Q – Laura Chico: Thank you.
Operator: Our next question is coming from Paul Matteis with Stifel. Your line is open.
Paul Matteis : Hey, thanks so much. I was wondering if you could expound upon what this midyear Huntington’s readout is going to look like. Like what are the key couple of analyses that you’re going to be doing? And more specifically I was wondering if you could sort of talk about your current thinking on endpoints and specifically the HD-CAB which I think you’re using as a primary in dimension, but more recently another company in the space had trouble getting the FDA on board with that measure? Thank you.
Barry Greene: Yes. Paul thanks for I guess the three or four questions in one. Let me turn it over to Laura to tackle the thousand questions you’re asking.
Laura Gault : Sure. Thanks for the question Paul. So the SURVEYOR study is the study that we expect to read out next in mid-2024. And that study is designed with a particular purpose in mind. It is designed to provide data to put context around the HD-CAB to help us understand what clinical clinically meaningful change looks like. And so with regard to how we designed the study there’s really two parts. The first part is comparing baseline HD-CAB scores for healthy participants versus patients with Huntington’s disease. And that looking at that delta is going to help us understand what the magnitude of the impairment is in this population and also hope to anchor the meaningfulness of any improvements that we see in the study.
The second part of the study takes those patients with Huntington’s and randomizes them one-to-one to Dalzanemdor placebo. Now this is a very small group of people 40 patients were randomized so you’re talking about 20 subjects in arm, and they’re treated for one month. And so what we’re looking at here is looking at trends in the data. We’re trying to understand how the magnitude of the change in cognition and how that pulls through the changes on the global measures and the functional measures. And again, these data are really important to help put the results of the HD-CAB in context. Operator, we can go to the next question.
Operator: Our next question is coming from Jay Olson with Oppenheimer. Your line is open.
Jay Olson : Hey, congrats on the ZURZUVAE launch progress. Since PCPs are relatively less familiar with scheduled drugs for mood disorders compared to psychiatrists and maybe OB/GYN’s. Can you talk about the strategy for increasing ZURZUVAE awareness and prescribing among PCPs? And then any color you could provide on your strategy for DTC? Thank you.
Barry Greene: Yes, I’ll start and then I’ll take it over to Chris. And thanks Jay. We’re also incredibly excited by the trends we’re seeing with the launch of ZURZUVAE. So as you highlighted while a majority of scripts are coming from OB/GYN, we are seeing prescriptions from psychs and primary care. And that pattern may shift over time although we’re very excited that OB/GYN were in the front line of picking up depression in moms here are the key prescribers. And we think that trend will continue. Now I talked about the patient journey. So what we are likely seeing if there’s been a prior history of depression and the moms diagnosed with depression in the pregnancy or postpartum and they are under the care of a psychiatrist a primary care physician.
We’re likely seeing scripts coming from that. If they’re newly diagnosed that’s where the OB/GYN are coming in. Actually primary care are very familiar with prescribing antidepressants. In fact the majority of SSRIs, SNRIs come from primary care versus special volumes. So they’re familiar with it, they’ve got licenses. They’re very familiar with scheduling vital drugs as needed. Chris, do you want to add anything more.
Chris Benecchi: Yes. I think the color that I would add to PCPs here Barry, is the group of PCPs that we’re calling on with the sales force right now. It’s a core group of PCPs, frankly who behave more like psychiatrist, they may be in a community where there is not a psychiatrist and therefore they become the de facto clinician to treat many of these patients. So that’s — those are the PCPs that are being called on from a sales force perspective. Obviously, as I had mentioned in my prepared remarks, we’re continuing to increase digital means in order to reach, broaden our reach and to increase our frequency across all physician types. And digital has been particularly effective in actually going forward in doing that and dialing up the investment in that over the course of the year, is going to have that impact, in terms of reaching PCPs as we go forward, because we know oftentimes, they’re the ones who become the first line of care after a woman has seen for pediatrician or other types of clinicians seeing women outside of OB/GYN in psychiatry.
So, we’ll continue to invest in that. I think your question around DTC is also an important one and certainly one I’m sure is on the mind of many people on the call here today. And we’ve talked about being focused with our investment in scaling with success. Obviously, the first step in this is making sure that we have a very well educated and prepared Cushion audience, so that when patients come in and ask for the medication by name, that they’re ready to effectively prescribe the metification with an understanding of the efficacy and the safety profile. Obviously, the first step is educating clinicians. We use both personal and nonpersonal to do that. And when the time is right to expand DTC, so that patients can go in and have that informed discussion, we’ll actually invest in that.
What I would be remiss though, if I didn’t mention was the helping tailwind that we have with respect to online and social media activity in and around Zurzuvae. And this is a popular topic of conversation. In many senses, that’s going to proceed and has preceded the DTC effort that we know will come in the future. And when the time is right, we’ll invest in DTC and moving forward.
Jay Olson: Thank you. Super helpful. Congrats again.
Barry Greene: Thanks, Jay.
Operator: Our next question is coming from Ami Fadia with Needham. Your line is open.
Ami Fadia: Good morning. Thanks for taking my questions and congrats on the progress on the Zurzuvae. Sorry about that. Could you talk a little bit more about the use of Zurzuvae in first line versus second line? And in what situation do patients get it — gets way as a second line treatment and are they getting it in combination with any existing SSRI-SNRI treatment? And just to follow up from an earlier topic. Could you sort of go over in what way the server data will inform the dimension study. Thanks.
Barry Greene: Yes. Let me start with your Zurzuvae question and I can ask Laura to talk about the dalzanemdor question. So, as we stated, Zurzuvae, the first and only oral medication specifically approved for postpartum depression. Our goal is for Zurzuvae to be used frontline. And what we’re seeing from a payer perspective is in fact support of that. As Chris highlighted, we’re seeing a very strong payer coverage. I call them kind of pair of tailwinds with no steps for majority of cut plans and very limited prior has. So that’s a very important thing. We’re seeing women’s step up to be treated. We’re seeing health care prescribers prescribe and OB/GYN leading that chart. So, all signals are that, Zurzuvae is becoming a frontline first choice for the treatment of postpartum pression.
I highlighted this earlier, but when we look at early claims data, almost half of the claims data suggests that those being prescribed Zurzuvae already in the first quarter which is pretty remarkable have not had an antidepression for the previous year. So, we are seeing the trend for Zurzuvae be used frontline and really no obstacles to make that happen. Laura, you want to talk about dalzanemdor?
Laura Gault: Sure. So your question related to dalzanemdor will inform the Dimension study. And I think there are really two main ways that we would see this happening. The first is, we will get some data that will help us understand the performance of the different scales that we’ve included in the studies because the scale is included in Dimension and survey are largely overlapping. The second is as I mentioned earlier, we’ll be looking to really better identify clinically meaningful change in patients with Huntington’s disease on the HD endpoints. And so that will help inform the data interpretation from Dimension. Of course, when we get the surveyor data, we’re going to learn as much as we can from it, but we don’t have plans at this time to change the DIMENSION study design. Well, as I mentioned, we’ll learn as much as we can from the data, but we don’t have plans right now to change the study.
Ami Fadia: Thank you.
Operator: And our next question is coming from Brian Abrahams with RBC Capital Markets. Your line is open.
Brian Abrahams: Hey, good morning, guys. Thanks for taking my question and congrats on the progress with the launch. I’m curious where are you seeing in these early days as the — what are you seeing in these early days is the biggest reasons why a diagnosed PPD patient might not receive a written prescription for a course of ZURZUVAE. Is it a matter of awareness or coverage? Are there certain types of practices or regions where these are — there are more later adopters, tend to be later adopters versus early adopters. I’m curious what you’re seeing on the ground there. Thanks.
Barry Greene: Yes, Brian, thanks for the question, and I appreciate the congratulatory note. Chris, do you want to take that?
Chris Benecchi: Yeah. So let me start with the payer piece here because I think it’s important to highlight this. I think with respect to where we stand today, we’re in a very privileged position with this medication and it’s launching and around payer coverage, as I noted in my prepared remarks, we’re encouraged by the progress that we’ve made with commercial and government payers. We know that are beginning to develop policies the majority that we’ve seen to date don’t come with onerous prior authorizations and step edits. And importantly, that enables a clinician when he or she wants to prescribe the medication to choose ZURZUVAE first line. We have 65% of all commercialized covered, that’s 180 million lives that are already under coverage with the majority of those being — or most of those being plans, that don’t have owners prior authorizations, and step and step edit.
So from a commercial perspective, we’re in good shape. Also with Medicaid, we see that with respect to the Medicaid coverage that we’ve had that over the first quarter of the year, almost half of the Medicaid states, including several of the largest stated already completed reviews. And again, those don’t come with onerous prior authorizations and step edits effectively meaning that patients can get access to this medication both equitably and affordably as we go forward. So what I would say to sort of round out my response is that ultimately, if a physician hasn’t prescribed ZURZUVAE yet, it’s a matter of getting to that clinician with the education that’s needed to ultimately understand the efficacy and safety profile of the medication. Between what we’re doing from a personal promotion perspective and now with increased and ongoing investment in non-personal efforts in addition to what we’re seeing from what’s being communicated socially and online.
