Greetings, welcome to Alkermes' conference call to discuss the approval of LYBALVI. My name is Devin, I will be your conference operator for today. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded. I would now like to turn the conference over to Sandy Coombs, Vice President of Investor Relations. Thank you, Sandy. You may begin.
Good morning. Welcome to the Alkermes plc conference call to discuss the FDA approval of LYBALVI for the treatment of schizophrenia and bipolar I disorder. With me today are Richard Pops, our CEO, Blair Jackson, our Chief Operating Officer, and Todd Nichols, our Chief Commercial Officer. Our Chief Medical Officer, Craig Hopkinson, will also join us for the Q&A. Before we begin, let me remind you that our discussions during the conference call will include forward-looking statements relating to, among other things, our expectations concerning the commercialization of LYBALVI, our future financial expectations and business performance, and our expectations concerning the therapeutic value of LYBALVI. These forward-looking statements are neither promises nor guarantees and are subject to a high degree of uncertainty and risk.
Please see our press release issued this morning and our most recent annual and quarterly reports filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed here or implied in forward-looking statements. We undertake no obligation to update or revise the information provided on this call as a result of new information or future results or developments. After prepared remarks, we'll open a call for Q&A. Now I'll turn the call over to Richard.
That's great. Thank you, Sandy. Good morning, everyone. This morning, we announced that FDA has approved LYBALVI, which you previously knew as ALKS 3831. It was approved for both the indications we sought, the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder. LYBALVI is our first oral antipsychotic agent, which we'll add to our portfolio of commercial products. It's a once-daily medication composed of samidorphan, which is a new chemical entity, co-formulated with the established antipsychotic agent olanzapine in a single bilayer tablet. LYBALVI will be available in the common olanzapine dosage strengths. In each case, co-formulated with 10 mg of samidorphan. Any approval is a major milestone for our company, but particularly so during the past year. Over the last few months, our focus has been on working with FDA while they completed their review.
As Blair will describe in a bit, we generated as much data as possible to facilitate FDA's remote records review, with the goal of avoiding the need for an on-site inspection or another review cycle. This was a successful strategy. Separate from the manufacturing elements of the review, we know that investors have been focused on three principal questions related to LYBALVI that could affect its positioning in the market. Would it include comparative weight data to olanzapine from our pivotal trial? Would it include a bipolar indication? Would we avoid having a REMS? We're pleased to say that the answer to all three of these questions is yes. LYBALVI is indicated for the treatment of adults with schizophrenia and bipolar I disorder. It was approved under the 505(b)(2) regulatory pathway, which means that its label leverages FDA's findings of safety and efficacy for olanzapine.
The label also reflects information from our program, from ENLIGHTEN-1, our phase III efficacy study in patients with schizophrenia, and ENLIGHTEN-2, our phase III weight study in patients with schizophrenia, which demonstrated that LYBALVI mitigated olanzapine-associated weight gain over a six-month period. Consistent with our expectations, FDA has not required a REMS. Appropriately, due to its samidorphan component, which is an opioid antagonist, LYBALVI is contraindicated in patients using opioids and who are undergoing acute opioid withdrawal. This approval is an important development for patients, for clinicians, and families seeking new treatment options for schizophrenia and bipolar I disorder. These are chronic, severe, and disabling brain disorders that affect millions of patients in the U.S. Despite the many approved antipsychotics, choosing among them often requires compromise, with difficult trade-offs being made between efficacy and tolerability.
If you followed our advisory committee meeting and the associated testimonials from patients and providers and advocates, you heard firsthand the significant need that remains. The average schizophrenia bipolar I patient switches therapy five to seven times over their lifetime, highlighting the need for new and differentiated treatment options. The treatment landscape for these illnesses is complex. The treatment system can be fragmented and confusing to navigate. There are multiple generic and branded products, and the reimbursement environment can be challenging as payers look to limit or slow the introduction of new medicines onto formularies. This is a market we have experience with. We've been establishing our presence and capabilities in the schizophrenia market with ARISTADA, our long-acting injectable antipsychotic, for five years now.
We know many of the healthcare providers treating these patients have experience with the reimbursement systems in which they operate and recognize the access barriers that we'll have to navigate. We know our competition, both generic and branded, and believe that LYBALVI represents an important new treatment option for patients and providers. Building these capabilities and developing a franchise of treatments for serious mental illness has been a centerpiece of Alkermes' long-term strategy. The approval of LYBALVI is a major achievement and represents an important growth opportunity for the company. COVID-19 presented a period of uncertainty related to regulatory reviews. We appreciate FDA's constructive collaboration during the review process. We were very pleased to have been able to secure approval through a remote review of our manufacturing records in lieu of an in-person inspection.
Now that LYBALVI is approved by the FDA and samidorphan has been decontrolled by the DEA, we're moving forward with our commercial preparation activities in advance of a planned launch in the fall. Blair will now walk us through some of the operational aspects of our launch preparations, and then Todd will outline our planned commercial activities. I'll hand it to Blair.
Thank you, Richard. This approval was a great achievement for everyone involved. LYBALVI, which has two active components and four dose strengths, represents the first approval of an oral dose product manufactured at our Wilmington, Ohio facility, where we have a long history of manufacturing long-acting injectable products. Over the last six months, our manufacturing, quality, and regulatory teams have been working diligently to respond to the agency's remote records request in advance of the PDUFA date. The complexities presented by the COVID-19 pandemic impacted FDA's ability to perform pre-approval inspections. Recognizing the potential delay that a pre-approval inspection could cause, over the past six months, we collaborated with the agency through the records review process and worked to provide the agency with data that we believed would best position LYBALVI for approval.
As part of this process, we generated a comprehensive data set related to LYBALVI's manufacture and quality controls. Our strategy was to prioritize approval in this review cycle with a goal of avoiding another potential delay due to a need for additional records requests or a pre-approval inspection. This turned out to be successful, and we're pleased with the outcome announced today. With approval in hand and the uncertainty of the regulatory review process behind us, and with DEA descheduling completed earlier this year, we're initiating the process of manufacturing LYBALVI in four dosage strengths. Bilayer tablets of five, 10, 15, and 20 mg of olanzapine, each co-formulated with 10 mg of samidorphan. We expect to be positioned to launch with commercial supply in the October-November timeframe. Consistent with our financial expectations provided in February, we continue to expect LYBALVI net sales of up to $10 million in 2021.
I will now turn the call over to Todd, who will outline our commercial pre-launch activities.
Thanks, Blair, and good morning, everyone. Let me begin by sharing the commercial organization's excitement and enthusiasm about the FDA approval and final labeling for LYBALVI. In the U.S., there are estimated to be between two and three million patients living with schizophrenia and a similar number living with bipolar I disorder. Despite the availability of generic treatment options, the significant unmet need that exists for these patients is evident in the treatment churn that occurs. Patients living with schizophrenia or bipolar I disorder commonly cycle through multiple therapeutic options in pursuit of better outcomes. While generic treatment options represent 90% of the volume in this market, branded oral atypical antipsychotics generate aggregate sales of approximately $3 billion annually for schizophrenia and bipolar disorder. Every month, there are estimated to be about 70,000 patients switching therapy in the oral atypical market for these diseases.
15,000 of which are switching to branded products. Each patient switch is an opportunity for LYBALVI to be considered by a healthcare provider. olanzapine was once the leading oral atypical antipsychotic treatment, but its utilization has declined, primarily due to its common weight and metabolic side effects. Even so, olanzapine still has 20% and 11% TRx share in schizophrenia and bipolar disorder, respectively. Our market research shows that antipsychotic efficacy is a critical attribute and considered first by healthcare providers when selecting a treatment. LYBALVI offers the proven efficacy of olanzapine while mitigating olanzapine-associated weight gain. We believe that the large potential patient population, the clear need for additional efficacious treatments, and the features of LYBALVI as reflected in the label together represent a meaningful value proposition and an important new treatment option for patients.
As the country continues to reopen and the frequency of in-person promotional activities increases, we believe that we will be well-positioned for a successful launch in the fall. In the interim, we will be focused on advancing key launch activities, including sales force readiness, payer access engagements, finalization of our promotional materials, thought leader engagements, and speakers bureau training. Let's focus first on the sales force. Over the next several months, we will complete our pre-launch sales force hiring and training our psychiatry commercial field organization for the launch of LYBALVI. Our existing ARISTADA team will serve as the core of the commercial effort for LYBALVI and already calls upon roughly 60% of the providers included in our anticipated prescriber call universe. Prior to launch, we plan to add approximately 50 additional sales representatives.
With this expanded footprint, we will have the capability to target healthcare providers that represent about 80% of the branded oral antipsychotic market. We plan to make further investments throughout the launch year in a staged fashion as payer access for LYBALVI is established, pandemic-related restrictions ease, and demand builds. In the meantime, as we prepare for launch, our sales force will continue to focus on driving growth and adoption of ARISTADA. With approval and final labeling in hand, our market access team will now begin the next phase of payer access engagements and negotiations.
This is a critical piece of preparation for launch that can be undertaken prior to having launch supply in the channel. Payer access barriers at launch are typical in the market, particularly for commercial payers, and we are prepared to implement programs to support patient access and help mitigate the impact of initial restrictions that may be in place. We expect access will improve throughout the first year of launch as formulary decisions are made. While that is happening, we plan to invest in initiatives such as medication access support and co-pay support. These initiatives are fundamental to a successful launch and are designed to enable patients and healthcare providers to gain experience with LYBALVI as we work to establish broader payer access.
We will also be focused on finalizing our promotional materials for healthcare providers and patients for submission to the Office of Prescription Drug Promotion for its review, and we anticipate having a full promotional campaign ready to support LYBALVI when it launches in the fourth quarter. Our disease state education program will be wrapping up shortly as we transition to conducting approved product presentations with healthcare providers, which will underpin our work to increase awareness of LYBALVI and drive demand at launch. We also plan to engage with thought leaders, including national, regional, and local speakers, to help support peer-to-peer education. The opportunity to advance a new efficacious treatment option for schizophrenia and bipolar I disorder where there is still significant unmet need is incredibly rewarding.
We have a lot of work ahead of us. Today marks the start of an exciting opportunity to have a meaningful impact on patients in these communities. With that, I'll turn the call back over to Rich.
Great. Thank you, Todd. Before we move into the Q&A, I just want to recognize the efforts of the many individuals at Alkermes who worked tirelessly to develop and secure approval of LYBALVI. A special note of thanks to all the patients and healthcare providers who participated in our clinical program, as well as the clinical thought leaders who worked with us in bringing LYBALVI to the treatment community. A guiding principle for Alkermes has always been to make medicines that seek to address real-life concerns of patients living with chronic diseases, and the approval of LYBALVI is an important achievement that absolutely reflects that mission. With that, I'll turn it over to Sandy for the Q&A.
Thanks, Rich. Devin will now open the call for Q&A.
At this time, we'll be conducting a question and answer session. If you would like to ask questions, please press star one on your telephone keypad. Upon permission, someone indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, as we poll for questions. Our first question comes from the line of Vamil Divan with Mizuho. Please proceed with your question.
Great. Thanks so much for taking my question. Maybe two, if I could. One, I think we appreciate the comments you made about what you need to do before you launch in the fourth quarter. I guess we've seen other companies launch right away and then work with the FDA to finalize the promotional materials and all that in the payer discussion. Maybe you can just share your thoughts on why not get the product out in the market sooner than waiting until the fourth quarter. On the payer side, obviously, I know that's still to get finalized now, but maybe what is your base case assumption at this point? I think a lot of questions about the amount of hoops patients might have to go through in terms of getting on the product.
Do you think they'll have to go through multiple generic products? Do you think they might have to go through a generic olanzapine before they can get on this product? Whatever your current thoughts there would be helpful. Thank you so much.
Good morning, Vamil. It's Rich. I'll take the first, then I'll ask Blair and Todd if they want to chime in on the second. The first is we're launching in Q4 primarily because we're going to complete the commercial manufacturing for the various dosage strengths. We've been focusing for the last few months on that first cycle review, getting that successfully completed, and getting the approval in hand. Now with a validated process and a completed FDA review, now we'll manufacture the commercial product for the channel. In the meantime, Todd's team can activate and begin the launch activities in anticipation of commercial supply being in the channel in the fourth quarter. As an overall matter, though, you're right.
Launching during COVID is a difficult thing to do. Actually, we feel like as weeks go by now and the country opens up, by the fourth quarter, we feel like we're going to be in a really strong position for a more traditional type of launch supported by in-person activities. Todd, go ahead.
Absolutely, Rich. Let me address the payer question, which is an important question. This is one that we get often, and we've thought very deeply about over the last year or so. With the label in hand now, which we're really pleased with the label. With the label in hand, our market access team can now start the next phase of their engagements with payers. We've been very active with payers over the last year. As we've said in the past, we've had over 50 IPP presentations with payers, and the payer reaction is similar to our assumptions, and that is that LYBALVI will be treated like a branded agent. Within this marketplace, generics are always considered first-line options. We are not positioning LYBALVI to be in place of a generic, especially in the market access landscape.
Our assumptions and our expectations is that the patients will continue to go through a generic before they get access to a branded agent. I think the important point to also recognize is that our research continues to show that about 20% of patients have already cycled through olanzapine or are consistently cycling through. As Rich said, there's a constant churn. There's five to seven different treatment options that the patients are cycling through. We have established a profile that there will be a pathway to access at launch. Patients will get access to the product at launch, but it will develop over time.
They're most likely going to have to step through one, maybe two generic treatment options before they get access, and we are prepared for that, and we're going to have access programs in place to make sure that we limit the impact with that and that patients do get access to treatment.
Okay. Thank you very much. Nice to see the approval come through. Thanks.
Our next question comes from the line of Brandon Folkes with Cantor Fitzgerald. Please proceed with your question.
Hi. Thanks for taking my question, and congratulations on the approval. Rich, I know you said the promotional campaign materials are currently under review, but can you give us any color in terms of how you can promote the weight claims? I ask this obviously just going back to ENLIGHTEN-2 because obviously some misconception, I'd say maybe, out amongst the investor community. Can you also just remind us, among the physicians and payers, how do they view that shift in population weight gain? Just any color there, just given you have the ENLIGHTEN-2 data in the label. Thank you.
Yeah, absolutely. Let me take that as well. I think first off is we haven't finalized our promotional claims at this point, and we're going to be doing so over the next couple of months. It is a very unique opportunity for us because, as I said, our plan is to launch in the fourth quarter with a full promotional campaign, which can be somewhat unique. Some companies don't have full promotional campaigns right at launch. That's our plan. I think in terms of weight gain, the important part is that we now have an indication for schizophrenia and bipolar I disorder, which is just very encouraging for us. Our label has a broad indication. We have a differentiated profile in terms of efficacy and tolerability, and we have a favorable safety profile as well too, with a de-scheduled asset and also without a REMS program as well.
Our HCP research continues to show that physicians are looking for an option where they don't have to make trade-off decisions. LYBALVI provides an additional option with the proven power and efficacy of olanzapine without the associated weight gain. We are very encouraged with that. I think it's important to also remember that olanzapine-associated weight gain is disease independent, and then our clinical trials also show that weight mitigation with LYBALVI is disease independent as well too. We are going to be able to promote, and we do have an indication for bipolar I disorder and schizophrenia.
Brandon, this is Rich. I want to add a couple things on here because I think you're right. Your question related to the population weight gain change, which is typically expressed as the mean. It's important, understanding Craig is here to give a little more color. The figure in the label that's actually more compelling is the six-month longitudinal weight profile. That's the flatness of the curve. That's what we find that payers and physicians, people react to very easily understood. Craig, I don't know if you have any more thoughts on that.
Yeah. I think some of the important aspects are really the relative risk reduction that you're seeing for a significant weight gain with LYBALVI, olanzapine. We're pretty encouraged by the amount of data from ENLIGHTEN-2 that is in the label and we believe is clearly differentiating.
Great. Thank you very much, and congratulations again.
Thank you.
Our next question comes from the line of Paul Matteis with [Stifel] . Please proceed with your question.
Paul. Congrats on the approval, first of all. I'm curious just a little bit about the inpatient versus telemedicine dynamics. From your perspective, where does that kind of breakdown sit today, and how do you expect that to evolve over the next few months as you kind of approach approval in Q4? Does that shift back to inpatient slowly affect how quickly you're going to bring on these 50 reps? Thanks.
Yeah, absolutely. Let me take that as well. We've actually considered all of the dynamics in the market for the last year. We've been working and watching this very closely since the start of the pandemic. As a commercial enterprise organization, we've made excellent strides in our go-to-market model. The underpinning of our model right now is a hybrid promotional model where we are able to effectively engage in-person plus remote. We're seeing encouraging signs with increasing access to physicians right now. It's a little bit north of about 50%. We're also starting to see that psychiatrists are seeing more patients in person, although their level of telemedicine is still high, still north of about 60%.
I think the interesting dynamic here when you think about the oral market is if you just look at overall volume, TRx volume, plus new patient share, overall it's relatively flat year-over-year. As you know, within the long-acting market, it's actually declined year-over-year. Oral products are typically used first. This actually gives us a chance, it gives Alkermes a chance to compete in a brand-new market. We're going to be a little bit more upstream with initial diagnosis, initial utilization before patients end up switching therapies over to a long-acting as well. We are expecting that we're going to be able to compete effectively here. We think that telemedicine will start to normalize in the back half of the year and going into 2022. We're not expecting the utilization of telemedicine to be a deterrent on the uptake of LYBALVI.
Thanks. Really appreciate the call.
Our next question comes from.
Great. I want to just make one more comment on that as it relates to telemedicine, because I think it's central to understanding the psychiatry markets. This two-pronged approach is a real advantage for Alkermes. We really believe that the combination of long-acting medicines plus telemedicine is a really strong offering for many patients around the country. We also know that oral medicines dominate the marketplace. To be able to go into the market with two medicines that share these common features of patient centricity and high efficacy that fit into the lifestyle of the particular patient is a really strong offering for us. We expect telemedicine to maintain an important role in psychiatry going forward, but it has to be coupled with in-person visits as well.
Our next question comes from the line of Cory Kasimov with JPMorgan. Please proceed with your question.
Great. Good morning, guys. Congrats on the approval. Wanted to ask you about the acute setting. As we think about that, roughly how many acute cases are treated per year? Do you have an idea of kind of the proportion of those that are on olanzapine? Kind of wondering the potential ability to get acute patients to stay on drug and become maintenance patients for you in the future. Thanks a lot.
Yeah, it's an important question. We've looked at this really deeply. Here's the interesting data that our research continues to show. About 70% of schizophrenia and bipolar patients are seen for maintenance treatment, and it's primarily in an outpatient setting. We've looked at this deeply for olanzapine, and it's about the same. It's about equal acute versus maintenance settings as well. We don't really see a big divergence there. Obviously, with our salesforce planning, one of the advantages that we have is our commercial scale. As I said earlier, we have a highly effective commercial sales organization and market access organization in terms of calling on physicians in the outpatient setting, but also in the inpatient setting as well too. We clearly know where the highest volume inpatient targeted accounts are, and we're actually going to cover that with our footprint as well.
We're going to make sure that we have broad coverage across the entire market, both inpatient and outpatient.
Great. Thank you.
Our next question comes from the line of Jason Gerberry with Bank of America. Please state your question.
Hey, good morning. Thanks for taking my questions. I just wanted to come back to some commentary around the ad com about some 20%-25% of patients on atypicals being opioid users. Your latest thoughts in lieu of the contraindication there, how that might impact your total addressable market. In the past, you guys have commented about a six- to nine-month new-to-market block post-launch. Should we really think about second half 2022 as really kind of where LYBALVI starts to hit its growth inflection? Thanks.
Yeah, I'll start with the question on patients that are on opioids plus olanzapine. In the ad com, there was a statistic of 21% of patients on olanzapine also had a prescription for an opioid. That's just drug utilization data. That doesn't really specifically call out patients for schizophrenia and bipolar disorder. It's very broad. It also doesn't take into account how long the patient is actually on the treatment. We've looked at this very deeply. All of our analysis externally shows that the concurrence is for patients that are dependent on opioids that also have schizophrenia, bipolar is anywhere in the range of about 4%-8%. We've also surveyed consistently our target audience to get their perspective on it as well too. Our physicians continue to tell us that it is a concern for them. It's something that they can manage.
They actively engage and discuss the use of opioids with this patient population, and they have mechanisms in place within their practice to be able to identify those patients that could be on an opioid.
Maybe I'll just add to what Todd's already said. It's obviously we've got a clear contraindication on our label for the use of opioids and in patients who are undergoing acute opioid withdrawal. We also believe that our precautions and warnings are very clearly outlined. As such, we will sort of undertake some additional voluntary education activities to educate our key external stakeholders on the contents of our label. Importantly, and the thing that we're most excited about is that we don't have a risk program.
Yeah, I'll just take the question on market access as well. Again, for this market, there's three primary channels. There's commercial patients, there's Medicare and Medicaid. The new-to-market block at launch really impacts the commercial patients. That's not unique to this category, and it will not be unique to LYBALVI. All commercial payers have what's called a new product block at launch. Those restrictions automatically will take anywhere in the neighborhood of about six to nine months to work through. That's something that our market access team will be engaging with. Medicaid is a little bit different. There's typically open access for Medicaid, especially across the country where there's approximately 11 states that have mental health exemptions in place. With Medicare Part D as well, usually access is defined within the first 90 days.
There will also be blocks in place. All of our programs, Medication Access Support, PA Support, Benefits Investigation, will all be in place to help mitigate some of those blocks as the profile of access starts to develop, which we believe will take place over the first 12 months of launch.
Great. Thanks.
Our next question comes from the line of Sumant Kulkarni with Canaccord. Please proceed with your question.
Good morning. Nice to see the approval, and thank you for taking my question. You mentioned the typical cycling through of medications by patients on these indications. Given there are other new products for schizophrenia that have an arguably much more benign side effect profile versus the older standards of care, and patients might already be switching to such newer products, do you think that cycling through patient niche remains as large or targetable as it has been before?
Yeah, absolutely. I'll take that. I think, yes, when you think about this market, 90% of the prescriptions, the TRXs, are generic, but there's 10% that are branded. There's a reason for this. The branded agents that have come out in the last 10 years or so have offered a different profile, a different balance. Now, efficacy is a key factor really in driving prescription decisions. Really, the key learning is that there has to be the right balance of efficacy and tolerability. The LYBALVI profile supports that. It's the right balance of efficacy and tolerability. When we look at just the churn in the marketplace, I mean, this is a switch market. That's really the way that we think about it, is a switch market. Overall, there's about 70,000 switches to oral products each month.
When you think about branded switches, overall, there's about 16,000 branded switches every single month, and about two-thirds of those are bipolar switches as well. We've got a really good handle on the switch market, and that's going to be the underpinning of how we position the product to physicians. It's not uncharacteristic. When we talk to a physician through all of our market research, they think about it as a market that's switching. If a patient is not getting the benefits of a product they need, the first thing that they do is they change the dose, which is an advantage for LYBALVI because we have multiple dosing options. The second thing that they would do is they would switch the product. That gives us a chance to compete in a very large switch market.
Got it. Thank you.
We do have a follow-up question from the line of Jason Gerberry with Bank of America. Please proceed with your question.
Okay. Thanks for taking my follow-up. Just curious, how you guys are thinking about when you might be in a position to potentially offer peak sales guidance for LYBALVI. I know the consensus is around $400 million-$500 million in the out years, which seems somewhat light relative to some other recent atypical branded antipsychotic launches. Just curious from your perspective when you might be in a position with payer coverage sort of shored up in a position to guide.
This is Blair. Thanks for the question, Jason Gerberry. We haven't obviously given guidance yet on peak sales, but we see a real interesting opportunity with this product. As Todd said before, there's really a unique value proposition with LYBALVI in that there's the efficacy of olanzapine while mitigating the associated weight gain. I think as we progress through the beginning of our launch through the first six to nine months, we'll start to see the physician utilization and be tracking that and really sharing some of our responses with this group as that progresses. We'll be in a better place in a year's time or in six months' time to have a sense of the trajectory of the product.
Got it. Thanks.
Our next question comes from the line of [Camille Dujovne] with Mizuho. Please proceed with your question.
Great. Thanks, Todd, for taking my follow-up as well. Maybe just a little bit more on the pricing side as we're sort of updating things here with the model and everything with the approval. Any more you could share on what we should be assuming for list price or anything around gross to net, just so we're all sort of roughly on the same page while waiting for the actual full launch? Thanks.
Yeah, this is Todd. I'll take that. We're not in a position yet to release the price. As we get closer towards commercialization, we're going to make the pricing available through all the pricing services and as we finalize some negotiations with payers. It'll be much closer towards launch.
Okay. Thank you.
All right. We have time for one more question.
Our final question comes to the line of Douglas Tsao with H.C. Wainwright. Please proceed with your question.
Hi, good morning. Thanks for taking the question. Just following up on Jason's question in terms of visibility on peak sales. I'm just curious what sort of metrics you're going to be most closely following in terms of assessing the commercial potential. Is it physician prescribing patterns or interest? Is it reimbursement? Just curious in terms of what those indicators you might be most focused on. Thank you.
I'll start and then if anybody else wants to add in. There's a lot of things you can look at in this market, but we're very focused and very clear that this is about physician demand. We're going to be watching very closely TRXs at launch and also breadth of utilization. The physician prescribing patterns are really the key leading indicator for us.
Great. Okay. I think that's it for today's question and answer. Thanks so much for joining us to hear about this morning's exciting news and the approval of LYBALVI. Please don't hesitate to reach out to us if you have any additional questions. Thank you.
This concludes today's conference. You may now disconnect your lines at this time. Thank you for your participation, and have a wonderful day.