Sage Therapeutics, Inc.

Q1 2023 Earnings Conference Call

5/2/2023

speaker
Operator
And by we're about to begin. 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. This call is the property of Sage Therapeutics and recording and reproduction, or transmission of this call without the express written consent of Sage Therapeutics is strictly prohibited. Please note that this call is being recorded. I would now like to introduce Helen Rubenstein, Director of Investor Relations at Sage.
speaker
Helen Rubenstein
Good morning, and thank you for joining Sage Therapeutics' first quarter 2023 financial results conference call. Before we begin, I encourage everyone to go to the Investors and Media section of our website at SageRx.com, where you can find the press release related to today's call, as well as the slides that we will be reviewing today. 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. 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. We will also be joined by Jim Daugherty, our Chief Development Officer, who will review recent progress in development activities across our programs. Our Chief Business Officer, Chris Benecke, will provide an update on our preparations for the potential launch of the rent alone in MDD and PPD. And we will then be joined by Kimmy 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
Barry Green
Thanks, Helen. And thank you, everyone, for joining us this morning. 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. We do this by acting with urgency and challenging scientific convention to think differently as we work to develop new and effective treatments. This month marks Mental Health Awareness Month, which is an important reminder that the need for innovative brain health medicines has never been greater. 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 in the U.S. by more than 40%. Simply put, Mental Health Awareness Month reminds us all that we must do more to challenge these trends. People with depression deserve better. Time is now. for SAGE to lead the way in making a difference for patients. 2023 will be a pivotal year for SAGE and is already off to a strong start. We are laser-focused on preparing for the potential launch of seranolone and believe we're on our way to achieving our vision of transforming the treatment of depression if seranolone is approved. We're also advancing our robust brain health pipeline comprised of several new chemical entity development candidates, that is a result of our product engine. We believe our pipeline holds the potential to help millions of people suffering from brain health disorders and deliver significant long-term value creation. Importantly, our work is backed by a strong financial foundation that we believe puts us in a position to further our pipeline ambitions with the goal of being able to launch new drugs or new indications for years to come. Looking forward, we have many key milestones on the horizon. First, the NDA filing for Zoranilone in MBD and PPD is under review by the FDA with a PDUFA action date of August 5th. Now, as I mentioned during our last earnings call, during this review period, we'll not be making detailed comments on the potential label, FDA interactions, or other related topics for Zoranilone. As we prepare for the potential launch of Zoranilone, We in Biogen are continuing permitted prelaunch commercialization activities. We're actively engaged in discussions with payers and 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. Additionally, our team and collaborators have presented data at several key meetings highlighting the negative impact of depression on patients, their families, and society. 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 call. We in Biogen are also advancing SAGE 324, which we believe holds potential to provide differentiated benefits to patients with essential tremor and other movement disorders. Now, turning to neuropsych, we're making progress across our wholly-owned SAGE 718 and MDA PAM programs. With Sage 718, we're leading with Huntington's disease, a devastating condition where deficits in executive function manifest during prime working years. We're also continuing to execute phase two studies with Sage 718 and cognitive impairment due to Parkinson's and Alzheimer's diseases. To close, I'm very pleased with our achievements so far this year and look forward to continued progress in 2023. The time is now to unleash the potential for our science and making meaningful impact on the lives of millions. With that, I'll turn the call over to Jim for a more detailed discussion of our recent portfolio progress and current clinical expectations.
speaker
Chris
Jim, over to you. Thanks, Barry, and good morning, everyone. Over the first quarter, we have made important progress on our pipeline program, and I am pleased to detail our recent advancements and our plans for continued execution throughout 2023. I'll start with depression, where we're continuing to prepare for the potential launch of Zoranlone in MDD and PPD. Our vision with Zoranlone, if approved, is to transform the way depression is treated, and we know this will require support from many key stakeholders. Throughout the development journey with Zoranlone, we have engaged with a broad set of key medical experts, including gathering insights from key thought leaders. Their feedback has been clear. They are increasingly recognizing that the episodic nature of depression means it could be treated as needed with treatment-free periods between episodes. Additionally, as we've engaged in discussions about the unmet need in 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. We have received consistent feedback on what they consider the main strengths of the Zaranlone clinical data. A robust clinical development program with approximately 3,500 subjects. Second, rapid onset of action seen in clinical trials with an improvement in depressive symptoms observed as early as day three. Third, improvement in depressive symptoms observed across multiples of round-loan use cases and patient populations in MDD and PPD. Fourth, a consistent safety and tolerability profile. Additionally, physicians note that this clinical profile has the potential to be particularly impactful if Zoranolin is approved, given Zoranolin's 14-day oral course of treatment. We believe that scientific forums will continue to play an important role in educating physicians on the clinical data seen to date with Zoranolin. 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. These data reinforced the significant negative impacts MDD can have on patients, their families, and society. These presentations highlighted the associations between MDD symptoms and reduced health-related quality of life scores and the burden that extends to other adults living in a home with someone with MDD. They also showed the increase in all health-related and MDD-related costs during the 90-day period following treatment with a current antidepressant. Taken together, we believe these results reinforce the significant unmet need in MDD 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. 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. Turning to neuropsychiatry, we announced earlier this quarter that our wholly owned lead NMDA receptor, 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. These designations advance our strategy to prioritize HD as the lead indication for Sage 718, where we are currently enrolling three studies. Population was chosen as the lead indication as it is a genetically defined disorder and thus is more homogeneous than other populations with cognitive impairment. there is a strong scientific rationale to support the use of an NMDA receptor PAM. Given the orphan nature of HD, we believe if our trials are successful, we have the potential to pave a novel regulatory pathway and to seek the globalized stage by pursuing an XUS strategy in a more concentrated orphan space first. We're also continuing research into the HD patient journey. and recently presented interim data at the CHDI annual meeting from 95 patients in a new U.S.-based HD real-world study in collaboration with Picnic Health. 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. The interim data cut demonstrated that patients with HD experienced cognitive impairment across all stages of the disease, impacting their independence and ability to function. Additionally, we are investigating Sage 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. These disorders represent some of the greatest areas of unmet need, and we know that globally they continue to become more prevalent and significantly disrupt lives. As we said, we expect data from the ongoing studies with SAGE 718 to start reading out in 2024, and we'll share more detailed timelines when appropriate. Our portfolio also includes SAGE 324, our lead neurology candidate. SAGE 324 is an investigational positive allosteric 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 IIb Kinetic II dose-ranging study for SAGE 324 late this year. We are also continuing to advance Phase I studies with a fast-acting balanced Gabapam SAGE 689 and an extra-synaptic preferring Gabapam SAGE 319, as well as IND-enabling studies for our next NMDA PAM SAGE 421. Importantly, all of our product candidates are SAGE-invented new chemical entities with differentiated profiles designed with pharmacologic characteristics that we believe are well-suited to the target indications the program is pursuing. We believe that with our product engine, we have the potential to create significant long-term value if we're successful. 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 Zoran Loan in MDD and PPD.
speaker
Jim
Chris? Thanks, Jim. I'm pleased to be with all of you this morning to share updates on our preparations for the potential commercialization of Zoran Loan. With our NDA filing for Zoran Loan in MDD and PPD under agency review, we are closely collaborating with Fireship to advance permitted discussions with payers continuing scientific exchange with HCPs, and engaging with patient advocates. Further, we're 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 Zoranolone. Based on our PDUFA action date of August 5th, if there are no review extensions and if Zoranolone is approved, We expect the potential launch of Zoranilone near the end of 2023, following an anticipated three-month DEA scheduling period. We will be prepared and anticipate entering a market that will be ready to think about the treatment of MDD and PPD differently. Our vision with Zoranilone is to transform the way depression is treated, focusing first on the PPD patient population, An estimated one in eight new mothers in the U.S. experience the symptoms of PPD 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. We believe Zoranolone, if approved, holds unique potential to be a first-line therapy for many of these mothers who need help. Our goal with Zoranalone, 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. 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 Zoranalone as an oral 14-day treatment option, it may serve as a critical tool and catalyst for HCPs to diagnose, and help mothers suffering from PPD. Based on the compelling and versatile profile seen in the landscape clinical program to date, we believe that Zoranilone, if approved, has high transformative potential as a first-line treatment option for MDD, especially in certain populations like young adults given the 14-day treatment course. We understand that while there is significant unmet need among the entire MDD patient population, we'll need to start our launch in a focused way given payer feedback in the current MDD market dynamics. Therefore, our planned 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. 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 six and a half million with a first add-on or switch launch strategy. Further, our launch strategy is designed to scale quickly with success, and we believe that over time, with focus and determination anchored to our data, Zoranolone has the potential to become standard of care in the treatment of MDD. To achieve our vision for Zoranolone in MDD and PPD, if approved, We must execute a fit-for-purpose launch that prioritizes deep and meaningful engagements with key stakeholders. We are advancing planned omnichannel efforts with a digital core designed to unite data from our content, media, and in-person interactions. Our ambition is to strategically increase the impact, efficiency, and agility of our execution through our Salesforce interactions and non-personal promotion. We're powering this approach with predictive analytics, which are intended to deliver customized, personalized information to key stakeholders. It's also vital that our omnichannel 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 Xeranalone and are prepared to self-advocate in discussions with their HCPs. We believe that if Xeranalone is approved, many people with MDD and PPD, when armed with appropriate education and information, will ask their HCP about it by name. Further, in order to be truly transformational, Zoranilone must be accessible. Our market access team is engaging payers through permitted interactions. To date, we're encouraged by the early enthusiasm we've seen in those interactions. Our goal, if Zoranilone is approved, is to ensure patients with MDD and TPD who are prescribed it can get it with minimal prior authorization and step-edit requirements. 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 for Xurandalone. We also know that early experience with Xurandalone in the treatment of MDD and PPD will be a driver of a successful launch. Our goal is to enable positive first impressions for both patients with MDD and PPD and providers. To support those positive experiences, if Xoranilone is approved, we plan to provide patient access and support service programs, which we believe will help patients with MDD and PPD navigate their Xoranilone treatment journey. As we continue to prepare for a potential launch later this year, I look forward to sharing additional details on our plans and expectations for the launch of Xoranilone. 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 given the real-life impact of depression on people suffering from it and those who love them. We will be ready to execute if Zorana Loan is approved, inspired by our vision for Zorana Loan of transforming the way depression is treated. Now, I'll turn the call over for a review of our financials. Kimmy?
speaker
Chris
Thanks, Chris. Our financial results for the first quarter of 2023 are detailed in our press release issued this morning. I'd like to take a moment to provide some context and highlight a few key points. We ended the first quarter with a strong cash position and have made important progress across our pipeline and launch preparation activities so far this year. We have also seen continued growth in the use of Xeratho. I'm proud that since its launch, we've been able to help hundreds of women with PPD with Xeratho. We look forward to potentially expanding treatment options in PPD with Zoranilone if approved. 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. As a reminder, as part of our collaboration with Biogen, we're jointly developing Zoranolone in stage 324 with a 50-50 cost sharing in the United States. We know that to achieve our vision of transforming the care of depression, we must begin with a focused strategy and be prepared to scale quickly with success. And we will remain mindful of capital allocation prior to potential launch. Our net loss for the first quarter of 2023 was $146.8 million, and we ended the quarter with cash, cash equivalents, and marketable securities of approximately $1.1 billion. 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 was primarily related to the hiring of employees and corporate infrastructure costs such as information technology costs to support the growth in our operation. SG&A expenses were 65.7 million in the first quarter of 2023. The increase compared to the first quarter of last year was primarily related to hiring employees to support ongoing activities in anticipation of the potential launch of Durandalon. We're also reaffirming that based on our current operating plan, we anticipate cash, cash equivalents and marketable securities, anticipated funding from ongoing collaborations, and potential revenue will support operations into 2025. Included in this guidance is the potential to achieve milestones totaling $225 million from Biogen related to the first commercial sales of geranolone in MDD and PPD. 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 and advance planned 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. and we're laser-focused on preparing to support the launch of Xerenon, if approved. Backed by a strong balance sheet, we remain committed to making strategic investments in our developing pipeline programs and further establishing ourselves as a leader in brain health. I'll now turn it over to Helen to handle Q&A with the operator. Helen?
speaker
Helen Rubenstein
Thanks, Kimmy. Before I turn it over to the operator, I'll ask that you 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. Operator?
speaker
Operator
Thank you. If you'd like to ask a question, please signal by pressing star 1 on your telephone keypad. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our 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 Rama with JP Morgan.
speaker
Anupam Rama
Hey, guys. Thanks so much for taking the question. Just on the mid-year shoreline update for Zorano, can you remind us of what the focus will be here? And will this be presented in conjunction with a medical meeting? I think in your comments, you highlighted that scientific medical forums remain kind of like really important on the medical education front. Thanks so much for taking the question.
speaker
Chris
Yeah, thanks for the question. So just on your last point, as collaborators of SAGE and SAGE people continue Science Exchange at Congresses, it's critically important. It's a critical forum for us to share information and get feedback from healthcare providers. And as I know you've noted in some of your notes, the volume of activity and the success of the Science Exchange continues to grow. People are very excited. if approved for Zoraniline to come to market. That's growing and growing. Shoreline's going to be a critical piece of that. What's new, and I'll ask Jim to comment a little bit further in the update, is that we will include the rollover patients from Coral. So I'll remind you that Coral was a Phase III study comparing Zoraniline plus an antidepressant versus an antidepressant, and we saw positive and statistically significant clinical meaningful results differentiating the two at day three. Those patients have an opportunity to rollover to Shoreline, and we're interested in whether the data are the same or slightly different in those arms. But, Tim, you want to take that?
speaker
Chris
Of course, and thanks for the question, Anupam. Yeah, absolutely. The shoreline study is a really important part of the overall surrounding program, in part 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 the surrounding will be used in the real world. 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 of patients that have gone through the study. To Barry's point, the last cohort to go through the study are patients that have the opportunity to roll over from the choral study. And what's really interesting there is, of course, the choral study, two arms, one with a standard of care antidepressant and another standard of care antidepressant plus seranolone. Both of those arms have an opportunity to roll into the short-life study. So we really get a good look at subjects who have been on a standard antidepressant and then starting Duranolin for the first time. So we're very interested to see the data. I think you can expect to see continued presentations around the shoreline study for quite some time.
speaker
Barry
I think we can take our next question.
speaker
Operator
Welcome next to Vituobarrel with P.D. Cowan.
speaker
Barry
Good morning, guys. Thanks for taking the question. I wanted to ask on a couple of comments that I heard about the Zoranalone commercial strategy. One, Chris, I believe you mentioned something about a patient access and service program. 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 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.
speaker
Chris
Yeah, Ritu, thanks for the question. So, as, and I will turn it over to Chris, but as we commented in our planned remarks, We're starting with a very focused approach to zirano-launched and omni-channel, so personal and non-personal promotion, which will include reaching out to potential patients directly. And as Chris said, we plan on scaling fast with success, starting with focus, sort of the think big, start small, scale fast scenario. But specifically to your patient access question, Chris, you want to take that?
speaker
Jim
Yeah, thanks, Barry. So good morning, Ritu. Our plan for launch is to make sure that Patients who need Zoranilone are 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, 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 services 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 to not only the ability to prescribe the product, but to provide early experience, essentially a trial program for physicians to make sure that they gain that early experience at launch and are able to use it in the types of patients that they want to use it in. I think in and around your question around DTC and DTP, obviously more to come 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. Obviously, broader 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 omnichannel efforts at the time of launch.
speaker
Barry
Great, thank you.
speaker
Chris
Thanks, Chris. Just to round that out, Ritu, you can understand that strategically and shoreline data are a good proof point where the majority of people that responded to xeranolone didn't need another medication for over a year. 80% required only the initial or second two-week course. This really is about physicians using xeranolone in their own hands and seeing the impact with their own eyes on their patient population. We believe if the real world is consistent with what we see in clinical trials, that some physicians will have the kind of comments you've heard from people like Greg Mattingly out of St. Louis, things like, I've never seen these kind of reactions before. If that happens out in the real world, and we believe it will, this really is about physicians getting comfortable using Zoran alone for the use to grow.
speaker
Operator
We'll go next to Yasmeen Rami with Piper Sandler.
speaker
Yasmeen Rami
Good morning, team, and 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 sort of what you're visualizing sort of the size of the commercial team to be? What is the involvement or preparation that BiGen is taking through this process? How should we look at sort of the ramp of bringing in the team throughout, you know, the next 12 to 18 months. Appreciate any color sort of on the execution side of the arm and specifically also what are your partners doing to help you. And I'll jump back into the queue.
speaker
Chris
Thank you, Yaz, for the question and your review, Yaz. I really appreciate it. What I can say at this point, I'll kick it over to Chris, is that we and Biogen are highly aligned on the go-to-market plan, the hiring plan, and the kind of think big, start small-scale fast. Chris, you want to take it?
speaker
Jim
Yeah, thanks, Barry. So, good morning, Yaz. Our ambition with the Salesforce is to really enable effective reaching frequencies, as you might imagine, on those clinicians who we believe will be new users of antidepressants like seranolone, if approved. The group that we intend to target includes psychiatrists, OBGYNs, a select group of primary care physicians, and nurse practitioners and PAs who are active in this market as well. We'll supplement, as Barry mentioned, our personal promotion efforts with a digital-first on-the-channel effort designed to deepen our reach and to provide frequency on an additional group of physicians who we believe that outside of the call universe that we'll reach with Salesforce need to absolutely hear the message because they have patients who are waiting as well for medication like Zoranilone. We really believe that it's imperative to deliver messaging to Zoranilone 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 about Biogen, as Barry mentioned, we're in lockstep with Biogen around our go-to-market strategy with Zoranolone, 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 DEA scheduling window so that once the product is approved, post-DEA scheduling, 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, we'll think about scaling with success in specific physician groups that we see really, really interest in as we move forward.
speaker
Barry
Thank you so much.
speaker
Operator
The next is Salveen Richter with Goldman Sachs.
speaker
Salveen
Hi, this is Salveen. Thank you for using my question. So with regard to the commercialization strategy, could you provide some color on your plans for sampling, as in providing samples to doctors to drive the uptake of the Ranlon during the early months particularly? And if you expect certain restrictions there, given that you expect a DEA scheduling for drug.
speaker
Chris
Yeah, thanks for the question. Please send our best to Salveen. You know, as I said, and I'll ask Chris to answer the specific question, but as I said at the beginning, strategically we believe that healthcare provider experience, treating patients with Duranolin and seeing the results with their own eyes is critical to our long-term outcomes. So, you know, as you said, many access opportunities, including sampling, will be a part of that overall strategy. But, Chris, do you want to take it from there?
speaker
Jim
Yeah. As a build, Barry, what I'd say is it's important that physicians, as we think about launching the medication, have a clear and compelling use case in mind anchored to the xeranolin data. And they couple that use case with early experiences Barry mentioned so that they get to see the impact that zirinalin 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 a full-course therapy for a select group of patients, for physicians to actually experience the medication, to see the impact that it can have, because we believe that kind of experience is truly an amplifier to how they think about using it more broadly across their patient populations.
speaker
Barry
If we can move on to our next question.
speaker
Operator
Next to Jay Olson with Oppenheimer.
speaker
Jay Olson
Oh, hey, congrats on the progress and thank you for the update. Can you talk about the impact of the IRA on your development plans for Sage 1A, especially since it's a potential pipeline in a molecule? What is the impact of the IRA on how you plan to develop broad indications, either sequentially or in parallel. And also, if you could comment on the impact of the IRA on your plans for pricings around loans, that would be great. Thank you.
speaker
Chris
Yeah, Jay, thanks for the question. So, you know, as we've said before, we think while there are important – positive components of the Inflation Reduction Act, things like smoothing of co-pays and minimizing out-of-pocket for patients and large. It's an act that will not be friendly to innovation. The good news for SAGE, however, is that we have a very robust product engine. So it's too early to share specifics, and with Zoranil and 324, we're partnering with guys, and so I need to completely align with them. But it's safe to say that we believe that innovators like SAGE, whereas we can develop many, many molecules and many indications for molecules, are well-suited to pave the way forward, depending on how IRA is implemented. So what that means is that for Zoranilone, we certainly could increase the use case with other studies like general anxiety disorder or others, or we could take other molecules that differentiate pharmacology to develop them for future indications. And it will be clear as IRA is implemented and we align with Biogen on the long-term use of both seranolone and J324. 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 to come.
speaker
Jay Olson
Great. Thanks for taking the question.