Greetings, and welcome to Alkermes Conference Call to discuss the approval of Libolvi. My name is Devin, and 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. Please note this conference is being recorded.
I would now like to turn the conference over to your host, 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 Libolby for the treatment of schizophrenia and bipolar 1 disorder. With me today are Richard Hopps, 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 and A. Before we begin, let me remind you that our discussions during this conference call will include forward looking statements relating to, among other things, our expectations concerning the commercialization of Libolby, our future financial expectations and business performance, and our expectations concerning the therapeutic value of Libolby.
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 or implied in the forward looking statements. We undertake no obligation to update or revise the information provided on this call as
a result of new information for future
results or developments. After our
That's great. Thank you, Sandy. Good morning, everyone. So this morning, we announced that FDA has approved Libolvii, which you previously knew as ALKS 3,831. It was approved for both the indications we saw, the treatment of adults with schizophrenia and the treatment of adults with bipolar 1 disorder.
Libolvi is our 1st oral antipsychotic agent, which we'll add to our portfolio of commercial products. It's a once daily medication composed of samidorphin, which is a new chemical entity, co formulated with the established antipsychotic agent elanzapine in a single bilayer tablet. Libolvi will be available in the common elanzapine dosage strengths, in each case co formulated with 10 milligrams of samindorphin. 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 on-site inspection or another review cycle. And this was a successful strategy. Separate from the manufacturing elements of the review, we know that investors have been focused on 3 principal questions related to Libalvi that could affect its positioning in the market. Would it include comparative weight data to olanzapine from our pivotal trial? Would it include the bipolar indication?
And would we avoid having a REMS? And we're pleased to say that the answer to all three of these questions is yes. Libalvi is indicated for the treatment of adults with schizophrenia and bipolar 1 disorder. It was approved under the 505(2) regulatory pathway, which means that its label leverages FDA's findings of safety and efficacy for olanzapine. But the label also reflects information from our program from ENLIGHTEN-one, our Phase 3 efficacy study in patients with schizophrenia and in LITEN-two, our Phase 3 weight study in patients with schizophrenia, which demonstrated that Libolvi mitigated olanzapine associated weight gain over a 6 month period.
And consistent with our expectations, FDA has not required REMS. Appropriately, due to its samidorphin component, which is an opioid antagonist, Libolvius contraindicated 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 1 disorder. These are chronic, severe and disabling brain disorders that affect millions of patients in the U. S.
And 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 or bipolar 1 patient switches therapy 5 to 7 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 5 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 LYVOLVI 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 Libolvii is a major achievement and represents an important growth opportunity for the company. COVID-nineteen presented a period of uncertainty related to regulatory reviews. We appreciate FDA's constructive collaboration during the review process and 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 Libolvay is approved by the FDA and samindorfin has been de controlled 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. Libolvii, which has 2 active components and 4 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 6 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-nineteen pandemic impacted FDA's ability to perform preapproval inspections.
Recognizing the potential delay that a preapproval inspection could cause, over the past 6 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 Libolvii for approval. As part of this process, we generated a comprehensive data set related to Libolby's manufacturer 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. Now 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 Libolvi in 4 dosage strengths.
Bilayer tablets of 5, 10, 15 20 milligrams of Olanzapine each co formulated with 10 milligrams of sanidorfin. 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 Libolvii net sales of up to $10,000,000 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 Libavie. In the U. S, there are estimated to be between 23,000,000 patients living with schizophrenia and a similar number living with bipolar 1 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 1 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 $3,000,000,000 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 Libavie 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 in metabolic side effects.
Even so, olanzapine still has 20% and 11% TRx share in schizophrenia and bipolar disorder, respectively. Our market research shows that and considered first by healthcare providers when selecting a treatment. Libavie 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 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 Libavie. Our existing ARISTADA team will serve as the core of the commercial effort for Libavie 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 Libavie 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 1st 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 Lebovie 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 Libavie when it launches in the Q4.
Our disease state education program will be wrapping up shortly as we transition to conducting approved product presentations healthcare providers, which will underpin our work to increase awareness of LYVOLVY 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 1 disorder where there is still significant unmet need is incredibly rewarding. We have a lot of work ahead of us, but today marks the start of an exciting opportunity that a meaningful impact on patients in these communities. And with that, I'll turn the call back over to Rich.
Great. Thank you, Todd. And before we move into the Q and A, I just want to recognize the efforts of the many individuals at Alkermes who worked tirelessly to develop and secure approval of Libavalli. Also a special note of thanks to all the patients and healthcare providers who participate in our clinical program as well as the clinical thought leaders who've worked with us in bringing LYVALI 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.
The approval of Libolvii is an important achievement that absolutely reflects that mission. So with that, I'll turn it over to Sandy for the Q and A.
Thanks, Rich. Devin, we'll now open the call for Q and A, please.
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. So maybe 2 if I could. So one, I mean, I think we appreciate the comments you made about what you need to do before you sort of launch the Q4. 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.
So maybe you can just kind of share your thoughts and why not sort of get the product out in the market sooner than waiting till the Q4? And then on the payer side, obviously, I know that's still to get finalized now, but maybe what is your sort of 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 in the product. So 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 into products of whatever yours are?
Current thoughts there would be helpful. Thank you so much.
Good morning, Vamil. It's Rich. I'll take the first and then I'll ask Blair and Todd if they want to chime in on the second. The first is we're going to launch in Q4 primarily because we're going to complete the commercial manufacturing for the various doses strengths. We've been focusing for the last few months on that first cycle review, getting that successfully completed and getting the approval we can.
So 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 Q4. As an overall matter though, you're right. Launching during COVID is a difficult thing to do. And actually, we feel like as weeks go by now and the country opens up by the Q4, we feel like we're in a really strong position from a more traditional type of launch supported by in person activities.
Todd, go ahead.
Yes, absolutely Rich. Let me address the payer question, which is an important question. This is one that we get often and we 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.
And 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 Libavie will be treated like a branded agent. Within this marketplace, generics are always considered first line options. And so we are not positioning Livalve to be in place of a generic, especially in the market access landscape.
So our assumptions, our expectations is that the payers will that the patients will continue to go through a generic before they get access to a branded age. 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 consistently cycling through. So as Rich said, there's a constant churn. There's 5 to 7 different treatment options that the patients are cycling through. We have established a profile that there will be a pathway to access at launch.
So patients will get access to the product at launch, but it will develop over time. So they're most likely going to have to step through 1, maybe 2 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 the 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 questions 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 kind of how you can promote the wage claims? And I'll ask this, obviously, just going back to Enlighten II, there's obviously some misconception, I'd say, maybe other than the investor community. But can you also just remind us among the physicians and payers, how did they view that shift in population weight gain?
Just any color there just given you have the enlarged 2 data in the label? Thank you.
Yes, 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, which is a very unique opportunity for us because as I said, our plan is to launch in the Q4 with a full promotional campaign, which can be somewhat unique. Some companies don't have full promotional campaigns right at launch. So 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 1 disorder, which is just very encouraging for us. So 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 the descheduled 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. And LYVOLVI provides an additional option with the proven power and efficacy of olanzapine without the associated weight gain.
So we are very our our clinical trials also show that weight mitigation with Libolvi is disease independent as well too. So we are going to be able to promote and we are we do have an indication for bipolar 1 disorder and schizophrenia.
Hey Brandon, this is Rich. I want to add a couple of 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 and that it's important to understand and Craig is here to give a little more color. The figure in the label that's actually more compelling is the 6 month longitudinal weight profile. That's the flatness of the curve.
That's what we find that payers and physicians people react to very, very easily understood. Craig, I don't know if you have any more thought on that.
Yes. I think the some of the important aspects of really the relative risk reduction that you're seeing for significant weight gain with Lavalby over olanzapine. And we're pretty encouraged by the amount of data from ENLIGHTEN-two that is in the label and we believe it's 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.
Congrats on the approval, first of all. But I'm curious just a little bit about the inpatient versus telemedicine dynamics. How from your perspective, like 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? And does that shift back to inpatient slowly affect like how quickly you're going to bring on these 50 reps?
Thanks.
Yes, absolutely. Let me take that as well. So 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. And as a commercial enterprise organization, we've made excellent strides in our go to market model.
So our market the underpinning of our model right now is a hybrid promotional model where we are able to effectively engage 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, it's 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.
And as you know within the long acting market, it's actually declined year over year. So, oral products are typically used first. So, 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. So we are expecting that we're going to be able to compete effectively here.
We think the telemedicine will start to normalize in back half of the year and going into 2022. But we're not expecting the utilization of telemedicine to be a deterrent on the uptake of Libavie.
Thanks. Really appreciate the color.
Our next question comes from
Rich, 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. And this 2 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. But we also know that oral medicines dominate the marketplace. So to be able to go into the market with 2 medicines that share these common features patient centricity and high efficacy that fit into the lifestyle of the particular patient is a really strong offering for us.
But we expect telemedicine to maintain an important role in psychiatry going forward, but it has to be coupled with in person business as well.
And 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. I wanted to ask you about the acute setting. And 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 kind of make to stay on drug and become maintenance patients for you in the future? Thanks a lot.
Yes, it's an important question. We've looked at this really deeply. About 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 the 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. So we don't really see a big divergence there.
Obviously with our sales force 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. So we clearly know where the highest volume inpatients targeted accounts are and we're actually going to cover that with our footprint as well. So 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 AdCom about some like 20% to 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? And then in the past, you guys have commented about a 6 to 9 month NDC block post launch.
So should we really think about second half twenty twenty two is really kind of where Libavie starts to hit its growth inflection? Thanks.
Yes. I'll start with the question on patients that are on opioids plus olanzapine. In the AdCom, there was a statistic of 21% of patients on olanzapine also had a prescription for an opioid. And that's just drug utilization data. So that doesn't really specifically call out patients for schizophrenia and bipolar disorder And 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 and 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% to 8%. We've also surveyed consistently our target audience to get their perspective on it as well too. And our physicians continue to tell us that it is a concern for them, but not something but 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.
Yes, maybe I'll just add to what Todd's already said. We believe that these patients are manageable. It's obviously we've got a clear contraindication in 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.
But importantly and the thing that we're most excited about is that we don't have a RINs program.
Yes. And I'll just take the question on market access as well. So again, for this market, there's 3 primary channels. There's commercial patients. There's Medicare and Medicaid.
The MDC block at launch really impacts the commercial patients. And that's not unique to this category and it will not be unique to Livalve. All commercial payers have what's called a new product block at launch. And so those restrictions automatically will take anywhere in the neighborhood of about 6 to 9 months to work through. And 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. And then with Medicare Part D as well, usually access is defined within the 1st 90 days, but 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 1st 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 in these indications. But 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?
Yes, 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. And 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. But really the key learning is that there has to be the right balance of efficacy and tolerability and the Libavie 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 2 thirds of those are bipolar switches as well. So 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. And it's not uncharacteristic. When we talk to physicians 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 they do is they change the dose, which is an advantage for Libavie because we have multiple dosing options. The second thing that they would do is they would switch the product. And so that gives us a chance to compete in a very large switch market.
Got it. Thank you.
And we do have a follow-up question from the line of Jason Gerberry with Bank of America. Please proceed with your question.
Hey, thanks for taking my follow-up. Yes, I was just curious how you guys are thinking about when you might be in a position to potentially offer peak sales guidance for Libolvii. I know the consensus is around $400,000,000 to $500,000,000 in the out years, which seems somewhat light relative to some other recent atypical branded antipsychotic launches. So just curious from your perspective when you might be in a position with payer coverage sort of shored up in a position to guide?
So this is Blair. Thanks for the question, Jason. 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 Libolpi in that there's the efficacy of Olanzapine while mitigating the associated weight gain. And so I think as we progress through the beginning of our launch through the 1st 6 to 9 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.
And we'll be in a better place in a year's time or in 6 months' time to have a sense of the trajectory of the product.
Got it. Thanks.
And our next question comes from the line of Vamil Divan with Mizuho. Please proceed with your question.
Great. Thanks for taking my follow-up as well. So 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 overall around roughly on the same page while waiting for the actual full launch? Thanks.
Yes. 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 as we finalize some negotiations with payers.
So it will be much closer towards launch.
Okay. Thank you.
We have time for one more question.
And our final question comes from 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 sort of peak sales, I'm just curious what sort of metrics you're going to be most closely following sort of in terms of assessing the sort of commercial potential? Is it physician sort of prescribing patterns or sort of interest? Is it reimbursement? Just curious in terms of sort of what those sort of indicators you might be most focused on?
Thank you.
Yes. I'll start and then if anybody else wants to add in. So the 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. So we're going to be watching very closely TRxs at launch and also breadth of utilization. So the physician prescribing patterns are really the key leading indicator for us.
Right. 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 Libolby. Please don't hesitate to reach out to us if you have any additional questions.
Thank you.
And this concludes today's conference. You may now disconnect your lines at this time. Thank you for your participation and have a wonderful day.