Alkermes plc (ALKS) Q2 2024 Earnings Report, Transcript and Summary

Greetings and welcome to the Alkermes' Second Quarter 2024 Financial Results Conference Call. My name is Rob and I'll be your operator for today's call. All participant lines will be placed on mute to prevent background noise. [Operator Instructions] Please note this conference is being recorded. I'll now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, you may now begin.

Thank you. Welcome to the Alkermes Plc conference call to discuss our financial results and business update for the quarter ended June 30, 2024. With me today are Richard Pops, our CEO; Todd Nichols, our Chief Commercial Officer and Blair Jackson, our Chief Operating Officer. During today's call, we will be referencing slides. These slides, along with our press release related financial tables and reconciliations of the GAAP to non-GAAP financial measures that we'll discuss today are available on the Investors section of alkermese.com. We believe the non-GAAP financial results, in conjunction with the GAAP results, are useful in understanding the ongoing economics of our business. Our discussions during this conference call will include forward-looking statements. Actual results could differ materially from these forward-looking statements. Please see slide 2 of the accompanying presentation, 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 or in the accompanying presentation as a result of new information or future results or developments. After our prepared remarks, we will open the call for Q&A. And now I'll turn the call over to Blair for a review of the quarterly financial results.

Thank you, Sandy. Our second quarter results reflect robust profitability and solid execution across our business, delivering double-digit year-over-year growth for our proprietary commercial product portfolio. The year is proceeding as planned and we enter the second half in a strong position with clear priorities to deliver on our 2024 financial expectations, which we are reiterating today. For the second quarter, we generated total revenues of $399.1 million, driven by our proprietary product portfolio, which grew 16% year-over-year. Starting with VIVITROL, net sales in the quarter were $111.9 million, compared to $102.1 million in the same period last year. For the ARISTADA product family, net sales were $86 million compared to $82.4 million for the same period last year. For LYBALVI, net sales were $71.4 million, compared to $47 million for the same period in the prior year, which represented 52% year-over-year growth driven by robust underlying demand. Across our proprietary commercial products, inventory in the channel returned to normal levels on a months on hand basis during the second quarter following the drawdown we experienced in the first quarter of this year. Moving on to our manufacturing and royalty business, in the second quarter of 2024, we recorded manufacturing and royalty revenues of $129.9 million. Revenues from the long-acting INVEGA products were $78.7 million compared to $321.2 million for Q2 last year, which included $245.5 million of back royalties and related interest following the successful resolution of our arbitration with Janssen. As previously disclosed and reflected in our financial expectations for the year, our royalties and net sales of INVEGA SUSTENNA in the U.S. will end in mid-August of this year. We expect the impact on our third quarter results will be approximately $20 million. We will continue to receive royalties on net sales of INVEGA TRINZA and INVEGA HAFYERA in the U.S. and on the long-acting INVEGA products outside the US. Revenues from VUMERITY were $35.2 million, compared to $32.3 million for Q2 last year. Now I'll turn to our operating expenses and our financial results from continuing operations following the separation of our oncology business late last year. Cost of goods sold were $61.5 million, compared to $63.2 million for Q2 last year. R&D expenses were $59.6 million, compared to $68.2 million for Q2 last year. This reflects focused investments in our neuroscience development programs, primarily related to the ALKS 2680 clinical program and support activities for our proprietary commercial products. We expect R&D expense to remain relatively steady at this level through the end of the year. SG&A expenses were 168.1 million compared to $195.8 million for Q2 last year. The decrease was primarily driven by operational efficiencies and a number of non-recurring expenses that were recorded in the second quarter of 2023. Looking ahead, we continue to expect SG&A expenses to decrease in the second-half of 2024, primarily reflecting the timing and mix of commercial promotional activities. We continue to focus on driving profitability and during the second quarter, we delivered GAAP net income from continuing operations of $94.7 million, non-GAAP net income from continuing operations of $123.4 million, and EBITDA from continuing operations of $118.6 million. Turning to our balance sheet, we ended the second quarter in a strong financial position with $962.5 million in cash and total investments. In May, we completed the sale of our Athlone, Ireland manufacturing facility to Novo Nordisk and received a cash payment of approximately $91 million for the facility and related assets. This transaction represents a key element of our multi-year strategy to drive operational efficiency and further align our infrastructure and cost framework with the anticipated needs of the business. Additionally, as part of the $400 million share repurchase program authorized earlier this year, the company repurchased approximately 3.5 million of our outstanding shares during the quarter for an aggregate purchase price of $84.7 million, and we have since continued to be actively repurchasing shares opportunistically in the market. Taking a step back, we are pleased with the progress we have made as we've continued to deliver on our multi-year plan to streamline the business and strengthen our financial operating profile while advancing ALKS 2680 rapidly in the clinic. As we look at the second-half of the year, we're in a strong financial position as we work to execute on our strategic priorities, drive momentum across our business and deliver robust profitability. With that, I'll now hand the call to Todd.

Thank you, Blair and good morning everyone. We generated strong growth for our proprietary product portfolio in the second quarter. This was an important priority for our annual plan and we delivered on that objective. During the quarter, our team drove net sales of our proprietary product portfolio of $269.3 million, reflecting 16% year-over-year growth. With two remaining quarters in the year, we are on track to achieve our previously announced financial expectations of our proprietary net sales in excess of $1 billion in 2024. I'll focus on LYBALVI, followed by quick updates on VIVITROL and ARISTADA. During the second quarter, we generated LYBALVI net sales of $71.4 million. Total prescriptions of LYBALVI grew 12% sequentially and 44% year-over-year to approximately 55,300 during the quarter, reflecting strong underlying demand and continued expansion of prescriber breadth and depth. Optimizing LYBALVI's access profile continues to be an important element of our long-term growth strategy for the brand, and compared to the beginning of the year, approximately 50 million additional lives now have improved access to LYBALVI. These enhancements are the result of our disciplined contracting strategy. During the quarter, we entered into a second major commercial contract as well as a contract that further improved formulary positioning on an important Medicare Part D plan, both of which took effect on July 1. Similar to the commercial contract we announced last quarter, these contracts are not expected to significantly impact our anticipated gross to net adjustments. Looking ahead for the full-year, we continue to expect LYBALVI net sales in the range of $275 million to $295 million. Turning to the ARISTADA product family, net sales in the second quarter were $86 million. While the long-acting antipsychotic market experienced some softness, ARISTADA new to brand prescriptions demonstrated encouraging growth. For the full-year, we continue to expect ARISTADA net sales in the range of $340 million to $360 million as we focus on commercial execution and continue to differentiate ARISTADA in the long-acting antipsychotics space. Moving to VIVITROL, net sales in the second quarter were at $111.9 million, representing 10% year-over-year growth driven by underlying demand. VIVITROL performance continued to be largely driven by the opportunity of alcohol dependence indication, which currently accounts for more than 75% of VIVITROL volume. For the full-year, we continue to expect VIVITROL net sales in the range of $410 million to $430 million. With a solid Q2 now behind us, looking ahead, we expect to see typical summer demand patterns across our proprietary commercial product portfolio. Against that backdrop, our team will maintain its sharp focus on strong execution, highlighting the differentiating features of our medicines and driving uptake of our products. We look forward to sharing our progress with you. With that, I will pass the call to Richard.

That's great. Thank you, Todd. Good morning, everyone. So, we're now mid-way through the year and making excellent progress across the objectives we set for 2024. Those objectives are driving commercial and financial performance, advancing ALKS 2680 in our neuroscience development pipeline, completing the sale of our Athlone manufacturing facility, and using our strengthened balance sheet to return capital to shareholders as opportunities present themselves. Alkermes is now a biopharmaceutical growth company with multiple proprietary commercial products, an efficient operating structure and a development pipeline with significant potential value. This is the result of a multi-year evolution from a legacy business as a partner to larger pharmaceutical companies to an integrated, pure-play neuroscience company with a financial profile driven by the performance of a proprietary commercial portfolio. Our proven ability to bring new neuroscience medicines with significant medical and economic value to market is the foundation for new growth opportunities. This is an important transition and we're well positioned to execute our plan to become a leader among neuroscience companies. ALKS 2680 is becoming an important element of our growth strategy. ALKS 2680 is our novel, investigational, once daily oral orexin-2 receptor agonist for narcolepsy, currently in Phase 2 development. During the quarter, we provided key data updates and met significant operational milestones in our expanding clinical program. As we enter Q3, ALKS 2680 is the only orexin agonist proceeding into Phase 2 in both narcolepsy Type 1 and Type 2, supported by positive early clinical data in both indications. So, let's start with our work in narcolepsy Type 1 or NT1. During the quarter, we initiated our Phase 2 study, Vibrance-1, which is a randomized, placebo-controlled, multinational study evaluating the safety, tolerability and efficacy of three different doses of ALKS 2680. We are initiating sites and beginning to enroll patients in the study. The Vibrance-1 Phase 2 study was informed by data from our phase 1b proof of concept study. Last month at the 2024 SLEEP Meeting in Houston, we presented data from the full NT1 cohort from the phase 1b study. This medical congress gave us the opportunity to share the data set with thought leaders and physicians within the broader clinical community, along with patient advocacy organizations that play a key role in this therapeutic space. Feedback from these stakeholders bolstered our belief that the orexin-2 receptor agonist mechanism represents an opportunity to transform the treatment of narcolepsy. In early April, we also announced positive top line data from the 1b cohorts with narcolepsy Type 2 or NT2 and idiopathic hypersomnia. We plan to present additional data from the phase 1b study at the upcoming SLEEP Europe meeting in September. The data from the 1b in NT2 support advancement into a planned Phase 2 study, which will be called Vibrance-2. Vibrance-2 will leverage much of the work we've been doing launching Vibrance-1, so we're moving quickly and expect to initiate that study and open it for patient enrollment toward the end of the summer. NT2 represents a significant potential opportunity for ALKS 2680 and advancing in the clinic in this patient population is becoming an important differentiating feature for ALKS 2680. A key element across the Phase 2 program is the range of doses that will be evaluated, 4, 6, and 8 milligrams in NT1 and 10, 14, and 18 milligrams in NT2. Exploring this continuous dose range will allow us to comprehensively establish the dose response curve and the safety and tolerability profile of ALKS 2680 in narcolepsy Type 1 and Type 2. This range of doses also presents the potential to accommodate a spectrum of patient profiles and treatment objectives. Beyond narcolepsy, data from across our phase 1 study of ALKS 2680 support our hypothesis that orexin-2 receptor agonist such as ALKS 2680 may have utility in treating a range of neurological disorders where excessive daytime sleepiness is a serious clinical consideration. The positive results in idiopathic hypersomnia or IH in the phase 1b study begin to build supporting evidence for this hypothesis. IH by itself represents a meaningful potential opportunity and we are evaluating our strategic development plan in that underserved disease area. But more broadly, the IH data further suggests that ALKS 2680 can drive meaningful changes in wakefulness in patients with relatively normal orexin levels and provide additional support for the evaluation of broader clinical uses for these agents. The work to explore these broader opportunities and advance our portfolio of preclinical Orexin-2 receptor agonists is well underway. We have been active with our preclinical experimentation and new IP filings are in process. We plan to share more about our development strategy later this year. I'm going to end with a brief update on our capital allocation strategy. The business is in a strong position to generate considerable excess cash flow while investing in the growth of our commercial portfolio and advancing our pipeline as evident in our results year-to-date. Based on the progress we're making in the business measured against the current valuation, we see a substantial opportunity to capture value for shareholders. In Q2, we activated our share repurchase program. We will continue to be active in the market, informed by the ongoing needs of the business and evolving market conditions. Across the business, we generated a strong financial and operational performance in the first-half of the year. Looking ahead, we have clear goals and priorities to advance the business and we'll maintain a sharp focus on execution and efficiency to deliver on those objectives. So, we look forward to sharing our progress with you. And I'll turn it back to Sandy to run the Q&A.

Great thanks. Rob, we'll now open the call for Q&A please.

Thank you Sandy. [Operator Instructions]

Hold on one second. Okay, Rob, go ahead.

Thank you. The first question is from the line of Umer Raffat with Evercore ISI. Please proceed with your questions.

Thanks for taking my question. Maybe a couple today, if I may, not on orexin specifically actually. I was curious as we think about sort of the value of the base business and the trajectory of your underlying EPS of the business, which is now profitable. Richard, how are you thinking about the M&A priorities and the types of things and assets you're considering? Are they more on the pipeline side? Or are they more on something that could add to the EPS or profitability in short order, if not right away? Because I think they'll be very relevant for us to think about in terms of the direction EPS is headed. And then secondly, by my math, it looks like there may be about $4 million worth of inventory build into -- or inventory recovery on liability this quarter. Could you please clarify that as well? Thank you.

Sure. I'll take the first one over, and then I'll let Blair and Todd weigh in on the inventory side. Yes, I think that our M&A priorities are consistent quarter to quarter, and we're actually really interested in both of those domains. EPS augmentation through commercial products that would drop profits to the bottom line, as well as expanding the pipeline. So, if we fast forward in a couple of years to look at this company, what should it look like? It should have a robust, growing top line, strong profitability, and an expanded pipeline. So, we need to build across each of those axes. Blair?

Yes. And then I think with regards to inventory, your math is great. So, we did see it. Remember, a shortness of inventory in Q1. We've recovered in LYBALVI in Q2 and the same goes for all of our other programs as well.

Thank you very much.

Our next question is from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your questions.

Hey. Good morning. Thanks for taking the question, and congrats on a good quarter. I had two questions, one on pipeline, one on commercial. The first is on the pipeline. With regard to Vibrance-1, you said that you've begun enrolling patients, and I guess I'm wondering, with that cadence, can you give us a sense of timing to data with Vibrance-1? And then with regard to the commercial question on LYBALVI, give us a little bit of color on in-market kind of dynamics. And what would you expect with a possible coming approval for KarXT and how that could be impacted? Thanks.

Good morning, Charles. It's Rich. I'll start. Yes, Vibrance-1, I think the primary operational, you know, managerial focus right now is site activation. So, we will be activating sites all through the summer into the fall. It's a fairly large national -- multinational study. So, it's too early now. We're just in the beginning of the enrollment curve. So, it's too early to extrapolate, but we will for sure give you guys better visibility into that as we get it ourselves, as sites get activated. And I'll let Todd and Blair comment on the end-market dynamics in LYBALVI right now.

Yes, absolutely. So, in general, the way we're thinking about LYBALVI and what we saw all in Q2 is we saw strong underlying demand overall that led to about 12% increase in TRx growth, which is really encouraging and what we expected, and that was really driven by new patient starts. New patient starts, which is defined as NBRx grew about 17% quarter-over-quarter. So, really solid growth on new patient starts, which was driven by breadth of prescribing. So, we continue to see breadth of prescribing expand year-over-year. Breadth of prescribing expanded about 23% and our expectation is that will continue that's supported by a lot of our market research. When we talk to HCPs in our target audience, greater than 90% of them tell us that they plan to continue to expand prescribing. So, we think it's a really encouraging trend. In terms of just market dynamics overall, looking at the category, you know, we obviously watch what's happening from a competitive standpoint. We are aware and watching that KarXT will -- is up further PDUFA date later this year. That's a product that will likely be approved in just schizophrenia. You know, that's a situation where the product is now going to move from the promise really to the reality of the situation being in the market. What we know about schizophrenia is we have deep experience there. It's a complex market. We do expect that they will compete aggressively, and we are ready for that. That really doesn't change how we think about the profile for LYBALVI and really what our focus is on driving growth within schizophrenia and also within bipolar.

Excellent, helpful information. Thanks.

Our next question comes from the line of Chris Shibutani with Goldman Sachs. Please proceed with your questions.

Good morning. Thanks very much. With the enrollment timelines, we appreciated that in terms of thinking about how you move Vibrance-1 and Vibrance-2. I believe you would be the only program advancing into NT Type 2. Would we expect, therefore, that there's potential for a quicker pace of enrollment there given that opportunity? And then secondly, you mentioned about some additional assets that you're looking to move in. How are you thinking about the potential to move into IH? I know you've made some comments before about the broader commercial considerations like IRA, but help us with some hints, possibly, on what you think would be your strategy for thinking about a different asset, more of a backup to NT1, NT2, or a different market target? Thank you.

Yes. Good morning, Chris, and thank you for the thoughtful questions. And they are thoughtful questions because I think what you're going to see in our company is an expansion of the prominence of this whole wakefulness circuitry in the brain and its relevance to underlying human disease. The core of the bullseye is narcolepsy, and narcolepsy is comprised of both NT1 and NT2. And what we're so pleased with, with the Vibrance-1 and Vibrance-2 studies, is that we're addressing narcolepsy writ large with a range of doses that are contiguous, and that's important. One of the things we took away from the SLEEP Meeting in Houston where we presented these data, at least I took away, was a tremendous desire from the IH community for new medicines. It's a very underserved population. So, we are actively really reconsidering what we're going to do with 2680 and follow on molecules that we're moving into the clinic in IH. We are going to be playing in IH. I can say that with some degree of certainty, and it's -- stay tuned for that. The program writ large is going to expand, and you'll see more about that in the fall when we open up some of the kimono about what we're doing with our subsequent molecules and some of the disease areas that we're moving into. There's been an enormous amount of preclinical work that's going on over the last year and associated IP filings. So, we're about ready to start talking about that publicly. So, stay tuned. But I think you're going to see the program based on the data we've generated. It's been so encouraging in the early studies to see the program expand.

Thank you.

Our next question is from the line of Paul Matteis with Stifel. Please proceed with your questions.

Hey, this is James on for Paul. Thanks for taking our question. Maybe just one here. So, you know, we've seen some others talk about, you know, others with high kind of Medicaid exposure talk about, Medicaid disenrollment kind of being higher and impacting numbers, and you know, VIVITROL had a great quarter this -- you know, in 2Q. But just wondering if you can speak to any of the -- any dynamics there, if it's impacting you, or you know, how we should think about kind of the rest of the year there? Thanks so much.

Yes, absolutely, James. I'll take that one. You know, that's something that we watch very closely, Medicaid enrollment. We've watched that for years. We look at that not only for VIVITROL, but across our entire portfolio. And what we see is that the mix of business is not really experiencing any type of dramatic changes. We're going to continue to monitor, but at this point right now, we haven't seen any reduction in Medicaid claims across our product portfolio.

Great, thanks.

Our next question is from the line of Joseph Thome with TD Cowen. Please proceed with your questions.

Hi there. Good morning and thank you for taking my questions. Maybe a couple of tips on dosing for the orexin programs with some of the other competitive agents. We've seen that some of the AEs maybe attenuate with time or patients tolerize to the therapies, especially in relation to maybe insomnia or other things. Have you ever considered maybe doing dose titration, maybe to get to the target doses? Do you think that would help with AEs? Maybe why or why not? And then when you think about the ideal number of doses to take forward to pivotal or commercial, is the goal from these Phase 2 is to identify one dose, or would you potentially take forward multiple? And then just one quick question on the commercial side. Can you talk a little bit about the potential impact of those new contracts coming online July 1, maybe? What have you seen so far for LYBALVI and how should we think about maybe what kind of revenues that could unlock going forward? Thanks.

I'll take the first two, and then I'll ask Todd to comment on the third. What's interesting about the data we've generated so far with ALKS 2680 is its tolerability profile is really good, and we've disclosed a lot of detail about that. And in NT1, the doses that we're using are quite low and quite well tolerated, and that can be the same also for NT2. So, the way we're going to run the Phase 2 is in these fixed lanes of doses. And that's where we'll fully elaborate the tolerability profile over time, over a six-week period in a large number of patients. And then you'll have the information to say, is a titration necessary? Or our pretest hypothesis is that it won't be necessary, but the virtue of having a range of contiguous doses that for any individual patient, then they have the ability to modulate the dose, they and their physician, to whatever level of activity or tolerability that is suitable for their particular circumstances. So, we think that's actually one of the major clinical advantages and ultimately the commercial advantages of the product. So therefore, answering your second question, for sure, we're interested in a range of doses for -- in a commercial presentation rather than a single dose because humans are variable and people's expectations and desires for the pharmacotherapy will vary. So, it's a market that's suited for a range of well-tolerated options.

Yes. And I'll take the -- I'll provide a little bit of color just on how we're thinking about market access. You know, as I said in my prepared remarks, since the beginning of the year, we've added approximately $50 million additional lives, which is something that we're really excited about. This has been part of our strategy since the launch of the brand. So, we're very focused right now on just optimizing the access profile, but the core element of this is really net sales. Right? So, we look at net sales and profitability for each unit. I can't get into a lot of detail in the specifics of the contracts for competitive reasons, and we're always having ongoing discussions overall, but it can take several quarters for these types of contracts to actually flow through all the way to the planned sponsors, all the way down at the local level. So, that's something that we're actively managing right now, is just the pull-through and the push-through element of this. When we thought about our full year range, we did anticipate that we could have some movement in some of our contracting strategy. So, if we think about just the guidance range overall, which is volume and gross to net, that really reflects and captures a range of scenarios. So, we've already embedded the thinking and that we would have some positive market access changes into that range. And today, obviously, we reiterated what the guidance range would be for LYBALVI.

Great, thank you.

Our next question is from the line of David Amsellem with Piper Sandler. Please proceed with your questions.

Hey, thanks. So, two questions. First, on LYBALVI, can you talk about how you're thinking about commercial spend as we move into '25? Is the salesforce right sized? Are you at steady state regarding DTC? Just talk about how you're thinking about that, particularly given the promotion sensitivity in the bipolar landscape. So, that's number one. And then secondly, on the Orexins, a high-level question. Richard, you talked about narcolepsy being in the bullseye, and then, of course, there's IH. But I'm wondering if, as you're thinking about additional molecules in the category and that you have in the portfolio, are there -- what other therapeutic adjacencies or even adjacent symptoms are you starting to think about as you broaden the development program in the class? Thanks.

Yes, absolutely. So, I'll start first with just the commercial spend questions. Yes, for LYBALVI, strategically, we're focused on really three elements. And first and foremost, it's driving HCP adoption through depth and breadth. Secondly, it's building and driving patient awareness, which continues to grow through our DTC efforts. And then thirdly, it's optimizing the access profile. So, that's not going to change going into '25. At this point, right now, we think our spend is appropriate with where the brand is, but as we move into '25, the market obviously is dynamic and we could add additional spend into '25 and it's something that we're looking at. But as at this point right now, we think the spend level is appropriate for where the brand is.

And David on the Orexins without giving too much specificity until later this year, I'd say that there are three categories of adjacencies that immediately come to mind within the context of our CNS focus. One is in psychiatry, where the affect or the sleepiness or tiredness during the day is an important feature of certain psychiatric conditions. The second is other neurological conditions where excessive sleepiness is a feature of the process, and then certain, even neurodevelopmental or neurodegenerative diseases, where that's also a major clinical feature. A number of these have relevant preclinical models, and so we've been mapping different compounds and different pharmacology onto those models, and that's what's maturing this year, and you'll hear more about.

Okay, helpful. Thanks.

Our next question is from the line of Marc Goodman with Leerink. Please proceed with your questions.

Yes. Rich, I heard you talk about business development. You mentioned commercial products that are already on the market. Obviously, those are pretty expensive. So, I was just curious, what level of transaction are you talking about here that's certainly a scenario? You know, are we talking about multiple billions? Are we talking about issuance of debt? Or how are you thinking about how big a product to do in the context of that, you know, and the share buyback that you're doing? Just give us a sense of how you're thinking about this.

Yes, Marc, it's -- I often say it's a target poor environment, but the targets that Wall Street has bid up significantly are not going to be targets for us. But with our specialized commercial infrastructure and our focus in addiction and in serious mental illness circumstances present themselves from time to time where you have assets that may not be major commercial products, but would drop a lot to our bottom line and would be a logical fit-in. So, I won't talk specifically about scale. I mean, obviously, we have a billion dollars of cash now. We're generating cash, and you know, we really don't see large merger of equal type transactions on the horizon at the moment and those are rare and rarely successful. But you know, I think that we have a specialized commercial infrastructure that we think is leverageable, and we'd be interested in doing that.

So, the size is, we're not talking about major products. We're talking about just opportunistic type of deals that are small.

Major being in the eye of the beholder. You know, I think that ones that could have a meaningful impact on EPS going forward it's -- sometimes you can do that over a series of deals or you could do it in one fell swoop, but we look at all those things.

And then just on orexin, one question, and that is, you know, there's a lot of players, obviously, and you're one of the leaders right now. How do you see this playing out? I mean, you're talking about a strategy of multiple molecules, you know, probably moving into different indications. Is that how you see this, a very fragmented type of situation because there could be five different systems, I don’t know how we end Orexin’s, and there could be multiple products from each company. I mean, how are you envisioning this?

Well, I think there's an early mover advantage, and you know, not to make the direct analogy, but look what's happening in the GLP1 space, where if you make new medicines that are really value added for patients, there are huge commercial and clinical opportunities that present themselves. The chemistry space here, as you know, is limited. There are a number of aspirants, but there's not that many companies that have data that show that they're going to be meaningful competitors in this space. So you know, I think that we can only rely on what we know in terms of the data that's been generated clinically. And we are in a very strong position, so we're going to move as fast as we can and cover as much of the waterfront as we can. So, I don't think at the end of the day, there's going to be lots and lots of players. I think there's too many optimization variables for the molecules, and I think better molecules will do better than inferior ones, and inferior ones won't find a place in the market as attractive as the ones that are better. So, we're going to exploit our advantage right now and move as quickly as we can. You know, Blair, I don't know if you have any thoughts on that as well.

No, I agree. I think we've already started to see that shake out in some of the early development, as we've seen competitors kind of come and go, and we would anticipate that moving forward.

Our next question is from the line of Joel Beatty with Baird. Please proceed with your questions.

Hi, congrats on my quarter, and thanks for taking the questions. The first one is on LYBALVI. What trends have you been seeing in the split of scripts between bipolar versus schizophrenia? And then on Vibrance-1, I believe this is a six-week randomized controlled trial followed by a seven-week extension phase. What is the design of that extension phase, particularly as it relates to how dose adjustments will be allowed and how that could add to a differentiated profile compared to other agents that may not have that same type of dose ranging available?

Yes, absolutely. I'll start with LYBALVI split, kind of the contribution to business, which has been relatively stable over the last, you know, two quarters. We saw some similar patterns from Q1. So overall, the split still in terms of overall TRx's is approximately 50:50 between schizophrenia and bipolar. The movement that we're starting to see and it's becoming more pronounced as we headed into this year, is just with new patient starts. So, when you look at just overall share of NBRx's quarter-over-quarter, Bipolar 1 disorder prescriptions for new patient starts represent about 57% right now. Obviously, year-over-year and quarter-over-quarter, we saw some really robust volume growth for bipolar and schizophrenia. But new patient starts, we're clearly seeing a leading indicator with bipolar right now. So, it's very encouraging for us. It's part of our long-term strategy, obviously through HCP adoption, also through our DTC campaign.

And your question about the Vibrance-1 extension is insightful and I think it's beginning to reveal what some of the potential advantages of C could be. So, indeed, in the seven-week extension phase, when people are done with the fixed lanes of the six-week randomized, controlled aspect of it, they can -- patients can opt for dose adjustment between the 4 milligram, 6 milligram and 8 milligram doses. So, it'll be really interesting to see how that settles out, particularly if we do see an attenuation of side effects over time and the tolerability profile as favorable as it has the potential to be. It'll be really interesting to see those data. We'll take that type of learning from that and the open label safety study that we'll run independently of that, all that information will go into designing the phase 3 protocol.

Thank you.

Our next question is from the line of Akash Tewari with Jefferies. Please proceed with your questions.

Hey, it's Manoj on for Akash. On your orexin program at SLEEP earlier this year, you had around 60% insomnia at the 8-milligram high dose in NT1. Where do you think this could be like these rates could end up with longer term dosing. What's an acceptable rate? And also, did you see any similar rates of insomnia in your NT2 -- IH data? Thanks.

Yes, I don't have the data immediately at hand, but I think one of the interesting things from competitive data that was shown at SLEEP in Houston was the attenuation of the side effect of insomnia after the first week. So, we think that's probably more of a class-wide phenomenon as patients get accustomed to being on orexin agonist. Our overall rates of insomnia were very acceptable and dose dependent. So, what we hear from clinicians is what I just mentioned, which is that you see an attenuation of it in real life over time, and we'll more fully elaborate all that in our Phase 2 study.

Thanks. Yes.

Our next question is from the line of Jason Gerberry with Bank of America. Please proceed with your questions.

Hey, good morning. Thanks for taking my questions. I guess first one is on ARISTADA and if there's any expectation that gross to nets, if they should be relatively stable next year, you know, when IRA shifts the catastrophic coverage costs onto payer plans, there's sort of an open debate of is there a risk that rebates materially increase in that category? And then my second question on the Orexins in lieu of Takeda's data and roughly mid 20 minutes MWT's placebo adjusted, should the street be focusing on this metric as the key area for differentiation in NT1? Or do you think that, you know, it's really more about a broader risk benefit evaluation and having breadth of indications like NT2 and IH, you know, that's ultimately kind of your area of focus? Thanks.

Yes. Hey, Jason, it's Todd. I'll start with ARISTADA with gross to net. It's -- this quarter and for the full year, it's relatively stable. Next year, there'll be some marginal increases. Obviously, we're very in-tune to the implications of the IRA. The way we're really thinking about that is there's really minimal impact in the near and mid-term across our portfolio. We don't expect that we're going to have significant inflation penalties because obviously we do very responsible pricing actions. None of our medicines are going to be part of the Medicare Part D negotiations. And in terms of the Part D redesign, keep in mind that our company Alkermes that we're classified as a specified small manufacturer. So, that enables us to a phase end in terms of the overall liability. So, it's very manageable for us and mitigates our risk starting in 2025.

And this is Rich. I'll take the question about the Orexin. I think the way to think about the category is the Orexins relative to what precedes them and then the Orexins relative to each other. In the former category, you know, MWT's that have been shown by Takeda and others, they're really good, they're really beneficial for patients. But recognize that MWT, the maintenance of wakefulness value is really just one dimension of the experience of being on a medicine for the treatment of a serious condition. It's an important metric. It's an approvable metric and has the virtue of being, you know, so quantitative. But I think relative to each other, if you stipulate that more than one orexin agonist crosses the finish line, then the question becomes them relative to each other. And this is exactly where a range of doses, tolerability and then also a range of indications. So, the differential diagnosis doesn't have to be quite so precise between NT1 or NT2 or IH. You basically have agents that can be dosed at multiple doses across a range of those indications. I think that's where the competitive dynamic really gets sharpened.

Got it, thank you.

Our next question is from the line of Jessica Fye with JPMorgan. Please proceed with your questions.

Hi, this is Na Sun on for Jessica Fye. Just wanted to ask about ARISTADA. First, was there an inventory benefit for ARISTADA, specifically in the quarter? And second, can you talk about what gives you confidence of hitting the guidance range for that product this year? Thanks.

Hi, Na Sun, this is Blair. With regards to inventory, just like with our other programs in Q1, we had a shortfall of inventory purchases, and so we saw with ARISTADA a rebound into Q2. The net effect of that for across the quarters was $2 million.

Yes. In terms of just the outlook for ARISTADA today, obviously we reiterated our guidance range. Obviously, you know, we're watching dynamics in the market right now, and the way we're thinking about it over the last several quarters. Last year, it's been a -- it has been a dynamic market for the LAI category. What we're most interested in is the performance and outlook for ARISTADA. The last two quarters, Q1 and Q2, we've seen some encouraging trends with new to brand prescriptions. So, we saw that within the category and we've seen that within ARISTADA. Secondly is we've seen encouraging trends within our non-retail sector, for ARISTADA as well, too. So, those give us a lot of confidence that we're right on track to achieve our objectives for the year.

Great. Rob, we have time for one more question.

All right. Next will be coming from the line of Douglas Tsao with H. C. Wainwright.

Hi, good morning. Thanks for taking the questions and sneaking me in. Maybe, Richard, starting with IH, I think you noted the importance of your finding that there -- you know, that you can have an impact on patients with normal orexin levels. I'm just curious, when you think about sort of follow on molecules or different molecules to develop, would they have, obviously there's sort of a strategic value from an IRA perspective and commercial perspective, but I'm just curious, from a pharmacology perspective, just given that difference of normal orexin levels, would there be other tweaks to the molecule that you would make that would make it a better suited molecule for IH versus what some others are doing, we sort of pursuing it sort of more of a one-size-fits-all approach?

Hey, Douglas, I don't think I'm prepared to answer that question publicly at this moment. I think that there's some learnings that we're learning both clinically and preclinically that inform that decision. But I'm not quite ready to go there yet. Other than to say what I said earlier, which is that I think we're pretty convinced that IH is a separate opportunity from narcolepsy. You might be lulled into thinking that NT2 and IH are interchangeable, but I think the more time that we spend with patients and clinicians treating patients with a differential diagnosis, they are different patients. And, you know, a single drug could be useful, but also more than one drug may be useful as well.

Okay, great. And then just as a follow-up, I mean, obviously there have been questions around the impact of KarXT. I'm just curious, from talking to clinicians, do you get a sense that they are targeting sort of the different patients that are the two drugs that sort of go after initially different patient sets, meaning LYBALVI in the early going, just because obviously they're very different drugs and LYBALVI has the sort of proven efficacy of olanzapine? Thank you.

Yes, I mean, just coming back to just KarXT in general, it's yet to be determined. First, you know, we've got to see the product has to get approved and there has to be a label. And obviously the company would have to promote on label right now. And it really -- it doesn't really change how we think about LYBALVI. That's most important to us. LYBALVI has a broad label, which is a huge benefit for the brand. And, you know, as I said earlier, if you just look at the underlying trends, we see a really healthy, strong mix across schizophrenia and bipolar. So, we think the addressable population is very large for LYBALVI.

And in terms of the growth you're seeing for schizophrenia, is that coming from new prescribers or just greater depth within the existing prescriber base? Thank you.

Yes, absolutely. We're seeing depth of prescribing really grow within our existing prescriber base. And it's healthy right now if you look at a quarter-over-quarter and year-over-year, and it's very consistent with the market research. Prescribers tell us once they start on LYBALVI, they get a positive experience, which we're hearing a lot of that, very positive experiences from HCPs and patients that they will prescribe utilization. So, we see a lot of the depth being driven by existing prescribers while driving breadth at the same time.

Okay, great. Thank you so much.

Thanks, Doug.

Thank you. We have reached the end of the question-and-answer session, and I'll now turn the call over to Sandy Coombs for closing remarks.

Great. Thanks everyone, for joining us on the call today. Please don't hesitate to reach out to us at the company if you have any follow-up questions. Have a great day.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.