank of America. Please go ahead. Your line is open.

Good afternoon. Thanks, so much for taking my question, maybe I ran a question for you I committed to point to say that the program.

Kevin C. Gorman: Pending approval of the IND later this year, we plan to initiate a Phase 2 study in a rare pediatric epilepsy starting in the second half of this year. In addition to the treatment of epilepsy, this mechanism has potential application across a broad range of important neurological disorders, including essential tremor and pain. Our collaborations with Eidosia and Xenon are not competitive; in fact, they are highly complementary and reinforce our commitment to addressing the needs of patients born with rare and devastating forms of epilepsy, for whom currently available treatment options are largely inadequate. It is our expectation to have these two molecules in Phase II for rare pediatric epilepsies by the end of this year. Through our internal research efforts and through collaboration agreements with Xenon, iDOSIA, and our gene therapy programs with Voyager, we've nearly doubled Neurocrine's pipeline over the last 12 months. Each program in our growing pipeline has the potential to make a dramatic impact on the lives of patients and their families. And I'd like to close by thanking the many cross-functional teams at Neurocrine and at our partner companies for their hard work to advance these important molecules. Kevin? Thank you, Eiry.

That you are partnered with with the Dorsey and seen on or not competitive with each other when do you think you would be in a position to talk about what specific indications he would be pursuing for from one or both of these programs and also how you're thinking about the general epilepsies space. It it does seem to be getting.

Crowded with with various mechanisms of action of drugs that are that are being investigated thanks.

Thanks, very much for that so first of all I mean, obviously many of their drugs that are currently used in the epilepsy safe, particularly in the broader more generalized epilepsies are actually I'm very old and in fact I am in terms of that benefit risk profile. We believe there is a significant opportunity still to sort of.

Patients and not broad epilepsy.

Environment, Yeah, if we think about the two mechanisms that we're focused on here, although sodium channel blockade on calcium channel blockers would have been the mainstay of treatment in epilepsy over the long standing Pos.

Sodium channel approach here with the xenon collaboration gives us the opportunity to target very specifically one of the sodium channels through not 1.6 and in doing that we believe we have the opportunity to much more selectively and on the precise way address the symptoms of epilepsy.

First obviously in the rare <unk> C N a pediatric epilepsy, but beyond that more broadly in adult focal epilepsy with respect to the other collaboration with I don't see a obviously we are still in the auction phase of that agreement on once we have the off the two.

Operator: Thank you, Eiry. So we're ready to take your questions at this time.

Operator: And if you'd like to ask a question today, please press star and then one on your touchtone telephone. You may withdraw your question at any time by pressing the pound key. To ensure we get to everyone's questions today, all participants will be allowed one question and one follow-up question only. Once again, it's star, then one for questions. And we'll take our first question of the day from Tazeen Ahmad from Bank of America. Please go ahead; your line is open. Good afternoon. Thanks so much for taking my questions. Maybe, Eiry, a question for you. You made it a point to say that the programs that you're partnered with, with Adorcia and Xenon, are not competitive with each other. When do you think you will be in a position to talk about what specific indications you would be pursuing for one or both of these programs?

Unity to talk more about that as VI, India is approved then we'll be able to say more about the potential indications the doctor collaboration.

Okay. Thank you.

Thank you.

We'll go next to upon the teachers with Stifel. Please go ahead.

Great. Thanks for taking my questions just starts you on aggressive.

I was wondering your comment a little bit on what you're seeing a with respect to contracting what fortunately for this year.

Huh.

Without certain plan picking one of the grads are you do it hurt but that not being rate limiting forgetting agreed to access.

So that dynamic is in Europe, and then second as it relates to what this year with about as.

Being a player this quarter and then also potential $11 million inventories headwind.

Is there risk that we could actually see the sequentially down quarter, how hard and thinking about that as the inventory not all at once or maybe overtime. Thanks, so much for any color.

Eiry W. Roberts: Thanks very much for that. First of all, I mean, obviously, many of the drugs that are currently used in the epilepsy space, particularly in the broader, more generalized epilepsies, are actually very old. And, in terms of their benefit-risk profile, we believe there is a significant opportunity still to serve patients in that broad epilepsy environment. And in doing so, we believe we have the opportunity to much more selectively and in a precise way address the symptoms of epilepsy, first, obviously, in the rare SCN8A pediatric epilepsy, but beyond that more broadly in adult focal epilepsy. With respect to the other collaboration with ADORCIA, obviously, we are still in the auction phase of that agreement, and once we have the opportunity to talk more about that as the IND is approved, then we'll be able to say more about the potential indications for that collaboration.

Hi, Paul will take those question sort of in reverse order. So as we think about the first quarter onto your 0.0, what we reported in Q4 was $238 million enough product sales that including <unk> and 11 million dollar inventory build so the right jump off point for Q4 would be to 27 now as you think.

About how that translates to Q1, there's really three dynamics at play that we would want to make sure everybody thinks about.

In forming a consensus and expectations for Q1, the first one being the gross to net discount Q1 is always our largest gross to net discount period because of Medicare part D Donut hole and commercial co pay assistance and as you think about what I said last year. Many people have estimated the impact of that.

Could be between four and 5%.

Sequentially as you think about Q4 versus Q1, so I think that's probably a directional number the second piece, which is actually the most material piece has to do what the delays that occur at the beginning of each year as as patients go through a reauthorization process with their existing plans and what occurs and that is it's just an.

Operator: Okay, thank you. Thank you. And we'll go next to Paul Matisse with the CFO. Please go ahead.

Extended cycle time for a patient to get their first Phil and ultimately leads to a lower refill rate.

Operator: Great. Thanks so much, Jake, for answering my questions.

Per per patient now the rate may be very similar this year as compared to last year, but the dollar magnitude will be significantly greater because we've actually doubled the number of patients on INGREZZA. If you compare this time.

Operator: Just two on Ingresa. I was wondering if you could comment a little bit on what you're seeing with respect to contracting, what you foresee for this year. In the past, you've talked about certain plans, picking one of Ingresa or Aceto as preferred, but that not being rate-limiting for getting Ingresa access.

Now it took to last year.

And just by way of illustration if you.

Just to frame out the quantification and is that on average a patient had a reduction of 0.25 scripts within the first quarter that would have a sequential headwind headwind of between four and 5000 trx. So it could be a meaningful impact it's not unique to us this happens to many of them.

Matthew C. Abernethy: Maybe you can just speak to if that dynamic is continuing. And then second, as it relates to 1-2, with seasonality being a player this quarter and then also a potential $11 million inventory headwind, is there risk that we could actually see a sequentially down quarter? How are you thinking about that? Is that inventory going to pull out all at once or maybe over time? Thanks so much for any comment.

Our specialty tier medicines and it is clearly not a reflection of the underlying demand for in Brazil purely just the fulfillment a challenge that you work through and the teams are working hard through right now.

In the third item.

The inventory bleed that you just brought up.

We have about 11 million dollar bill it's hard to predict.

Matthew C. Abernethy: Yeah, hi, Paul, we'll take those questions sort of in reverse order. So as we think about the first quarter, to your point, what we reported in Q4 was $238 million in net product sales that included an $11 million inventory build. So the right jump-off point for Q4 would be 227. Now, as you think about how that translates to Q1, there are really three dynamics at play that we would want to make sure everybody thinks about in forming consensus and expectations for Q1. The first one being the growth to net discount.

About will materialize in the first quarter, but surely something that should be on your radar as far as.

Setting expectations and I'd, just say, although I'm highlighting all these Q1 dynamics the real emphasis here just to make sure people understand and set appropriate expectations for the first quarter, but it does not reflect a our long term belief in the opportunity that we have within 2020.

To help many more patients within Graz, though we're in the mid teens of diagnosis with a fraction of that actually receiving treatment. We have a lot of opportunity ahead of us but very complicated.

But but we're working through those Q1 dynamic and we wanted to make sure we provided adequate color anything else there.

Yeah, Paul if I remember correctly. The first part of your question was really related to contracting activity and sort of expectations.

Matthew C. Abernethy: Q1 is always our largest growth to net discount period because of the Medicare Part D donut hole and commercial copay assistance. And as you think about what I said last year, many people have estimated the impact of that could be between 4% and 5% sequentially as you think about Q4 versus Q1. So I think that's probably a directional number.

Coverage in 2020.

So I'll start off by saying that patient access is critically important for us and throughout the course of the launch Weve invested significantly in making sure that patients and providers have relatively open access to INGREZZA. This is a specialty medication virtually all the prescriptions require.

Prior authorization through the plan before claims are approved in the patient can initiate treatment.

Matthew C. Abernethy: The second piece, which is actually the most material piece, has to do with the delays that occur at the beginning of each year as patients go through the reauthorization process with their existing plans. And what happens in that is it's just an extended cycle time for a patient to get their first fill, which ultimately leads to a lower refill rate per patient. Now, the rate may be very similar this year as compared to last year, but the dollar magnitude will be significantly greater because we've actually doubled the number of patients on Ingressa as compared to this time last year. And just by way of illustration, and just to frame out the quantification, is that if on average a patient had a reduction of 0.25 scripts within the first quarter, that would have a sequential headwind of between 4,000 It's not unique to us. This happens to many that are specialty tier medicines, and it is clearly not a reflection of the underlying demand for Ingressa. It's purely just a fulfillment challenge that you work through, and the teams are working hard on it right now. And then the third item is the inventory bleed that you just brought up.

But we've really been I'm very pleased with the success that we've had through the early days a launch and all the way up you know to current times with over 70% of written prescriptions being filled and from an affordability perspective, three quarters of patients paying less than $10 per month for Phil.

So in the more recent phase of the launch we started to gather more attention from heres as INGREZZA has become a larger brand and certainly you know we've said previously that we started to engage selectively with plans in terms of contracting activity.

And I will reemphasize that we're selectively because over the course of the launch we've we found that regardless of whether we were on formulary or not on formulary, we've been successful in securing approval or helping to secure approval for for patients in need of INGREZZA.

So where we stand today is that you know were approximately a month into the quarter in a month into the year, we feel good about.

The coverage landscape looks like for INGREZZA.

We expect access remains strong in 2020 and as Matt said in his prepared remarks, we expect a net revenue per script in 2020 to be similar to what it wasn't 2019 as well and about the only thing that I would like to add to what Matt and and Eric of said is that you know the.

The good news is that we start 2020 with nearly twice as many patients as we started 2019 and that's great. It shows the acceptance.

Eric S. Benevich: We have that $11 million build. It's hard to predict. How that will materialize in the first quarter, but it's surely something that should be on your radar as far as setting expectations is concerned. And I just say, although I'm highlighting all these Q1 dynamics, the real emphasis here is just to make sure people understand and set appropriate expectations for the first quarter. But it does not reflect our long-term belief in the opportunity that we have within 2020 to help many more patients within Graza. We're in the mid-teens of diagnosis, with a fraction of that actually receiving treatment. We have a lot of opportunity ahead of us, but it's very complicated. But we're working through this Q1 dynamic, and we wanted to make sure we provided adequate color. Anything else?

Of INGREZZA in the patient population and also by our our customers the Allied health professionals, but the downside if that is as we've talked about it leads to a odd the challenge in a in Q1 and you have seen in the past and as we talk about before.

That it's an ebb and flow. So Q1 is is the up Q2 generally is the flow as we come out of it and we have a strong year. So that as we just wanted to be able to give as much color to this quarter and to the year as we could on this call.

Great. Thank you very much appreciate the detail.

And next well go to Brian Skorney with Baird. Please go ahead.

Hey, good afternoon, everyone. Thanks for taking my question I guess, maybe if I can ask about you see T. 7094, 78 program and just kind of walk us through your thoughts on the development program. How you envision this drug being used and maybe your thoughts on on clinical trial design and.

Eric S. Benevich: Yeah, Paul, if I remember correctly, the first part of your question was really related to contracting activity and sort of expectations for coverage in 2020. So I'll start off by saying that patient access is critically important for us. And throughout the course of the launch, we've invested significantly in making sure that patients and providers have relatively open access to Ingresa because this is a specialty medication. Virtually all the prescriptions require prior authorization through the plan before those claims are approved, and the patient can initiate treatment. But we've really been very pleased with the success that we've had through the early days of the launch and all the way up, you know, to current times, with over 70% of written prescriptions being filled.

Mechanism, how you can overcome some of the difficulties others have had and developing.

Recent rather than epileptic indication.

What about.

We're primarily but also do walk you type calcium channels and where do you envision. This phase two study being lets people controlled or a comparator study.

Thanks for the question, Brian So I think just and as an initial statement with respect to the mechanism of action of the I don't see a molecule. This is a very highly potent and very brain penetrant calcium channel antagonist and.

We believe that those cost him on China channel antagonist that have been used in the past I'm quite extensively form the mainstay all epilepsy treatment really haven't been able to fulfill the promise of that mechanism because of the low potency on the relationship that has to the inability to dose to doses that can.

Eric S. Benevich: And from an affordability perspective, three-quarters of patients paying less than $10 per month per fill. So in the more recent phase of the launch, we started to gather, you know, more attention from payers as Ingresa has become a larger brand. And certainly, you know, we've said previously that we started to engage selectively with plans in terms of contracting activity. And I will reemphasize the word selectively because, over the course of the launch, we found that regardless of whether we are on formulary or not on formulary, we've been successful in securing approval or helping to secure approval for patients in need of Ingresa. So where we stand today is that, you know, we're approximately a month into the quarter and a month into the year. We feel good about what the coverage landscape looks like for Ingresa. We expect access to remain strong in 2020, and as Matt said in his prepared remarks, we expect the net revenue per script in 2020 to be similar to what it was in 2019.

Produce the required efficacy without side effect issues on in many cases off target side effect challenges as well and so in terms of that alone. We believe that is a significant opportunity to demonstrate value through this mechanism in the field of epilepsy I can't really comment on the.

Ah development plan for this molecule specifically as I mentioned earlier, we still in the option phase a with this collaboration on but we are very excited about the opportunity to to move forward in this space and we hope that the I N. D becomes approved later this year that we'll be able to say a lot more about our intention.

Move this molecule forward in this space of initially rare pediatric epilepsy, but subsequently more broadly and other areas such as though as I mentioned earlier essential tremor and potentially paying.

Great. Thank you.

And next well go to Brian Abrams with RBC capital markets. Please go ahead.

Hey, guys is going on for Brian. Thanks for a thanks for taking my question here. So.

Two from me first on the T.H. program I know the data is coming in in March just wondering if you could give a little more color on maybe what we should expect to see there whether youre reports sort of patient by patient or whether you'll have a responder analysis versus absolute reductions in the Biomarkers and then second one actually on auto pick up on I'm just one.

Kevin C. Gorman: And about the only thing that I would like to add to what Matt and Eric have said is that, you know, the good news is that we start 2020 with nearly twice as many patients as we started 2019. And that's great. It shows the acceptance of Ingresa by the patient population and also by our customers, the allied health professionals.

During about how that how the familiarity is with the U.S. physician population given that the drugs been approved in Europe, and maybe there's some some cross talk there just general familiarity with with the drug in the approach that could potentially drive drive the launch. Thanks, Oh, sorry, so and first with C. H and we will be reporting the data from.

Operator: Great. Hey, thank you very much. I appreciate the detail.

Operator: And next, we'll go to Brian Skorney with Baird. Please go ahead.

Eiry W. Roberts: Hey, good afternoon, everyone. Thanks for taking my question. I guess maybe if I can ask about the ACT 709478 program, can you just kind of walk us through your thoughts on the development program, how you envision this drug being used, and maybe your thoughts on clinical trial design and mechanism and how you can overcome some of the difficulties others have had in developing recent drugs and epileptic indications, specifically thinking about some of the recent neurosteroids that are primarily GABAergic but also do block T-type calcium channels And would you imagine this Phase II study being placebo-controlled or a comparator study?

All four cohorts of the adult proof of concept study as that I think we've mentioned before the design of that study was an adopted study which allowed us to look at optimizing both sides dose and dosing schedule for the CH program and a molecule connect the font in adult.

In terms of the type of data, we will be presenting obviously that is a at 14 day treatment proof of concept study. So we won't be presenting both summary on individual data around the biomarkers measured.

Several different approaches to the analysis of those data.

As I think I mentioned earlier that a presentation will be an oral presentation on March lessons here.

In San Francisco about the Endo meeting beyond that I will vary and I'm pleased with what we always this ph program. Both in adults armed in Pediatrics, we received clarity on the adult Registrational path forward at the end of last year from agencies, both in the U.S. on Europe on.

Eiry W. Roberts: Thanks for the question, Brian. So, just as an initial statement with respect to the mechanism of action of the idosia molecule, this is a very highly potent and very brain penetrant calcium channel antagonist, and we believe that those calcium channel antagonists that have been used in the past and quite extensively form the mainstay of epilepsy treatment. But we are very excited about the opportunity to move forward in this space, and we hope that as the IND becomes approved later this year, we'll be able to say a lot more about our intention to move this molecule forward in the space of initially rare pediatric epilepsy but subsequently more broadly in other areas such as those I mentioned earlier, essential tremor, and potentially pain. All right, thank you.

Moving ahead to implement the adult registration trial, which will be a global trial starting in the middle of this year and we continue to make progress with the pediatric program as well with respect to pick upon medical affairs organization in preparation for the.

Upcoming PDUFA dates in April has been working hard with than urology community to help educate around the role of cone, we believe that there's been.

No it little opportunity to deliver on the promise of comp for the currently available Comped inhibitors.

Operator: And next, we'll go to Brian Abrahams with RBC Capital Markets. Please go ahead.

But that are available to us right now and so as we interact with neurologists, we hear excitement from those.

Eiry W. Roberts: Hey guys, this is Owen on for Brian. Thanks for taking the question here. So, two for me. First, on the CAH program. I know the data is coming in March. Just wondering if you could give a little more color on maybe what we should expect to see there, whether you'll report sort of patient by patient or whether you'll have a responder analysis versus absolute reductions in the biomarkers. And then, actually, on Opicapone, just wondering about how familiarity is with the U.S. physician population given that the drug's been approved in Europe and maybe there's some crosstalk there, Thanks.

Prescribers about the opportunity to bring forward another potential option for their patients and moved to fluctuations in particular, we're very encouraged by the profile that we see for a pick up on its a very straight forward once a day treatment with.

An extensive clinical trial program that demonstrated I really favorable benefit risk profile and a and we have very much looking forward to bring that fourth for patients in the United States.

Great. Thank you.

And next well go to honor Rama with JP Morgan. Please go ahead.

Hi, great that asking this is tough on the call today.

Eiry W. Roberts: Well, thanks, Owen. First, with CAH, we will be reporting data from all four cohorts of the adult proof-of-concept study. As I think we've mentioned before, the design of that study was an adaptive study, which allowed us to look at optimizing both dose and dosing schedule for the CAH program in molecule chronesophon in adults. In terms of the type of data we will be presenting, obviously, that was a 14-day treatment proof-of-concept study, so we will be presenting both summary and individual data around the biomarkers measured and several In particular, we're very encouraged by the profile that we see for Opicapone. It's a very straightforward once-a-day treatment with an extensive clinical trial program that demonstrated a really favorable benefit-risk profile, and we're very much looking forward to bringing that to patients in the United States.

Thank you for for taking my question here, a little ones in my Hmm.

<unk> can be.

Perhaps you know where do you feel that gating factor through a machine that study I think that.

By themselves the first half of this yeah, and then moving my comment on overall rationale to pursue.

Can you give on competition in this space.

Thanks, so much.

Thanks, very much tests as Irene Yeah first of all just a clarification, we actually did initiate the connect H.D. study at the end of last year in November and just as a reminder, that is a phase three placebo controlled study of 120 subjects with.

Yeah, and Huntingtons disease, I, comparing valbenazine to up to see Boeing not population and we anticipate that that study of the 120 subjects will be enrolled over this year and that we will have data sometime in 2021 and the Oh Wow.

It's back to can you remind me the second part of your question that's right.

Operator: Great, thank you.

Yeah, So oh no.

Yeah, I'm realizing that the study and then machine has initiated right I'm wondering overall rationale indication given overall competition among them, maybe how you're thinking about differentiation relative to tevas asking you get ido within the form application. Okay. Okay fine. So so they're up there.

Operator: And next, we'll go to Anupam Rama with J.P. Morgan. Please go ahead. Hi, great, good afternoon. This is Tessa on the call today for Anupam.

Eiry W. Roberts: Thank you for taking our questions here. Maybe one from us on the CONNECT-HG study in Huntington's disease. Perhaps you might review for us any dating factors for initiating that study. I think that guidance there is for the first half of this year. And then maybe you might comment on the overall rationale to pursue this indication given competition in the space. Thank you so much.

2000 patients in the United States is huntingtons disease, all that population about 80% to 90% to them have troublesome Korea, but even though the be not to mechanism has been proven and not a patient population. That's still only about 20% of those patients with Korea that received treatment with a V not two inhibitor.

And so from that perspective, we believe there's significant opportunity left.

That said these patients and what we're particularly interested in is the profile, but we have all fall benefiting with its once a day treatment simple tightrail action on favorable benefit risk profile.

Eiry W. Roberts: Thanks very much, Tessa. It's Eiry here.

Eiry W. Roberts: First of all, just for clarification, we actually did initiate the CONNECT-HD study at the end of last year in November. And just as a reminder, that is a Phase 3 placebo-controlled study of 120 subjects with Chorea in Huntington's disease, comparing valbenazine to placebo in that population. And we anticipate that that study of 120 subjects will be enrolled this year and that we will have data sometime in 2021. With respect to... Can you remind me the second part of your question, Tessa? Sorry

Great.

How much we're taking a question.

And we'll take our next question from Jay Olson with Oppenheimer. Please go ahead.

Okay. Thanks for taking the question and congrats on all the business development activity in 2019 I was wondering if you could comment on a your plans for BD and 2020 should we expect you to do more of the types of deals that you did.

Last year, and then separately any comments you could make on the timeline.

Eiry W. Roberts: Yeah, sorry, I may not have come through clearly, realizing that the study has begun, right? I'm wondering about the overall rationale for the indication, given overall competition, and then maybe how you're thinking about differentiation relative to Teva's osteo within the same indication.

For the collaboration with Voyager on Parkinson's disease gene therapy.

What are the next.

Data read outs, there and how you see the competition shaping up.

[music].

Okay.

Hi, This is Kyle thanks for the question on the on the BD front.

Right now there's lot of great science.

Going on outside the doors here of NERC on and we appreciate that and considering our long term goal here is to be a leading.

Eiry W. Roberts: Okay, okay, fine. So, there are 30,000 patients in the United States with Huntington's disease. Of that population, about 80 to 90% of them have troublesome careers, but even though the VMAT-2 mechanism has been proven in that patient population, there's still only about 20% of those patients with careers that receive treatment with a VMAT-2 inhibitor. And so, from that perspective, we believe there's a significant opportunity left to serve these patients. And what we're particularly interested in is the profile that we have of valbenazine with its once-a-day treatment, simple titration, and favorable benefit-risk profile.

Neuro Science company.

Number one what those studies and products in various markets no. It's our goal here at American to invest both internally and externally. So we'll continue to look for projects that are aligned with our strategic thoughts and goals and objectives here and if we find a good fit well look at bringing the project in house, So I think that the.

The party word here as we continue to be active in business development and looking to bring new programs and the company's they make sense.

On the Voyager collaboration we had interactions with the agency towards the end of last year, which gave US good clarity on the registration program for.

Parkinson's disease, a we got clarity on the Mystore one trial on how we could ensure that that was viewed as a registration quality study that involves an amendment to that call and when moving forward with implementing the amended restore one protocol at right now in parallel with.

Operator: Great. Thanks so much for taking our questions. And we'll take our next question from Jay Olson with Oppenheimer. Please go ahead.

We're also starting at Bristow to the second pivotal trial that will be a global try them, we'll be starting later this year.

The only thing I'd actually is a we will be releasing the 36 month data from the P.D. 11, No. One study, which was the dose finding study I am a and this year.

Kyle Gano: Thanks for taking the question and congratulations on all the business development activity in 2019. I was wondering if you could comment on your plans for business development in 2020. Should we expect you to do some more of the types of deals that you did last year? And then separately, any comments you could make on the timeline for the collaboration with Voyager on Parkinson's disease gene therapy? What are the next data readouts there, and how do you see the competition shaping up?

Great. Thank you very much.

Thank you and next well go to Barack Christiansen with Cowen. Please go ahead.

Great. Thanks for taking my question I guess going back to see age I'm curious if the endo data that you're planning on presenting in March will include and analysis comparable to what we can expect in the Registrational trial, whether you'll be looking at the same primary endpoint plans for that trial and then.

Kyle Gano: Hi, this is Kyle. Thanks for the question. On the BD front, right now, there's a lot of great science going on outside the doors here at Neurocrine, and we appreciate that. And considering our long-term goal here is to be a leading neuroscience company and a global one with studies and products in various markets, it's our goal here at Neurocrine to invest both internally and externally. So we'll continue to look for projects that are aligned with our strategic thoughts, goals, and objectives here. And if we find a good fit, we'll look at bringing the project in-house. The parting word here is that we will continue to be active in business development and looking to bring new programs into the company if they make sense.

Secondly in your interactions with the FDA [laughter] you have a sense of how important it has to show that the drug allows for reduction in steroids and if that will be part of T. alternative dosing regimen I wonder if the cohorts that will be presented.

Thanks.

Well initially the proof of concepts that he is a two week studying dosing in adult.

Subject on the outcomes looked at and not exploratory study, where the on hormone biomarker levels and so that's what we will be presenting together with obviously the full tolerability profile. The endo meeting with respect to the endpoints for the registration trial, we haven't commented to.

Any great extent on that as soon as the trial would like actually is up and running we will post on clinical trials Dot Gov, and obviously that will include a full description of the study design on the the sample size and also the endpoints that when looking at its clear, though that the I stared at home.

Kyle Gano: On the Voyager collaboration, we had interactions with the agency towards the end of last year, which gave us good clarity on the registration program for Parkinson's disease. We got clarity on the Restore One trial and how we could ensure that that was viewed as a registration quality study. That involves an amendment to that protocol, and we're moving forward with implementing the amended Restore One protocol right now. In parallel, we're also starting up Restore Two, the second pivotal trial. That will be a global trial, and we'll be starting later this year. The only thing I'll add, actually, is that we will be releasing the 36-month data from the PD1101 study, which was the dose-finding study at AAN this year.

Among levels.

I'm proud of this diseases managed on how.

Patients could be impacted by a novel treatment and so that will be a core part of the program moving forward. It's also very important to us that we understand steroid dosing in the context of use of this new novel non steroids mechanism.

Perfect. Thank you.

Thank you and next well go to Charles Duncan with Cantor Fitzgerald. Please go ahead.

Hi, Kevin and team. Thanks for taking my question, saying congratulations on a very good years and Cressa gross [laughter]. My first question is related to continued and grass fed grows to not be overly simplistic, but wondering if you could point to just one key drivers that you would highlight.

Kyle Gano: Great, thank you very much.

Light as important to you executing your business plan this year to driving graduate growth would it be additional or increase diagnosis additional penetration in new or existing prescribers or you know such as pricing change, but what is the one thing that you want to see happening.

Operator: Thank you. And next, we'll go to Laura Christensen with Cowen.

Eiry W. Roberts: Please go ahead. Great, thanks for taking my question. I guess going back to CAH, I'm curious if the ENDO data that you're planning on presenting in March will include an analysis comparable to what we can expect in the registrational trial, whether you'll be looking at the same primary endpoint planned for that trial, and then, secondly, in your interactions with the FDA, if you have a sense of how important it is to show that the drug allows for a reduction in steroids, Thanks.

Sure.

Yes.

Hi, Charles This is Derek all actually gives you too.

Okay. We.

Mentioned earlier, the hair dynamics in Q1, and the fact that we've got a plan in place to mitigate the impact of all these patients that require.

Reauthorization or patients that are switching plans et cetera et cetera. So you know one of the priorities for our team is to make sure that we're executing against that plan minimize the impact on that all these beginning of the year pair dynamics can have on disrupting treatment and make sure that were really fell.

Eiry W. Roberts: Well, initially, the proof-of-concept study was a two-week study of dosing in adult subjects, and the outcomes looked at in that exploratory study were hormone biomarker levels. And so that's what we will be presenting together with, obviously, the full tolerability profile at the ENDO meeting. With respect to the endpoints for the registration trial, we haven't commented to any great extent on that. As soon as the trial actually is up and running, we will post that on clinicaltrials.gov, and obviously, that will include a full description of the study design and the sample size and also the endpoints that we're looking at. It's clear, though, that steroid hormone levels are part of how this disease is managed and how patients could be impacted by a novel treatment. And so that will be a core part of the program moving forward. It's also very important to us that we understand steroid dosing in the context of the use of this new novel non-steroid mechanism.

Focused on executing that as well as a driving new patient starts in Q1, you may recall that last year Q1 was really a tale of two half quarters. The first half of Q1.

Was a strong focus on making sure that any patients that were experiencing treatment lapses, we're able to get back on treatment second half the quarter, we saw a real surge in new patient starts and so we want to make sure that we're executing against our plan in Q1 and setting ourselves up nicely for the rest of the year.

And then you know as Matt mentioned earlier as yet almost three years into this launch.

The vast majority of patients with tardive dyskinesia have yet to be diagnose we think that diagnosis rates are in the in the mid to high teens Ah. So that means over 80% of people out there that have TD haven't been given the diagnosis and haven't been offered treatment for it. So the focus and has been and will remain for.

Quite some time to bridge that gap between the.

Kevin C. Gorman: Perfect. Thank you. Thank you. And next, we'll go to Charles Duncan with Cantor Fitzgerald. Please go ahead.

The undiagnosed patient population and the prevalent population and so we're going to continue to focus on disease recognition, helping to improve the diagnostic acumen.

Eric S. Benevich: Hi Kevin and team, thanks for taking my questions and congratulations on a very good year of Ingressive Growth. My first question is related to continued Ingressive Growth, and not to be overly simplistic, but I'm wondering if you could point to just one key driver that you would highlight as important to you executing your business plan this year to drive Ingressive Growth. Would it be additional or increased diagnosis, additional penetration in newer or existing prescribers, or such as a pricing change? What is the one thing that you want to see happen this year?

Prescribers that are out there.

We've also been investing in helping patients to recognize when they're experiencing PD system or what may be TD and encouraging them to have a conversation with their doctor and as you're probably aware one of the.

Big ticket items in our plan this year at last year in into this year has been our unbranded.

DTC disease awareness campaign called talk about Cds. So we're going to continue to execute on our plan. We're continuing to educate providers on what is TV and what isn't TD the benefits of INGREZZA.

Finally at work.

And the.

Reductions of on involuntary movements that are seen in our clinical data.

Eric S. Benevich: Hi Charles. This is Eric. I'll actually give you two. Okay.

But getting getting a good start in Q1 mitigating the impact of hair disruption.

Eric S. Benevich: We mentioned earlier the pair dynamics in Q1 and the fact that we've got a plan in place to mitigate the impact of all these patients that require reauthorization or patients that are switching plans, et cetera, et cetera. So one of the priorities for our team is to make sure that we're executing against that plan, minimize the impact that all these beginning-of-the-year pair dynamics can have on disrupting treatment, and make sure that we're really focused on executing that as well as driving new patient starts in Q1. You may recall that last year Q1 was really a tale of two half-quarters.

They're continuing to raise awareness and driving diagnosis of TD, you're going to be key for us in 2020.

Perfect that's helpful.

Hi, Eric I appreciate that added color. One quick question I'll pick Apone. When you look at the opportunity set there is it one that will be measured by initial prescriptions for open component. The P D community or increase mindshare with <unk> within the neurology and.

Thanks for taking the questions.

Sure.

You had commented a little bit earlier about the receptivity that we've seen thus far here in our and our preparation for and launch later this year.

I will say that given the established treatment options, it's going to take time for us to remind people about the role of Oh comped in optimizing leave it open therapy.

Eric S. Benevich: The first half of Q1 was a strong focus on making sure that any patients that were experiencing treatment lapses were able to get back on treatment. In the second half of the quarter, we saw a real surge in new patient starts, and so we want to make sure that we're executing against our plan in Q1 and setting ourselves up nicely for the rest of the year. And then, as Matt mentioned earlier, as yet, almost three years into this launch, the vast majority of patients with tardive dyskinesia have yet to be diagnosed. We think that diagnosis rates are in the mid to high teens, so that means over 80% of people out there that have TD haven't been given a diagnosis and haven't been offered treatment for it.

This is a little bit of any unusual dynamic and that all the clinical studies in there for all the clinical experience. Thus far is outside of the U.S.

So for a the average neurologists or community physician. This treating parkinsons patients that may not be aware or that familiar with a pick up on I will say, though that key opinion leaders thought leaders in movement disorders, specifically Parkinson's are generally familiar with the data on or enthused.

He asked about having this new.

Treatment option available to them the other side of NFC approval. So we're doing the work to prepare now for an eventual launch later this year.

Certainly a as I already mentioned the medical organization has started that process of reminding people about the important role Compton optimize and leave it open treatment.

Eric S. Benevich: So the focus has been and will remain for quite some time to bridge that gap between the undiagnosed patient population and the prevalent population, and so we're going to continue to focus on disease recognition, helping to improve the diagnostic acumen of the prescribers that are out there. We've also been investing in helping patients to recognize when they're experiencing T.D. symptoms or what may be T.D. and encouraging them to have a conversation with their doctor. And, as you're probably aware, one of the big ticket items in our plan this year, last year, and into this year has been our unbranded DTC Disease Awareness Campaign called Talk About T.D. So we're going to continue to execute on our plan. We're continuing to educate providers on what TD is and what isn't TD, and the benefits of Ingresa.

And as you may recall, when we expanded our field sales team towards the end of 2018. It was a with dual goals in mind to optimize the team for the TD opportunity, but also to prepare for the eventual launch in Parkinson's disease. So we've got our team in place we cover all of the move and just.

Order specialists that are out there.

And as we progress towards the launch we're going to be doing additional things like training our team on disease state and so on so that we can be well prepared to launch.

After we get an FDA approval.

He's for they added color.

Q and next well go to Paul choice with Goldman Sachs. Please go ahead.

Thank you and good afternoon, everyone I.

Two questions on credentialed upon for for CH.

First just on the pivotal trial design could you maybe just clarify for us whether you. This trial can be used for global Registrational purposes.

Eric S. Benevich: How quickly it works and the reductions in involuntary movements that are seen in our clinical data. But getting a good start in Q1, mitigating the impact of payer disruption, and then continuing to raise awareness and drive diagnosis of TD are going to be key for us in 2020.

And if you will have European sites on board I think in the past few you've talked about this being you know do your potential for actually becoming a a global company and selling in Europe and.

There are any and.

Kevin If you count can comment on that and the second question I have is just also on T.H. with regard to the.

Eric S. Benevich: Perfect. That's helpful, Eric. I appreciate the added color.

Pediatric phase two that's ongoing I didn't see it in the slides, but is the plan still to topline those results later this year.

Eric S. Benevich: One quick question on opicopone. When you look at the opportunity set there, is it one that will be measured by initial prescriptions for opicopone in the PD community or increased mind share within the neurology community? Thanks for taking the time to answer my question.

And could you maybe speak to the development path and the pediatric population and whether you intend to.

Pursue it and younger patients as well thank you.

Yeah. Thanks, Paul.

You are correct in in your recollection that.

This Ah this adult.

Eric S. Benevich: Sure, Eiry had commented a little bit earlier about the receptivity that we've seen thus far here in our preparation for a planned launch later this year. But I will say that, you know, given the established treatment options, it's going to take time for us to remind people about the role of COMPT in optimizing levodopa therapy. This is a little bit of an unusual dynamic in that all the clinical studies and, therefore, all the clinical experience thus far have been outside of the U.S. So for the average neurologist or community physician that's treating Parkinson's patients, they may not be aware or that familiar with a pick-up cone.

Phase three study we look at as a global registration study we've been in contact with.

Both the European regulatory agencies as well as the a as the FDA and so that is a that is what we're doing a little later this year as being able to do that.

With sites, all throughout Europe, and the United States.

And it will be a situation that we have reached the.

The level and the company of sophistication and resources that we can commercialize this ourselves over in Europe. So we would not be seeking a partner there and that would be our first foray into becoming a global pharmaceutical company and IRA you want to talk about the second.

Eric S. Benevich: I will say, though, that key opinion leaders, thought leaders in movement disorders, specifically Parkinson's, are generally familiar with the data and are enthusiastic about having this new treatment option available to them on the other side of an FDA approval. So we're doing the work to prepare now for an eventual launch later this year. Certainly, as Irie mentioned, the medical organization has started that process of reminding people about the important role of COMPT in optimizing levodopa treatment. And as you may recall, when we expanded our field sales team towards the end of 2018, it was with dual goals in mind, to optimize the team for the TD opportunity but also to prepare for the eventual launch in Parkinson's disease. So we've got our team in place. We have all of the movement disorder specialists that are out there, well-prepared to launch after we get FDA approval.

Half of Paul's question, So with respect to the pediatric program. The proof of concepts that he is obviously the first step in that regard and we continue to make progress with that that is a an adaptive trial similar to our previous adult proof of concept study I'm in power that was on ongoing study, though we are engaging with the regulated.

Both in the U.S. on Europe, right now to determine the registration trial design for the at pediatric indication, which will also be a global program and so as we go through this year and we gain more clarity on that we can certainly provide a in a more information.

And is the plan to go into younger patients as well versus the sort of teenagers that are currently being studied in the phase two yes, okay fine.

Thank you.

Thank you and next we'll go to Evan Siegelman with Credit Suisse. Please go ahead.

Hi, guys. Thank you for taking my question, it's great to see you a couple of weeks ago in San Francisco. One specific question. So when you think about the net well or the price increase you had mentioned how much about do you expect to get on a net basis and then my second question is just on a high level, what opportunity or opportunities do senior prom pipeline and portfolio.

Kevin C. Gorman: Thanks for the color. Thank you. And next, we'll go to Paul Troy with Goldman Sachs. Please go ahead.

Operator: Thank you and good afternoon, everyone. I had two questions on Cronosultant for CAH. First, just on the pivotal trial design, could you please just clarify for us whether this trial can be used for global registration purposes and whether you will have European sites on board? I think in the past, you've talked about this being your potential foray into becoming a global company and selling in Europe. And Irini and Kevin, if you could comment on that. And the second question I have is also on CAH with regard to the pediatric phase two that's ongoing. I didn't see it in the slides, but is the plan still to topline those results later this year? And could you maybe speak to the development path for the pediatric population and whether you intend to pursue it in younger patients as well? Thank you.

That could be as significant as impactful as INGREZZA.

Well I'll take the I'll take the second one Evan I think theres. Several several compounds that we have there that can be as impactful and even more impactful to patients.

Because of the devastating effects of these pediatric epilepsy that we see.

These these children. These babies need these medications like right now.

We have a tremendous sense of urgency in going forward.

Im going forward with those also within CH, there's been nothing for these patients.

For a four decades now and again the the impact that can be seen there, but at the end of the day I would say that you know.

It sounds it sounds trite.

But we wouldn't work on a clinical program or preclinical program for a research molecule or mechanism unless we thought that there was real impact that is going to be there and so with everything that were working to bring to market right now or whether you talked about a pick up home.

Kevin C. Gorman: Yeah, thanks Paul. You are correct in your recollection that this adult phase 3 study we look at as a global registration study. We've been in contact with both the European regulatory agencies as well as the FDA, and so that is what we're doing a little later this year, being able to do that with sites all throughout Europe and the United States. And it will be a situation where we have reached the level in the company of sophistication and resources where we can commercialize this ourselves in Europe. So we would not be seeking a partner there, and that would be our first foray into becoming a global pharmaceutical company. And Irie, do you want to talk about the second half of Paul's question? Yes, so with respect to the pediatric program, the proof of concept study is obviously the first step in that regard, and we will continue.

On a whether you talked about Huntingtons, whether you talk about uterine fibroids and I know that that's our partner the spring enough work, but there's millions of women suffering from that and as I said. These these these rare pediatric diseases.

Our work with Voyager on the programs that we have going on there. This is all something we don't we don't prioritize and rank here.

At American and we think that they all deserves our attention.

Evan This is Matt swung the net pricing front. If you recall, we took a price increase in the middle of November and Weve not disclosed exactly how much of that sticks.

But I would just tell you a large majority of that flows through.

Kevin C. Gorman: to make progress with that. That is an adaptive trial similar to our previous adult proof-of-concept study. In parallel with that ongoing study, though, we are engaging with the regulators both in the U.S. and Europe right now to determine the registration trial design for the pediatric indication, which will also be a global program. As we go through this year, and we gain more clarity on that, we can certainly provide more information.

But it's not a 100% so you would get about a half a quarter's benefit of that price increase in the in the first quarter.

Alright. Thanks, so much guys appreciate the color.

Thank you and we'll go next to do that and someone with Piper Jaffray. Please go ahead.

[noise]. Thanks, So just a couple on first on in Gray. So this is more of a longer term question regarding the payer landscape as were footprints other product grows.

And.

Given the commentary about Reauthorizations and in some of the things that you're working through at least.

In the first quarter as we think about in various beyond.

2020 should we thinking about a more restrictive.

Pair landscape, but do you expect that there's going to put up more roadblocks.

Eiry W. Roberts: and this is a plan to go into younger patients as well versus the sort of teenagers that are currently being studied in phase two. Okay, okay. Thank you.

As a as volumes for the product gross that's number one and then number two is on the coupon maybe a little bit early for you to talk about this but can you give us a sound so where do you think gross to nets will shake out on that product and also your expectation regarding a step edits and prior ops on that thanks.

Operator: Thank you. And next, we'll go to Evan Seigelman with Credit Suisse. Please go ahead.

Kevin C. Gorman: Hi guys, thank you for taking the question. It was great to see you a couple weeks ago in San Francisco. One specific question, so when you think about the net or the price increase that you had mentioned, how much of that do you expect to get on a net basis? And then my second question is, just on a high level, what opportunity or opportunities do you see in your pipeline and portfolio that could be as significant and impactful as Ingresa?

Yes, David So I'll comment on sort of.

How how we're thinking about the future from a payer perspective for INGREZZA.

We've got a little over two years in market now.

And actually we've been as I said earlier very pleased with the coverage that we've gotten and the high rate of of filled prescriptions versus written prescriptions.

You know we care a great deal about patient access and Weve invested heavily to make sure that patients that need INGREZZA can get access to it and we're going to continue to do so.

Kevin C. Gorman: Well, I'll take the second one, Evan. I think there are several compounds that we have there that can be as impactful and even more impactful to patients because of the devastating effects of these pediatric epilepsies that we see. These children, these babies need these medications right now. We have a tremendous sense of urgency in going forward with those. Also within CAH, there's been nothing for these patients for decades now. And again, the impact that can be seen there. But at the end of the day, I would say that, you know, it sounds trite.

You know you say that rightly that the profile of INGREZZA has grown as as a product has grown.

But the reality is that we've also been very heartened by the willingness of the providers to go through that necessary steps to get access for their patients.

Two INGREZZA odd to doing prior authorizations and providing the information that the health plans require in order to evaluate a.

Request for coverage.

The reality is that INGREZZA is the most preferred and the most prescribed Vms two inhibitor.

Kevin C. Gorman: But we wouldn't work on a clinical program or a preclinical program or a research molecule or mechanism unless we thought that there was real impact that was going to be there. And so with everything that we're working to bring to market right now, whether you talk about picapone, whether you talk about Huntington's, whether you talk about uterine fibroids, and I know that that's our partner that's bringing that forward, but there are millions of women suffering from those. And as I said, these rare pediatric diseases, our work with Voyager on the programs that we have going on there, this is all something we don't prioritize and rank here at Neurocrine. And we think that they all deserve our attention.

And I think thats reflected in the willingness to providers to go the to the go to the extra lengths and to go to the next step in terms of helping their patients to get access to it so I.

I don't want to say never but the reality is that I think that were in somewhat of a state of homeostasis, where we are now in terms of plans that are looking at making changes to their.

To their coverage criteria, it's always going to be evolving over time.

And we'll continue to work with health plans to help them understand the value of that treatment with INGREZZA provides.

For these patients and also to make sure that they're they're covers criteria remain appropriate medically appropriate for this complicated patient populations that develop TD.

So we've been successful we're going to continue to invest in making sure that theres theres. Good coverage for these patients because that's our responsibility.

Matthew C. Abernethy: Evan, this is Matt. So on the net pricing front, if you recall, we took a price increase in the middle of November, and we've not disclosed exactly how much of that sticks. But I would just tell you a large majority of that flows through, but it's not at 100%. So you would get about a half-quarter's benefit of that price increase in the first quarter.

And I think the second part of your question was really around a pickup phone maybe what the what the coverage might look like early on and I think you asked also about gross to net I'm not going to comment on the gross to net piece, we certainly don't provide that kind of.

Detail with regards to INGREZZA today, but I will say that just like with thing INGREZZA access for patients with Parkinson's disease to pick up on will be critically important and we recognize that there are.

Operator: All right, thanks so much, guys. I appreciate the color.

Operator: Thank you. And we'll go next to David Ancelon with Piper Jaffray. Please go ahead.

Eric S. Benevich: Thanks. So just a couple. First on Ingresa, this is more of a longer-term question regarding the payer landscape. As the footprint of the product grows, and given the commentary about reauthorizations and some of the things that you're working through, at least in the first quarter, as we think about Ingresa beyond 2020, should we think about a more restrictive payer landscape? Do you expect that payers are going to put up more roadblocks as volumes for the product grow? That's number one. And then number two is Opicapone. Maybe it's a little bit early for you to talk about this, but can you give us a sense of where you think GrossDinet will shake out on that product and also your expectations regarding step edits and prior operations on that? Thanks.

Treatments out there.

For patients on with Parkinson's on leave it open that are experiencing motor fluctuations. We've also said previously that we don't expect to price. This as a specialty medicine in other words, it would be a whack price below $600 a month and that's really part of our.

Part of our strategy to make sure that we have the best possible access for patients.

We'll be able to use some of the learnings from our resident launch on the resources that we've developed in the infrastructure such as our our patient access team, which is in the field to help support customers understanding what the coverage criteria are but the reality as early in the launch a it's not going to be on any formulary isn't so we're gonna have to help.

Them understand that you know for these patients that there will be a formulary exceptions process to get prescriptions approved.

For a pickup pounds. So we're going to make sure that we can do everything in our power to make it as convenient as possible for patients.

Eric S. Benevich: Yeah, David. So I'll comment on sort of how we're thinking about the future from a payer perspective for Ingresa. You know, we've got a little over two years on the market now, and actually, we've been, as I said earlier, very pleased with the coverage that we've gotten and the high rate of filled prescriptions versus written prescriptions. We care a great deal about patient access, and we've invested heavily to make sure that patients that need Ingresa can get access to it, and we're going to continue to do so. You stated rightly that the profile of Ingresa has grown as the product has grown, but the reality is that we've also been very heartened by the willingness of providers to go through the necessary steps to get access for their patients to Ingresa, to get prior The reality is that Ingresa is the most preferred and the most prescribed VMAT-2 inhibitor, and I think that's reflected in the willingness of providers to go to extra lengths and to go to the next step in terms of helping their patients to get access to it.

For providers to get those prescriptions written unfilled and we're going to take everything that we've learned from the gross and launch and apply it here.

A component because we believed that there is as yet a room remaining significant unmet need in this patient population a lot of people that that are not optimized with their leave it open therapies that are experiencing hours and hours per day of off time.

And we've got a product that we hope to bring to market.

In the in the not too distant future that that can make a significant difference for those patients.

Hi, Thanks again.

And next we'll go to Marc Goodman with STB Bank.

Okay.

Yeah, Matt It was wondering if you could talk about the spending and just the push and pull some from year to year and how to think about.

Any more color you're willing to give us on SJ versus R&D or just you know just on a relative basis, even if you don't want to talk absolutes. Thanks.

Yeah sure Mark appreciate the question. So 2020 is going to be another investment your for NERC friend and in particular on the research and development front as we mentioned earlier doubling the pipeline puts us in a place where we're going to have a larger portion of our spend increase year on year going towards R&D in that.

Really sets us up to fund the three registrational programs funded the hunting some huntingtons disease program see age as well as the a view why do you see.

Eric S. Benevich: So I don't want to say never, but the reality is that I think that we're in somewhat of a state of homeostasis where we are now in terms of plans that are looking at making changes to their coverage criteria. It's always going to be evolving over time, and we'll continue to work with the health plans to help them understand the value that treatment with Ingresa provides for these patients and also to make sure that their coverage criteria remain appropriate and medically appropriate for these complicated patient populations that evolve. So, you know, we've been successful.

Trial as well and then in addition to that funding some of the earlier stage programs like seen on.

And the and getting that program up and running so a lot a dollars going beyond R&D on the M&A front really focused on continuing to invest dollars behind INGREZZA as well as then the marketing costs associated with preparing for the pickup Paul.

So we're looking forward to the investments that we're going to be putting in place. So next year, we really feel like it's going to position us to continue to evolve our pipeline and really a set us up well going into the future.

Are those line items, increasing year over year.

Eric S. Benevich: We're gonna continue to invest in making sure that there's good coverage for these patients because that's our responsibility. And I think the second part of your question was really around a picapone, maybe what the coverage might look like early on. And I think you asked also about gross-to-net. I'm not going to comment on the gross-to-net piece.

Yeah, both both line items or are increasing year on year, but wouldn't say both from a percentage and the dollar perspective R&D would be.

Going up faster rate.

Thanks.

[noise] kill and our final question will come from Joseph <unk> with Needham and company. Please go ahead.

Hi, This is joey on for Alan Thanks for taking our questions.

Another one on a pickup phone you talk just generally about marketshare total market share for Conti therapies, given the generic options available.

Eric S. Benevich: We certainly don't provide that kind of detail with regard to Ingresa today, but I will say that, just like with Ingresa, access for patients with Parkinson's disease to picapone will be critically important. And we recognize that there are treatments out there for patients with Parkinson's on levodopa that are experiencing motor fluctuations. We've also said previously that we don't expect to price this as a specialty medicine. In other words, it would be a WAC price below $600 a month.

And maybe just in terms of.

The patients that you'll be targeting in terms of maybe a breakdown of patients that are currently on therapy.

Who are inadequate responders versus.

You know patients who have discontinued the current standard of care therapy, and then maybe treatment naive patients maybe give a.

If you could comment on where you expect to see the most initial use thank you.

Yes, so comped a utilization in the U.S. is about.

Eric S. Benevich: And that's really part of our strategy to make sure that we have the best possible access for patients. We'll be able to use some of the learnings from our Ingressa launch and the resources that we've developed in the infrastructure, such as our patient access team, which is in the field, to help support customers understanding what the coverage criteria are, but the reality is, early in the launch, it's not going to be on any formularies, and so we're going to have to help them understand that, you know, for these patients, that there will be a formulary exceptions process to get prescriptions approved for a pickup pump. So, we're going to make sure that, you know, we can do everything in our power to make it as convenient as possible for patients and for providers to get those prescriptions written and filled, and we're going to take everything that we've learned from the Ingressa launch and apply it here to a pickup pump, because we believe that there is, as yet, a remaining significant unmet need in this patient population, a lot of people that are not optimized with their levodopa therapy, that are experiencing hours and hours per day of off time, and we've got a product that we hope to bring to market in the not-too-distant future that can make a significant difference for those patients.

8% to 10% of the total.

Junk of treatment market and so taking a step back there's roughly a million patients in U.S. with Parkinson's of those about 70% are currently taking leave it up and of those another 70% or so or on an adjunct of treatment.

Comped is not broadly used in the U.S. I think because of the deficiencies of the existing treatments.

Historically, the current Comped inhibitors have failed to deliver on the promise of comps inhibition.

Due to safety issues, tolerability issues, and frankly inconvenient into convenient dosing regimens.

So you do see a relatively higher utilization of drugs from other adjuncts of classes, including dopamine agonists and I'm also MLB inhibitors.

Those medications also have their limitations, especially from a tolerability standpoint, certainly heard loud and clear from our advisors concerns about for example, impulsivity often seen in patients taking doesn't mean agonists.

So in terms of Ah our approach to the market. Obviously, we expect that patients that are currently or had previously been treated with comps inhibitors would be natural candidates for treatment.

With a pick a pound.

The other thing to keep in mind is that in this particular category patients don't usually switch from one adjunct up to another the physicians tend to sort of stack them up sequentially and so they may go on one adjunct of they start to see winning results and then they add a second age and then potentially a third.

Operator: Okay, thanks again.

Operator: And next, we'll go to Mark Goodman with SBB B-Rank. Please go ahead.

Matthew C. Abernethy: Yeah, Matt, I was wondering if you could talk about the spending and just the push and pulls from year to year and how to think about, you know, any more color you're willing to give us on SG&A versus R&D or just, you know, just on a relative basis, even if you don't want to talk absolutes. Thank you.

Okay.

So for us to be successful overtime, we expect to displace not only.

Existing comps inhibitors, but to also expand that comp class and displays medications from those other classes of dopamine agonists and EMEA obese ultimately we want to be considered the go to adjunctive treatment, when a physician and patient or having a conversation that they're.

Matthew C. Abernethy: Yeah, sure, Mark. I appreciate the question. So, 2020 is going to be another investment year for Neurocrine, and in particular on the research and development front. As we mentioned earlier, doubling the pipeline puts us in a place where we're going to have a larger portion of our spend increase year-on-year going towards R&D, and that really sets us up to fund the three registrational programs, the Huntington's Disease Program, CAH, as well as the VYADC trial as And then, in addition to that, funding some of the earlier stage programs like Xenon and getting that program up and running. So, a lot of dollars are going into R&D. On the SG&A front, we're really focused on continuing to invest dollars behind Ingresa, as well as then the marketing costs associated with preparing for the pickup home launch. So we're looking forward to the investments that we're going to be putting in place next year. We really feel like it's going to position us to continue to evolve our pipeline and really set us up well going into the future.

They're leave adult <unk> regimen is no longer adequately controlling helping to control their movements that they're experiencing significant off time, that's sort of the moment of truth in there, they're making a decision about whether to increase the dosing of leave adelpha or to add an adjunct of treatment given the mechanism of action with a pickup hone it makes all the sense.

In the world of having that conversation around optimizing leave adult but before you start to escalate the dosing or before you use drugs from other classes that don't optimize leave it up a treatment. So we're really excited about the opportunity here to make a difference for many thousands of patients.

Once we get approval later this year.

Great. Thanks for the additional detail.

And do you have no further questions in queue at this time I'd like to become a floor back to Mr. Kevin Gorman.

Thank you very much and and I really appreciate everyone's participation on the call today I do want to make a few closing statements and I'll start with a welcoming our two newest board members Leslie Norwalk and Shalini sharp.

Matthew C. Abernethy: Are both line items increasing year over year?

Matthew C. Abernethy: Yeah, both line items are increasing year-on-year, but I would say, both from a percentage and a dollar perspective, R&D would be the best, going up at a faster rate. Thanks.

I'm going to use us a bit of a sports analogy here in a moment following our an exciting Super Bowl game.

We have a we have a very good board.

And have had this board together now for a number of years, we have brought in new members from time to time and each time that we go out looking to expand the board generally we're not looking for a position player. What we're looking for is the best athlete that is out there and that has worked well.

Operator: Thank you. And our final question will come from Joseph Stringer with Needham & Company. Please go ahead.

Eric S. Benevich: Hi, this is Joey on behalf of Alan. Thanks for taking our questions. Another one on Opicapone, if you talk just generally about market share, total market share for Compti therapies, given the generic options available, and maybe just in terms of the patients that you'll be targeting in terms of maybe a breakdown of patients that are currently on therapy who are inadequate responders versus, you know, patients who have discontinued the current standard of care therapy and then maybe treatment-naive patients. Maybe give a, if you Thank you.

So for us over the years and and welcoming Shalini in and lastly, there we have two very great athletes that we're bringing to the sport and our board certainly deserves.

A lot of the credit for the success that we've had over the years.

What I would also like to come and here is that our commercial teams on our medical affairs organizations.

Because they also have a direct impact on this the the absolute stellar results that we've had in the fourth quarter.

And also for the year of 2019.

With INGREZZA and they are out there on the front lines advocating for patients each and every day.

Eric S. Benevich: Yeah, so comp utilization in the US is about 8 to 10 percent of the total. Adjunctive treatment market, and so we are taking a step back. There are roughly a million patients in the US with Parkinson's disease. Of those, About 70% are currently taking levodopa, and of those, Another 70% or so are on an adjunctive treatment. Compt is not broadly used in the US. I think because of the deficiencies of the existing treatment. Historically, you know, the current COMPT inhibitors have failed to deliver on the promise of COMPT inhibition due to safety issues, tolerability issues, So, you do see relatively higher utilization of drugs from other adjunctive classes, including dopamine agonists and also MAOB inhibitors. However, those medications also have their limitations, especially from a tolerability standpoint. We've certainly heard loud and clear from our advisors concerns about, for example, impulsivity, often seen in patients taking dopamine agonists.

Now finally, the ultimate goal for all of US in this industry has to discover and develop and bring life changing medicines to patients.

And at New York, and we are truly fortunate and we know it to have INGREZZA or less and potentially soon.

A pickup pound in patients hands.

Together with our partners xenon Voyager and endorse yet we are driven to bring precision therapies targeting.

It had been previously intractable in devastating diseases and now potentially curative.

There appears to patients who need them right now and that's what we look forward to speaking to you in the future about thank you very much.

Thank you. This will conclude today's program. Thank you again for your participation you may now disconnect have a wonderful day.

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Eric S. Benevich: So in terms of our approach to the market, obviously, we expect that patients that are currently or have previously been treated with COMPT inhibitors would be natural candidates for treatment with picapone. The other thing to keep in mind is that in this particular category, patients don't usually switch from one adjunctive to another. Physicians tend to sort of stack them up sequentially, and so they may go on one adjunctive. They start to see waning results, and then they add a second agent and then potentially a third.

Eric S. Benevich: So for us to be successful over time, you know, we expect to displace not only existing COMPT inhibitors but also expand that COMPT class and displace medications from those other classes of dopamine agonists and MAOBs. Ultimately, we want to be considered the go-to adjunctive treatment when a physician and a patient are having a conversation that their levodopa regimen is no longer adequately controlling, helping to control their movements, or that they're experiencing significant off time. That's sort of the moment of truth, and they're making a decision about whether to increase the dose of levodopa or to add an adjunctive treatment. Given the mechanism of action with picapone, it makes all the sense in the world to have that conversation around optimizing levodopa before you start to escalate the doses or before you use drugs from other classes that don't optimize levodopa treatment. So we're really excited about the opportunity here to make a difference for many thousands of patients once we get approval later this year.

Operator: Great, thanks for the additional detail.

Kevin C. Gorman: And we have no further questions in queue at this time, so I'd like to return the floor to Mr. Kevin Gorman.

Kevin C. Gorman: Thank you very much, and I really appreciate everyone's participation in the call today. I do want to make a few closing statements, and I'll start by welcoming our two newest board members, Leslie Norwalk and Shalini Sharp. I'm going to use a bit of a sports analogy here for a moment following an exciting Super Bowl game.

Kevin C. Gorman: We have a very good board and have had this board together now for a number of years. We have brought in new members from time to time, and each time that we go out looking to expand the board, we're generally not looking for a position player. What we're looking for is the best athlete that is out there, and that has worked well for us over the years. A lot of the credit for the success that we've had over the years goes to them. What I would also like to commend here is our commercial teams and our medical affairs organizations, because they also have a direct impact on the absolute stellar results that we've had in the fourth quarter and also for the year of 2019, with Ingressa, and they are out there on the front lines advocating for patients each and every day.

Uhhuh.

Ooh Ooh.

[music].

Kevin C. Gorman: Now, finally, the ultimate goal for all of us in this industry is to discover, develop, and bring life-changing medicines to patients. And at Neurocrine, we are truly fortunate, and we know it, to have Ingressa, Oralissa, and potentially soon picapone in patients' hands. Together with our partners Xenon, Voyager, and Adorcia, we are driven to bring precision therapies targeting what have been previously intractable and devastating diseases and now potentially curative therapies to patients who need them right now. And that's what we look forward to speaking to you about in the future. Thank you very much.

[noise] days have been has concluded thanks again for your participation you may now.

Operator: Thank you, this will conclude today's program. Thank you again for your participation. You may now disconnect. Have a wonderful day.

Operator: Today's program has concluded. Thanks again for your participation. You may now disconnect and have a wonderful day.

Now disconnect and have a wonderful day.

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