So, we’re excited by that. We continue to work on the value proposition here. Obviously, ZURZUVAE is the first and only oral medication specifically approved for PPD. Its rapid onset of activity is key to the value proposition. So, the sooner mom gets drug, the better off mom is to reattach with family and baby. So, we’re cognizant of that. We had many shipments that were done in 24 to 40 hours. Of course, some took longer. So, that’s really an engineering issue as we optimize the processes, payers come online, and healthcare providers get comfortable with exactly how to get ZURZUVAE to moms. But again, highly encouraged in the early days.
Operator: We’ll move to our next question from Tazeen Ahmad with Bank of America. Please go ahead.
Tazeen Ahmad: Hi, thanks for taking my question. With regards to the prescriber base, you’ve talked about now for a bit interest coming in from the OBs in addition to psychiatrists, but how important is it going to be to penetrate PCPs, and what is your strategy? Can you just remind us of how the sales force is structured? Does a salesperson just target a particular specialty, or are they detailing all three specialties at the same time? Thanks.
Barry Greene: Yes, Tazeen, thanks for the question. I’ll start and then Chris can provide more color. So, again the fact that literally the about 10 days ZURZUVAE was available, in that short period of time, we already saw prescriptions coming in, not only from psychs, but also OB-GYNS and primary care, is really indicative of the recognition of PPD as a severe medical condition, not a moral failing. The awareness that our omnichannel approach and the media had in raising awareness of PPD. Chris, you want to talk about the sales force targeting, omnichannel, and sort of how we were approaching that?
Chris Benecchi: Yes, Barry. What I would say first is that what I think we’re seeing here is a paradigm shift. Historically, what’s happened in the diagnosis and treatment of PPD is clinicians have suspected and then they’ve referred out. What we’re actually seeing here are clinicians, the clinicians that we’re calling on, the clinicians that we’re reaching through omnichannel, diagnosing and treating, which is very different than what we’ve historically seen. In terms of the call universe that we’re calling on, we are calling on high prescribing, high volume clinicians with experience in treating postpartum depression. It’s a mix of OB-GYNs, psychiatrists, and a handful of PCPs that are all part of that cohort that we’re calling on actively with a sales force.
Obviously, we’re using omnichannel to broaden our reach and deepen our frequency because we believe all clinicians who see women with PPD need to hear the messages that we’re delivering and have access to the information, enable them to effectively treat women with PPD as we go forward. In terms of PCPs, what I believe will happen over time is that we’ll continue to expand with that first group that we’re calling on now, broadening to a broader group of PCPs, as well as psychs and OBS as we go forward, but that to come in time as we move forward.
Operator: We’ll move to the next question from Brian Abraham with RBC Capital Markets. Please go ahead.
Brian Abraham: Hey, good morning. Congrats on all the progress and thanks for taking my question. Maybe shifting gears to the pipeline, on 718, can you expand on what you’re looking for out of the SURVEYOR study in terms of trends and correlations? And I guess I’m curious how that might influence how you would tweak the DIMENSION study size, endpoints, population, or something else, and whether the goal would be for DIMENSION to potentially be registrational for Huntington’s. Thanks.
Barry Greene: Yes, Brian, well, first of all, thanks for the congratulations. We really are excited by the progress, and I congratulate you on sneaking five or six questions into your one question. That was good. I’ll turn it over to Laura to talk more about it, but before I do, so you’re talking about Dalzanemdor SAGE-718, which is our fully owned NMDA positive allosteric modulator that we’re studying in neurodegenerative diseases. And we’re excited to have readouts for both Huntington’s, Parkinson’s, and Alzheimer’s this year. Strategically, as we talked about, and Laura will get into specifics, as we’ve designed the series of Huntington’s studies, we’ve done so recognizing that Huntington’s is a rare orphan disease. We’ve done so in a way that if the data are positive, and let me emphasize, data matter here, that we believe that we have a package to work with regulators on speeding Dalzanemdor to help those suffering from cognitive disorders in Huntington’s.
The Parkinson’s and Alzheimer’s are truly Phase 2 studies where they’re learning studies that gives us better support and understanding of designing the Phase 3s. But, Laura, you want to talk more about the DIMENSION and SURVEYOR studies and how they fit together?
Laura Gault: Sure. So, as I mentioned in the introductory remarks, SURVEYOR is a study that really was designed to serve two purposes. First, to compare the degree of cognitive impairment in patients with Huntington’s Disease to healthy volunteers. And that’s important so that we can understand the clinical meaningfulness of the treatment effect that we see in our studies, both for SURVEYOR and DIMENSION. The second purpose of this study was to evaluate how changes in cognition track with changes in function. And this is important to provide supportive evidence both to regulators and to other stakeholders about the relationship between these two metrics. Of course, when we get the SURVEYOR data, we will look at it very carefully.
If there are suggestions in that data that there would be a benefit to changing something in the DIMENSION design, we would do that. It’s important to note that those changes would be limited to ordering of endpoints, not changes related to adding new endpoints or doing something that would really prolong the study length.
Operator: We’ll move to our next question from Ami Fadia with Needham & Company. Please go ahead.
Poorna Kannan: Hi, this is Poorna Kannan for Ami. Thank you for taking a question. Just had a question about the bridging program. Could you please talk about it and what type of utilization you’re seeing on this program? Should we be expecting use of this program as you complete your peer negotiation?
Barry Greene: Poorna, I’m not sure I understood. The bridging program?
Poorna Kannan: Yes.
Barry Greene: I’m not sure I understand the question.
Chris Benecchi: Yes, patient support, I believe. So, what we said is ZURZUVAE For You is a program that’s in place that’s largely designed to make sure that we’re mitigating patient out of pocket. And we talked about that, being able to mitigate the vast majority of these patients that are commercially insured down to a $0 out of pocket copay. We also make sure that patients who fundamentally fall in this functionally uninsured group of patients, patients that you would call in other organizations, bridge program patients, are actually able to access the medication. So, we have that resource in place to actually make sure that those patients don’t fall through the system, that they can actually get access to the medication. But as we also said, the vast majority of patients that are flowing through right now are actually covered patients, whether they are commercially insured or Medicaid patients, which again, is a very good sign or signal from payers around the support that they’re providing for women with PPD.
Barry Greene: Yes. And important, keep in mind that as Chris has mentioned many times, we believe that if a prescription’s written for a woman’s suffering from PPD, that we want to make sure that that woman had drugs. So, in our case, it’s not really a bridge because it’s a 14-day complete course of treatment, not a bridge to a chronic medication.
Operator: We’ll move to our next question to our next question from Laura Chico with Wedbush Securities. Please go ahead.
Laura Chico: Hey, good morning, guys. Thanks for the question. I had one on SURVEYOR and DIMENSION, and just kind of following up, I was wondering if you could talk a little bit more about the endpoint, and specifically I’m trying to understand, well, you’re using the primary endpoint as the Huntington’s Cognitive Assessment Battery. I’m trying to better understand how the Hi-DEF scale fits in here. And I guess, Laura, based on your comments, could that become a primary endpoint? Thanks.
Barry Greene: Yes, thanks for the question, Laura. On Dalzanemdor, I’ll turn it over to Laura to answer.
Laura Gault: Yes, thank you, Laura. As you noted, the HD-CAB is the primary endpoint for the DIMENSION Study. We have also included the Hi-DEF measure, which is a measure of function, and it’s a patient reported outcome that SAGE has developed specifically for this population. We have developed and validated that measure, and it would be appropriate to be in an application to support the efficacy profile of SAGE-718 or Dalzanemdor. At this point, we will take what we learned from the SURVEYOR study and make a decision about what the proper endpoints should be for DIMENSION, keeping in mind, of course, that the Huntington’s Disease Cognitive Assessment Battery is a battery that has been developed by experts in the field to measure domains of cognition that are impacted by Huntington’s, and actually reflect some of the domains that we believe Dalzanemdor will improve.
