Q3 2019 Earnings Call

Audio systems, Please press star in zero.

Operator: Star and zero. Good day, everyone, and welcome to the Neurocrine Biosciences third quarter 2019 results call. At this time, all participants are in a listen-only mode. Later, you'll have the opportunity to ask questions during the question and answer session. Today's program is being recorded, and I will be standing by if you should need any assistance. It is now my pleasure to turn today's conference over to the CEO of Neurocrine Biosciences, Kevin Gorman.

Good day, everyone and welcome to the Neurocrine Biosciences third quarter 2019 results call.

This time all participants are in listen only mode. Later, you'll have the opportunity to ask questions. During the question answer session.

Today's program is being recorded and I will be standing by for you should need any assistance.

My pleasure to turn todays conference over to the CEO of Neurocrine Biosciences, Kevin Gorman.

Kevin C. Gorman: Thank you and welcome everyone to our earnings call. I'm joined today by Matt Abernethy, our Chief Financial Officer, Eiry Roberts, our Chief Medical Officer, Eric Benevich, and Kyle Gano, our Chief Business Development and Strategy Officer. Before we begin, I'd like to ask Todd to read our Safe Harbor Statement.

Thank you and welcome everyone to earnings call I'm joined today by Matt Abernathy, Our Chief Financial Officer, I, We Roberts, our Chief Medical Officer, Eric benefits benefit.

Lastly, there.

Kinda GAINO.

Cheap so set out in a strategy officer and.

I have a investor relations.

Before we begin I'd like to ask Todd to read our Safe Harbor statement, yes. So good afternoon everyone.

Todd: Yes, so good afternoon, everyone. Certain statements made in the course of this conference call that are not historical statements may be forward-looking statements, which are subject to risks and uncertainties. Information concerning factors that could cause actual results to differ materially from those contained in or implied by the forward-looking statements is contained in the company's SEC filings, including but not limited to the company's third quarter, 2019, Form 10-Q, filed today, 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.

Statements made in the course of this conference call that are not historical statements maybe forward looking statements, which are subject to risks and uncertainties.

Information concerning factors that could cause actual results to differ materially from those contained and or implied by the forward. Looking statements is contained in the company's FCC filings, including but not limited to the company third quarter 2019 Form 10-Q filed today and in today's press release.

Copies may be obtained by visiting the Investor Relations page all 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.

Todd: Thank you, Todd.

Kevin C. Gorman: Thank you, Todd. So this quarter, I'm very pleased yet once again to have another record number of new patients initiated with the excellent efforts of our Neurocrine colleagues in the field, health care providers, their patients, and more confident in diagnosing those with tardive dyskinesia. Now, as I've always said, there's still much more work to be done here, as the vast majority of TD sufferers remain undiagnosed and untreated. We continue to focus on educational programs in the physician's office and at medical conferences and to grow awareness of TD through our Talk About TD campaign.

Thank you Todd So this quarter I'm very pleased yet once again to have another record number of new patients initiated a wet.

Well it out for each of our network and colleagues in the field a health care providers.

There are patients and more confident than diagnosing those with tardive dyskinesia now as I've always said, there's still much more work to be done here as the vast majority of TD suffers remain on diagnosed and treated.

We continue focused on educational programs and the physician's office and at medical conferences and to grow awareness of TD through our talk about TV campaign.

Kevin C. Gorman: Now I'd like to drill down just a little bit more into the results this quarter. As you know, we've talked about the seasonality of Ingressa. We've said that medications for this patient will be Q3, but we haven't been able to accurately predict what those will be for Ingresa. That is because in last year's Q3, as you recall, we were going through a Salesforce expansion and the experience of a third quarter where we can observe seasonality without any confounding variables, or at least none that we are aware of. While there was a seasonal impact, it was relatively small.

Now I'd like to drill down just a little bit more into the results this quarter.

As you know we've talked about the seasonality of congrats on a we've said that medications for those patients hot.

Thank you very well, we haven't been able to accurately predict what those will be from grass.

That is because in last year's Q3 as you recall, we were going through a salesforce expansion and.

Experience to the third quarter, where we can observe seasonality without any confounding variables or at least none that we are aware as.

Well there was a seasonal impact it was relatively small we've said all along.

Kevin C. Gorman: We've said all along that it's a learning launch, and going through this quarter adds one more piece to the puzzle, our understanding of serving this patient, healthcare provider, and payer dynamic. Matt and Eric and the rest of the team will be happy to discuss this further in the Q&A portion of the call. Now, in addition to Ingressa, we've made significant progress on our pipeline. A few of the highlights... with valvenazine to treat chorea associated with Huntington's disease. [inaudible] Initiation of a Phase 2 trial, or we've also been engaged in encouraging and collaborative discussions with FDA and European regulators on the pivotal programs for adults suffering from CEH. And in addition to those discussions with the FDA, we're looking forward to our FDA interactions to discuss gene therapy for Parkinson's patients and the pivotal program at VYADC. And then finally, we're making good progress on our anticipated launch preparations for a pick-a-pone for people suffering with Parkinson's. As you'll see, the due date for the pick-a-pone is April 24th.

Launch and going through this quarter adds one more piece of the puzzle our understanding of serving this patient health care provider and payer dynamic.

Matt and Eric and the rest of the team will be happy to discuss this further in a in the Q and a portion of the call.

Now in addition, doing graphs that we've made significant progress on our pipeline a few of the highlights.

Be trial with valve and it seemed to treat Korea associated with Huntingtons disease.

H. patients.

Initiation of a phase two trial.

Our we've also been engaged.

And encouraging and collaborative discussions.

With half the a and European regulators on the pivotal programs for adults suffering from C. H.

And in addition to those discussions with the F.D.A., we're looking forward to our FDIC interactions to discussing the gene therapy for Parkinsons patients and the pivotal program be why a D.C.

And then finally, we're making good progress on our anticipated launch preparations for a pickup Holland for people suffering with Parkinson's as you.

Today for a pick a pound is April 24th.

So those are my brief opening remarks, what I'd like to do is for the remainder of the column in a turn it over first to Matt then to Iran.

Kevin C. Gorman: So those are my brief opening remarks. What I'd like to do is, for the remainder of the call, I'm gonna turn it over first to Matt, then to Eiry. So Matt, please.

Sure. So Matt. Please yeah. Thank you Kevin in one clarification. The PDUFA date is actually April 26 of 20 Twond.

Matthew C. Abernethy: Yeah, thank you, Kevin. And one clarification, the PDUFA date is actually April 26.

Kevin C. Gorman: I knew I'd miss that. I've given like to that 24th date in the wrong a couple of times.

No I'd mess that [laughter] I've, given like to that 24 stake in wrong a couple of times.

Matthew C. Abernethy: But thank you all for joining our third quarter 2019 earnings conference call. Our Q3 results featured another strong and aggressive performance and included the recent NDA submission of elegolics for uterine fibroids, which was submitted by our partner, AbbVie. In the third quarter, Ingresa prescription volume increased to approximately 34,800 scripts, resulting in 198. Product Sales. This compares to 19,400 scripts and $111 million in 2018.

Thank you all for joining our third quarter 2019 earnings conference call or Q3 results featured another strong aggressive performance and included the recent Andy a submission of Elagolix for uterine fibroids, which was submitted by our partner Abbey.

During the third quarter and grows a prescription volume increased to approximately 34800 scripts, resulting in 198.

How to excel.

This compares to 19400 scripts and $111 million.

T.

Our third quarter sequential growth of 3200 to your axis was primarily driven by another record quarter of new patient addition.

Matthew C. Abernethy: Our third quarter sequential growth of 3,200 TRXs was primarily driven by another record quarter of new patient additions, tempered slightly by seasonal pressures impacting refill rates per patient. Importantly, we are seeing continued new patient demand as a result of the success of our expanded commercial organization, our patient-focused Talk About T.D. Disease State Awareness campaign, and our ongoing healthcare provider educational initiative.

Tempered slightly by seasonal pressures impacting refill rates per patient.

Importantly, we are seeing continued new patient demand as a result of the success of our expanded commercial organization.

Our patient focused talk about TV disease state awareness campaign.

And our ongoing health care provider educational initiatives.

Sequentially Q3, net revenue per script held steady at $5700 per script.

Year to date through Q3.

$515 million, representing over 80% year over year growth.

Q3, net income was $54 million or 56 cents diluted earnings per share, which.

Matthew C. Abernethy: Sequentially, Q3 net revenue per script held steady at $5,700 per script, year-to-date through Q3. $515 million, representing over 80% year-over-year growth. Q3 net income was $54 million or $0.56 diluted earnings per share, largely related to the FDA's acceptance of the NDA for elegolics.

Related to the F.D. is acceptance of the India for Elagolix.

In addition, net income was impacted by 28 million dollar unrealized noncash loss due to the mark to market impact of our Voyager therapeutics like equity investment.

Turning to the balance sheet, we exited the quarter with $875 million in cash and investments.

$109 million sequentially, driven by a strong Q3 operating performance, our cash position and profit profile provided sufficient capital to execute our near term strategy to maximize their opportunity within Brazil.

Matthew C. Abernethy: In addition, net income was impacted by a $28 million unrealized non-cash loss due to the mark-to-market impact of our Voyager Therapeutics equity investment. Turning to the balance sheet, we exited the quarter with $875 million in cash and investments, up $109 million sequentially driven by our strong Q3 operating performance. Our cash position and profit profile provide us with sufficient capital to execute our near-term strategy to maximize our opportunity with Ingresa and invest in our internal R&D program to expand our pipeline through business development activities. Regarding our expenses, we are expecting full-year SG&A and R&D expenses to range from $540 to $550 million, which compares to our previous guidance range of $540 to $570 million.

Invest in our internal R&D.

Well you to expand our pipeline through business development activities.

Regarding our expense.

Being IP R&D, we're expecting full year as she ne and R&D expenses to range from $540 million to $550 million, which compares to her previous guidance range of $540 million to $570 million.

I'd like to provide a few comments about a revenue outlook for the fourth quarter 2019, we remain encouraged by the progress our entire team is making in developing the tardive dyskinesia market.

Our commercial efforts remain unchanged with a focus on increasing awareness of tardive dyskinesia and increasing the number of patients being treated for their tardive dyskinesia.

In addition, we expect there to be.

And that does county in Q4 as a result on the accounting dynamics associated with year end channel inventory.

In closing we were pleased with the strength of our quarterly performance looking ahead by this.

Medicines across four indication.

We've made great progress with our commercial loan pipeline <unk> programs and continue on a path towards becoming a leading global biopharmaceutical organization with that I'll now hand, the call over toward Chief Medical Officer I re Roberts.

Matthew C. Abernethy: I'd like to provide a few comments about our revenue outlook for the fourth quarter of 2019. We remain encouraged by the progress our entire team is making in developing the Tardive Dyskinesia market. Our commercial efforts remain unchanged with a focus on increasing awareness of Tardive Dyskinesia and increasing the number of patients being treated for their Tardive Dyskinesia. In addition, we expect there to be a Q4 as a result of the accounting dynamics associated with year-end channel inventory. In closing, we are pleased with the strength of our quarterly performance. Looking ahead, by this time, we will be at the end of our presentation across four indications. We've made great progress with our commercial and pipeline programs and continue on a path towards becoming a leading global biopharmaceutical organization. With that, I will now hand the call over to our Chief Medical Officer, Eiry Roberts.

Thank you, Matt and good afternoon.

I'm happy to provide an update on clinical assets this quarter in support of movement disorder profile for tardive, dyskinesia, I'd say hands disease, and Parkinson's disease, as well as our congenital adrenal hyperplasia I'm phase one profound.

Yeah.

And bio sciences presented data from in grades that I pick apart.

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Congrats Parkinson's disease and movement disorders.

Hey, congrats reinforce our commitment to educating healthcare providers I'm to improving the lives of patients living with movement disorders.

Well I'm glad that we presented data demonstrating robust long term clinically significant benefits in patients with tardive dyskinesia, both 40 milligram.

10 milligram dose strengths across a broad range of patient subset.

Don't know pools clinical trial data presented showed a greater than 50% improvement in abnormal movements in more than Oh patients taking the once daily 40 milligram dose of INGREZZA.

Eiry W. Roberts: Thank you, Matt, and good afternoon. I'm happy to provide an update on clinical efforts this quarter in support of our movement disorder programs for tardive dyskinesia, Huntington's disease, and Parkinson's disease, as well as our congenital adrenal hyperplasia and phase 1 programs.

In addition in August we published an in direct treatment comparison about managing this is.

Using pools clinical trial data, which demonstrated that.

Eiry W. Roberts: Neurocrine Biosciences presented data from Ingresa, Apicopone, and VYAAD at the National Congress of Parkinson's Disease and Movement Disorders. The presentations at this congress reinforce our commitment to educating health care providers and to improving the lives of patients living with movement disorders. For Ingresa, we presented data demonstrating robust, long-term, and clinically significant benefits in patients with tardive dyskinesia for both 40mg and 80mg dose strengths across a broad range of patient subsets. Furthermore, pooled clinical trial data presented showed a greater than 50% improvement in abnormal movements in more than half of patients taking the once-daily 40mg dose of Ingresa. In addition, in August, we published an indirect treatment comparison of valbenazine versus doxazosin using pooled clinical trial data, which demonstrated that, particularly at the 80 milligram dose level.

Particularly 80 milligram dose level.

It is however important to note in this study the difference in dose titration and dose equivalency should be considered when interpreting the result.

These days.

Got it provide health care professionals with important additional information to inform choices.

Dose selection for INGREZZA in patients with tardive dyskinesia.

No no two Parkinson's.

Oh, yes presented data on a pickup.

Demonstrating that once daily dose.

See resulted in substantial and prolonged inhibition of the topical Oh meets all trying to raise any side.

[laughter] patients experiencing motor fluctuation.

They should have this important enzyme prevents leave it open break.

That's probably more and even though but to be converted to doping, meaning the brain, resulting in reduced off time with increased on time without troublesome dyskinesia.

From a regulatory perspective for a pickup however, we remain on track for a Paducah date of April 26 2020.

Eiry W. Roberts: It is, however, important to note in this study that differences in dose titration and dose equivalency should be considered when interpreting the results. These data, in aggregate, provide health care professionals with important additional information to inform choice of treatment and dose selection for Ingresa in patients with tardive dyskinesia. Moving now to our Parkinson's. At MDS, we presented data on a picaphone demonstrating that once daily doses of the compound resulted in substantial and prolonged inhibition of the catechol-O-methyltransferase enzyme. For Parkinson's patients experiencing motor fluctuations, inhibition of this important enzyme prevents levodopa breakdown, thus allowing more levodopa to be converted to dopamine in the brain, resulting in reduced off-time with increased on-time without troublesome dyskinesia. From a regulatory perspective for a picaphone, we remain on track for a PDUFA date of April 26, 2020. For the VYAADC Gene Therapy Program, acquired through our strategic collaboration with Voyager Therapeutics, at MDS, we presented data from a longitudinal analysis of Parkinson's disease stage for patients treated in the open-label phase 1. These data demonstrate that a single administration... overall disease severity as assessed by the modified HONIN-YAR stage.

Well see a D.C. gene therapy program acquired through our strategic collaboration with Biogen therapeutic.

Yes, we presented data from a long just use on the analysis Parkinson's disease stage for patients treated in the open label.

What.

These data demonstrates that a single administration.

Overall disease severity as assessed by the modified hone in yachts stage.

Hey, I am sorry to interrupt we're getting a lot of text messages right now that we're cutting out a quite a bit of our discussion here.

Operator, David if you're if you're listening right now.

Yes, Sir I can pull your line separately and we can address the issue.

Okay. So why don't a why don't we take a or a one minute time out or what.

Believes the issue is a is resolved.

Well.

We'll do a pretty and initiate day.

Participants please stay on the line until we have renegotiated todays call.

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Thank you for your patience all lines are reconnected.

Yeah, I apologize everyone for this and Ah. Thank you for and bring it to our attention by texting Mountain myself. If there are continued problems don't hesitate to text us yet once again hopefully this is going to go better this time.

What we're going to do is because it's unclear how much was lost by everyone in going through this and we want to make sure the transcript as clear, we'll just start over again so.

Kevin C. Gorman: Eiry, I'm sorry to interrupt. We're getting a lot of text messages right now, so we're cutting out quite a bit of our discussion here. Operator, David, if you're listening right now? Yes, sir.

Again, I am joined by Matt Abernathy, our CFO I re Roberts, our CMO, Eric benefits, our CCOH, Kyle GAINO, our chief business development strategy officer, and tied to slow the head of HR.

Operator: Yes, sir. I can pull your line separately, and we can address the issue.

Todd could you IR I'm, sorry, [laughter] Todd could you. Please read our safe Harbor Steakhouse. Good afternoon, everybody certain statements made in the course of this conference call them or not historical statements may be forward looking statements, which are subject to risks and uncertainties information concerning factors that could cause actual results to differ materially from those.

Kevin C. Gorman: Okay, so why don't we take a one-minute timeout, or I believe the issue is resolved.

Operator: will do. Participants, please stay on the line until we have reinitiated today's call. Thank you for your patience. All lines are reconnected.

Contained in or implied by the forward looking statements contained in the company's FCC filings, including but not limited to the company third quarter 2019 Form 10-Q filed today and in today's press release.

Kevin C. Gorman: Yeah, I apologize to everyone for this and thank you for bringing it to our attention by texting Matt and myself. If there are continued problems, don't hesitate to text us yet once again. Hopefully, this is going to go better this time. Again, I am joined by Matt Abernethy, our CFO, Eiry Roberts, our CMO, Eric Benevich, our CCO, Kyle Gano, our Chief Business Development and Strategy Officer, and Todd Tushla, the head of HR. Todd, could you... I.R., I'm sorry. Todd, could you please read our safe harbor state? Yes, good afternoon, everybody.

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. Thanks, Todd as I said, we've had yet another record number of new patients initiated.

Treatment with INGREZZA.

This is through the skill and the diligence of our newer cannot colleagues in the field.

Addressing health care providers, allowing them to be more skilled in recognizing abnormal involuntary movements among their patients and actually more confident in diagnosing those with tardive dyskinesia.

I keep saying that Theres a lot more work to be done here as the vast majority of TD suffers remain on diagnosed and treated we'll continue our focus on educational programs both in the physician's office and the presentation.

Todd: Certain statements made in the course of this conference call that are not historical statements may be forward-looking statements, which are subject to risks and uncertainties. Information concerning factors that could cause actual results to differ materially from those contained in or implied by the forward-looking statements is contained in the company's SEC filings, including but not limited to the company's third-quarter 2019 Form 10-Q filed today 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, and we disclaim any obligation to update these forward-looking statements.

Presentations at medical conferences and to grow awareness of TD through our talk about TD campaign now.

Now going into a little more detail.

With the INGREZZA results this quarter I know, we've talked about seasonality quite a bit in the past, we've said that medications for this paper patient population experience.

Challenge as headwinds in Q3, but we haven't been able to accurately predict what those will be for INGREZZA. This quarter. This past quarter and that was because in last year's Q3, we were going through a sales force expansion now this year was our first experience of Q3, where we could observe seasonality.

Kevin C. Gorman: Thanks, Todd. As I said, we've had yet another record number of new patients initiate treatment with Ingressa. This is thanks to the skill and diligence of our neurocrinology colleagues in the field, addressing healthcare providers, allowing them to be more skilled at recognizing abnormal involuntary movements among their patients and actually more confident in diagnosing those with tardive dyskinesia. I keep saying that there's a lot more work to be done here as the vast majority of TD sufferers remain undiagnosed and untreated. We'll continue our focus on educational programs, both in the physician's office and in presentations at medical conferences, and to grow awareness of TD through our Talk About TD campaign. Now, going into a little more detail with the INGRESA results this quarter, I know we've talked about seasonality quite a bit in the past.

Without any known confounding variables and well, while there was a seasonal impact.

It was relatively small.

Now this this experience of going through this Q3 it adds one more piece to the puzzle of our understanding of this patient population the healthcare providers and the payer dynamic and Matt Eric in the rest of the team.

If you care to speak about this more can can go into this in a further in the queue in a portion of the call.

In addition to the outstanding results within grass up we've made significant progress in our pipeline.

One we've been initiation of phase three trial with about Valbenazine to treat the Korea associated with Huntingtons disease to the initiation.

Of the phase two trial in pediatric patients.

With CH.

Three we've also been engaged in encouraging and collaborative discussions with FDA and European regulators on the pivotal program for adults suffering with CH.

Kevin C. Gorman: We've said that medications for this patient population experience challenges, headwinds in Q3, but we haven't been able to accurately predict what those will be for INGRESA this quarter, this past quarter. And that was because, in last year's Q3, we were going through a Salesforce expansion. Now, this year was our first experience of Q3 where we could observe seasonality without any known confounding variables. And while there was a seasonal impact, it was relatively small.

And in addition, with after FDA, we are looking forward to discussing our gene therapy.

For Parkinson's disease with the pivotal program with the why a DC.

And then finally, we're making very good progress on our for our anticipated launch getting prepared for that with a pickup phone for patients suffering from Parkinson's disease.

Given the second chance around now the PDUFA date for a pickup phone as April 26.

So with that I'm going to turn it over to map.

Thank you Kevin and good afternoon. Thank you for joining our third quarter 2019 earnings Conference call. Our Q3 results featured another strong aggressive performance that included the recent NDA submission of Elagolix for uterine fibroids, which was submitted by our partner Abbvie.

Kevin C. Gorman: Now, this experience of going through this Q3, it adds one more piece to the puzzle of our understanding of this patient population, the healthcare providers, and the payer dynamic. Matt, Eric, and the rest of the team, if you care to speak about this more, can go into this further in the Q&A portion of the call. In addition to the outstanding results with Ingressa, we've made significant progress in our pipeline. For example, we initiated a phase three trial with valbenazine to treat the chorea associated with Huntington's disease. Two, the initiation of the phase two trial in pediatric patients with CAH. Three, we've also been engaged in encouraging and collaborative discussions with FDA and European regulators on the pivotal program for adults suffering with CAA.

During the third quarter INGREZZA prescription volume increased to approximately 34800 scripts, resulting in a $198 million in net product sales.

This compares to 19004, hundreds growth and $111 million than not product sales for the third quarter of 2018.

Our third quarter sequential growth of 3200 Trx is was primarily driven by another record quarter of new patient addition, tempered slightly by seasonal pressures impacting refill rates per patient.

Importantly, we are seeing continued new patient demand as a result of the success of our expanded commercial organization. Our patient focused talk about TV disease state awareness campaign in are ongoing healthcare provider educational initiatives.

Sequentially Q3, net revenue per script held steady at $5700 per script.

Year to date from Q3 in resin net sales were $515 million, representing over 80% year over year growth.

Kevin C. Gorman: And in addition, with FDA, we are looking forward to discussing our gene therapy for Parkinson's disease in the pivotal program with VYAADC. And then, finally, we're making very good progress for our anticipated launch, getting prepared for that with picapone for patients suffering from Parkinson's disease. Given a second chance around now, the production date for a pick-a-pone is April 26. So with that, I'm going to turn it over to Matt.

Q3, net income was $54 million or 56 cents diluted earnings per share, which included a $20 million event based milestone from abbvie related to the FDA acceptance of the NDA for Elagolix.

In addition, net income was impacted by 28 million dollar unrealized noncash loss due to the mark to market impact of our Voyager therapeutics equity investment.

Turning to the balance sheet, we exited the quarter with $875 million in cash and investment.

$109 million sequentially.

Driven by our strong Q3 operating performance, our cash position and profit profile provide us sufficient capital to execute our near term strategy to maximize our opportunity within groza.

Matthew C. Abernethy: Thank you, Kevin, and good afternoon. Thank you for joining us on our third quarter 2019 earnings conference call. Our Q3 results featured another strong Ingressa performance and included the recent NDA submission of elegolics for uterine fibroids, which was submitted by our partner, AbbVie. During the third quarter, Ingressive Prescription Volume increased to approximately 34,800 scripts, resulting in $198 million in net product sales. This compares to 19,400 scripts and $111 million in net product sales for the third quarter of 2018. Our third quarter sequential growth of 3,200 TRXs was primarily driven by another record quarter of new patient additions, tempered slightly by seasonal pressures impacting refill rates per patient. Importantly, we are seeing continued new patient demand as a result of the success of our expanded commercial organization, our patient-focused Talk About T.D. Disease State Awareness campaign, and our ongoing healthcare provider educational initiative.

Invest in our internal R&D programs inability to expand our pipeline through business development activities regarding our expense guidance for 2019, excluding IP R&D, we're expecting full year, SGN and R&D expense to range from $540 million to $550 million, which compares to a preview.

This guidance range of $540 million to $570 million.

I'd like to provide a few comments about our revenue outlook for aggressive for the fourth quarter 2019.

We remain encouraged by the progress our entire team is making in developing the tardive dyskinesia market.

Our commercial efforts remain unchanged with a focus on increasing awareness of tardive dyskinesia and increasing the number of patients being treated for their tardive dyskinesia.

In addition, we expect there to be an elevated gross to net discount in Q4 as a result of accounting dynamics associated with year end channel inventory.

In closing we are pleased with the strength of our quarterly performance looking ahead by this time next year Neurocrine disposition of three ft approved medicines across four indications, we've made great progress with our commercial and pipeline programs and continue on a path towards becoming a leading global biopharmaceutical organization.

With that I'll now hand, the call over toward Chief Medical Officer, I re Roberts.

Thank you, Matt and good afternoon, I'm happy to provide an update on clinical efforts this quarter in support of our movement disorder programs Petard, Dyskinesias huntingtons disease and pockets.

As well as ARINC congenital adrenal hyperplasia in phase one program.

In the third quarter Neurocrine Biosciences presented data from INGREZZA Pik component and the why AIDC at the International Congress of Parkinson's disease and movement disorders.

Matthew C. Abernethy: Sequentially, Q3 net revenue per script held steady at $5,700 per script. Year-to-date, through Q3, Ingresa net sales were $515 million, representing over 80% year-over-year growth. Q3 net income was $54 million, or $0.56 diluted earnings per share, which included a $20 million event-based milestone from AbbVie related to the FDA's acceptance of the NDA for elegolics. In addition, net income was impacted by a $28 million unrealized non-cash loss due to the mark-to-market impact of our Voyager Therapeutics equity investment.

Presentations that this congrats reinforce our commitment to educating healthcare providers onto improving the lives of patients living with movement disorders.

Good morning, guys that we presented data demonstrating robust long term clinically significant benefit in patients with tardive dyskinesia for both 40 milligram and 80 milligram dose strengths across a broad range of patient subset.

Got a mall pools clinical trial data presented showed a greater than 50% improvement in abnormal movements in more than half of patients taking the once daily 40 milligram dose of INGREZZA.

In addition in August we published and direct treatment comparison of Valbenazine. This is due tetrabenazine efficacy using pools clinical trial data, which demonstrated that valbenazine with generally favorable overdue tetrabenazine, particularly if the 80 milligram dose level it.

Matthew C. Abernethy: Turning to the balance sheet, we exited the quarter with $875 million in cash and investments, up $109 million sequentially driven by our strong Q3 operating performance. Our cash position and profit profile provide us sufficient capital to execute our near-term strategy to maximize our opportunity with Ingresa, invest in our internal R&D programs, and ability to expand our pipeline through business development activities. Comparing our expense guidance for 2019, excluding IP R&D, we are expecting full-year SG&A and R&D expense to range from $540 to $550 million, which compares to our previous guidance range of $540 to $570 million.

However, the important to note in this study that differences in dose titration and dose equivalency should be considered went into it became the result.

These data in aggregate provide health care professionals with important additional information to inform choice of treatment and dose selection for INGREZZA in patients that Todd if dyskinesias.

Moving now to our Parkinson's disease program.

Yes, we presented data on a pickup.

Demonstrating that once daily dosing in patients with Parkinson's disease resulted in substantial and prolonged inhibition of the capital O. meets our transferase enzyme.

For Parkinsons patients experiencing move to fluctuation inhibition of this important enzyme prevent sliva duopa break down that's allowing more me the doe, but to be converted still coming in the brain, resulting in reduced off time with increased on time without troublesome dyskinesia.

Matthew C. Abernethy: I'd like to provide a few comments about our revenue outlook for Ingressive for the fourth quarter of 2019. We remain encouraged by the progress our entire team is making in developing the TARDEV Dyskinesia Market. Our commercial efforts remain unchanged with a focus on increasing awareness of TARDEV dyskinesia and increasing the number of patients being treated for their TARDEV dyskinesia. In addition, we expect there to be an elevated gross-to-net discount in Q4 as a result of accounting dynamics associated with year-end channel inventory. In closing, we are pleased with the strength of our quarterly performance. Looking ahead, by this time next year, Neurocrine is positioned to have three FDA-approved medicines across four indications. We've made great progress with our commercial and pipeline programs and continue on a path towards becoming a leading global biopharmaceutical organization. With that, I will now hand the call over to our Chief Medical Officer, Eiry Roberts.

From a regulatory perspective for a pick a phone we remain on track for a PDUFA date of April 26 2020 .

For the V. why AIDC gene therapy program acquired through our strategic collaboration with voice Voyager Therapeutics at Mds, We presented data from a longitudinal analysis of Parkinson's disease stage for patients treated in the open label Phase one trial PBM that no one.

These data demonstrate that a single administration of the why AIDC improved patients overall disease severity as assessed by the modified hone in Yaffe stage, we continue to work closely with our colleagues at Voyager to progress the phase two.

A DC gene therapy program, including engagement with the FDA before year end to gain further clarity on the registration plan.

During Q3, we also continue to work with Voyager therapeutics to bring forward subsequent programs targeting friedreichs ataxia on two novel newer logical target.

Turning now to our other clinical development program.

Last month, we initiated a phase three connect HD trial.

Benzene for the treatment of Korea in Huntingtons disease. This study will enroll approximately 120 subjects across multiple sensors in the us beginning this month.

Eiry W. Roberts: Thank you, Matt, and good afternoon. I'm happy to provide an update on clinical efforts this quarter in support of our movement disorder programs for tardive dyskinesia, Huntington's disease, and Parkinson's disease, as well as our congenital adrenal hyperplasia and Phase I programs. In the third quarter, Neurocrine Biosciences presented data from Ingresa, Apicopone, and VYAADC at the International Congress of Parkinson's Disease and Movement Disorders. The presentations at this Congress reinforce our commitment to educating healthcare providers and to improving the lives of patients living with movement disorders.

The primary efficacy endpoint compares change from baseline in the unified Huntingtons disease rating scale total maximal Korea school between Valbenazine Unfussy, though we're pleased to be collaborating with the Huntington study group in the design and implementation of the steady and anticipate completion of the study during 2000.

21.

Well congenital adrenal hyperplasia, we made progress on several fronts. During Q3, the adaptive phase two proof of concept study of NB seven 470 day in adult subjects to CHF nearing completion, and we intend to present data from this study is a scientific meeting doing 2020 . We also had disk.

Yes, that's with the FDA to gain alignment on the Registrational trial design required for the adult CH program. We're currently in the process of reviewing this plan with regulators that fight the us with the intensive initiating a global registration trial in adult subjects with CH during mid 2020 .

Eiry W. Roberts: For Ingresa, we presented data demonstrating robust, long-term, and clinically significant benefits in patients with tardive dyskinesia at both 40 milligram and 80 milligram dose strengths across a broad range of patient subsets. Furthermore, pooled clinical trial data presented showed a greater than 50% improvement in abnormal movement in more than half of patients taking the once-daily 40mg dose of Ingreza. In addition, in August, we published an indirect treatment comparison of valbenazine versus dutetrabenazine efficacy using pooled clinical trial data, which demonstrated that valbenazine was generally more favorable over dutetrabenazine, particularly at the 80 milligram dose level. It is, however, important to note in this study that differences in dose titration and dose equivalency should be considered when interpreting the results.

Finally, our internally discovered the secular Monterrey mean transported to inhibitor with potential for use in the treatment of a range of neuroscience disorders continues in phase one evaluation.

In summary, I'm very pleased with the progress in our pipeline this quarter I want to thank our cross functional teams for their hard work in support of both the portfolio with that I'll hand, the call back to Kevin. Thank you Larry So at this time I'd like to open it up for questions.

At this time, if you'd like to ask your question. Please press the star and one keys on your telephone keypad keep in mind, you may or move yourself from the question Q at any time by pressing the pound.

In the interest of getting everyone's question in we do ask that you limit yourself to one question and one follow up.

And we will take our first question from Brian Skorney with Baird. Please go ahead. Your line is open.

Hey, good afternoon, guys. Thanks for taking the question.

Eiry W. Roberts: These data, in aggregate, provide healthcare professionals with important additional information to inform the choice of treatment and dose selection for Ingresa in patients with tardive dyskinesia. Moving now to our Parkinson's disease program. At MDS, we presented data on picapone demonstrating that once daily dosing in patients with Parkinson's disease resulted in substantial and prolonged inhibition of the catechol-O-methyltransferase enzyme. For Parkinson's patients experiencing motor fluctuations, inhibition of this important enzyme prevents levodopa breakdown, thus allowing more levodopa to be converted to dopamine in the brain, resulting in reduced off time with increased on time without troublesome dyskinesia.

First question just on the plan to move Valbenazine into the 100 tons Korea study during the past kind of been skeptical about pursuing.

Today's one.

Tetrabenazine was in clinical development.

We have changed in your view Kevin to move forward here is it really just a function of saying why not work to expandable able to capture some of these.

Sales available or is there something then.

The commercial launch that you guys.

Yes, Brian It it was you're right in the past we had de prioritized huntingtons, because we had prioritize tourette.

After.

The Tourettes study, that's when we Reprioritize backup Huntingtons disease, we think theres still very much a role.

That's vendors in can play in the Huntingtons population and so thats why weve gone back into it and I think theres more to learn about drug development within Huntingtons til and Thats. Another they do you have anything to add to that diary, yeah. I mean, the or that is you know there off 30000 patients with Huntingtons and the Korea symptom is a very common up to nine.

Eiry W. Roberts: From a regulatory perspective for the picaphone, we remain on track for a PDUFA date of April 26, 2020. For the VYAADC Gene Therapy Program acquired through our strategic collaboration with Voyager Therapeutics, at MDS, we presented data from a longitudinal analysis of Parkinson's disease stage for patients treated in the open-label Phase 1B trial, PD1101. These data demonstrate that a single administration of VYAADC improved patients' overall disease severity as assessed by the modified Honan-Yar stage. We continue to work closely with our colleagues at Voyager to progress the Phase II VYAADC gene therapy program, including engagement with the FDA before year-end to gain further clarity on the registration plan. During Q3, we also continued to work with Voyager Therapeutics to bring forward subsequent programs targeting Friedrich's ataxia and two novel neurological targets. Now, we turn to our other clinical development programs. Last month, we initiated a phase three CONNECT-HD trial of valbenazine for the treatment of chorea in Huntington's disease. This study will enroll approximately 120 subjects across multiple centers in the U.S. beginning this month.

Ben to patients with Huntington Pap symptoms the Korea.

And 70% of those huntingtons patients that seems to have moderate to severe symptoms, but less than 20% of them at treated today with the map to inhibitor and so given the favorable benefit risk that we have a profile that we haven't tardive dyskinesia, the well tolerated once a day regimen that we have with.

Simple titration schedule and we were really interested in understanding.

Benefiting in the context of treatment of Korea, and Huntingtons disease as well.

Great and then just another question on the.

You mentioned that you would expect a little bit of a separation gross to net in fourth quarter can you just walk through exactly.

What's happening on the fourth quarter, that's driving that.

Operation.

Sure Brian if you recall, we discuss this last year as well so since we recognize revenue on a sell in basis now what you have to do from a gross to net perspective is think about when that ultimately gets sold through to the code customer what would the associated discount be surrounding that so.

When you think about be slightly elevated gross.

But I flagged it really pertains to thinking through.

Our channel inventory getting sold through two patients in Q1, which is our highest gross to net discount period due to items like the donut hole.

Alright, thank you.

We'll take our next question from disease happened with Bank of America. Please go ahead. Your line is open.

Eiry W. Roberts: The Primary Efficacy Endpoint compares change from baseline in the Unified Huntington's Disease Rating Scale total maximal career score between valbenazine and placebo. We are pleased to be collaborating with the Huntington Study Group in the design and implementation of this study and anticipate completion of the study during 2021. For congenital adrenal hyperplasia, we made progress on several fronts during Q3. The adaptive phase 2 proof of concept study of NBI 74788 in adult subjects with CAH is nearing completion, and we intend to present data from this study at a scientific meeting in 2020. We also had discussions with the FDA to gain alignment on the registrational trial design required for the adult CAH program. We're currently in the process of reviewing this plan with regulators outside the U.S. with the intent of initiating a global registration trial in adult subjects with CAH during mid-2020.

Hi, good evening or good afternoon. Thanks for taking my question.

Maybe one I'll pick upon.

Kevin can you give us an idea of what youre potential at least targeted market might be at the onset of the launch and.

Can you talk about what kind of investment in your commercial organization, you're going to need.

Any at all from here in order to make that a successful launch and then I've a follow up thanks.

Okay, hydrazine I'm going to pitch that over to Eric to my left yes, Hello, So I didnt catch all of your question, but I think I got the gist of it you were talking about you're asking about sort of the target audience and incremental investment.

So one of the things that makes it pick upon attractive to us amongst many is the fact that it is a really nice synergistic add into our commercial footprint as you're aware, we are ready call on all of the movement disorder, neurologists and the country foreign Groza.

And when we looked at the opportunity with a pickup on it became clear that there really was very few additional neurologists that we would need to.

Eiry W. Roberts: Finally, our internally discovered vesicular monoamine transporter 2 inhibitor, with potential for use in the treatment of a range of neuroscience disorders, continues in phase 1 evaluation. In summary, I'm very pleased with the progress in our pipeline this quarter and want to thank our cross-functional teams for their hard work in support of the portfolio. With that, I'll hand the call back to Kevin. Thank you, Eiry.

Add into our call universe to adequately cover the opportunity.

With regards to the incremental investment when we made the expansion of our field sales team in 2018. It was with two goals in mind, one was to optimize for the PD opportunity with INGREZZA.

The second goal was to prepare for the eventual approval and launch of pick a phone so.

We've already expanded our team adequately to cover both of those goals and like I said, we're currently calling on on the target audience. So from an incremental investment perspective, we're really just talking about.

Kevin C. Gorman: Thank you, Eiry. So at this time, I'd like to open it up to questions.

Additional.

Outside spend associated with sales and marketing advertising those kinds of activities, but not really much of the way of headcount.

Operator: At this time, if you'd like to ask a question, please press the star and one keys on your telephone keypad. Keep in mind, you may remove yourself from the question queue at any time by pressing the pound key. In the interest of getting everyone's question in, we do ask that you limit yourself to one question and one follow-up. And we will take our first question from Brian Skorney with Baird. Please go ahead. Your line is open.

Okay and are you able to share Eric with us any of some market data that you've collected about where and their treatment regimen doctors would feel this drug would be most.

Thoughts.

Yes, I'll I'll give you a little bit of color.

Currently there are three different classes of adjunct of treatments that are used to.

Brian P. Skorney: Hey, good afternoon, guys. Thank you for taking the time to answer the question. My first question is just on the plan to move valbenazine into the Huntington's Korea study. I think in the past, you were kind of skeptical about pursuing this back in the days when dutetrabenazine was in clinical development. What sort of changed in your view, Kevin, to move forward here? Is it really just a function of saying, why not work to expand the label to capture some of these sales available, or is there something in the commercial launch that you guys have been working through that you're learning?

Essentially improve the effectiveness of leave it up add ons to leave it up a therapy.

You've got dopant mean agonists, you've got EMEA will be inhibitors, and you've got comps inhibitors in terms of Comped inhibitors. This is really a class that has been somewhat dormant for a number of years here in the us.

Two different agents were introduced.

The first one toll capone.

Exhibited good efficacy there was a lot of enthusiasm in the neurology community than unfortunately, hepatic toxicity emerged in that product was pulled off the market the second product and tack Apone was introduced.

With I would say mixed results in mixed receptivity.

Kevin C. Gorman: Yeah, Brian, you're right. In the past, we had deprioritized Huntington's because we had prioritized Tourette. After the Tourette study, that's when we reprioritized Huntington's disease. We think there's still very much a role that valbenazine can play in the Huntington's population, and so that's why we've gone back into it, and I think there's more to learn about drug development within Huntington's disease, too. Do you have anything to add to that, Irie?

Certainly it didnt have the hepatic toxicity issue, but.

It's a relatively less.

In agent from an efficacy standpoint.

Inconvenience in terms of being needed to be dose every time, a patient takes there.

Our leave it open dose so 3456 times a day, they would need to take that medication and there's a number of other rate limiting side effects associated so.

Certainly the feedback that we've gotten from.

From leaders in the field and from market research indicates there is a need for an agent that addresses those deficiencies done deficiencies in the.

Eiry W. Roberts: Yeah, I mean, all I'd add is, you know, there are 30,000 patients with Huntington's, and the career symptoms are very common; up to 90% of patients with Huntington's have symptoms of career. And, you know, 70% of those Huntington's patients are deemed to have moderate to severe symptoms, but less than 20% of them are treated today with VMAP2 inhibitors. And so given the favorable benefit risk that we have, a profile that we have in tardive dyskinesia, the well tolerated once a day, the measurement that we have with a simple titration schedule, we were really interested in understanding valbenazine in the context of treatment of career and Huntington's disease as well.

Comps class and certainly an opportunity to.

To grow not just within the class, but to grow at the expense of the other classes.

And our aspiration is to.

Make pick Apone.

Go too.

Adjunctive treatment for patients on leave it open therapy.

We'll take our next question from Paul Matteis with Stifel. Please go ahead. Your line is open.

Great. Thanks, so much for taking my questions and congratulations on all the progress.

I had one follow up questions for matts comments surrounding scripts or average script per patient.

New scripts sequentially were not nearly as much as they were.

Couple of quarters, but you still we're at a record number of new patient adds could you quantify for your existing patient base coming into the quarter. The average number of script per patient in Threeq. This compares to two Q or if you can't quantify maybe you can qualitatively comment and then separately I was wondering if you could talk about just visibility into contracting.

Brian P. Skorney: Great, and then just another question on the, you mentioned that you expect a little bit of a separation in quarters to net in the fourth quarter. Could you just walk through exactly what's happening in the fourth quarter that's not driving that separation?

Okay.

How you're thinking about that for 2020.

You are expecting gross and Thats a change materially in the foreseeable future. Thanks, so much.

Paul just the just quickly.

Kind of fit.

Tail end of your first question you cut out for a few words could.

Matthew C. Abernethy: Yeah, sure, Brian. If you recall, we discussed this last year as well. So since we recognize revenue on a sell-in basis now, what you have to do from a gross net perspective is think about when that ultimately gets sold through to the customer, and what the associated discount would be surrounding that. So when you think about the slightly elevated gross net that I flagged, it really pertains to thinking through our channel inventory getting sold through to patients in Q1, which is our highest gross net discount period due to items like the donut hole.

Could you try that again and operator, if you could maybe look into if theres anything else that we might be worried about with this line, but Paul could you try that question again, yes short Kevin. Thanks, basically I was alluding to script growth this quarter.

And how it's still it's still solid but there seems to be a discrepancy this quarter between script growth and then you still reiterating that you're at a record number of new patient adds. So I was wondering if you could speak to the underlying patient base coming into the quarter and what you observed in Threeq you for average script per patient and how that may have changed.

As it relates to past quarters.

Yes, Paul This is Matt I appreciate the question in.

Brian P. Skorney: Right. Thank you.

As as Kevin said in his prepared remarks, and viewed as you've heard us comment on before our number one focus as an organization is to drive the new patient additions and get more patients on on and grows and thats exactly what we have seen in water initiatives continue to push towards.

Tazeen Ahmad: We'll take our next question from Tazeen Huppent with Bank of America. Please go ahead, your line is open.

Eric S. Benevich: Hi, good evening, or good afternoon. Thanks for taking my question. Maybe one on a pick-up phone. Kevin, can you give us an idea of what your potential, at least, you know, targeted market might be at the onset of the launch? And can you talk about what kind of investment in your commercial organization you're going to need, if any at all from here, in order to make that a successful launch? And then I have a follow-up. Thanks.

But on the existing patient front as we alluded to and as I alluded to in my prepared remarks, we saw no deviation and discontinuation rates and then from a from a refill rate per existing patient as Kevin said, we did see some level of seasonality, but it was it was various.

Mall and likely not not worth calling out.

The other aspect just to contextualize and remind.

Remind everyone is that when you look at our sequential growth in Q2 that was largely a factor of having a really low baseline in Q1 and patients getting normalize back onto what a standard.

Eric S. Benevich: Okay, hi Tazeen. I'm going to pitch that over to Eric on my left.

Refill rate per patient so how I would describe a refill rate per patient Q2 versus Q3 is just slightly less and in Q3.

Eric S. Benevich: Yeah, hello. So I didn't catch all of your questions, but I think I got the gist of it. You were talking about, you're asking about the sort of target audience and incremental investment.

I'll let.

Eric comment on where we're from a from a contracting perspective, but oh I'll take the gross to net front based upon what we know today Paul is that we wouldn't expect.

Any meaningful change and where we're from a net revenue per script perspective perspective based upon everything that we know at this time.

Eric S. Benevich: So, one of the things that makes picapone attractive to us, amongst many, is the fact that it is a really nice, synergistic add-on to our commercial footprint. As you're aware, we already call on all of the movement disorder neurologists in the country for Ingresa, and when we looked at the opportunity with picapone, it became clear that there really were very few additional neurologists that we would need to add to our call universe to adequately cover the opportunity.

Hi, Paul so.

As as as we've said before patient access is it really critical priority for us.

And historically being on or off formulary hasn't had a really meaningful impact on reimbursement we've had over 70% of Britain prescriptions have been Phil.

To date through the launch.

And certainly we've been pleased with the affordability where over three quarters of patients are paying less than $10 per month for INGREZZA.

In terms of the way that we worked with the plans.

Our goal has been to ensure equal access we really want to make sure that patients and providers have a choice of therapies.

Eric S. Benevich: With regard to the incremental investment, when we made the expansion of our field sales team in 2018, it was with two goals in mind. One was to optimize for the TD opportunity with Ingresa. The second goal was to prepare for the eventual approval and launch of picapone. We've already expanded our team adequately to cover both of those goals, and like I said, we're currently calling on the target audience. So, from an incremental investment perspective, we're really just talking about additional outside spend associated with sales and marketing, advertising, those kinds of activities, but not really much in the way of headcount.

And that's the approach that we've taken in looking at contracting opportunities and so we've said that we would address contracting opportunities on a plan by planned basis.

Here, we are its Q4.

The plans are just now starting to publish.

There are contract or excuse me their formulary designs for 2020.

I'm not going to comment on a plan by plan basis, but I will say that it's a little bit early and I think we'll know more as we get into next year, but overall, we've been like I said successful with our efforts to ensure patients have affordable access to INGREZZA and Thats really what we endeavor to ensure going forward into 2020, so stay tuned.

Okay, great. Thanks, guys for the color.

We'll take our next question from Phil Nadeau with Cowen and company. Please go ahead. Your line is open.

Eric S. Benevich: Okay. And are you able to share with us any of the market data that you've collected about where in their treatment regimen doctors would feel this drug would be most impactful?

Good afternoon, Thanks for taking my questions and congrats on the progress first just one more on the gross to net.

Curious if you care to quantify how much of an increase we could see Q4 versus Q3.

Eric S. Benevich: Yeah, I'll give you a little bit of color. You know, currently, there are three different classes of adjunctive treatments that are used to essentially improve the effectiveness of levodopa, add-ons to levodopa therapy. You've got dopamine agonists, you've got MAOB inhibitors, and you've got COMPT inhibitors. In terms of COMPT inhibitors, this is really a class that has been somewhat dormant for a number of years here in the U.S. However, two different agents were introduced. The first one, tolcopone, exhibited good efficacy, and there was a lot of enthusiasm in the neurology community.

One follow up on the pipeline you mentioned the DCH protocol I think has been defined with the FDA can you confirm whether that's correct.

Curious whether you.

People to provide as with any information with the primary endpoint of the studies.

We will be assuming the European regulators group the plant.

So let's start with Matt with the first part.

Hi, Phil Thanks for the question.

On.

To think about Q4 would I would maybe recommend as look what happened last year Q3 to Q4, we did have a slight decline in our net revenue per script and then also consider we did have a price increase.

Eric S. Benevich: Then, unfortunately, hepatotoxicity emerged, and that product was pulled off the market. The second product, intacopone, was introduced with, I would say, mixed results and mixed receptivity. Certainly, it didn't have the hepatictoxicity issue, but it's a relatively less potent agent from an efficacy standpoint. It's inconvenient in terms of being needed to be dosed every time a patient takes their levodopa dose. So, three, four, five, six times a day, they would need to take that medication, and there are a number of other rate-limiting side effects associated with it. So, certainly, the feedback that we've gotten from leaders in the field and from market research indicates there is a need for an agent that addresses those deficiencies, known deficiencies, in the COMPT class. And certainly, an opportunity to grow not just within the class but to grow at the expense of the other classes. And our aspiration is to make picopone the go-to adjunctive treatment for patients on levofopa therapy.

I believe at some point middle of the quarter last year. So it's not.

It's not a 3% to 5% type gross to net discount it's less than that but I think if you look back on what happened in the prior year that that may get you into to the right ballpark.

And I really want to do you want to talk about our FDA.

Interactions, thus far I can talk about that in general so as I mentioned in the written comments I Miss spoken comments.

We where we've been encouraged by our interactions with the agency. They clearly have been responsive to our discussion with them around the design.

Proposal for the registration plan for.

I don't see age.

In terms of the design and Blincyto, just say that learnings has been very consistent with what we've reflected in the past we understand that for these patients management of key satellite hormone levels, such as androgens that critical and in addition, we know that there is a desire in the patient population and in Memphis.

Greivis to be able to optimize the at the requirement of Google politically dosing and so we've taken those into consideration as we've designed study on does I mentioned, where.

Paul Matteis: We'll take our next question from Paul Matisse with Stiefel. Please go ahead. Your line is open.

Quite pleased with the progress forward with both the FDA and now in terms of our interactions in European regulated yen and Phil will will be more forthcoming as we get closer to launching the study off and.

Paul Matteis: Great. Thanks so much for taking my questions and congratulations on all the progress. I had one follow-up question for Matt's comments surrounding scripts or average script per patient. You know, new scripts sequentially were not up nearly as much as they were the past couple quarters, but you still were at a record number of new patient ads. Could you quantify, for your existing patient base coming into the quarter, the average number of scripts per patient in 3Q as it compares to 2Q? Or if you can't quantify it, maybe you can qualitatively comment. And then separately, I was wondering if you could talk about just visibility into contracting, how you're thinking about that for 2020, and if you're expecting gross net to change materially in the foreseeable future. Thanks so much.

As you can appreciate you want to complete all of your discussions with regulators before you really start talking about them in detail.

Got it the progress was for Q4 launches that's still on track.

Well, we're looking at now with with the discussions we've had and bringing the European regulators into this both and wanting to quickly is off and make sure that we have a completely harmonized interaction we're looking into the middle of next year.

Perfect. Thanks for taking my questions. Thank you Phil.

We'll take our next question from onto Pam Rama with JP Morgan. Please go ahead. Your line is open.

Hi, guys. Thanks for taking the question and congrats on all the progress.

Just gotten more market data here on INGREZZA launch.

What are your latest thoughts on giving forward looking guidance here for INGREZZA and I've gotten this question a couple of times in the last week, but perhaps giving guidance at this small investor conference in San Francisco in the second we to January .

Well on upon them.

Definitely understand where you're coming from Mr. Tom.

Your small conference will will not be so small but.

Paul Matteis: Hey Paul, just quickly, kind of at the tail end of your first question, you cut out for a few words, could you try that again? And operator, if you could maybe look into if there's anything else that we might be worried about with this line, but Paul, could you try that question again? Yeah, sure.

As you know as a company our approach to guidance has been to just give a qualitative color as to what we would expect.

For the for the coming quarter. This launch has definitely been a launch that we've learned a lot over the last two and a half years post launch and then walking into this year thinking about expanding or Salesforce, but 50% and then also launching the unbranded.

Matthew C. Abernethy: Yeah, sure, Kevin. Thanks. Basically, I was alluding to script growth this quarter and how it's still solid, but there seems to be a discrepancy this quarter between script growth and then you still reiterating that you're at a record number of new patient ads. So I was wondering if you could speak to the underlying patient base coming into the quarter and what you observed in 3Q for the average script per patient and how that may have changed as it relates to past quarters.

Talk about TD disease State awareness campaign those were two very large variables that we wanted to work through so if we did ever provided guide it would likely be in the form of annual God. That's something we have continued conversations and considerations around but at this time.

For 2019.

Or not providing a an aggressive guide.

Great. Thanks for taking my question.

We'll take our next question from beer and to meet Jefferies. Please go ahead. Your line is open.

Hi, guys. Thanks for taking my questions.

Maybe just a follow up on the CH pivotal program, Kevin what is how consistent or the regulatory requirements going to be across both ftn M&A clearly I think you talked about pursuing a biomarker strategy with the possible possibility of.

Eric S. Benevich: Yeah, Paul, this is Matt. I appreciate the question. And as Kevin said in his prepared remarks, and as you've heard us comment on before, our number one focus as an organization is to drive new patient additions and get more patients on Ingress. And that's exactly what we have seen and what our initiatives continue to push toward. But on the existing patient front, as we alluded to, and as I alluded to in my prepared remarks, we saw no deviation in discontinuation rates. And then from a refill rate per existing patient, as Kevin said, we did see some level of seasonality, but it was very small and likely not worth calling out. The other aspect, just to contextualize and remind everyone, is that when you look at our sequential growth in Q2, you know, that was largely a factor of having a really low baseline in Q1.

Evaluating steroid reduction do you think that will be consistent across both agencies, so I'm going to just.

You cut out a little bit there, but I think what you're asking about us the endpoints that consistency between both regulators.

I'm, just kind of preface it by saying that while we still are in active dialogue.

With with both agencies.

We're not going to go into great details on things I would say.

That the steroid biomarkers are at the heart of what we're looking at in this and Ari Kelly you would like to add to this if any I think the learning is very consistent with what we've discussed previously in terms of both the that Darren hormone levels themselves, particularly androgens being a great importance to patients on too.

All of the stakeholders in addition.

The ability with this mechanism of action to reduce the level of long tymkowych quota quite treatment Thats required is also.

Not surprisingly coming across as an important feature.

The impact of the DTC campaign and.

Yes, it's been ongoing for several quarters now has it met your expectations do you plan to change or modify the program at all.

Eric S. Benevich: And patients getting normalized back to what I would describe as a standard refill rate per patient. So how I would describe a refill rate per patient, Q2 versus Q3, is just slightly less in Q3. I'll let Eric comment on where we are from a contracting perspective, but I'll take the gross net front. Based upon what we know today, Paul, we wouldn't expect, you know, any meaningful change in where we're at from a net revenue per script perspective, based upon everything that we know at this time.

So anytime I am I'm going to assume that your entire question. There was about the DTC comp bear and I'm sorry.

Hello.

I think the entire that's your question was about.

Entirely to the DC DTC program.

Thanks.

If we can tell you about the.

The impact that it's had as of yet was there anything that you preface that width.

Thanks.

I do apologize we're getting.

The level of static from his line.

So on upon we'll we'll try to looks right.

I'm, sorry, Baron Jeez, I don't know why keep doing that Baron let's have Eric answer that question.

Sorry about what may be happening the airline I hope this isn't systemic.

Eric S. Benevich: So, as we've said before, patient access is a really critical priority for us, and historically, being on or off formulary hasn't had a really meaningful impact on reimbursement. We've had over 70% of written prescriptions filled to date through the launch. And certainly, you know, we've been pleased with the affordability, where over three-quarters of patients are paying less than $10 per month for Ingresa.

Yes, So hey, Brad what.

What I would say in terms of.

The experienced that we'd have thus far with the disease state awareness campaign for TD, which is talk about TD.

Is that we've been very pleased with the response.

We launched say that beginning of this year, we were hopeful that we would get a good response in terms of unique visitors people spending time looking at the content downloading the videos registering to come into our database and thus far it's exceeded all of our expectations.

Eric S. Benevich: In terms of the way that we've worked with the plans, you know, our goal has been to ensure equal access. We really want to make sure that patients and providers have a choice of therapies. And that's the approach that we've taken in looking at contracting opportunities. And so, you know, we've said that we would address contracting opportunities on a plan-by-plan basis. You know, here we are. It's Q4. The plans are just now starting to publish their contract or, excuse me, their formulary designs for 2020. I'm not going to comment on a plan-by-plan basis, but I will say that it's a little bit early and I think we'll know more as we get into next year. But overall, we've been, like I said, successful with our efforts to ensure patients have affordable access to Ingresa, and that's really what we will endeavor to ensure going forward into 2020. So stay tuned.

Anecdotally, we've heard very positive feedback from our customers through our field sales team of people going into clinics and going into some of these.

Practices and being asked are you the company that sponsoring the educational content that I saw on that add last night. So.

Plan going forward is to continue to invest in this on this disease state awareness campaign.

We expect that.

We will continue to have time periods, where we're on the air and then time periods, where we're off the air.

But going forward into 2020.

This is just another area, where we're going to continue to invest in what is still a very.

Early stage of the overall development of this TD of this TV market and certainly we think it's to the benefit of the many many patients out there.

Whether as yet undiagnosed and suffering from TD. So you can expect that we're going to continue to focus on educational efforts in this area and in others.

Paul Matteis: Okay, great. Thanks, guys, for the color.

Phil Nadeau: We'll take our next question from Phil Nadeau with Cohen & Company. Please go ahead, your line is open.

We'll take our next question from Jay Olson with Oppenheimer. Please go ahead. Your line is open.

Phil Nadeau: Good afternoon. Thanks for taking my questions and congrats on the progress. First, just one more on the gross to net. Matt, I'm curious if you'd care to quantify how much of an increase we could see in Q4 versus Q3 and then follow up on the pipeline. You mentioned that the CAH protocol, I think, has been defined with the FDA. Can you confirm whether that's correct? And I'm curious whether you'd be able to provide us with any information on the primary endpoint of the studies, which will be assuming the European regulators agree with the plan. So we'll start.

Hey, Thanks for taking the questions and congrats on the record number of new patient starts can you describe some of the key levers that you're pulling to drive those three consecutive quarters of new patient starts and are these new patient dynamic something that we should expect to continue in the future.

And then I had a follow up question on connect H.D. It doesn't show the dose on clinical trials Dot Gov. So I was wondering if you're starting to same 40, an 80 milligram doses of fell benzene used for tardive dyskinesia or if it's a different dose.

Matthew C. Abernethy: So we'll start with Matt on the first part.

Matthew C. Abernethy: Hi Phil. Thanks for the question. To think about Q4, what I would maybe recommend is look at what happened last year, from Q3 to Q4. We did have a slight decline in our net revenue per script, and then also consider that we did have a price increase, I believe, at some point in the middle of the quarter last year.

And if it is a different dose does that allow from additional for some additional.

P and or differentiated pricing and if it's not different dose.

Did you weigh the alternative of starting your next Gen three Matt inhibitor for Huntingtons disease instead of Feldman.

Matthew C. Abernethy: and I...

Eiry W. Roberts: I can talk about that in generality. As I mentioned in the written comments, and in the spoken comments, we were, and have been encouraged by our interactions with the agency. They clearly have been responsive to our discussion with them around the design and proposal for the registration plan for adult CAH. And in terms of the design and the end points, I would just say that our learnings have been very consistent with what we've discussed in the past.

Thank you.

So Jay I feel I should call you bear and at least three times.

Just make up.

But I'm going to let Eric take the first part of your question, Yes first of all congratulations Jay on the Multipart second question I'll tackle the first question.

Which is really around what's driving.

This record new patient starts that weve experience for the past few quarters and I really do think it is the cumulative effect.

Eiry W. Roberts: We understand that for these patients, management of key steroid hormone levels, such as androgens, is critical. And, in addition, we know that there is a desire among the patient population and their prescribers to be able to optimize the requirement for glucocorticoid dosing. And so we've taken those into consideration as we designed the study. And, as I mentioned, we're quite pleased with the progress forward with both the FDA and now in terms of our interactions with European regulators.

Everything that we're doing in the marketplace.

Certainly I think we're seeing the benefit of the expanded sales team you know about this time last year, we had just expanded the field sales team and we're talking back then about.

Legacy salespeople versus new higher sales people and the need to.

Get everyone up to the same level of.

Experiencing capability and I think at this point in time window longer thinking of our of our team that that way.

We've got a good really good cohesive experienced team out there that's doing great work in terms of helping their customers to identify appropriate candidates for treatment with INGREZZA.

Phil Nadeau: And Phil, we'll be more forthcoming as we get closer to launching the study, and as you can appreciate, you want to complete all of your discussions with regulators before you really start talking about them in detail.

So the expanded sales team I think is a big driver of the success site. This talked a moment ago about.

Kevin C. Gorman: The programs for the Q4 launch, is that still on track?

Kevin C. Gorman: No, we're looking now with the discussions we've had and bringing the European regulators into both and wanting to kick these off and make sure that we have a completely harmonized interaction. We're looking into the middle of next year.

The disease State awareness campaign talk about TD and the fact that we're continuing to see really strong response to that campaign and I think it's indicative of the the interest and maybe the need for more information.

Phil Nadeau: Perfect. Thanks for taking my questions. Thank you.

For patients and loved ones that are suffering from involuntary movements and wondering could this be TV.

Anupam Rama: We'll take our next question from Anupam Rama with J.P. Morgan. Please go ahead, your line is open.

And then I think that also some of the other elements of our of our promotional efforts, including peer to peer educational.

Anupam Rama: Hey guys, thanks for taking the question and congrats on all the progress. Just as you've gotten more market data here on Ingresa's launch, what are your latest thoughts on giving?

Events et cetera are really really what's driving the the record new patient starts as Matt mentioned earlier, it's a critical area of focus for us to continue to grow this market opportunity and we're doing it organically so.

Anupam Rama: forward-looking guidance here for Ingresa, and I've gotten this question a couple times in

Anupam Rama: Thank you for watching a couple of times in the last week but perhaps giving guidance at this small investor conference in San Francisco in the second week of January.

It's hard to tease out which element is having the biggest impact, but I think cumulatively, they're all critically important and that's really a testament to the strong execution.

Kevin C. Gorman: Well, Anupam, I definitely understand where you're coming from with your comment. Your small conference will not be so small. But, you know, as a company, our approach to giving guidance has been to just give qualitative color as to what we would expect for the coming quarter. This launch has definitely been a learning experience from which we've learned a lot over the last two and a half years post launch. And then walking into this year, thinking about expanding our sales force by 50 percent, and then also launching the unbranded talk about T.D. disease state awareness campaign.

Of all of our customer facing teams the field sales team our field reimbursement team our field medical team I want to just say that they're doing great job out there.

Thanks, Jay and I don't have a comment at the moment around the IP strategy and you're correct at the current time, we did not publish the doses.

Valbenazine that were being used in the HD connect trial in controlling dot Gov, and so but it just a couple of comments around that we're obviously extremely comfortable with the full 10 milligram at 40, an 80 milligram doses on the simple dosing regimen that we have currently in tardive dyskinesia and the.

Kevin C. Gorman: Those were two very large variables that we wanted to work through. So if we did ever provide a guide, it would likely be in the form of an annual guide. That's something we have continued conversations and considerations around. But at this time for 2019, we are not providing an aggressive guide.

Encouraging benefit risk profile that we've continued to see around that.

But in a similar fashion to our exploration of tourettes.

Disorder, we came to ensure that we provide flexibility in dosing, we don't want to assume that the dosing strategy in each different disease state would essentially be the same as Todd can easier and so we designed the connects HD as study in that fashion and that also would translate I think.

Biran Amin: Great, thanks for taking our questions. We'll take our next question from Biran Amin, Jefferies. Please go ahead, your line is open.

Potentially into all future evaluation of next generation Abbvie, Matt to inhibited candidates.

Kevin C. Gorman: Hi guys, thanks for taking my questions. Maybe just to follow up on the CEH pivotal program, Kevin, how consistent are the regulatory requirements going to be across both FDA and EMA? Clearly, I think you've talked about pursuing a biomarker strategy with the possibility of evaluating steroid reduction. Do you think that will be consistent across both agencies?

Great. Thank you very much congrats again.

Thank you.

We'll take our next question from Charles Duncan with Cantor. Please go ahead. Your line is open.

Hi, guys. Congrats on the topline and new patient starts performance in the quarter had a couple of questions one commercial one.

Pipeline, so start with commercial on that is I think he kind of addresses to on Toms question, which is guidance, but going into 2020, I guess I'm wondering what you're thinking in that needs to be needs to occur to be able started to provide guidance seems like you have better hand on this market.

Eiry W. Roberts: So I'm going to just, you cut out a little bit there, but I think what you're asking about is the endpoints, the consistency between both regulators. I'm just going to preface it by saying that while we still are in active dialogue with both agencies, we're not going to go into great detail on things. I would say that the steroid biomarkers are at the heart of what we're looking at in this, and Eiry, Cully, what would you like to add to this, if any?

And then are you thinking about pricing increases going into 2020.

So.

Charles I'll take the second one we wouldn't be discussing.

Eiry W. Roberts: No, I think the learning is very consistent with what we've discussed previously in terms of both the steroid hormone levels themselves, particularly androgens, being of great importance to patients and to all of the stakeholders. In addition, the ability of this mechanism of action to reduce the level of long-term glucocorticoid treatment that's required is also, not surprisingly, coming across as an important feature.

Any.

Potential future price increases.

So we don't discuss those and but what I wouldn't want to add is that I think in the short history that neurocrine has been a commercial company.

We've shown ourselves have great restraint and to be.

Very sensitive.

To price and taking any incremental increases.

Matt you want to the in regards to guidance absolutely we've invested in a internal forecasting group and.

Biran Amin: The impact of the DTC campaign and, you know, it's been ongoing for several quarters now. Has it met your expectations? Do you plan to change or modify the program at all?

Do have a much better pulls than we had say two years ago.

The the at the time of launch better insight into.

Patient patients rate of continuation and then also better understanding of the impact from the expanded Salesforce and disease state awareness campaign. So as we contemplate guidance one of the one of the questions is do we feel comfortable to provide a guide and then the second piece is really as a company.

Eric S. Benevich: So, Anupam, I'm going to assume that your entire question there was about the DTC camp. Bjarne, I'm sorry, I think your question was about, in its entirety, the DTC program. If we could tell you about the impact that it's had as of yet, was there anything that you prefaced that with?

From an investment community perspective is is that something that's that's beneficial and inappropriate for us to do so we do we do gather all the information that we have now and do something if we did provide to guide we would want to make sure. We're comfortable on and we do have a lot more insight today them than we did even at the beginning of.

Biran Amin: I do apologize; we are getting a heavy level of static on this line.

This year.

Okay, That's fair man and and Kevin. Thank you I wanted to ask a follow up.

Kevin C. Gorman: So Anupam, we'll try to, I'm sorry, Biren, jeez, I don't know why I keep doing that. Biren, let's have Eric answer that question. Sorry about what may be happening to your line. I hope this isn't systematic.

Our two part question so it's a warning.

Every which is if he just think about the Huntingtons Chorea program. I think you mentioned that you'd be finishing that study in 21 and given the use of standard of care, which is pretty small in that patient population I'm really kind of wondering what you think about the timing of data.

Eric S. Benevich: Yeah, so, um, hey Brian, what, uh, what I would say in terms of, uh, the experience that we've had thus far with the, uh, Disease State Awareness Campaign for, for TD, which is Talk About TD, uh, is that we've been very pleased with the response You know, we launched it at the beginning of this year, we were hopeful that we would get a good response in terms of unique visitors, people spending time looking at the content, downloading the videos, registering to come into our database, and thus far it's exceeded all of our expectations. And anecdotally, we've heard very positive feedback from our customers through our field sales team. People going into clinics and going into some of these practices and being asked, are you the company that's sponsoring the educational content that I saw on that ad last night?

And the rate limiting steps in that program and then as a follow up list just jumping over to a DC.

I'm wondering if and I know that you haven't completed your discussions with agency, but if you. If you can imagine being in a pivotal program and 20 was that one.

So on the first question I actually Didnt catch the very end of the question and so would you mind just repeating that first part of the question for me.

Yes, just really rate limiting steps to enrollment and timing of data and Huntingtons program.

So they did the patient population for that to trial is 120 subjects approximately and that will be performed doesn't multicenter trial across the United States and that we are actually pretty encouraged by the enrollment rate that we predict that trial based on our collaboration with the Huntington study group.

And what appears to be a significant level of interest in continuing to evaluate a novel the Matt you inhibitor in Valbenazine in this patient population.

Eric S. Benevich: So, you know, our plan going forward is to continue to invest in this disease state awareness campaign. We expect that, you know, we'll continue to have time periods where we're on the air and then time periods where we're off the air. But going forward into 2020, this is just another area where we're going to continue to invest in what is still a very early stage of the overall development of this TD market. And certainly, we think it's to the benefit of the many, many patients out there that are as yet undiagnosed and suffering from TD. So, you can expect that we're going to continue to focus on educational efforts in this area and in other areas.

I'd also add to me reinforces the fact that there is still significant unmet medical need in the space. So patients with Huntingtons disease in the treatment of that Korea, and so were very encouraged with that and that's what's really driving our thinking about a 2021 data really timing that.

With the voyage it'd be why Hdc program, it's really too early for me to give any comments around thinking with the interaction with the agency as Kevin mentioned, we will be.

In dialogue with the FDA this year and were continuing to progress that initial study as there is still one study as rapidly as possible and we are obviously starting to think about him plan the.

Subsequent restored to study.

Thanks for the added color and taking my questions.

Jay Olson: We'll take our next question from Jay Olson with Oppenheimer. Please go ahead, your line is open.

Thank you chest.

Take our next question from Brian Abrahams with RBC capital markets. Please go ahead. Your line is open.

Jay Olson: Oh hey, thanks for taking the questions and congrats on the record number of new patient starts. Can you describe some of the key levers that you're pulling to drive those three consecutive quarters of new patient starts? And are these new patient dynamics something that we should expect to continue in the future? And then I had a follow-up question on ConnectHD.

Hi, there thanks very much for taking my questions. Just wonder if you had any updates around the competitive dynamics in TD and maybe the balance between overall market growth versus share growth that you might be seeing and then just as a second question is a follow up on Huntingtons might you expect any additional sort of or any sort of additional monitoring.

Acquirements in that study or possible class labeling with respect to the boxed warning and how that might potentially impact adoption to on TD if at all thanks.

Yes, so thanks.

I'll answer the second part of your question really easily that talking about labeling when we've just started out in the indication is premature so I really don't have.

Jay Olson: It doesn't show the dose on clinicaltrials.gov, so I was wondering if you're studying the same 40 and 80 milligram doses of valbenazine used for tardive dyskinesia, or if it's a different dose. And if it is a different dose, does that allow for some additional IP and or differentiated pricing? And if it's not a different dose, did you weigh the alternative of studying your next-gen VMAT inhibitor for Huntington's disease instead of valbenazine? Thank you.

We really don't have a position on that right now.

And the fact that we have a very nice label with ingress and tardive dyskinesia on your first question. Once you said competitive dynamics I apologize again, you cut out for.

A moment there. So you were talking about TV in the competitive dynamic how did you in that first question. Just wondering if you could speak to the balance between overall market gross versus share growth within the market that you're saying.

Go ahead, Eric, Yes, Hey, Brian So.

With regards to competitive dynamics.

Obviously, we're very bullish on the TV market opportunity, it's a as yet.

Eric S. Benevich: So Jay, I feel I should call you Baron at least three times just to make up for it. But I'm going to let Eric take the first part of your question.

Mostly undeveloped.

Opportunity here most patients today still remain.

Eric S. Benevich: Yeah, first of all, congratulations, Jay, on the multi-part second question. I'll tackle the first question, which is really around what's driving this record number of new patient starts that we've experienced for the past few quarters. And I really do think that it is the cumulative effect of everything that we're doing in the marketplace. Certainly, I think we're seeing the benefits of the expanded sales team. You know, about this time last year, we had just expanded the field sales team, and we were talking back then about legacy salespeople versus new hire salespeople and the need to get everyone up to the same level of experience and capability. And I think at this point in time, we're no longer thinking of our team that way.

Undiagnosed and untreated and so our efforts are primarily focused on helping providers recognize make the appropriate and correct diagnosis for TV and then of course.

INGREZZA is the most preferred and most prescribed the Matt two inhibitor for TD.

And so we have the majority of market share in fact, just looking at.

The reported sales.

For brands to be met twos over the last.

Four quarters the market share has has remained stable.

So we continue to invest in developing the market opportunity as I mentioned the expanded salesforce the unbranded.

Awareness campaign for TV.

But the majority of our focus is really helping patients.

Eric S. Benevich: You know, we've got a really good, cohesive experience team out there that's doing great work in terms of helping their customers to identify appropriate candidates for treatment within GRESA. So, the expanded sales team, I think, is a big driver of the success. I just talked a moment ago about the disease state awareness campaign talking about TD and the fact that we're continuing to see really strong responses to that campaign. And I think it's indicative of the interest and maybe the need for more information for patients and loved ones that are suffering from involuntary movements and wondering, could this be TD. And then, you know, I think that also some of the other elements of our promotional efforts, including peer-to-peer educational events, et cetera, are really, really what's driving the record number of new patients.

That are currently I'm undiagnosed to have that conversation with their provider and determine whether or not its TD and then of course, whether or not they're going to get treated.

When they do most of the time INGREZZA is the choice so I.

I hope that answers your question about competitive dynamics, but we feel very good that theres still a lot of opportunity for our product in this market.

That's really helpful. Thanks, Eric Thanks, Kevin and congrats again on the next quarter. Thank you very much.

We'll take our next question from David himself with Piper Jaffray. Please go ahead. Your line is open.

Thanks, So I wanted to come back to contracting.

And ingress and this is a long term question, but as the footprint or the product grows and the footprint of sito grows.

Do you start to think about.

Contracting differently or just as the footprint grows.

In dollars does that necessitate.

Discussions with payers regarding contracting over the long term. So that's number one and then another commercial question and this is on let's take a phone I apologize if you alluded to this earlier, but can you give us some color on your payer strategy there.

Eric S. Benevich: As Matt mentioned earlier, it's a critical area of focus for us to continue to grow this market opportunity, and we're doing it organically. So, you know, it's hard to tease out which element is having the biggest impact, but I think, cumulatively, they're all critically important, and it's really a testament to the strong execution of all of our customer-facing teams. The field sales team, our field reimbursement team, our field medical team, and I want to just say that they're doing a great job out there.

Specifically, how aggressively you're going to need to contract and how restrictive are not restricted as the payer landscape.

Maybe for that product thanks.

David.

When you cut out at the beginning of your second question without one about a pickup phone and.

Contracting.

It was in the question I'll just repeat a real quick the question was.

On the payer landscape for OPEC, a phone and the extent to which that landscape will be restrictive.

Yes, so I'll just real quickly and briefly on on the second question, which was a pickup cone again.

Jay Olson: Thanks Jay and I don't have a comment at the moment around the IT strategy and you're correct at the current time we did not publish the doses of valbenazine that were being used in the HD connect trial in Contrails.gov and so but just a couple of comments around that we're obviously extremely comfortable with the 40 and 80 milligram doses and the simple dosing regimen that we have currently in tardive dyskinesia and the you know encouraging benefit-risk profile that we've continued to see around that but in a similar fashion to our exploration of Tourette's disorder we are keen to ensure that we provide flexibility in dosing and we don't want to assume that the dosing strategy in each different disease state would essentially be the same as tardive dyskinesia and so we've designed the connect HD study in that fashion and that also would translate I think potentially into our future evaluation of next-generation VMAT2 inhibitor candidates.

Little early to be discussing the pair landscape I think there is a fundamental difference that will be.

With from a pick phone from INGREZZA is that we don't.

Yeah.

We don't plan on moving or having a price that would put us in the specialty tier.

Our category with a pickup pounds. So it's it's going to be a different dynamic there and I'll leave it at that Eric you want to talk about the first.

Yes, David So the answer to your question is does the contracting or the payer strategy evolve as we move through the launch and the answer is definitely yes.

What we had said at the time of the launch and subsequently in 2017 in 2018 was that.

It was a little bit early for us to engage in.

Contracting discussions with payers, we wanted to better understand what the emerging payer mix was going to look like for INGREZZA I think payers wanted to better understand.

What the volume was going to look like for this class as well as.

Through use of prior authorizations and someone.

Who are the patients getting treated who are the providers that we're writing the prescriptions and was was our medication being prescribed appropriately now were two and a half years into the launch it as you alluded to in gross is becoming a much more prominent medication and.

Eiry W. Roberts: Alright, thank you very much. Congratulations again.

Jay Olson: Thank you.

Charles Duncan: We'll take our next question from Charles Duncan with Kantor. Please go ahead, your line is open. Hi guys, congrats on the top line and new patient starts performance in the quarter. Had a couple of questions, one commercial, and one pipeline. So I'll start with the commercial.

And beginning of this year I commented that we're at the point, where we're starting to engage with plans in terms of looking at formulary admissions and so on whereas at the beginning to launch a little bit too early for that kind of engagement with plans, where the point now where we have start.

Charles Duncan: And that is, I think he kind of addressed this to Anupam's question, which is guidance. But going into 2020, I guess I'm wondering what you think needs to occur to be able to start to provide guidance. Seems like you have a better handle on this market. And then are you thinking about pricing increases going into 2020?

Good to engage with plans and we have started to contract selectively where we make where we think it makes sense to benefit patient access so.

This does along.

A long time horizon, we want to make sure that we're we're sort of balancing our gross to net with.

The desire in the frankly, the imperative to make sure that patients have affordable access to INGREZZA and so we'll continue to look at these opportunities on a planned by plan basis.

Kevin C. Gorman: So, Chas, I'll take the second one. We wouldn't be discussing any potential future price increases, so we don't discuss those. But what I would want to add is that, in the short history of Neurocrine being a commercial company, we've shown ourselves to have great restraint and to be very sensitive to price and to take any incremental increases.

And invest where we think it makes sense, but overall, we we've been very successful.

Through the launch and we we aim to continue to have that success going forward.

Okay. Thank you.

We'll take our next question from Evan Siegel with Credit Suisse. Please go ahead. Your line is open.

Matthew C. Abernethy: Matt, do you want to go?

Hi, guys. Thank you so much for taking my question is congrats on the quarter. One from Matt just can you help us think or quantify any inventory build we saw in Threeq you and what we should think about informed view and then what I've a follow up for IRA.

Charles Duncan: Yeah, in regards to guidance, absolutely. We've invested in an internal forecasting group and do have a much better pulse than we had, say, two years ago at the time of launch. Better insight into patients' rates of continuation and then also better understanding of the impact from the expanded sales force and disease state awareness campaign. As we contemplate guidance, one of the questions is, do we feel comfortable providing a guide? And then the second piece is really, as a company and from an investment community perspective, is that something that's beneficial and appropriate for us to do? We do have all the information that we have now, and that is something that, if we did provide a guide, we would want to make sure we're comfortable with, and we do have a lot more insight today than we did even at the beginning of this year.

Sorry, Evan could you repeat the first question.

Yeah, sorry about the phones are not working today. My question was on inventory build in Threeq and Fourq, you any color or quantify quantification you can provide.

Yes, so in Q3, nothing bad flag as you know in of the second quarter, we did call out an incremental build that occur that.

Cause or days on hand to go up nothing that I would call out being material in Q3 as you think about Q4 I think some of the economics associated with INGREZZA make it difficult for there to be a massive stocking for example, or any pull ahead of prescriptions bye bye.

Patients, so not something that I would specifically call out.

And you had a site and then yes I got a second question for Irey, which we didnt catch.

Eiry W. Roberts: Okay, that's fair, Matt and Kevin, thank you. I wanted to ask a follow-up, call it two-part question, so it's a warning, of Eiry, which is, if you just think about the Huntington's Korea program, I think you mentioned that you'd be finishing that study in 21, and given the use of standard of care, which is pretty small in that patient population, I'm really kind of wondering what you think about the timing of data and the rate-limiting steps in that program, and then as a follow-up with just jumping over to AADC, wondering if, and I know that you haven't completed your discussions with agency, but if you can imagine being in a pivotal program in 20 with that one.

I did I did I don't think I asset so for Iraq. So on the Parkinsons gene therapy program can you just help us better understand just the rationale of using a gene therapy with this complex procedure for these patients for what seems to be more support of treatment versus something thats purely disease modifying what do you actually view this as disease modifying and.

And when should we expect updates on both the Parkinsons and the Epay program.

Hi, Thanks, very much for that Evan so.

As you know there a 1 million patients in the United States with Parkinson's disease, and 6 million patients worldwide. So it's the second most common unit degenerative facilities and although there are a lot of therapeutics orally available there is still huge unmet medical need as as evidenced by the fact that when patients progress through disease.

And get to that stage of mode to fluctuations at its a continuing decline and there.

Let's see to respond to leave it up a confident that treatment changes over time and becomes less predictable and becomes more problematic.

Charles Duncan: So in the first question, I actually didn't catch the very end of the question, and so would you mind just repeating that first part of the question for me?

So the goal of the why AIDC program is to replay in the brain of patients with Parkinson's disease experiencing much fluctuation a critical enzyme that results in the production of mall.

Eiry W. Roberts: Yeah, just really rate limiting steps to enrollment and timing of data in the Huntington's program.

Eiry W. Roberts: Okay, so the patient population for that trial is 120 subjects, approximately, and that will be performed as a multi-center trial across the United States, and we're actually pretty encouraged by the enrollment rate that we predict for that trial based on our collaboration with the Huntington Study Group and what appears to be a significant level of interest in continuing to evaluate a novel VMAT2 inhibitor in valbenazine in this patient population. You know, that also, to me, reinforces the fact that there is still significant unmet medical need in this space for patients with Huntington's disease and for their treatment throughout their careers, and so we're very encouraged by that, and that's what's really driving our thinking about a 2021 data release timing there.

I mean in a more realistic on on that systematic fashion right in the place where it's needed and so it is actually a very.

Clever approach to treatment of the disorder, and one in which we anticipate that isn't enable people to have a significantly better control of that disease, a in assessing that that is problematic.

At the very lease NAFLD patients in terms of managing oral treatment. The intent of the update on where we are with the program. We continue to progress the store one study, which is our hopefully pivotal phase two study at for treatment of the Parkinson's disease patients is motive.

Actuation and we are in the process as I mentioned earlier of interacting with the FDA to get feedback on the overall program moving forward.

Eiry W. Roberts: With the Voyager VYA-ADC program, it's really too early for me to give any comments around our thinking about the interaction with the agency. As Kevin mentioned, we will be in dialogue with the FDA this year, and we're continuing to progress that initial study, the Restore 1 study, as rapidly as possible, and we are obviously starting to think about and plan the subsequent Restore 2 study.

Great. Thank you.

We'll take our next question from Marc Goodman with SVB. Please go ahead. Your line is open.

Yes, hi.

I was curious about your latest meeting with with Abbvie regarding or alissa, and what they're saying about the product right now and second of all I may have missed us, but can you just comment again on R&D and why it was a little light in the quarter. Thanks, Matthew want to take the.

Charles Duncan: Thanks for the added color and taking my questions.

Brian Abrahams: Thank you, Jeff.

Brian Abrahams: We will now take our next question from Brian Abrahams with RBC Capital Markets. Please go ahead; your line is open.

Yes, sure Mark if you if you look back to last quarter. We did have a milestone that we paid to BL, though was $10 million that that caused the step up in.

Eric S. Benevich: Hi there, thanks very much for taking my questions. I was just wondering if you have any updates around the competitive dynamics in TD and maybe the balance between overall market growth versus share growth that you might be seeing. And then just as a second question, as a follow-up to Huntington's, might you expect any additional sort of or any sort of additional monitoring requirements in that study or possible class labeling with respect to the boxed warning and how that might potentially impact adoption at all in TD, if at all? Thanks.

R&D expenses I think if you want to want to want to to look forward to 2020, it's going to be a year of significant investment behind many of our R&D programs between the CH Global Registrational program as well as the Huntingtons disease trial, that's going to add to our R&D investment.

In addition, as you've heard I re talk and speak about between our view ITC program or friedrichs attacks in the other two programs with Voyager we would expect that to also be increasing as those programs overall, and then last but not least on the R&D front is.

Kevin C. Gorman: Yeah, so, thanks. I'll answer the second part of your question really easily: talking about labeling when we've just started out in an indication is premature. So, I really don't have, we really don't have a position on that right now, other than the fact that we have a very nice label with Ingressa and Tardive Dyskinesia. On your first question, once you said competitive dynamics, I apologize again; you cut out for a moment there. So, you were talking about TD and the competitive dynamic. How did you end that first question?

We continue to invest in our overall R&D structure infrastructure to support a platform to be able to put one to two compounds into the clinic per year. That's our that's our goal or target. So are you will see 2020 being an investment year.

On the on the R&D front, but in this quarter in particular.

Just say the deviation down was largely just because of the milestone that had been in R&D last quarter, and so mark when it comes to or listen and our meetings with Abbvie.

No.

Abbvie acknowledges that the launches going slower than what they had anticipated, but they continue to believe it or listen will ultimately be a very significant product for them.

They are in still the early stage or market creation for that and what they're doing is is that there.

They're looking at all the barriers that exist for adoption and then they are adjusting their marketing efforts right now.

Brian Abrahams: Just wondering if you could speak to the person

Brian Abrahams: Speak to the balance between overall market growth versus share growth within the market that you're seeing.

So in addition to DTC to create a broad market awareness, they're looking at certain new marketing programs, the better contextualize, the orla profile and differentiate for both HCP and and patients. So.

Eric S. Benevich: Go ahead.

Eric S. Benevich: Go ahead, Eric.

Eric S. Benevich: Yeah, hey Brian, so... With regard to competitive dynamics. You know, obviously, we're very bullish on the TD market opportunity. It's, as yet, mostly undeveloped, opportunity here.

Their goal is to drive a higher degree of urgency as you can imagine and over the past several decades, there's been a real resignation.

Eric S. Benevich: Most patients today still remain undiagnosed and untreated. And so our efforts are primarily focused on helping providers to recognize, make the appropriate, and correct diagnosis for TD. And then, of course, Ingresa is the most preferred and most prescribed VMAT2 inhibitor for TD.

On the patients side and complacency quite honestly on the physicians side. So that is what they put.

Additional efforts behind but they are remain very dedicated to this evidenced by the submission of the U F.

Eric S. Benevich: And so we have the majority of the market share. In fact, just looking at the reported sales for branded VMAT2s over the last... The market share has remained stable. So we continue to invest in developing the market opportunity, as I mentioned, the expanded sales force, and the unbranded awareness campaign for TD. But the majority of our focus is really helping patients that are currently undiagnosed to have that conversation with their provider and determine whether or not it's TD and, then of course, whether or not they're going to get treated. When they do, most of the time, Ingresa is the choice. So I hope that answers your question about competitive dynamics, but we feel very good that there's still a lot of opportunity for our product in this market.

And da and also starting the the polycystic ovarian syndrome studies.

Thanks.

We'll take our next question from Muting, some Joe with Guggenheim Partners. Please go ahead. Your line is open.

Hey, guys congrats on the quarter and thanks for squeezing me in the question is more on the long term business trend could you maybe comment on the rate.

You might be able to grow the business going forward on a yearly basis without having new indication. If you look at 2018 2019. It seems like you are adding about 300 million on incremental sales.

Base is that a healthy run rate that you could sort of grow the business going forward.

Yes, sure were quite enthused around the long term opportunity around and grows if you think about 2019. This was a tremendous year for us and in helping many patients.

Brian Abrahams: That's really helpful. Thanks, Eric. Thanks, Kevin. And congrats again on the next quarter. Thank you very much.

Good on a medicine, Mike can grow didn't help them with their with their movements and that was really on the backs of significant investment behind or Salesforce expansion and then also the disease state awareness campaigns. So.

Kevin C. Gorman: Thank you very much.

David A. Amsellem: We'll take our next question from David M. Sellen with Piper Jaffray. Please go ahead, your line is open.

This year was it was a tremendous year and as we get into 2020 will will provide you specific color.

David A. Amsellem: Thanks. So I wanted to come back to contracting in Ingressa, and this is a long-term question, but as the footprint of the product grows and the footprint of Auspito grows, do you start to think about contracting differently, or just as the footprint grows in dollars, does that necessitate discussions with payers regarding contracting over the long term? So that's number one. And then another commercial question, and this is on Opicapone, and I apologize if you alluded to this earlier, but can you give us some color on your payer strategy there, and I guess specifically how aggressively you're going to need to contract, and how restrictive or not restrictive the payer landscape may be for that product? Thanks.

As to what we would expect in 2020, either qualitatively or quantitatively, but.

But just know as a company and as an organization. Our number one priority is to continue to to invest in INGREZZA and.

Continue to develop but it's hard.

Thats good news.

On market band and what I would add to this as I go back to if its first principles I don't know if that's the best term to use with this but as we said using kind of in precise numbers, we think that that now there's maybe between 10 and 12%.

Of TD patients have received the diagnosis and still only a fraction of them that are being treated for tardive dyskinesia. So there is still.

A real long runway ahead of us and so I I'm, not saying that that's going to be a smoothes line that just keeps going up but what I'm, saying as it's probably going to have punctuation, where where we will have more and more adoption of the drug so.

Kevin C. Gorman: Hey David, again, you cut out at the beginning of your second question. Was that one about pick-a-pone and pay or contracting?

And in addition, as we move forward, we plan on being a global pharmaceutical company.

David A. Amsellem: It was, and the question, I'll just repeat it real quick, the question was, you know, your thoughts on the payer landscape for Opicapone and the extent to which that landscape will be restrictive or not.

We have.

Viasat two follow on programs, we've got the Huntingtons indication that we're going into and and we also just have a real commitment to the Vms two franchise. So I think all those things together.

Kevin C. Gorman: Yeah, so I'll jump real quickly and briefly in on the second question, which was a pick-a-pone. Again, a little early to be discussing the pair landscape, but I think there's a fundamental difference that will be from a pick-a-pone from Ingresa is that we don't plan on moving or having a price that would put us in the specialty tier or category with a pick-a-pon

Is going to lead to a good sustained increasing growth in the future.

But it just quick one format.

Could you comment on the tax rate going forward is that something you're going to start paying on a regular basis. Thank you.

Yes. So so we entered the year with about a billion in federal unwell. So it's going to be quite some time before we get into a a cash tax.

Eric S. Benevich: So it's going to be a different dynamic there, and I'll leave it at that. Eric, you want to talk about the first one? Yeah, Dave.

That us with with the with the Federal government and then on the street level. We do have stayed on noel's, but those are specifically earmarked in in California. So we will be a speed.

Eric S. Benevich: Yeah, David. So the answer to your question is, does the contracting or the payer strategy evolve as we move through the launch? And the answer is definitely yes. You know, what we had said at the time of the launch and, you know, subsequently in 2017 and 2018, was that it was a little bit early for us to engage in contracting discussions with payers. We wanted to better understand what the emerging payer mix was going to look like for Ingresa. I think payers wanted to better understand what the volume was going to look like for this class, as well as through the use of prior authorizations and so on, who were the patients getting treated, who were the providers that were writing the prescriptions, and was our medication being prescribed appropriately.

Tax payer here and Thats, what you see running through our piano from a longer term perspective based upon what we know today, we would expect or our effective tax rate to be around 24% or so but as our tax strategy evolves and that's a that's a domestic number but as our tax strategy evolves and we continue.

Mature into profitability will provide incremental color in the future.

Thank you very much.

We'll now turn the program back over to our CEO , Kevin Gorman for any closing comments.

Yes, Thank you and I really appreciate everyone's patience throughout this call.

I know its.

With that cutting in and out on your end and actually different apparently specific to US we were only catching up bits and pieces of some of the questions.

I'm sure it's been frustrating to all of you, but thank you for bearing with us what I'd like to close with is that we remain and I hope that youve that you realize this through this call and all of our interactions singularly focused on bringing important new medicines to patients not just today, but well into the future.

Eric S. Benevich: Now we're two and a half years into the launch, and as you alluded to, Ingresa is becoming a much more prominent medication. And at the beginning of this year, I commented that, you know, we're at the point where we're starting to engage with plans in terms of looking at formulary additions and so on, whereas at the beginning of the launch, it was a little bit too early for that kind of engagement with You know, we're at the point now where we have started to engage with plans, and we have started to contract selectively where we think it makes sense to benefit patient access. So this is a long-term horizon. We want to make sure that we're sort of balancing our growth to net with the desire and, frankly, the imperative to make sure that patients have affordable access to Ingresa. And so we'll continue to look at these opportunities on a plan-by-plan basis and invest where we think it makes sense. But overall, we've been very successful through the launch, and we, you know, we aim to continue to have that success going forward.

I look at us in just the near term and if we look at the same time next year, we hope to have three medicines approved and for patient populations behind that we'll have three pivotal programs underway and then behind that we'll have our organic internal programs moving forward.

Our our already the partnerships that we have those moving forward and then.

As of yet to be identified.

Business development opportunities that I hope to come through over the coming years that'll that'll add to that pipeline. So were dedicated to be the leading neuroscience company focused on the intersection Moneris psychiatry, and neuroendocrinology now and in the future and so once again. Thank you for your patience I look forward to meeting up with all of you in.

Having meetings take care.

This does conclude today's program. Thank you very much for your participation you may now disconnect.

Evan Siegelman: Thank you. We'll take our next question from Evan Siegelman with Credit Suisse. Please go ahead. Your line is open. Hi guys. Thank you.

Evan Siegelman: Alright guys, thank you so much for taking the questions and congrats on the quarter. One for Matt, can you help us think about or quantify any inventory build we saw in 3Q and what we should think about in 4Q? And then I'll have a follow-up question for Eiry.

Matthew C. Abernethy: Sorry, Evan, could you repeat that first question?

Evan Siegelman: Yeah, sorry about that. The phones are not working today. My question was on inventory build in 3Q and 4Q. Any color or quantification you can provide to us?

Matthew C. Abernethy: Yeah, so in Q3, nothing that I'd flag. As you know, in the second quarter, we did call out an incremental build that had occurred that caused our days on hand to go up. Nothing that I would call out as material in Q3. As you think about Q4, I think some of the economics associated with Ingresa make it difficult for there to be, you know, a massive stockpile, for example, or any pull ahead of prescriptions by patients. So it is not something that I would specifically call out.

Evan Siegelman: You had a second question for Eiry, which we didn't catch.

Evan Siegelman: I did, I did. But I don't think I asked for it.

Eiry W. Roberts: So for Eiry, on the Parkinson's gene therapy program, can you just help us better understand just the rationale for using gene therapy with this complex procedure for these patients, you know, for what seems to be a more supportive treatment versus something that's purely disease-modifying? Or do you actually view this as disease-modifying? And when should we expect updates on both the Parkinson's and the FA program?

Mm Hmm.

HM.

Mhm.

Dave.

Eiry W. Roberts: Thanks very much for that, Evan. So, as you know, there are one million patients in the United States with Parkinson's disease and six million patients worldwide, so it's the second most common neurodegenerative disorder. And although there are a lot of therapeutics orally available, there's still a huge medical need, as evidenced by the fact that when patients progress through disease and get to that stage of motor fluctuations, it's a continuing decline, and their ability to respond to levofopa-carbidopa treatment changes over time and becomes less predictable, and becomes more problematic. In terms of the update on where we are with the program, we continue to progress the Restore One study, which is our hopefully pivotal phase two study for treatment of Parkinson's disease patients with motor fluctuations, and we are in the process, as I mentioned earlier, of interacting with the FDA to get feedback on the overall program moving forward.

Mm.

Evan Siegelman: All right, thank you.

Kevin C. Gorman: We'll take our next question from Mark Goodman with SVB. Please go ahead, your line is open. Yes, hi.

Marc Goodman: I was curious about your latest meeting with AbbVie regarding Oralisa and what they're saying about the product right now, and second of all, I may have missed this, but could you just comment again on R&D and why there was a little light in the corner, thanks Matt. Do you want to take part in that?

Matthew C. Abernethy: Yeah, sure, Mark. If you look back to last quarter, we did have a milestone that we paid to Bial for $10 million, which caused a step up in our R&D expenses. I think if you want to look forward to 2020, it's going to be a year of significant investment behind many of our R&D programs, including the CAH Global Registrational Program, as well as the Huntington's Disease Trial. That's going to add to our R&D investment. In addition, as you've heard Irie talk and speak about, between our VYADC program or Friedrich's Ataxi and the other two programs with Voyager, we would expect that to also be increasing as those programs evolve. And then, last but not least, on the R&D front, we continue to invest in our overall R&D infrastructure to support a platform to be able to put one to two compounds into the clinic per year. That's our goal and our target. You will see 2020 being an investment year on the R&D front, but in this quarter in particular, I would just say the deviation down was largely just because of the milestone that had been in R&D last quarter.

[noise].

Kevin C. Gorman: And so, Mark, when it comes to Auralisa and our meetings with AbbVie, you know, AbbVie acknowledges that the launch is going slower than they had anticipated, but they continue to believe that Auralisa will ultimately be a very significant product for them. They are still in the early stage of market creation for that, and what they're doing is that they're looking at all the barriers that exist for adoption, and then they're adjusting their marketing efforts right now. So, in addition to DTC to create broad market awareness, they're looking at certain new marketing programs to better contextualize the Auralisa profile and differentiate it for both HCPs and patients. So their goal is to drive a higher degree of urgency. As you can imagine, over the past several decades, there's been a real resignation on the patient side and complacency, quite honestly, on the physician side. So that is what they've put additional efforts behind, but they remain very dedicated to this, evidenced by the submission of the UF NDA and also starting the polycystic ovarian syndrome studies.

[noise].

Yatin Suneja: We'll take our next question from Yatin Suneja with Guggenheim Partners. Please go ahead. Your line is open. Hey, guys. The question is more about the long-term business trends. Could you maybe comment on the rate you might be able to grow the business going forward on a yearly basis without having new indications?

Kevin C. Gorman: Yeah, sure. We're quite enthused about the long-term opportunity for Ingreso. If you think about 2019, this was a tremendous year for us in helping many patients get on a medicine like Ingresa and help them with their movements. And that was really on the back of significant investment behind our Salesforce expansion and then also the disease data awareness campaign. So this year was a tremendous year, and as we get into 2020, we'll provide you with specific color as to what we would expect in 2020, either qualitatively or quantitatively. But just know that, as a company and as an organization, our number one priority is to continue to invest in Ingresa and continue to develop the Tardive Dyskinesia market.

HM.

Mm.

[noise].

Matthew C. Abernethy: And what I would add to this is, you know, if it's first principles, I don't know if that's the best term to use with this, but as we said, using kind of imprecise numbers, we think that now there are maybe between 10 and 12 percent of TD patients who have received a diagnosis, and still only a fraction of them are being treated for tardive dyskinesia. And in addition, as we move forward, we plan on being a global pharmaceutical company. We have VMAT2 follow-on programs. We've got the Huntington's indication that we're going into. And we also have a real commitment to the VMAT2 franchise. So I think all those things together are going to lead to good, sustained, increasing growth in the future.

Dave.

[noise] [noise] [noise].

Yatin Suneja: Just a quick one for Matt. Could you comment on the tax rate going forward? Is that something you're going to start paying on a regular basis? Thank you.

Matthew C. Abernethy: Yeah, so so we entered the year with about a billion in federal NOLs so it's going to be quite some time before we get into a cash tax status with with the with the federal government and then on the state level we do have state NOLs But those are specifically earmarked in in California, so we will be a state Taxpayer here, and that's what you see running through our PNL from a longer-term perspective based upon what we know today We would expect our our effective tax rate to be you know around 24% or so But as our tax strategy evolves and that's a that's a domestic number But as our tax strategy evolves and we continue to mature into profitability will provide incremental color in the future

[noise].

Yatin Suneja: Great, thank you very much.

Kevin C. Gorman: I'll now turn the program back over to our CEO, Kevin Gorman, for any closing comments.

Mm.

Kevin C. Gorman: Yeah, thank you. And I really appreciate everyone's patience throughout this call. I know it's cutting in and out on your end, and actually, apparently, specifically to us, we were only catching bits and pieces of some of the questions.

[noise] [noise].

Operator: I'm sure it's been frustrating for all of you, but thank you for bearing with us. What I'd like to close with is that we remain, and I hope that you realize this through this call and all of our interactions, singularly focused on bringing important new medicines to patients, not just today but well into the future. I look at us in just the near term, and if we look at this same time next year, we hope to have three medicines approved in four patient populations. Behind that, we'll have three pivotal programs underway. And then behind that, we'll have our organic internal programs moving forward; already the partnerships that we have, those moving forward. And then, as yet to be identified, business development opportunities that I hope to come through over the coming years that'll add to that pipeline. So we're dedicated to being the leading neuroscience company focused on the intersection of neuropsychiatry and neuroendocrinology, now and in the future.

[noise].

Operator: And so once again, thank you for your patience. I look forward to meeting up with all of you at upcoming meetings. Take care. This does conclude today's program. Thank you very much for your participation.

Operator: This does conclude today's program. Thank you very much for your participation, and you may now disconnect.

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