Q1 2023 Sage Therapeutics, Inc. Earnings Call
Speaker 1: And we're about to begin.
Speaker 1: Good morning. Welcome to Sage Therapeutics first quarter 2023 financial results conference call. Currently all participants are in a listen-only mode. This call is being webcast live on the investors and media section of Sage's website at sagerx.com.
Speaker 1: This call is the property of Sage Therapeutics and recording, reproduction, or transmission of this call without the express written consent of Sage Therapeutics is strictly prohibited.
Speaker 1: Please note that this call is being recorded. I would now like to introduce Helen Rubenstein, Director of Investor Relations at Sage.
Speaker 2: Good morning, and thank you for joining Stage Therapeutics' first quarter 2023 Financial Results Conference call.
Speaker 2: Before we begin, I encourage everyone to go to the investors and media section of our website at stageRx.com where you can find the press release related to today's call as well as the slides that we will be reviewing today.
Speaker 2: I would like to point out that we will be making forward-looking statements which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please review the risk factors discussed in today's press release and in our SAC filings for additional details. Thank you.
Speaker 2: We will begin the call with prepared remarks by Barry Green, our Chief Executive Officer, who will provide an overview of our progress during the first quarter of 2023.
Speaker 2: by Kimi Eguchi, our Chief Financial Officer, who will review the financial results from the first quarter of 2023. Laura Galt, our Chief Medical Officer, will be available during the Q&A portion of the call. With that, I'll now turn the call over to Barry.
Speaker 3: Thanks, Helen, and thank you everyone for joining us this morning.
Speaker 3: At SAGE, we are driven by our mission to develop brain health medicines that deliver what matters most to patients so every person can thrive.
Speaker 3: We do this by acting with urgency and challenging scientific conventions to think differently as we work to develop new and effective treatments.
Speaker 3: This month marks Mental Health Awareness Month, which is an important reminder that the need for innovative brain health medicines has never been greater.
Speaker 3: Depression is the leading cause of disability for young people and those in their prime working years. And the problem, as we all know, continues to grow. Alarming research published recently by the World Health Organization shows that rates of suicide have increased to the US by more than 40 percent.
Speaker 3: This is what mental health awareness month reminds us all that we must do more to challenge these trends.
Speaker 3: mental health awareness month reminds us all that we must be more to challenge these trends. People with depression deserve better.
Speaker 3: for patients. 2023 will be a pivotal year for save and is already off to a strong start. We are laser focused on preparing for the potential launches of the ran-alone and believe we're on our way to achieving our vision of transforming the treatment of depression if the ran-alone is free. We're also advancing our robust brain health pipeline comprises several new chemicals
Speaker 3: to further our pipeline ambitions, with the goal of being able to launch new drugs or new indications for years to come.
Speaker 3: actions or other related topics for your own ones.
Speaker 3: As we prepare for the potential losses of the round-arm.
Speaker 3: We, in Biogen, are continuing permitted to pre-launch commercialization activities.
Speaker 3: We're actively engaged in discussions with pairs of policymakers and collecting key insights from healthcare providers and patient advocates, with a goal of providing a model of care that works in the best interest of patients with MDD and PPD.
Speaker 3: Additionally, our team and collaborators represented data at several key meetings highlighting the negative impact of depression on patients, their families, and society.
Speaker 3: These findings provide an important backdrop to our ongoing launch preparation. Chris will provide additional details on our ongoing and planned commercialization activities later in the fall.
Speaker 3: We advise you are also advancing stage 324, which we believe holds potential to provide differentiated benefits to patients with a central chamber and other treatment disorders.
Speaker 3: Now, turning to Neurosite, we're making progress across our Holy Own State 718 and MDA PAM program.
Speaker 3: we're leading with hunting through disease, a devastating condition where deficits and executive function manifest during prime working years.
Speaker 3: We're also continuing to execute phase two studies, SAID 7-1-8, and Collegiate impairment through departements and all summaries to use. To close, I'm very pleased with our achievements so far this year and look forward to continue progress in 2023. The time is now to unleash the potential for our science and making meaningful
Speaker 3: Over the first quarter, we have made important progress on our pipeline programs, and I am pleased to detail our recent advancements and our plans for continued execution throughout 2023.
Speaker 3: I'll start with the pression where we're continuing to prepare for the potential launch of Zaramelom in MDD and PPD.
Speaker 3: Our vision with Xaranlone, if approved, is to transform the way depression is treated, and we know this will require support from many key stakeholders.
Speaker 3: Throughout the development journey was around, we had engaged with a broad set of key medical experts, including gathering insights from key thought leaders.
Speaker 4: Their feedback has been clear.
Speaker 4: They are increasingly recognized in that the episodic nature of the prescient means it could be treated as needed with treatment-free periods between episodes.
Speaker 4: Additionally, as we've engaged in discussions about the unmet need and depression, physicians continue to highlight that the potential to achieve both a rapid and sustained effect matters deeply to them and remains critical to their patients.
Speaker 4: We have received consistent feedback on what they consider the main strengths of the Zeranlo and clinical data. First, a robust clinical development program with approximately 3,500 subjects.
Speaker 4: Second, rapid onset of action seen in clinical trials with an improvement in depressive symptoms observed as early as day three.
Speaker 4: Third, improvement in the press of symptoms observed across multiple around-alone use cases and patient populations in MDD and PPD.
Speaker 4: Or if a consistent safety and tolerability profile.
Speaker 4: Additionally, physicians note that this clinical profile has the potential to be particularly impactful is around, let us approved, given around on 14-day oral course treatment.
Speaker 4: We believe that scientific forums will continue to play an important role in educating physicians on the clinical data seen to date with Xaranilin.
Speaker 4: We are also continuing to highlight data on the substantial economic burden associated with depression. In March, we presented important health economics and outcomes research at the Academy of Managed Care Pharmacy Annual Meeting.
Speaker 4: These data reinforce the significant negative impacts MDD can have on patients, their families, and society.
Speaker 4: These presentations highlighted the associations between NDD symptoms and reduced health-related quality of life scores.
Speaker 4: during the 90-day period following treatment with a current antidepressant.
Speaker 4: Taken together, we believe these re-involts reinforce the significant on that need in NGD and PPD and suggest an opportunity for new treatment options that have the potential to improve quality of life and reduce economic burden associated with depression.
Speaker 4: Combined with additional research our team has presented and published over the last year, these data provide an important backdrop as we continue to engage with payers, policymakers and patient advocates in pursuit of transforming the way depression is treated.
Speaker 4: Turning to neuropsychiatry, we announced earlier this quarter that our wholly-owned LEED NMDA Acceptor PAM, Stage 718, has been granted orphan drug designation by the EMA, which follows the fast-track designation granted by the FDA in September 2021 in both cases in Huntington's disease.
Speaker 4: These designation's advance our strategy to prioritize HD as the lead indication for SAG 718 where we are currently enrolling through studies.
Speaker 4: Population was chosen as the lead indication that it is a genetically defined disorder, and thus is more homogeneous than other populations with cognitive impairment. And there is a strong scientific rationale to support the use of an NMVA receptor pan. Given the orphan nature of HD, we believe if our trials are successful.
Speaker 4: We have the potential to pave a novel regulatory pathway and to seek the globalized stage by pursuing an XUS strategy.
Speaker 4: in a more concentrated orphan space first.
Speaker 4: We're also continuing research into the HD patient journey and released recently presented interim data at the CHDI annual meeting from 95 patients in a new US-based HD real-world study in collaboration with PICNIC Health.
Speaker 4: This study is examining the impact of HD on patients' activities of daily living, their health-related quality of life, functional independence, and work productivity.
Speaker 4: The Interim Data Cut demonstrated that patients with HD experienced cognitive repairment across all stages of disease, impacting their independence and ability to function. Additionally, we are investigating stage 718 in people with mild cognitive impairment due to Parkinson's disease and people with mild cognitive impairment and mild dementia due to Alzheimer's disease.
Speaker 4: appropriate.
Speaker 4: Our portfolio also includes SAGE 324, our lead neurology candidate. It's 324 is an investigational and positive-alcoholic modulator of GABA receptors with significant potential in the treatment of movement disorders like essential tremor. Along with our collaborator biogen, our goal is to complete enrollment in the ongoing Phase to be a candidate.
Speaker 4: as well as IMD enabling studies for our next NMDAPAM Sage 421.
Speaker 4: Importantly, all of our product candidates are sages and new chemical entities with different U.F. Bureau, designed with pharmacologic characteristics and
Speaker 4: that we believe are well suited to the target indication the programs pursuing.
Speaker 4: We believe that with our product engine we have the potential to create significant long-term value for successful.
Speaker 4: 2023 is already off to a strong start and I look forward to providing continued updates on our clinical execution throughout the remainder of the year. Now I'll turn the call over to Chris to provide additional context on our planned approach as we prepare for the potential commercialization of Zoranloon in MGB and PPD.
Speaker 4: strong start and I look forward to providing continued updates on our clinical execution throughout the remainder of the year. Now I'll turn the call over to Chris to provide additional context on our planned approach as we prepare for the potential commercialization of Zoranloan in MGBD and PPD. Chris?
Speaker 3: Thanks, Jim. I'm pleased to be with all of you this morning to share updates on our preparations for the potential commercialization of xerandolone.
Speaker 4: With our MBA finaling for Zarenalone in MDD and PPD under agency review, we are closely collaborating with Firetions to advance permitted discussions with payers, continuing scientific exchange with HCPs, and engaging with patient advocates. Further, we are building our internal capabilities by hiring experienced commercial leaders whose depth and breadth of knowledge further expand our commercial expertise. Together, these are important steps towards our goal of a rapid and successful launch of Zarenalone.
Speaker 4: to transform the way depression is treated.
Speaker 4: focusing first on the PVD patient population, an estimated one in eight new mothers in the US experienced the symptoms of PVD each year that's nearly half a million women and their newborn babies and broader families who are adversely impacted during what should be one of the most treasured times for new parents.
Speaker 4: We believe Zarenalone, if approved, holds unique potential.
Speaker 4: to be a first-line therapy for many of these mothers who need help.
Speaker 4: Our goal with the RAN alone, if we're successful, is to provide HCPs with the first and only oral treatment specifically indicated for PPD and to improve PPD diagnosis rates.
Speaker 4: We understand this will require working with the entire healthcare ecosystem to change the diagnosis and treatment paradigm. We believe that if we are able to offer Zaranolone as an oral 14-day treatment option, it may serve as a critical tool in catalyst for HCPs to diagnose and help mothers suffering from PPD.
Speaker 4: Based on the compelling and versatile profile theme in the landscape clinical program today, we believe that Zarenalong, if approved, as high transformative potential, is a first-line treatment option for MDD, especially in certain populations like Young Adults, given the 14-day treatment course.
Speaker 4: We understand that while there is significant unmet need among the entire MDD patient population.
Speaker 4: You'll need to start our launch in a focused way, giving payer feedback and the current MDD market dynamics.
Speaker 4: Therefore, our plan strategy at launch is to focus our efforts on a subset of those 6.5 million patients already diagnosed with MDD, who are early in the course of their treatment and in need of a new medication as a first add-on or switch therapy.
Speaker 4: While many believe that branded entrants to the MDD treatment market are often restricted to much later use, our payer, HCP, government affairs, and patient advocacy discussions all point to the potential for us to help a portion of those 6.5 million with a first add-on or switch launch strategy.
Speaker 4: Further, our launch strategy is designed to scale quickly with success, and we believe that over time, with focus in determination anchored to our data, Zarenalong has the potential to become standard of care in the treatment of MDD.
Speaker 4: To achieve our vision for surrender on an MDD and PPD, if approved, we must execute a fit-to-purpose launch that prioritizes deep and meaningful engagements with key stakeholders.
Speaker 4: We are advancing planned on the channel efforts with a digital core designed to unite data from our content, media, and in-person interactions.
Speaker 4: Our ambition is to strategically increase the impact, efficiency, and agility of our execution through our Salesforce interactions and non-personal promotion.
Speaker 4: Reppower use approach with predictive analytics, which are intended to deliver customized, personalized information to key stakeholders.
Speaker 4: It's also vital that our on the channel work directly reaches people with MDD and PPD at launch. Our planned efforts are intended to directly engage them with education and resources, so they're aware of the run-along and are prepared to self-advocate in discussions with their HDPs.
Speaker 4: We believe that if Zeranolores proved many people with MDD and PPD when armed with appropriate education and information will ask their HCP about it by name.
Speaker 4: Further, in order to be truly transformational, Zarenola must be accessible.
Speaker 4: A market-accessing is engaging pairs through permitted interactions. The date we're encouraged by the early enthusiasm we've seen in those interactions. Our goal, as the Rennelone has approved, is to ensure patients with MDD and PPD who are prescribed it can get it with minimal prior authorization and step-out at requirements.
Speaker 4: As such, we're continuing to explore the use of proactive value-based agreements that we believe may help provide the budget predictability that payers are looking for and favorable access to Zarendelon.
Speaker 4: We also know that early experiences that are antelone in the treatment of MDD and PPD will be a driver of a successful launch.
Speaker 4: Our goal is to enable positive first impressions, verbal patient with MDD and PPD and providers. To support those positive experiences, if Zoraan alone is approved, we plan to provide patient access and support service programs.
Speaker 4: which we believe will help patients with MDD and PPD navigate their Zeranolone treatment journey.
Speaker 4: As we continue to prepare for a potential launch later this year, I look forward to sharing additional details on our plan and expectations for the launchers around alone.
Speaker 4: We're working diligently to deliver a novel treatment option for those living with MDD and PPD and are highly motivated with a sense of urgency.
Speaker 4: given the real life impact of depression on people suffering from it and those who love them.
Speaker 4: We will be ready to execute if Zoranalone is approved, inspired by our vision for Zoranalone of transforming the way depression is treated.
Speaker 4: Now I'll turn the call over for a review of our financials. Give me.
Speaker 4: Thanks, Chris. Our financial results for the first quarter of 2023 are detailed and our press release issued this morning. I'd like to take a moment to provide some context and highlight a few key points.
Speaker 5: We ended the first quarter with a strong cash position and it made important progress across our pipeline and launch preparation activities so far this year.
Speaker 5: We have also seen continued growth in the use of the RESTO. I'm proud that since it's launched, we've been able to help hundreds of women with PPD with RESTO.
Speaker 5: We look forward to potentially expanding treatment options in PPD with Zarenalone if approved.
Speaker 5: We're executing from a position of strength in a difficult macro environment as we prepare to support the potential commercialization of Zoranolone and invest in development of our robust pipeline.
Speaker 5: As a reminder, as part of our collaboration with Biogen, we're jointly developing Zeranolone and Sage 324 with a 50-50 cost sharing in the United States.
Speaker 5: We know that to achieve our vision of transforming the care of depression, we must begin with a focus strategy and be prepared to scale quickly with success.
Speaker 5: and we will remain mindful of capital allocation prior to potential one.
Speaker 5: Our net loss for the first quarter of 2023 was 146.8 million, and we ended the quarter with cash equivalent to marketable securities that approximately 1.1 billion.
Speaker 5: Turning to operating expenses, R&D expenses were $92.8 million in the first quarter of 2023. The increase compared to the first quarter of last year, which primarily related to the hiring of employees and corporate infrastructure costs such as information technology costs to support the growth in our operation.
Speaker 5: S-GNA expenses were $65.7 million in the first quarter of 2023.
Speaker 5: The increase compared to the first quarter of last year, which primarily related to hiring employees to support ongoing activities in anticipation of the potential launch of Duranoan. We're also reaffirming that based on our current operating plan, we anticipate cash. We're also reaffirming that based on our current operating plan, we anticipate cash.
Speaker 5: Kesha equivalents immarkable securities.
Speaker 5: and anticipated funding from ongoing collaborations and potential revenue will support operations into 2025.
Speaker 5: Included in this guidance is the potential to achieve milestones totally 225 million from biogen related to the first commercial sales of Durantlon and MDD and PPG.
Speaker 5: As we said at the beginning of the year, given how dynamic we expect 2023 to be, including preparing for a potential launch, we're not providing year-end cash guidance at this time. However, looking forward, we expect that our spend will increase as we continue our ongoing and planned commercialization efforts.
Speaker 5: and advanced plans and ongoing studies for our brain health pipeline throughout the year. As we approach crucial catalysts, I'm confident that our strong balance sheet will enable us to execute from a position of strength. We have multiple upcoming potential value-creating milestones on the horizon. Thank you.
Speaker 5: at a lear and brain health.
Speaker 5: I'll now turn it over to Helen to handle Q&A with the operator. Helen?
Speaker 2: Thanks, Kimmy. Before I turn it over to the operator, I'll ask you to limit yourself to one question. If you have an additional question, please feel free to return to the queue. Now I'll turn it over to the operator to handle Q&A. Operators? Thank you. If you'd like to ask a question, please signal by pressing star one on your telephone keypad.
Speaker 1: If you are using a speaker phone, please make sure your mute function is turned off to buy your signal-treature equipment. Again, press star 1 to ask a question. We'll pause for just a moment to allow everyone an opportunity to signal for questions. We'll take our first question from Anupam Rahma with JP Morgan.
Speaker 4: Hey guys, thanks so much for taking the question. Just on the mid-year shoreline update for Zoranlo, can you remind us of what the focus will be here?
Speaker 4: Will this be presented in conjunction with a medical meeting? I think in your comments, you highlighted that scientific medical forms remain kind of like really important on the medical education front. Thanks so much for taking the question.
Speaker 3: Yeah, and upon thanks for the question. So just on your last point as as.
Speaker 3: A collaborator of SAGE and SAGE people continue science exchange at Congress. It's critically important. It's a critical form for us to share information and get feedback from healthcare providers. And as I know, you've noted in some of your notes the...
Speaker 3: the volume of activity and the success of the excitement of changing continues to grow. People are very excited if the proofers around come to market. That's growing and growing. Sure, I'm doing a critical piece of that, what's new and I'll ask you in the coming over further in the update is that we will include the role of repassions from coral. So, remind you that
Speaker 3: Coral was a phase three study comparing Zerano and Pustin antipressin, birthed antipressin, and we saw positive and significant clearly meaningful results, differentiating the two at day three. Those patients have an opportunity to roll over to shoreline and we're interested in whether the data are the same or slightly different in those arms. Can you want to?
Speaker 3: Take that? Absolutely. The short-line study is a really important part of the overall stride on the program, because we get so much information out of it. Of course, we get a fair amount of safety data given how large the study is. But perhaps even more importantly, it really answers a number of questions around how it's around how we'll be using the real world.
Speaker 6: And so, as Barry said, what you're seeing is an increasing amount of scientific exchange as we're presenting data from what is a very large study. There are multiple cohorts patients that have gone through the study. To Barry's point, the last cohort to go through the study are patients who have the opportunity to roll over from the coral study. And what's really interesting there is, of course, coral study.
Speaker 6: two arms, one with a standard of care antidepressant and another standard of care antidepressant plus ceramolone. Both of those arms have an opportunity to roll into the short on study. So really get a good look at subjects who have been on a standard on antidepressant and then starting ceramolone for the first time. So we're very interested to see the data. I think you can expect to see continued presentations.
Speaker 1: around the shoreline study for quite some time. We can take our next question. We'll go next to the two borrower with...
Speaker 1: PD Cowan.
Speaker 2: Good morning, guys. Thanks for taking the question. I wanted to ask on a couple of comments that I heard about the Zoranolone commercial strategy. One, Chris, I believe he mentioned something about a patient access and service program.
Speaker 2: Is this going to be something like a hub that we see for more specialty diseases with like reimbursement support, paperwork support, diagnostic support? And then just holistically, between your comments and Barry's, it sounds like there might be a DTC element out of the gates.
Speaker 2: with something like this, given you mentioned that you expect patients to ask their doctors or clinicians about this, is that something that I interpreted correctly? Thanks. I read you thanks for the question. So as an log will turn over to Chris, that has be commented in our plan remarks.
Speaker 3: We're starting with a very focused approach to Zerano-Loncid, Omnitalo, the personal non-personic emotion, which will include reaching out to potential patients directly. And as Chris said, we plan on scaling fast and success starting with focus. So to think big starts small scale fast.
Speaker 4: But specifically to your patient access question, Chris, you want to take that? Yeah, thanks, Barry. So, good morning, Ritu. Our plan for launch is to make sure that patient who needs a rental owner absolutely able to get it regardless of the nature of the patient's payer status. And to that end, what we want to make sure that we do is that for patients at the time of launch, as they have a need for the product.
Speaker 4: that we provide the appropriate access and reimbursement support services to ensure that when that prescription gets filled that that prescription actually gets adjudicated and the patient's able to get into the pharmacy for an affordable out-of-pocket. So having a full complement of patient access and support service is going to be absolutely paramount. I think also what's going to be important is for physicians who want to experience the product to have access.
Speaker 4: become in and around DTC and DTP. But as Barry mentioned, that there are patients waiting for this medication. We want to make sure that at the time of launch, we're able to provide information and education directly to patients and to those suffering with MDD and PPD and access to tools and resources so that they can engage their clinicians in informed discussions as we go.
Speaker 4: Obviously, blotter DTC is something that we would reserve for later in the launch, but focused DTC and DTP is definitely something that we want to make sure that we're able to offer through on the channel efforts at the time of launch. Great. Thank you. Thanks for just around that, I'm happy to. You can understand that strategically and shoreline data are a good group point where majority of people that responds to rent on didn't need another medication for over a year or 80%.
Speaker 3: or a world we believe it well, this really is about traditions getting comfortable using Zeradalone for the use to grow.
Speaker 1: Thank you. Good morning, team. Thank you so much for the remarks. I'm going to stick with the topic of commercial preparation. Could you maybe provide a little bit of color on what you're visualizing the size of the company?
Speaker 2: any color sort of on that execution side of the arm and specifically also what your partner is doing to help you and I'll jump back into the queue.
Speaker 3: Thank you, yeah, that's for the question. And you're really appreciated. What I can say at this point, I'll kick it over to Chris, is that we invite you in our highly aligned on the go-to-market plan, the hiring plan, and the things big start small scale fast. I'll try to do Chris, you want to take it?
Speaker 4: Yeah, thanks very, so good morning, yes. Our ambition with the Salesforce is to really enable effective region frequencies, as you might imagine, on those clinicians who we believe will be new users of antidepressants like Saranalan, if approved. The group that we intend to target includes psychiatrists, OBGYNs, a select group of primary care physicians and nurse practitioners and PAs were...
Speaker 4: because they have patients who are waiting as well for medication like serenolone. You know, we really believe that it's imperative to deliver messaging to serenolone on a broad group of these potential prescribers because patients with depression, as you might imagine, are waiting and deserve better. Now, with respect to the comment of our biogen, as Barry mentioned, we're in boxed up with biogen around our go-to-market strategy.
Speaker 4: with Zorana alone, inclusive of how we think about deploying sales representatives at the time, well obviously right now we're thinking about deploying it at the time of effectively the PDUFA date, making sure that we have representatives in the field who are ready to go and are able to optimize the time in between the PDUFA date and the time.
Speaker 4: the DEA scheduling window so that once the product is approved, both the DEA scheduling there, they're ready to go with full promotion. In terms of how we're thinking about moving beyond that, obviously we'll continue to read data, and as the data reads out, you'll think about scaling with success in specific physician groups that we see really, really interesting as we move forward. Thank you so much.
Speaker 7: Next to Salveen Richter with Goldman Sachs. Hi, this is Srinath Khan for Salveen. Thank you for giving my question. So with regard to the commercialization strategy, could you provide some color on your plans for sampling? Karen King already told us that we cover arecord making of Salveen which is a
Speaker 7: as in providing samples to doctors who drive the uptake of the run alone, during the early months particularly. And if you expect certain restrictions there given that you expected DEA scheduling or should you for drop?
Speaker 3: Thank you for the question. Please send our best to Saladin. As I said, in all aspects of Christmas, it's a specific question. But as I said at the beginning,
Speaker 3: strategically we believe that that healthcare provider experience
Speaker 3: treating patients with the rannel and seeing the results of their own eyes is critical to our launch long-term success. So you know, as you said many access opportunities including sampling will be a part of that overall stride. Chris, you want to take it from there? Yeah, it's a it's a build-berry. What I'd say is
Speaker 4: It's important that physicians, as we think about launching the medication, have a clear and compelling use case in mind, anchored to the Xerenolone data, and they couple that use case with early experiences Barry mentioned, so that they get to see the impact that Xerenolone can have in the specific patients that they want to use it in. So with respect to how we think about that, we're going to make available, effectively, I think you used the word samples, we would consider it.
Speaker 6: Oh, hey, congrats on the progress and thank you for the update. Can you just talk about the impact of the IRA on your development plans for stage 1A, especially since it's ...
Speaker 6: potential pipeline in a molecule. What is the impact of the IRA on how you plan to develop?
Speaker 6: broad indications either sequentially or in parallel. And also if you could comment on the impact of the IRA on your plans for pricing of the rental loans, that would be great. Thank you.
Speaker 6: pointually or in parallel. And also, if you could comment on the impact of the IRA on your plans for pricing's around loans, that would be great. Thank you. Thank you.
Speaker 3: Yeah, Jay, thanks for the question. So, you know, as we've said before, we think while there are, you know, important, positive components of the Inflation Reduction Act, things like SUDU, COPE, Minimum, and Pockets, for patients in large. It's an act that will not be friendly to innovation.
Speaker 3: The good news for SAID, however, is that we have a very robust product engine. So it's too early to share specifics and was around on three to four apartment dies. So I need to complete the line with them. But it's safe to say that we believe that innovators like SAID, whereas we can develop many, many molecules and many, the case from molecules are well suited.
Speaker 3: to pharmacology to develop them for future indications, then it will be clear as IRAs implemented and we align with Biogen on the long-term use of both sirenolone and SAGE324. But great question Jay, and again the good news for SAGE is that we've got a robust pipeline and a product engine capable of many many products.
Speaker 1: Great. Thanks for taking the question. Okay.
Speaker 8: Okay, thanks so much for taking my questions. In your prepare remarks and talking to the commercial strategy, I find it really striking you're talking about positioning Zoran alone is a first ad on anti-depressant. I think pretty much any company in depression would love that to be the case, but...
Speaker 8: It just seems to never happen historically. All these new drugs get stuck in the treatment refractory population. So I guess like point blank specifically, how are you actually going to do that? Are you making significant price concessions? Like how's this gonna play out? And then I wanted just to ask Barry for just a quick comment on any thoughts, and I don't know exactly what you can say on, where biogen is at as it relates to psychiatry. They're talking about that as a potential area for business development. They've talked about wanting revenue generating assets.
Speaker 8: If they were to in-license a site drug, how might that impact sage? And I guess how are you kind of thinking about whether or not that's a good or bad thing for your positioning as you launch this product? Thanks so much.
Speaker 3: That's a great question. Let me start with the second question, then I'll talk to the first one and ask Chris. Come and think of it, you really have to advise him about their strategy. When it can tell you from our interactions is that Chris Vibachress significant experience with depression given his glass of days. On public record he's very excited about potential for Toronto to help millions of patients and very bullish. And that's a great question.
Speaker 3: about the revenue consequence of helping millions of patients. So all that's very, very well aligned. In terms of how they grow in this development, that's really a question you'll have to ask about it. And I can tell you that a top, top, top priority of biogen right now is the successful launches around. So very well aligned with that.
Speaker 3: From a stage perspective, as we think about potential in licensing, our bar is very, very high. And I can't speak for bias. If I expect to hold her by her bar, very high as well. That's certainly how we think about it. In terms of position with the rental loan, we come in earlier in the call that strategically, we invite in from the very beginning, a line on proactive value-based agreement.
Speaker 3: will grow and their inability to budget. We're partnering with the pairs makes that more, more predictable. And what we've heard from pairs and crystal comment is that for post-partum depression, since this will be the first, if it's approved, the first formal medicine ever specific for PVD, that it doesn't make sense for moms to suffer for weeks or months on a unspecifically approved generic for PVD. If they could get better into risk of days, we connect with baby in the long term health economic consequences of not having a mom connect with baby or severe. And we presented data on this. In terms of MDD, what we're hearing from pairs,
Speaker 3: is that in certain use cases, young adults, the elderly, a frontline might make sense. And there's been recent brand launches where about 10 to 15% of the drug use frontline. But primarily at launch, we believe that in MDD, we'll be used with cases that already diagnosed with MDD that are on or tried something that are not yet satisfied with their level of wellness. Chris, do you want to take it from there? Yes.
Speaker 4: Yeah, thanks Barry. So Paul, I've been personally engaged with payers now for the better part of the year and a half. And those conversations initially started around unmet need in the MDD and PPD markets. And we haven't had a payer yet that hasn't acknowledged the unmet need in MDD and PPD. And we progress through to conversations around the compelling nature of the landscape and nest data and what we saw on our clinical studies. And we've anchored our conversations.
Speaker 4: in and around proactive value-based agreements, and the potential impact that those agreements can have with respect to providing pairs with predictability and budget certainty that they are so looking for. So between the unmet need and the data from those studies, it's really propelled conversations forward in and around how to think about BBAs and contracting more specifically. And as I mentioned,
Speaker 4: I've been personally engaged in conversations with national recon pairs, inclusive of PBMs for quite some time. And what I can tell you is the byproduct of those discussions is there's significant pair interest in Zoranolog. At launch, we're working to have as many pairs lined up as possible to make Zoranolog accessible. And from a medical policy perspective, as you noted, what pairs are telling us is there is a clear and compelling use case.
Speaker 4: is really specific for early line of therapy. Now, compare that with Axon's recent launch. What we've seen is restricted coverage, we've seen rejections, and we've seen later line of therapy use. I think there's a number of reasons for that. But given the nature of how Zerino and works, there's physician interest and urgency to use it and a pair willingness to recognize that the impact that it can have by allowing first line use in VPD and first out of first switch in MDD. Awesome. Thank you guys, appreciate it. Thank you all. Great question.
Speaker 4: earlier line of therapy. Now, compare that with Axon's recent launch. What we've seen is restricted coverage, we've seen rejections, and we've seen later line of therapy use. I think there's a number of reasons for that. But given the nature of how Zereno works, there's physician interest and urgency to use it and a pair of willingness to recognize the impact that it can have by allowing first line use in Ph.D.D. and first out of first switch in MDD. Awesome. Thank you guys. Appreciate it. Thank you. Well, great question. For the next two Amy of Ph.D.D.D.D.D with Needham.
Speaker 8: Hi, good morning. This is Ethan Leon from Army. Thanks for taking our question. Maybe if I can ask one on 324, I guess there's, you know, there's been discussion from another company in the essential tremors space that the Tetris ADL subscale, maybe the preferred end point for regulatory purposes. You, as I believe, based on your face to be the primary endpoint is item 4, the performance of scale. So just curious, you know, what do you guys think is ultimately what the FDA wants to see in terms of a registration line points? Thank you. Yeah, and the great question. Please send our best to Tommy. I'll start on GM to comment further. So for same 324, which is a GABAPAN that we developed specifically for chronic abuse.
Speaker 3: in movements or starting with potential tremor, we saw pretty spectacular results in the kinetic study. And that is a statistically significant reduction in tremor scale, as you said, measured by Tetris. We also saw statistically significant alignment in activities of daily living. So while we haven't had the phase 3 discussion with FDA on the end point, we saw a significant increase in the number of patients with the COVID-19 vaccine in the last three years. And we saw a significant increase in the number of patients with the COVID-19 vaccine
Speaker 6: we've got tremendous optionality depending on which way we want the endpoints to go given the data we've seen to date. Anyone want to comment? Yeah, I think Barry nailed the key point of what we're seeing from the data are certainly clear results both from the primary end point but also to the question that is matched by a similar effect on ADLs. And that's really what you're looking for here is that there is a benefit, a meaningful benefit to patients. And we believe that
Speaker 6: the Gabbos system would say 324, add a truly novel way to treat a central trauma.
Speaker 9: All right. Thank you. Thank you.
Speaker 1: All right, thank you. Thank you. We're going next to.
Speaker 10: Kocarni with Connacord. Good morning, thanks for taking my question. Your curly Zuranlon is a path-breaking product for depression, and you mentioned your preliminary engagement with various stakeholders have been largely positive. But if there's been any pushback or any portions of the value proposition of Zuranlon that requires the most effort on convincing, what have those been about? 10.
Speaker 3: Has that been from experts, payers, or some other source? Yeah, Sumon, thanks for the question. I'll ask Chris to comment. But, you know, what I can say is, temporarily, the feedback has gotten more and more positive as the data has been understood, actually, on all fronts. I mean, from the very beginning, patient and patient advocates told us there's significant unmet needs of depression.
Speaker 3: Even those that are on anti-depressant stably aren't well, they're just numbed. We heard that, you know, two and a half, three years ago from the beginning. I think the big change we've seen from key opinion leaders is that they've moved from a disbelief, there's never been anything new in 35 years other than monoid approaches.
Speaker 3: How can that be to a huge belief given the total of these data particularly strong on that? Wow, there's a new medicine that works quickly with the patients who responded to those two or three days and the majority only require two weeks of treatment and they're well. And we've got the SF-36 data to support that state. So I think we've seen a big shift.
Speaker 3: The pushback historically has been, you know, and how do I know when to retreat? And I think people have understood and Laura has talked about this extensively. While this changes the approach to treating depression, it doesn't change the practice of medicine. So treating the patients and monitoring them out of going forward. From a pair perspective, and Chris highlighted this earlier on the call,
Speaker 3: is here's all of knowledge that I met need and realize when talking about the totalities around the loan data that were offering something very, very new in treating paradigm. This is not the new entrance that might work a little faster, might offer a little bit of less side effect, this is a completely new approach to depression. So it's not being looked at as the 456 as...
Speaker 3: Launch needs to be pushed to backline. You know, Laura or Chris, anything to comment? Maybe Laura first?
Speaker 11: Yeah, so I think as a clinician that's treated patients with depression, the thing that really strikes me about the Zaramone data is the rapidity of the response and the durability of that response. And how it will really change the conversation that you have with patients when you sit down with them and prescribe that initial treatment for depression. Instead of having a conversation about needing to wait for a response for six to eight weeks.
Speaker 12: healthcare providers here in front.
Speaker 4: Yeah, I think there are three things some of them that are going to drive our success from a healthcare provider in Paraphan. I think the first is giving physicians or healthcare professionals more broadly, clearing compelling use case that's really anchored to the data. I think Laura hit it nicely around the profiles are in alone and why it's desirable for patients that are living with both MDD and DPD.
Speaker 4: So again, I think that clearly in the case of essential. I think the second thing is to enable early experience where they get to see the power of the medication in their hands, and they get to have the patient's feedback. And I think that's to Barry's point about when we've heard from investigators the impact that they've seen by virtue of that experience has been really, really meaningful.
Speaker 4: And lastly, it's working to able broad unmitigated access without prior authorization to step that it's better onerous using proactive EBAs to make sure that payers have the budget predictability and certainly that they're looking for. I think when we do those three things successfully at launch, we're going to have a very successful launch. Thanks.
Speaker 13: Thanks, Yimam. We'll go next to Vikram Pirahit with Morgan Stanley . Hi, thanks. This is Steve from Viquen. Thanks for taking our question. So I want to ask about the scope of the lifecycle innovation work you are conducting for the run-and-roll, and what kind of snobby we can...
Speaker 6: There are a number of patient populations who we think have benefited from Dr. Anlohn. I think you begin to think about, given the types of responses we're seeing when it's around, in the NPD and PBD, as well as the robust effects we're seeing in those patients on anxiety symptoms.
Speaker 6: You begin to think about other related anxiety disorders, impressive disorders, as potentials. But really, going to specifics is going to require some detailed discussions with our collaborators' advisers. Those discussions are underway. And so as we get a little bit farther down the road and sort out the sequence of activities that we'll go to only to doubt for you. But I think...
What we can certainly tell you is that there's a lot of active discussion around which patient populations, in addition to MDD and PPP, we think could benefit from serotinoma. Thank you. Thanks, Steve. We'll go next to Yatin Sunja with Guggenheim. Hi, good morning. This is Eddie on Friaten. Thanks for taking our question. Just from a high level, when we think about...
price per patient per year for Zoranolun? Should we be thinking about it in terms of treatment courses or some weighted average of patient costs that would include some number of possible retreatments? And then for PPD, should we expect a similar rate of yearly retreatments? And do you have data beyond Shoreline to look at PPD retreatment? Thanks.
Yeah, great, great question. So we've commented on actress before, you know, you heard Chris and me say several times this call already, it really starts with a proactive value rate agreement. And those provide some risk taking in our part and some budget predictability and price protection from.
For repairs, those two early to talk about specific evaluative agreement in every pair is in different treatment. The context here is that what we're hearing from pairs is that it's important for us to stay below that specialty tier since the sovolding launch years ago, every pair of put.
automatic, automatic mechanisms in place if people are in that specialist tier to put prior ops and steps in place. So please stay below specialist tier. And they're talking about per patient tier, not per pill or per pack. And that number is roughly around $10,000 per patient per year. So that's broadly how we're thinking about it. We then cycle that and think about the per pack price. Now.
It's unlikely that an indication specific pricing makes sense here will be a price for the around-home pack of 14 days to 50 milligrams and that's how we'll think about price.
it's unlikely that an indication specific type pricing makes sense here. Will be a price for, is around on pack of 14 days, milligrams is that how we'll think about price.
Yeah, you talked about re-treatment data with PPD. So, you know, right now, what we've seen for the most part is that in both phase three trials that the moms that respond in day three and day fifteen hold that response up to day forty-five. So, we expect that that will hold true in the real world.
Gotcha. And then just really quickly, I know in the shoreline, there was very few patients that needed multiple retreatments, but is there going to be a maximum number of yearly retreatments allowed maybe by the payer or from a safety standpoint? Yeah, I think you're cheating. That's two questions. But let me answer that quickly. So, thank you so much.
Again, we said we're not going to talk about exhibits of label. What do you see typically in label? Do we said this before, the statements about, you know, surround and study, X amount of time, there's not a study over X amount of time, things like that. We don't think from a payer perspective, there'll be any kind of registration.
Thank you. Thank you. And just as a reminder, please limit yourself to one question.
And we'll go next to Brian Abrahams with RBC. Hi, yeah, this is a Leonid on Fur Brian . Thanks for taking our question. I wanted to ask on some of the recent ended competitor launches and how you're taking up the learnings from those, both on size of the market targeting prescribers.
potential detailing and then also maybe just a quick follow-up. Do you have any views on how Ziranilone may pair with potentially anti-psychotics given the growing role that class is playing in treating MDD and not necessarily just in combination with SSRIs and SNRIs. Thanks. Yeah, Leona, thanks for the questions and please send our best to Brian .
But, Chris, why don't you take that.
Chris, why don't you take that? Yeah, thanks Barry. So we.
As you take a step back and you think about the launch as we pay is very said very close attention to all facets from The way that they target their customers besides of the sales force the tools and resources that they're using to Effectively manage their launch all the way through to the external median how they're spending their media dollars so we we have Quite a close lens trained on the various competitors and
that has a new mechanism of action and works a little bit faster than maybe some of the other medications that have historically been available in the market for the last 30 to 35 years. I think this really demonstrates that there's unmet need for new treatment options for the management of MDD. As you know, there still is no treatment and orally available treatment for PPD. And there is significant need there for a product like Xerenolone. So we anticipate that the opportunity for Xerenolone to be used...
most effective way. Great, and second part of the question on 8. So in regard to your question about use of adrenaline with atypical antipsychotics, I think it's really important to consider the context in which atypical antipsychotics are used to question them. That is, they're typically used as an ad on treatment when patients have an insufficient response to their standard of care.
before they add an antipsychotic on because of the side effect profile. And so, as a physician myself, when I think about how duranilone is going to be used in the future treatment paradigm, given the efficacy data that we've demonstrated in use both as mono and add-on, and the side effect profile of duranilone, which is clearly different and has much fewer side effects related to metabolic syndrome and weight gain compared to atypical antipsychotics,
It's my belief of a position that the adrenaline would be used as an out-on ahead of a trivial evidence of the problem.
Yeah, thanks for the question. Or as a model therapy, the key that we see in depression and lorissa as well is when patients don't respond well, it becomes about polypharmacy. And as you know, polypharmacy and patient populations continue to be an issue particularly with people age and their own other medications. So the opportunity to use a medication like the drugs around on every night for 14 days.
appreciate it. Thank you.
Hey guys, thank you for taking my question. Just kind of a follow up to the last question. I'm just wondering how you educate, I guess, patients and physicians on the need to actually take the full two week course. I guess what I'm trying to get at is, you know, is there a risk that patients, you know, take a few days of, of those things, you know, kind of get well within that two to three day period.
a question of educating prescribers and patients on the importance of finishing the 14-day course. That is the treatment course that was studied in clinical trials and support the efficacy and the benefit that Duranteload has demonstrated. So it will really be about making sure that the patient understands the need to finish that 14-day course. Thank you.
ideas how my lives are covered to those agreements or at least expected be covered at the time of launch and is this a process which would be gradual throughout the years of the launch and the life cycle of the product or is this something that is looking to be now down as early as possible.
Yes, and this is great question. Chris, why don't you take that and then I'll come and move back to the end. Yeah, what I would take him is it's early to talk about specific numbers. You know, we're active and engaged with a number of pairs right now around proactive value-based agreements of what contract you would look like. I think as you take a step back and think about, you have to think about it temporarily. There are some pairs who I think in and around the time and approval of Zorena Lone will be.
you know, active and engaged around the conversation. I think there are other payer types, you know, who may take a little bit of a longer approach, you know, in particular, you think about some of the the payer types in and around Medicare may take a little bit longer to take a step back and review the product. We're actively engaged with all of those payers right now and engaged to make sure that as quickly as possible is those payers are ready to to agree to value-based agreements.
and contract to contract specifically that we're going to have the product available in that Perry launch window as rapidly as possible. That's a great answer, Chris. And just to provide some further context, what I've seen in the past as being involved in the database agreement is a number of payers who are the more innovative payers get involved earlier and then other payers see press releases or other payers talk about it. They will call and say, hey, we need to get involved. Now, the interesting piece here is that everybody you talk to is highly focused.
Next to Mark Goodman with SVB Securities. Good morning. On the milestone slide for SAGE 324 talks about additional data that you're going to be showing this year for ET. Can you talk about what that data is? And just secondly, are you considering potentially studying that in tremor in Parkinson's disease? We've heard from doctors that
that actually could be another population, maybe even easier population to demonstrate efficacy. Thanks. But thanks Mark. Do you want to take that? Yeah, absolutely. So thanks for question Mark. We continue to do analysis on the data that we have from the Kinetic Study. Remember as well that the target reason we've moved into this place.
is that we've done early pilot studies initially with LORESSO and then with XORANMLO really to identify whether or not this patient population would benefit. So we've got quite a lot of data all throughout the program so far around the benefits of this mechanism in the treatment of essential tremor.
And so, you know, those are the data that we're talking about, and you'll see those data continue to emerge as good as it is. Bye, thank you there.
the Q&A portion of today's call, with that I will turn it back over to Mr. Green for closing remarks. Thanks, Jennifer. And thanks again to everyone for joining us this morning to review our results from the first quarter of 2023. Our progress during the first quarter of 2023 is the result of the teamwork and dedication of everyone at SAGE and our flyers.
This does conclude today's conference. We thank you for your participation.