Todd Tushla: Nikki, let’s take a couple more questions.
Operator: We’ll move next with Ami Fadia with Needham. Please go ahead.
Ami Fadia: Hi. Good morning. Congratulations on the strong quarter. I wanted to follow up on the 352 asset. Can you elaborate on what other aspects of the study beyond obviously the seizure rate reduction and safety data that would be important to watch when you announce the data? And could you lay out some sort of scenarios or what is the likely next development stage? Should you see strong safety and efficacy somewhere around kind of that bar that you laid out of, say, 15% placebo, but then the drug does about 30%. Would that allow you to go directly into pivotal trials? Thanks.
Eiry Roberts: Yeah. I mean, we’re focused right now on really just getting to the data and reading out the data. I think what I mentioned is that we will have safety and tolerability information. We will also have the information focused on understanding the impact of 352 at the doses in this study on seizure, both seizure frequency, seizure freedom and responders in terms of ability to reach a 50% reduction in seizures. That’s really the totality of the data from this study and it’ll depend on how the strength of the information that we read out as to what our next steps are.
Todd Tushla: Nikki, let’s take two more questions.
Operator: We have Uy Ear with Mizuho. Please go ahead.
Uy Ear: Hey, guys. Thanks for taking my questions and congrats on the good quarter. So my question is, could you sort of speak a little bit about the timing of the R&D Day and whether this has related in any way to any change of your level of confidence in the upcoming data readout for any of the studies, particularly the two that we’ll read out at the end of this year? Thanks.
Todd Tushla: Hey, Uy. This is Todd. Yeah. The Analyst Day is going to be on December 5th, and it’s really a two-pronged agenda as outlined in our earlier comments. The first part is on R&D strategy and vision, and our Chief Scientific Officer, Dr. Jude Onyia, is going to lead that discussion on that day. And then the second part will be focused on CAH and really helping the analyst community understand the burden of disease and the treatment challenges today and how crinecerfont, if approved, could potentially help out with those patients and the people who care for them.
Uy Ear: Thanks.
Matt Abernethy: So that’s a really clear expectation. We’re not expecting to unveil data from either of the studies that we’ve discussed. That’s not going to be part of the R&D Day in terms of an unveiling or a long-term financial guidance. It’s clearly this is something that’s been we haven’t done in over 10 years, I believe, and I think we’ve got a great pipeline, and we have a great team and look forward to meeting with all of you here in a few weeks.
Todd Tushla: Thanks, Uy.
Uy Ear: Thanks.
Todd Tushla: Nikki, let’s take one last question.
Operator: We’ll take our last question from Evan Seigerman with BMO Capital Markets. Please go ahead.
Conor MacKay: Hi there. This is Conor MacKay on for Evan. Thanks for taking our question and congrats on a great quarter. I just had one follow-up on the TD market opportunity. You guys mentioned that 65% of patients who are undiagnosed do expect that to shrink going forward. I’m just curious about that patient profile and what you expect for the percentage of those newly diagnosed patients, how many of them will be then treated. Is the expectation that it’ll still be around roughly half or do you expect that to grow? Thank you.
Matt Abernethy: I’ll start with the second part of your question first. I do think that the percent of patients that are diagnosed that are offered treatment with the VMAT2 inhibitor has grown over time. If you think about it, at the time that we launched INGREZZA, VMAT2 inhibitors were not available and the standard-of-care back then was either watchful waiting to see if the symptoms worsened over time or what I call the three R’s, remove, replace or reduce the antipsychotic. In some cases, patients were treated with benztropine, which is inappropriate. So if you sort of compare and contrast, the rate of offering VMAT2 treatment in the early days of the launch to where we are today, obviously, we’ve made progress. However, still half the time, patients are not offered a VMAT2 inhibitor and so I expect that that will continue to improve over time, especially as we continue to leverage the updated APA guidelines.
And so between a driving diagnosis and treatment with VMAT2 inhibitors, we’re going to continue to make a difference for the hundreds of thousands of people living with TD today that are currently undiagnosed and untreated.
Conor MacKay: Thank you.
Kevin Gorman: So I’d like to make just a brief closing statement. This quarter, as we all started out saying, what a tremendous quarter. You don’t get many quarters like this, but one has to put it in perspective that, the regulatory approval, the Phase III success and two Phase III clinical trials, and the continued success with INGREZZA are years in the making. These aren’t just things that we did this quarter. And when you think back on the challenges that have hit our entire industry over the last several years, it makes a tremendous quarter even all that more remarkable. So I’m very proud of the teams that have been involved in all of these successes. And I’m looking forward to having our R&D Day or Analyst Day, we use them interchangeably, because I think it’s going to be a very good time for us to get a little more in depth with you and to be able to give you a bit of an idea on the vision that we have for the future.
And with the current state that we have, I think, we are extremely well positioned to deliver well into the 2030s with our company as being a leader in neuroscience. With that, thank you very much and look forward to talking to you all later.
Operator: And this does conclude today’s program. Thank you for your participation. You may disconnect at any time. Good-bye.
