We believe that we’re going to be able to enact that change to help a clinician we may not offer the message hear it and begin to prescribe ZURZUVAE.
Barry Greene: Yeah, Brian, just to round that out, I’d say that just like in drug development, the biology of the launch is working. Patients are advocating, health care prescribers — do you want to prescribing and payers are paying, as Chris highlighted. The rest of it is classic engineering of a launch. We need to get reach and frequency to educate and as you every well known, changing health care provider practice behavior is the key to success, and that’s what we’re in the midst of doing.
Brian Abrahams: Thanks, Barry. Thanks, Chris.
Barry Greene: Thanks, Brian.
Operator: Our next question is coming from George Farmer with Scotiabank. Your line is open.
George Farmer: Hi. Good morning. Congratulations on all the progress. I was wondering if you could comment on expanded geographies for ZURZUVAE and how that might be progressing and what other steps might be necessary. I think Biogen mentioned maybe another trial would be required. Wondering if you could potentially comment on that.
Barry Greene: So George, you talked about — when you say geography you’re talking about ex-US?
George Farmer: Yeah.
Barry Greene: Yeah. So I remind you that the relationship that we have in partnership with Biogen is we’re 50-50, co-co in the United States. You’ve heard over and over, that’s going incredibly well and outside, Japan, Korea and Taiwan, or we have another part Biogen response for the rest of the world. So it’s really a Biogen question to answer.
George Farmer: Okay. Thanks.
Barry Greene: Thanks, George.
Operator: Our next question is coming from Sumant Kulkarni with Canaccord. Your line is open.
Sumant Kulkarni: Good morning. Nice to see the progress on ZURZUVAE and thanks for taking my questions which is on dalzanemdor. So other than some factors you mentioned before that might make read-throughs to upcoming trial readouts challenging. Is there anything specific payment in Huntington’s and Alzheimer’s different versus Parkinson’s? I’m asking because there are most likely some nuances involved in specific areas of neuronal loss in these disease states and to see if there’s a potential mechanistic basis for a dozen to target specific parts of the brain in different ways.
Barry Greene: Yeah, Sumant. Thanks for the congratulations on ZURZUVAE and great question on dalzanemdor and a very important one. Let me ask Mike to start with the biologic appreciation that started Huntington’s in 24S, maybe Laura to talk about why we think the results we see are not necessarily predictive of future results. Mike?
Mike Quirk: Yeah. Thanks Barry. So what I would say is that there are decades of research that have really implicated NMDA receptor hypofunction and a range of disorders associated with cognitive impairment. And further there’s increasing evidence specifically in of NMDA receptor if loss or expression changes in disorders such as Huntington’s disease, Parkinson’s disease and Alzheimer’s disease. That being said, while cognitive impairment is a common feature across these diseases the underlying pathophysiology and the relative contribution of NMDA receptor dysfunction is likely to be distinct across these groups and we really have different hypothesis that we’re testing across the three studies that we’re running. And so for this reason we’ve always seen the studies in HD, Parkinson’s disease and Alzheimer’s disease as distinct and independent test of the NMDA receptor hypofunction where we’re really looking at different pathophysiological consequences there.
So as Barry mentioned in the context of Huntington’s disease, which is our lead indication, we’re really focusing on the loss of the endogenous modulator 24S hydroxy-cholesterol as the rationale for why a molecule such as dalzanemdor should work in treating these cognitive impairments. So that’s sort of the scientific rationale across these diseases. I’ll let Laura comment a little bit more about this distinct symptomology and as we think about the disorders.
Laura Gault: Right. So these disorders obviously are all characterized by impairment but they have accompanying symptoms that are quite different across. As we talked last week about Parkinson’s disease that’s the disorder where you see the onset of cognitive impairment after motor symptoms appear in most cases. In Huntington’s disease, the reverse is true. The onset of symptoms can be 10 or 15 years even before the onset of the motor symptoms. And so it’s a very different progression. You’re looking at a younger population, you’re also looking at a much more homogeneous population based on the underlying etiology. And then you move over to Alzheimer’s, disease a very different population again in terms of the underlying pathophysiology.
We have the amyloid plaques and the neurofibrillary tangles, which are driving the downstream pathology and NMDA receptor hypofunction, but that is a very distinct driver compared to Huntington’s and Parkinson’s. So for all these reasons as Mike said these are really distinct disorders with differences in the symptomatology differences in the study design and we expect that each of these is an independent test of the hypothesis.
Sumant Kulkarni: Thanks.
Barry Greene: Thanks, Sumant.
Operator: Our next question is coming from Yatin Suneja with Guggenheim. Your line is open.
Yatin Suneja: Thank you for taking my question, and congrats on the nice launch. Question on 324 with regard to the KINETIC 2 study, could you maybe help us understand the difference between the endpoint between KINETIC and KINETIC 2, what you would like to show? And then how should we think about pivotal endpoint, because I think there are other companies that are using ADL as an endpoint from pivotal development. So anything you can talk from the regulatory perspective on the endpoints? Thank you.
Barry Greene: Yeah, Yatin thank you for congratulating on our launch. Laura, you want to take the 324 question?
Laura Gault: Sure. So with regard to the original KINETIC study and the KINETIC 2 study that’s currently ongoing, we actually use the same primary endpoint, which is the upper limb extremity score from the TETRAS performance scale, I’m not sure because it’s a sensitive measure to the tech change. We are aware as you are that there has been regulatory feedback about using the ADL scale associated with the TETRA. We are collecting all of that data in the ongoing KINETIC study and we will be poised with a lot of data to discussions with regulators at the end of Phase II about, which instrument would be the best for a Phase III endpoint.
Barry Greene: Thank you, Yatin.
Operator: Our next question is coming from Douglas Tsao with HC Wainwright. Your line is open.
Douglas Tsao: Hi, good morning. Thanks for taking the question, and congrats on the progress. Just curious, what percentage of the overall sales details so far have been made by you versus Biogen? And I’m just curious in terms of how when you contemplate scaling up the launch, how do you coordinate that? And sort of determine or sort of the needed resources?
Barry Greene: Hi, Doug. Let me start and then Chris can keep up. So I was actually with our field team a couple of weeks ago and I can tell you that whether you’re Sage or Biogen they’re working incredibly all together as a wealth functioning machine. And the team is very well integrated or helping each other literally every day to do what’s right which is get mom diagnosed and treated with ZURZUVAE, ZURZUVAE get quickly as possible. So it’s a very well coordinated effort. Chris, do you want to talk about just mentioned the kind of scaling spec?
Chris Benecchi: Yes. I think in terms of the activity at a field level it’s 50-50 between the two organizations. We really work well and collaboratively around how we execute at a field level with respect to reach and frequency. I think in terms of scaling those are conversations that are ongoing. The teams talk about the future of this product on a daily basis. And it’s everything from the strategy that we employ all the way through to the tactics and specifically how we’re going to execute. And again I think as Barry noted that’s an ongoing interaction between the two business — two organizations that are committed to fundamentally changing the way PPD is thought about and treated for women that are suffering with the condition.
Douglas Tsao: Okay. Great. Thank you.
Chris Benecchi: Thanks, Doug.
Operator: Our next question is coming from Vikram Purohit with Morgan Stanley. Your line is open.
Unidentified Analyst: Hi. Thanks for taking my question. This is Morgan on for Vikram. So on reimbursement for ZURZUVAE, I know you had mentioned not guiding to gross to net just yet but where would you expect steady state growth in that to potentially settle out? And how long do you think it would take to reach this steady state? Thank you.
Barry Greene: Thanks for the question Morgan. Kimi, do you want to take that?
Kimi Iguchi: Yes. As we mentioned and as you just mentioned we are not guiding to gross to that today. But again we’ve been talking about the fact that we don’t anticipate kind of discounting that you’re seeing for recent branded antidepressants. And so — and another thing is if you think about the key components of we expect in our gross to net. There is a typical component. The rebates and discounts we’ll see the patient assistance programs including financial assistance. So all the similar kinds of things you’ll see but we just don’t anticipate the same type of discounting you see for the other recent antidepressants.
Barry Greene: Thanks, Morgan.
Operator: Thank you. That will conclude the Q&A portion of today’s call. With that I will turn it back over to Mr. Greene for closing remarks.
Barry Greene: Thanks, Shelly. Thanks again to everyone for joining us this morning to review our results from the first quarter of 2024. Just to close it out. The full quarter of ZURZUVAE launch has been completed and we remain highly encourage with the process and we are excited to helps the many moms suffering with PPD. Of course, we were disappointed with the outcome of the PRECEDENT study. But as you heard from Mike and Laura, we remain on track to read out important data across our pipeline throughout the remainder of the year. And we do not believe the PRECEDENT is necessarily predictive of future studies as you heard on the call. We’re also well positioned financially to take us through key milestones and we remain focused on our mission to develop and launch life-changing brain health medicines so every person can thrive. Thanks again everyone and have a great day. Bye.
Operator: This concludes today’s call. Thank you for your participation. You may now disconnect.
