Neurocrine Biosciences, Inc. (NBIX) Earnings Call Transcript & Summary

The next panel or well, expanded fireside, I should say. Everyone's representing the same company. So I'm Yigal Nochomovitz, Biotechnology Analyst here at Citi. So we have Neurocrine Biosciences as our next company. To my left is Kyle Gano, the CEO and everyone could...

Yes, Matt Abernethy, CFO. I've been with the company about 7 years, and really exciting time for the company with INGREZZA, crinecerfont and a few Phase III programs are starting. So feel quite fortunate to be with the company, Yigal. Nice to meet you as well.

Yes, Yigal, thanks for having us. Your far, far left, I'm Todd Tushla, Investor Relations Vice President. Grateful to be here.

Okay. And remember, for those here in the room or if you're on the webcast, you can type your questions in, and I'll see them and I'll be able to relay them to management. So maybe just as a high level, just kind of give us a 30-second state of the union on Neurocrine, how is the business shaping up through the rest of 2024 and what should investors look forward to for next year?

Thanks, Yigal. Maybe I'll take a moment, just a quick introduction on myself. This is my first Citi conference being the CEO here at Neurocrine. I've been in the seat now for almost 2 months after a long time CEO, Kevin Gorman retired in early October. I've been at the company for 25 years. So a lot of the things that you may hear from me today come from a historical standpoint. I've been here through a lot of the ups and downs at Neurocrine and really brings us to this time point here as Matt said, a really exciting time at Neurocrine. And if you want that 30-second overview, I reflect on where we were towards the end of the year in 2016 when we were talking about the potential launch of INGREZZA. It was in review at that time. And one of us probably said it felt like Neurocrine when it was a tightly oiled or tightly coiled spring, ready to spring out there with all the things that we had ongoing at the company. So valbenazine, now INGREZZA was in review, we had another program in Phase III, and crinecerfont was just starting to get some interest out there in the area of CAH. Fast forward to today, valbenazine was approved. It's INGREZZA. In Q3, we reported $613 million in revenue. That's about 25% year-to-year growth, outstanding medicine there with a lot of time and opportunity left to continue to grow. crinecerfont, the medicine that was in early phases of development back in late 2016 is now an FDA review. And we look at that as being a potential blockbuster for Neurocrine and also something that will diversify our revenue profile as time moves along. And we have not 1 but 2 programs in Phase III, that being NBI-'568 and NBI-'845 for schizophrenia and depression, respectively, and then 10 other programs in clinical development. So in 2016, we were a tightly coiled spring. Today in 2024, looking to 2025, we have a lot of growth opportunities across the medicines that we have at commercial with INGREZZA or near commercial with crinecerfont and all the good things that are happening in the pipeline.

Kyle, do you think the spring is tighter now or back then because it's amazing to think about everything we have going on inside the company.

Well, there is a factor. Those of you that are familiar with physics called Hooke's law. So exactly. So the constant here now is a little bit higher in magnitude than it was in 2016. That just tells you the force that we're seeing ourselves potentially spring it if we want to keep this analogy going is much higher today, and that's what makes this all exciting.

I think -- well, first of all, I was commenting earlier today with somebody about how dumb I feel from time to time being an MBA and not a PhD. So you just made me feel that way again, Kyle. But I also think it was interesting. And for me, in particular, just great to join the company 7 years ago and be in a position like this. And I think earlier, you were mentioning, you've been working on CRF for like for over 20 years at this point. And so to be at a place to take over as CEO, Kyle, I would just say it's quite an honor to be part of the company. And I know Yigal probably didn't expect this type of back and forth. It is a quite a cool perspective in the midst of sort of what you'd call -- I'd call turmoil in the industry. There's great hope right now in terms of new patients -- or sorry, new medicines that can be brought forth to help benefit patients. And fortunately, we're going to be able to do that for the first time in 70 years with the CAH medicine this coming year. So irrespective of the challenges, I guess, with the industry and some of the political dynamics, a lot is going well at Neurocrine as it relates to future innovation of medicines.

Just give us a little bit of the background. What roles did you have in the company from the beginning through till now you're elected to the CEO position?

It's a great question. And I'll tell you, it's a little -- it's a bit of a funny story. I started at Neurocrine as a summer intern back in 2001 and between my first and second year in business school. And rest assured, our HR group really allows to take advantage of that each year when we roll out our summer interns at Neurocrine, and they say this could be you in 25 years if you stick around long enough. So I started off as a summary intern, mainly on the marketing side of things when we struck a couple of partnerships at the time I joined in 2001 namely with Pfizer. I learned a lot about this space through our collaboration with Pfizer being a really top marketing organization back then and today, and that allowed me to move into other roles in the company, in particular, in business development. I've served in a role either directly entitled or indirectly, just trying to help out being in a small biotech company over the years, every role within the company and that help me appreciate really those things that drive value for the company, things that help things move things along and give me a good opportunity to succeed in this role at I'm now. And you layer on top of that a lot of pride in what we've done over the years. Matt mentioned the time that we spent on CRF. The corticotropin-releasing factor as a target was a founding technology to company back in the early '90s. And for those of you that followed our story, you know that we leverage that knowledge -- that platform through many early partnerships with a lot of the major pharmaceutical companies and that help bootstrap the company into its maturation to where it is today. A little did we know back then that CRF's best role was in the endocrinology, a lot of the early work that was done in this space was in depression and anxiety. But that's something that you learn along the way and something that I appreciate. There's always ebbs and flows in the programs that you work on. There's rarely a linear path. There's a lot of things that you learn along the way. And the key is that you apply those learnings to future studies and future programs. We did that initially with a medicine that's now approved through Elagolix to ORIAHNN, which is currently being commercialized by our partner, AbbVie. And then from valbenazine to INGREZZA. These are things that had multiple Phase II setbacks that we're able to learn from and eventually get those study designs right and they've led to the medicines that we have today.

And then that sort of sets me up for my next question, which is are you going to essentially continue to steer the ship in the same direction with the same vision? Or is there a different or a modified vision for the company now, now that you're the leader?

Well, I do appreciate that we've got a lot on our plate right now. Obviously, you've seen in the press, we've expanded our sales force for INGREZZA this quarter. That's to recognize the significant growth that's still ahead, but that requires more work and attention as we think about investing INGREZZA over the course of the remaining patent life for INGREZZA. That's another 14 years. We're also looking at a medicine that's in late-stage review right now, which in a couple of weeks' time, we're hoping that we get an approval and then we're looking at launching a new medicine. On top of that, we have 2 programs that are moving into Phase III for the first time in Neurocrine's history, we've tackled 1 program in Phase III per unit of time. And now this is the first time that we have 2 and working in the psychiatry space, we all know the importance of managing studies, managing sites. So there's a lot of oversight that's required there. I want to make sure we do those 3 things really, really well as a company. Coming from a business development perspective, I do get a lot of questions, are you going to continue down that path of acquiring assets, acquiring technologies. Those are things that we continue to do and look at from a sense of urgency perspective, but right now, with an eye on INGREZZA, launching crinecerfont, getting our hands around doing quality Phase IIIs. I want to make sure that we do that really well before we look at other things within business development to add to the portfolio.

Observing Kyle for the last 7 years, but then also last 3 months, one of the things I appreciate as a CFO, it really comes down to, our job is to develop medicines but also to drive shareholder value. And I think that the components of where are we going to invest into the future, driving topline growth in INGREZZA and crinecerfont, capital allocation priority 1 and 2 and then investing in our pipeline. I think we recently did a share repurchase in ASR, well, I know we did in ASR and I think we did. And that was just purely a reflection of our stock price being dislocated from our value and it was an efficient use of capital. But by and large, our capital is going to be redirected to investing in the business to grow a leading neuroscience company. And that's going to come through growing revenue and then also investing in quality assets in the pipeline. So from a capital allocation perspective, because it's also -- since we did the ASR right around when Kyle became CEO, it's a question of, are you guys going to continue to buy back a whole lot of shares. We might opportunistically, but that's not going to be a core component of our capital allocation philosophy. We're a growth company and expanding our businesses is what we're ultimately paid for and shareholders will be rewarded for.

Yes. I think just to add to that, the key in our mind for a high-growth company is that you have an eye on near- and long-term value creation. So looking at INGREZZA, looking at crinecerfont, that's your near and midterm value drivers in the long term. It's those programs in Phase III. We can win on all those.

Okay. Well, rather than talk about the INGREZZA growth trajectory right now, let's go with the thematic question. We know what happened in the space with AbbVie, Cerevel, some criticisms of that study with respect -- and not just them, but just in general, in neuropsychiatric studies, issues with the placebo effect, issues with "professional patients", you mentioned having very good stewardship of clinical trials. So maybe you can just talk about your thoughts on that competitive data point, but then just more generally, how you solve for minimizing some of these risks, which are obviously more present in neuropsychiatry than maybe what I do a lot of work in is oncology, for example.

So maybe I'll start, and then I'll ask my team to add anything here that I missed. But when it comes to the emraclidine AbbVie data, obviously, not a great time to think about a potential new medicine that could be useful for patients. So that's why we're all in this business. But when it comes to the data in and of itself, you look at the changes that were made between more of an academic Phase Ib trial to the larger Phase II/III trials that were conducted. And there were a lot of changes there that were made, both in terms of moving from 80 subjects to 375 or 5 sites to 25 or however many there were and then a U.S.-based study that included U.S. and European studies. During the course of the program, obviously, Cerevel was acquired by AbbVie that always adds swirl in unknowns to those that are working on the program and then the use of CROs for the Phase III trial. You can still lend with all those different things that are ongoing in the background. But ideally, you wouldn't like to have all those different variables there. So whether those played a role or not, I can't say. In our view, with the placebo effect being as high as it was it's hard to make any inferences about the biology. We would say that just because of placebo effect alone, they were failed studies in of themselves, and I would be not surprised to see that AbbVie continues investing in the asset, either in schizophrenia or in other indications as they look to manage future studies on their own. And I'm sure they'll take all the learnings they've had over the years from VRAYLAR as well, which is a very valuable asset they have in the psychiatry space. So that's probably all I want to say about emraclidine. Other than it's a segue for us to explain the differences between an M4 PAM, which is what emraclidine is and our approach with NBI-'568, I can't think of 2 different approaches to activate a receptor that being M4 then between these 2 programs. Emraclidine being a positive allosteric modulator requires acetylcholine as the endogenous ligand to activate them for receptor. We know acetylcholine, at least by age, is variable, potentially by disease state as well. And that's not something that we have to worry about with our program. And the reason for that is that '568 is an orthosteric agonist, it selectively and directly activates him for all by itself, doesn't require any co-optivity of acetylcholine and even if you want to compare it to COBENFY, we don't have to add anything to it to block side effects. It works just fine by itself. And that's a very attractive differentiator in our mind. And that's why we took this particular molecule and put it into a Phase II trial a couple of years back, it read out in Q3. This is a Phase II trial that had 210 subjects, about 15 clinical sites, and we looked at 4 doses of active versus placebo, randomized in the 2:1 active placebo ratio. This was an ambitious study that we admit on face. And the reason for that is that at the time of designing the study, we knew we were playing catch-up to KarXT now COBENFY as well as emraclidine in the hands of Cerevel at the time. We didn't have the luxury of KarXT. That's a combination product. Today, it's COBENFY of xanomeline and trospium, we didn't have 30 years of experience working with '568 as the data is out there for xanomeline and we didn't have a pet ligand that Cerevel was able to lean on to help triangulate on doses for their early study. We were really doing that first inpatient study with our molecule. We had a number of questions that we're trying to address all in one study. That set us up with the potential of moving directly into a registration program after this Phase III trial. So the 3 goals: number one, was understand the risk benefit of a selective and orthosteric agonist 1 in 4 and patient population that be in schizophrenia. The other one was to explore efficacy above 20 milligrams a day, which we always felt was an anchor dose for efficacy based on our preclinical and Phase I work. And then lastly, to pick a dose or doses and dosing regimen that would be appropriate for Phase III. And we're able to check all those boxes. Now what we found was the 20-milligram dose, the dose that we had the most data on outperformed the doses that were higher in magnitude in terms of milligrams per day. And that's where we had some noise around that because I think individuals in the field, we're thinking that we should see a consistent dose linearity in terms of going from low to high dose that you would see a commensurate increase in efficacy. And we didn't see that. We saw all doses reactive, but the 20-milligram dose outperformed the higher doses. And what we saw at the 20-milligram dose was a very nice profile. The total PANSS improvement was 18.2 points. Not the placebo-corrected PANSS improvement was 7.5 points. We saw an effect size of 0.61. We saw a separation of the endpoints, both primary and secondary, starting from week 1 and NeuroSTAT sig from week 3 all the way to the end of the study, which was week 6. All the data was consistent across all the sites. We didn't have any broke sites that performed higher or lower than other sites. They all look very similar across the board. And with the medicine that was once a day, no titration, no food effect and a very good safety and tolerability profile. Overall, that puts us in a very rare air in terms of a profile relative to other medicines in this category, the antipsychotics and certainly, as we think about it today relative to COBENFY on the market today. So that's a little bit about our feel on emraclidine, the differences in the pharmacology, what we've seen with '568 in our Phase II trial. The reasons why some uncertainty around the program in terms of the nonlinearity of the dose response. The next steps for us are into Phase II meeting in the next couple of months. And if the FDA agrees with our plan then we'll look on starting a registration program in the first half of next year and equally important, looking at pivoting into a second indication that we can take '568 into this year, this, let's say, 2025 as well.

One thing I just reminded of going through this process and observing what's happened. Neuropsych is tough. You have a lot of surprises along the way. Not all that can be rationalized scientifically and 2/3 of approved medicines today have a nontraditional dose response. So it's not easy in terms of looking at the data and trying to understand exactly why did that happen. But when you see safety, like what we saw with our muscarinic program, that's what we have found in engaging with clinicians. Safety matters in a significant way when treating patients with schizophrenia and a lot of the other mental health disorders that this could potentially be taken into. So we look at this as a bit of a gift if positive, the fact that we could be second to market. It's something that we'll only know if that gift is a great surprise in the box at the end of a 3-year period. But we've interrogated our data to convince ourselves that we do see a signal there. There's other biomarkers that help give us confidence such as heart rate increase and everything of that nature that helps us understand whether we've engaged the target that would align with the efficacy. So we do feel quite confident, but it's also a reminder of neuropsych is difficult. There's a reason why companies run 2 trials to -- or 3 trials to get too positive. It does take a lot of effort.

Yes. I mentioned at the outset here of my view or a lot of things comes from my history at Neurocrine and it is a good reminder based on what Matt just mentioned through our studies with valbenazine we failed the first Phase II/III, Phase II trials for valbenazine. Each study we learn more in terms of the appropriate trial design before the fourth 1 was positive. . It is the nature of the business. And I think there are a couple of things that you take away from that. You got to be able to appreciate when you have a good outcome and now want to take advantage of that. And you also need to know when there's probably no path forward and want to give up. And I think that Neurocrine shown over the years that it can strike the right balance on those 2 extremes.

And sorry, the last piece strategically for our company, INGREZZA today represents over $2 billion of sales for us. The large majority, call it, 80% of our business with INGREZZA comes from psych. And so when you think about leveraging 1 of our greatest assets for whether it's '568 and/or '845 major depressive disorder, come the end of the decade, we're looking to continue to transform what we're able to deliver, but then also leveraging our P&L profile to be an incredibly profitable company.

While you mentioned INGREZZA, so how much -- what's the growth expectation over the next -- the near mid and long term, how much more you believe the brand could grow?

Well, I think where we are today, and this has come out in some of our remarks over the past couple of weeks and months is, we touched on the expansion of our sales force this quarter. Our work on expanding appreciation of expanded prevalence of $800,000. Where we are ending this year is about 85% of that $800,000 are still patient-wise are not VMAT2 inhibitor. So we're 7 years into launch. We're talking about a medicine that on a year-to-year basis on the revenue side of things has grown nearly 25%. So if we think about 85% of patients still have not been treated with the VMAT2 inhibitor, our guidance this year of $2.3 billion to $2.32 billion, 14 more years of patent life, there's a lot of room left to grow in this program, this franchise that we have really with INGREZZA across TD and Huntington's chorea, the majority of the growth is from TD. So we're very excited about the opportunity that lies ahead for us. We know that there's work to be done. It's not easy to go out and strike the right amount of awareness with patients and physicians to make sure that they get their diagnosis of TD. I think most physicians are still doing the right thing in terms of making sure that the underlying disease is being picked up and treated appropriately. TD comes after that. That's how we have experienced our interactions with physicians over time. But the work goes into working through the new realities of what we see in the space, mainly in psychiatry, a reliance on telemedicine, for example. When physicians are not in the office, they rely on nurse practitioners. And there's a lot of turnover of that personnel within offices. They're highly sought after and they can go to another office and do better from a salary and even benefits perspective. So the education that we do takes time. And when the nurse practitioner moves on, you start all over again. And even with that said, once you make your progress there, there is still this underlying foundation of education from physicians that the best way to treat TD is to reduce the dose of the offending agent, which is an antipsychotic, replace it with another antipsychotic or remove it all together. You have to work through all of these things. And the best thing that we found to do that is to increase your frequency of interaction between all the stakeholders along the way here. That decreases the white space, if there's a new individual that you're trying to educate. It keeps TD top of mind when the physicians are always looking at the underlying disease first. You remind them about TD, and they do ask the patients about that in combination with their underlying disease, commentary and discussions and all those things help. But it's not something that you'd see as kind of a hockey stick type of growth trajectory that you see with increased awareness. It's a steady flow of new patients that are coming into the system, asking about their symptoms or family members and ultimately getting a diagnosis. And that's been playing out in the growth rates that we see from year-to-year. It's been steady double-digit growth year in and year out. So I think as we move into 2025, we mentioned the sales force expansion. That always causes some noise in the quarter that you have, and we expect that to start paying dividends around the middle of next year. We'll look and see what our growth trajectory is into 2025, and we'll look at supplying an annual guide as we typically do in the February time frame.

What other strategies are you using to get exposure to that 85% where you don't have share right now, for example, using more sophisticated newer methods like maybe even AI or machine learning to look at electronic medical records and try to find patients that may have symptoms that are consistent with TD? It's obviously social media campaigns, some companies leveraged influencers?

Yes, we should hire you to come in and help with the strategic marketing aspects. But a lot of that is being deployed now in terms of being able -- especially on the marketing side, being able to look at whether it's Google searches, social media activity, who would be a potential candidate to have tardive dyskinesia. On the chart side, it's quite difficult because there's really no upside to noting and movement disorder for a psychiatrist in particular. A lot of what they're talking about is anything that the customer might be -- or the patient might be complaining about. And then in terms of asking if there's any side effects with their antipsychotic, most patients would have no idea the movements are caused by the antipsychotic. So we've tried some of that, and it's just unfortunately, at the time of launch in 2017, this is how underdeveloped the market was. Only 2% of patients actually had any notation of tardive dyskinesia in their chart. And so a lot of the additional marketing activities we're doing now have to do with on the marketing side. We're also looking at -- or we also had a direct-to-consumer advertising campaign that's been ongoing for the last several years, that continues to look to be really an effective tool because it's encouraging that patient to go in and talk to their psychiatrists about a movement disorder. That's like asking somebody go to the dentist and asking the dentists look at their ankle. So I think the direct-to-consumer advertising campaign is just given that frequency that these movements, they might be able to be treated by psychiatrists. But we're always looking at different ways to help expedite the diagnosis of tardive dyskinesia, including facial recognition, for example, or something that could help with screening or whether even if it's with the patient doing it autonomously. So there is going to be evolution in this space that I think we're all looking at. But at the end of the day, it's going to really come down to that either advanced practice practitioner or that psychiatrist going be on the mental health aspect of that patient and caring for the movement, which is usually a secondary or third concern as they're going through their 20-minute visit with the patient.

And maybe just to add to that. We also know, and for those of you that track the space on the antipsychotic side of things, the use of antipsychotics continues to grow quite meaningfully, low single digits, certainly multiples of the growth rate of the general population. And with that growth in antipsychotics comes to new prescribers. So one way to help educate more is to make sure that you have the right number of personnel out there trying to educate these new prescribers of antipsychotics. So that's another advantages of having a larger sales organization out there. The other piece is appreciating that while most of the business goes through psychiatry, there is an element that's kind of an element of within psychiatry, within long-term care and understanding the opportunity there in LTC is something that we've seen pick up a little bit over the past couple of years as well. The problem and challenge with LTC is that they're not necessarily concentrated in small geographies, they're spread out across the entire U.S. So again, having more individuals out there to look at this potential area of patients that need help is also advantageous.

One thing I wanted to come back to on '568. As far as the data that you showed there, so it's a plateau effect or it's more of an upside down you response? Is that how to think about it? Which is more correct?

What we typically say out there is that all doses that we saw in the Phase II were active. I would say if you -- at a high level, they all look similar across the board in terms of where they land in terms of PANSS total score, the 20-milligram dose thus separate. So it's not necessarily an inverted view. Inverted view would expect to see that the highest dose performs the lease and actually our highest dose amongst their remaining 3 doses did probably second best if you look at just overall PANSS scores improvement. So it was really an irregular dose response is how I would characterize it.

And the other thing I've sort of gleaned from talking to some of the neuro experts, this aspect of the frequency of checking -- questioning the patient regarding their scores and that you don't want to do that too frequently because you can ramp up the placebo effect if you're always interrogating the patient. Do you buy into that thesis or not? And how does that impact how you design your trials?

Yes, there is certainly an element of that. A lot of these patients in clinical trials may have not had much of any care at all during the course of their life, and they come into a clinical trial setting. And all of a sudden, they have 24-hour care. And of course, that's going to make everyone feel better about participating in the trial. So obviously, you want to strike the right balance between doing what you need for the care of the subject and the study, but not going over the top on that to help add to the placebo effect. We've seen that in other trials over the years. I wouldn't say that our trials, when it comes to interaction or frequency of interaction with subjects is any different than what other companies may be doing or have done in the past. I think what we just try to do is make sure that we have great oversight of what's happening overall on a site and making sure that there's no overly high placebo responses among particular sites, and that's something that you can monitor for over a period of time. And when you see that, you can go into those sites and try to figure out what's happening, in particular with how the PANSS scores are applied and making sure that the investigator who else is supplying those scales is doing so in a way that's consistent. And if not, is there an opportunity to go through the education process once again to make sure that the PANSS score is applied, the PANSS scale is applied in a way that it should be at that particular site. And then you can compare that to other sites and see how things are going. If you don't see the response that you're looking for, there's always an opportunity to close down the site and making sure that they're not contributing negatively to the overall conduct of a trial within psychiatry. We know 1 or 2 sites that are off in terms of their placebo response can take a trial that would have been positive and convert that to a failed study.

Yes, it's amazing as you speak. Just thinking, like I said earlier, the complexities of neuropsych are great, given the thought of 3 more meals a day for a patient, even if they're on placebo, provides a benefit to those patients. And so these sites who run these trials are very good at trying to minimize the just natural placebo response because of the change in environment for these patients. So it's not easy, and that's why it's very important to ensure that inclusion, exclusion criteria very clear, baselines are appropriately set and then who's administering these somewhat subjective scales week-to-week really know what they're doing and you can reduce variability.

The funny historic history lesson here for valbenazine, INGREZZA in our first Phase II trial. So reason why those failed is that we put the application of the movement scale, the AIMS scale in the hands of the psychiatrist. As Matt mentioned, having a psychiatrist diagnosed of LUMA disorder is like going to a dentist to look at your ankle. No matter how much training we did with the psychiatrist, they couldn't apply to scale similarly across sites. So we took that out of their hands and we basically had them hold the camera and have them video tape patients and send those videos to movement disorder specialists that were neurologist. And only when we did that, did we get the nice clean, pristine wins that we saw -- that you all saw ultimately that led to the approval of valbenazine.

Okay. Let's -- in the last few minutes, let's just sort of expand the discussion to some macro topics, one sort of geopolitical actually and the other regulatory. So starting -- this might be an easy one because I don't know the details of your supply chain, but where is your manufacturing? Where do you do your API and your fill finish? And are there any risks associated to potential tariff -- changes in tariffs?

Yes. I mean we're still going through that assessment process. A lot has still to be determined. What I can tell you from a manufacturing perspective, we have very little exposure to China. But we do have manufacturing like many people in Europe in the pan-European region. So I think that, that's something that we'll look at from a tariff perspective. Regarding the actual cost of production, as you can see, we have a 99% gross margin on the product with INGREZZA, and we'll see what the margin ultimately is with crinecerfont, but quite high. But I would just say that it's something from a tariff perspective, we are keeping a pulse on that, trying to better understand what the financial implications of any tariffs would be. But thankfully, sitting here today, don't see a whole lot of financial implications, but that's with the strong asterisk of -- it always comes down to the finer points within how it ultimately gets with the...

Do you have contingency plans to do -- to build the U.S. manufacturing plant? Or is that too far field right now?

For us, none of our volume would be sufficient for our own manufacturing plant. And since most of what we do are small molecules, we do have redundant sites in the U.S. primarily on the finished product side and in drug product development. But on the API side, I think that's where a lot of the industry probably has most exposure. So we're not alone in that regard.

You're a lot in the same boat there for sure.

I think the key is that with respect to INGREZZA, crinecerfont, these are small molecules we've manufactured. Whether we have commercial manufacturers today for both products, they've been manufactured by many different CDMOs over the years. And if there was a real need to have to shift things and particularly for API here in the U.S., that's something that would be eminently doable.

Okay. And then I mentioned regulatory. So in the last minute here, the potential changes in leadership at not only HHS but CMS, FDA, to what extent may those impact or not impact your business?

I think where we are right now is that we see a lot of nominations being made by the Trump administration and coming Trump administration. Right now, they're just nominations. So until they become real, and we hear some of the language coming out of the people that are moving into these slots, it's really hard to know specifically what we're in store for. The good news is that we've seen even in the prior Trump administration moving to the Biden administration, there's always challenges that are introduced to our industry. And I fully expect there to be opportunities as well. We have a government affairs team in D.C. that keeps a pulse on this for us, and we'll keep managing this in real time as it is. We will make sure that we don't -- as a strategy for the company, get ourselves in any long-term commitments that we can unwind as we move into this new administration, see all things ultimately shake out. But ultimately, what it comes down to for us is still just controlling those things that we can control. We can control right now INGREZZA in the U.S., making sure that we continue to commercialize well there and continue to grow that medicine and treat more patients, helping the FDA move through the approval process for crinecerfont, having a good launch there for CAH and then making sure that we execute high-quality Phase III studies, and that's where we're going to focus.

All right. Well said. So I think we'll leave it there. You want to make another comment. All right. Thank you all so much. Appreciate it. Enjoy Miami.