NASDAQ:ALKS Alkermes Q3 2026 Earnings Results & Report $47.03 +0.05 (+0.11%) Closing price 11/13/2026 04:00 PM EasternExtended Trading$47.02 -0.01 (-0.01%) As of 11/13/2026 07:30 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Alkermes beat analyst expectations on both earnings and revenue in its Q3 2026 results, released November 4, 2026. The company reported EPS of $0.09 versus the -$0.0818 consensus estimate, while revenue of $480.13 million topped the $463.48 million estimate by $16.65 million. Revenue increased 21.8% year over year. Research:ProfileEarnings HistoryForecast Earnings Announcement Details QuarterQ3 2026Report DateNovember 4, 2026TimeBefore Market OpensConference Call DateNovember 3, 2026Conference Call8:00 AM ET Alkermes EPS ResultsActual EPS$0.09Consensus EPS -$0.0818Beat/MissBeat by +$0.1718One Year Ago EPS$0.49EPS Beat Rate4 of last 8 quartersAlkermes Revenue ResultsActual Revenue$480.13 millionExpected Revenue$463.48 millionBeat/MissBeat by +$16.65 millionYoY Revenue Growth+21.80%Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)SEC FilingEarnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Alkermes Q3 2026 Earnings Call TranscriptProvided by QuartrNovember 3, 2026ShareShareShare This ReportLink copied to clipboard.Key Takeaways Positive Sentiment: Proprietary product sales rose 31% year over year to $417.3 million in Q3, supported by the addition of LUMRYZ and continued demand growth across VIVITROL, ARISTADA, and LYBALVI. Positive Sentiment: LUMRYZ reached approximately 4,100 patients on therapy, while LYBALVI prescription volume is expected to grow nearly 20% next year following expanded payer access to roughly 80% of covered lives. Negative Sentiment: LYBALVI’s gross-to-net adjustment was approximately 42% in Q3 and is expected to rise to about 45% in 2027, which may delay the conversion of prescription growth into net-sales growth. Positive Sentiment: Alkermes reported strong pipeline momentum, including ongoing Phase III narcolepsy studies for alixorexton, an expanding ALKS 7290 program in ADHD and major depressive disorder, and planned Phase II testing of ALKS 4510 in fatigue. Neutral Sentiment: The company expects a data-rich 2027, with idiopathic hypersomnia results for alixorexton around year-end 2026 or early 2027, narcolepsy Phase III readouts beginning in mid-2027, and additional ADHD and fatigue data later in 2027; full 2027 financial guidance will be provided in February. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallAlkermes Q3 202600:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Greetings, and welcome to the Alkermes third quarter 2026 financial results conference call. My name is Dylan, and I will be your Operator for today's call. All participant lines will be placed on mute to prevent background noise. If you should require Operator assistance during the call, please press star zero from your telephone keypad. Please note, this conference is being recorded. I will now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, you may now begin. Sandra CoombsSVP of Investor Relations and Corporate Affairs at Alkermes00:00:32Welcome to the Alkermes plc conference call to discuss our financial results and business update for the quarter ended September 30th, 2026. With me today are Blair Jackson, our Chief Executive Officer, Todd Nichols, our Chief Commercial Officer, and Joshua Reed, our Chief Financial Officer. A slide presentation, along with our press release, related financial tables, and reconciliations of the GAAP to non-GAAP financial measures that we will discuss today are available on the Investors section of alkermes.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. Sandra CoombsSVP of Investor Relations and Corporate Affairs at Alkermes00:01:19Please see slide two of the accompanying presentation, our press release issued this morning, and our most recent annual report 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. I will now turn the call over to Blair for some opening remarks. Blair JacksonCEO at Alkermes00:01:51Thank you, Sandy. Good morning, everyone. On my first quarterly call as CEO of Alkermes, I would like to start with a few thoughts on the opportunity ahead and the priorities that will guide us. We have a clear strategy and a strong foundation. Our focus now is on execution. That means advancing our pipeline with rigor and urgency, driving strong commercial and financial performance, and allocating capital thoughtfully to our highest value opportunities. Our commercial business is an important element of our strategy and provides a strong financial foundation to invest in innovation. Our greatest opportunity for growth and value creation lies in our pipeline, particularly our leadership in orexin research and the potential of our orexin development portfolio to yield important new treatment options in neuropsychiatry. I will discuss the significant momentum across our development pipeline in more detail following the discussion of the quarterly results. Blair JacksonCEO at Alkermes00:02:46The combination of commercial strength, financial performance, and a differentiated pipeline positions Alkermes well for its next chapter and the potential for meaningful long-term value creation for shareholders. I am incredibly proud and honored to lead Alkermes at this important point in its evolution, and I am confident in our strategy, our people, and the opportunities ahead. With that, let's turn to the quarter, Todd. Todd NicholsChief Commercial Officer at Alkermes00:03:09Thank you, Blair. Good morning, everyone. I am pleased to report that we delivered strong performance across our commercial portfolio in the third quarter, reflecting contributions across addiction, psychiatry, and sleep medicine. Our teams remain focused on driving demand, broadening patient access, and building on the opportunities across our four proprietary products. In the third quarter, net sales from our proprietary product portfolio increased 31% year-over-year to $417.3 million, reflecting the addition of LUMRYZ and continued demand growth across our established commercial portfolio. Starting with VIVITROL, net sales in the third quarter were $127.6 million. VIVITROL continued to see strong demand driven by penetration in the alcohol dependence market. Net sales also benefited from approximately $8 million in gross-to-net favorability, primarily driven by favorable patient mix. For the full year, we continue to expect VIVITROL net sales in the range of $460 million-$480 million. Todd NicholsChief Commercial Officer at Alkermes00:04:20We remain confident in the strength and durability of our VIVITROL business and look forward to continuing our impact with this important medicine. Turning to our psychiatry franchise, third quarter net sales for ARISTADA product family were $103.9 million. ARISTADA continued to see demand growth driven by expansion in HCP adoption. Net sales also benefited from approximately $7 million of gross-to-net and inventory favorability. We are encouraged by ARISTADA's continued strong performance within this category. For the full year, we continue to expect ARISTADA net sales in the range of $365 million-$385 million. LYBALVI net sales were $95.9 million in the third quarter, with underlying TRX growth of 18% year-over-year, supported by new patient starts and broader prescriber adoption. Net sales also reflected approximately $2 million of inventory benefit. Todd NicholsChief Commercial Officer at Alkermes00:05:22Last quarter, we implemented a strategic expansion of the LYBALVI market access profile that we believe will position LYBALVI for long-term growth. Access now stands at approximately 80% of covered lives, and as a result, we have already seen positive trends on volume demand and prescription fulfillment. As expected, gross-to-net adjustments were approximately 42% during the third quarter. For the full year, we continue to expect LYBALVI net sales in the range of $380 million-$400 million. Looking ahead to next year, we expect gross-to-net adjustments for LYBALVI to be in the 45% range. We expect the benefits of expanded payer access to be reflected first in prescription volume, which we expect will continue to grow nearly 20% year-over-year, with an acceleration in net sales growth expected to follow. Beyond 2027, we expect volume growth and net sales growth to track more closely together again. Todd NicholsChief Commercial Officer at Alkermes00:06:23Turning to our sleep franchise. LUMRYZ net sales were $89.9 million in the third quarter. We reached approximately 4,100 patients on therapy at quarter end, reflecting strong underlying demand, broader prescriber adoption, and increased use among existing prescribers. Net sales also reflected the drawdown of approximately $7 million of inventory build that we highlighted in our second quarter results. Last month, we presented results from the positive phase III REVITALYZ study of LUMRYZ in idiopathic hypersomnia at the Sleep Europe meeting. IH is a fast-growing segment for the oxybate market. The REVITALYZ data will serve as the foundation for the sNDA submission for IH, with a potential launch in March 2028, if approved. IH represents an important potential growth opportunity for LUMRYZ, and we look forward to updating you on our progress. Todd NicholsChief Commercial Officer at Alkermes00:07:20For the full year, we continue to expect total LUMRYZ net sales of $350 million-$370 million, of which Alkermes expects to record $315 million-$335 million, reflecting the mid-February close of the Avadel transaction. Supporting LUMRYZ, we have an established sleep medicine platform that includes an experienced commercial and medical organization with a deep understanding of the market dynamics and HCP and patient journeys. This platform provides a strong foundation to support the potential launch of alixorexton and our broader ambition to become leaders in sleep medicine across multiple treatment modalities. Across our proprietary portfolio, we expect net sales to be in the range of $400 million-$420 million in the fourth quarter. We are pleased with what we have accomplished so far this year and remain focused on delivering against our 2026 objectives. Todd NicholsChief Commercial Officer at Alkermes00:08:15As we enter the final quarter, our priorities remain clear: drive demand for our medicines, expand patient access, and position our brands for continued growth. With that, I will pass the call to Joshua to review the financial results for the quarter. Joshua ReedCFO at Alkermes00:08:31Thank you, Todd. We delivered solid financial results in the third quarter, supported by the strength of our commercial portfolio and disciplined management of the business. Through the first nine months of the year, our financial position has provided the flexibility to advance our strategic priorities and invest in key opportunities that we believe will support our future growth. During the quarter, we generated total revenues of $480.1 million. As Todd outlined, our portfolio of proprietary products generated net sales of $417.3 million. These results reflect contributions from all four of our proprietary products and positive underlying demand trends across the commercial business. Manufacturing and royalty revenues were $62.9 million for the quarter, including $29.5 million from VUMERITY and $26.4 million from the long-acting INVEGA products. Joshua ReedCFO at Alkermes00:09:34Turning to expenses, cost of goods sold in the third quarter was $94.2 million, which includes the purchase price fair value accounting of LUMRYZ inventory that we described last quarter. This compared to $51.6 million in Q3 of the prior year. R&D expenses in the quarter were $121.1 million compared to $81.7 million in Q3 of the prior year, reflecting continued investment in our orexin development portfolio. Of note, our development activities during the quarter included the alixorexton phase III studies initiated earlier this year and clinical development activities to advance ALKS 7290 in ADHD and MDD, as well as ALKS 4510 in fatigue associated with Parkinson's disease or multiple sclerosis. Joshua ReedCFO at Alkermes00:10:30SG&A expenses were $208.5 million for the quarter compared to $171.8 million in Q3 of the prior year, with the addition of the Avadel commercial infrastructure as the primary driver of the year-over-year change. During the quarter, we also recorded amortization of acquired intangible assets of $19.7 million and net interest expense of $21.1 million. In Q3, we recorded GAAP net income of $16.3 million and EBITDA of $63 million. Adjusted EBITDA was $120.1 million, which we believe provides a useful measure of the underlying cash-generating performance of the business during the quarter. From a balance sheet perspective, we entered the third quarter in a strong position with approximately $787.6 million in cash and total investments. For the year, we are reiterating our 2026 financial expectations provided in July across all line items. Joshua ReedCFO at Alkermes00:11:43Our performance through the first nine months of the year positions us well to deliver against these expectations. Our 2026 financial performance and operating expenses reflect a number of Avadel transaction-related costs. As we look ahead to our 2027 operating expense profile, there are a few important dynamics to keep in mind, beginning with cost of goods sold. With the vast majority of the non-cash LUMRYZ inventory fair value step-up associated with the Avadel acquisition being recognized in 2026, we expect cost of goods sold to be lower in 2027, reflective of more normalized patterns. For SG&A, excluding the transaction-related costs recorded in early 2026, we expect a broadly similar expense profile for 2027. For R&D, our 2027 investment will reflect the growing number of programs across the portfolio and the broader level of clinical activity planned. Joshua ReedCFO at Alkermes00:12:48Importantly, we expect to deliver strong cash generation and adjusted EBITDA performance in 2027 while continuing to invest in the significant opportunities across our pipeline. We believe this balance demonstrates our ability to fund future growth drivers while maintaining financial discipline. We will provide our full 2027 expectations on our February call. With that, I will now hand the call to Blair. Blair JacksonCEO at Alkermes00:13:15As you've heard from Todd and Joshua, our commercial business continues to perform well, with the proprietary product portfolio expected to deliver net sales of nearly $1.6 billion in 2026. That foundation allows us to advance an increasingly broad pipeline, led by our portfolio of orexin 2 receptor agonists. We are in the early stages of understanding the full therapeutic potential of orexin biology. Over the past several years, we've been generating a substantial body of clinical evidence across central disorders of hypersomnolence, and we are now generating our first clinical datasets from our orexin portfolio in broader areas of neuroscience. Starting with alixorexton, our most advanced orexin candidate, we reached several important milestones across the development program during the quarter. Our phase III Brilliance studies in narcolepsy type 1 and narcolepsy type 2 are underway, and we are pleased with enrollment progress across the program. Blair JacksonCEO at Alkermes00:14:14We continue to expect top-line results from these studies beginning in mid-2027. In idiopathic hypersomnia, we completed enrollment in the Vibrance-3 phase II study, which enrolled approximately 130 participants and will represent the first multi-week clinical dataset of an oral orexin 2 receptor agonist in IH. The study is evaluating wakefulness and IH symptom severity with the Epworth Sleepiness Scale and Idiopathic Hypersomnia Severity Scale as primary and secondary endpoints, respectively. Beyond evaluating the safety, tolerability, and efficacy of alixorexton in patients with IH, we expect the study to provide important insights to inform a potential registration program, including dose selection, dosing regimen, and endpoint strategy. The study also includes our first evaluation of split dosing in a hypersomnolence disorder, which we believe could provide additional flexibility to address the diverse needs of patients. Blair JacksonCEO at Alkermes00:15:14We expect top-line results around year-end or in early 2027 and look forward to sharing those data. Hypersomnolence disorders represent a significant market opportunity, and this month, the first orexin 2 receptor agonist is expected to become commercially available for the subset of patients with narcolepsy type 1. As this new therapeutic category enters the commercial landscape, we believe that if approved, alixorexton's wide therapeutic range, dosing optionality, and broad anticipated utility across narcolepsy types 1 and 2, and potentially IH, will support a differentiated profile with the potential to provide an important new treatment option to providers and patients. While the commercial opportunity begins to take shape in hypersomnolence disorders, we are advancing our strategy to develop orexin 2 receptor agonists for a range of neuropsychiatric and neurodegenerative disorders. Last month, we reported the first clinical results for ALKS 7290 in adults with ADHD. Blair JacksonCEO at Alkermes00:16:17This was a 50-subject phase I-B proof-of-concept study designed primarily to evaluate safety and tolerability and to generate initial data characterizing the effects of ALKS 7290 across a range of established clinical scales for ADHD, CNS biomarkers, and objective cognitive performance tests. In the study, ALKS 7290 was generally well tolerated, with no serious treatment-emergent adverse events and no treatment discontinuations among participants who received ALKS 7290. Most treatment-emergent adverse events were mild and largely consistent with on-target effects for orexin 2 receptor agonists. Across the two doses evaluated, ALKS 7290 demonstrated dose-dependent, clinically meaningful improvements from baseline on exploratory endpoints evaluating established measures of ADHD symptoms and disease severity. We were pleased to observe improvements across both the inattentive and the hyperactivity-impulsivity subscales of the Adult ADHD Investigator Symptom Rating Scale, or AISRS, with effects emerging as early as the first assessment on day six. Blair JacksonCEO at Alkermes00:17:29ALKS 7290 also demonstrated clinically meaningful improvements from baseline in overall ADHD disease severity, as measured on the CGI-S scale. In addition, we observed treatment effects across objective measures related to processing speed, information processing, working memory, and attention. These findings provide the first clinical evidence of the effects of an orexin 2 receptor agonist in the treatment of adults with ADHD and further support the dose range selected for the ongoing phase II study. That phase II study is already enrolling adults with ADHD and is designed to evaluate once-daily and split-dose regimens of ALKS 7290, with change from baseline in AISRS total score compared with placebo at week four as the primary endpoint. We expect the ADHD phase II data in the second half of 2027. Blair JacksonCEO at Alkermes00:18:24Building our momentum in diseases outside of hypersomnolence, last week we announced the expansion of the ALKS 7290 development program into major depressive disorder, or MDD, with the initiation of a 150-patient phase II study evaluating ALKS 7290 as an adjunct to antidepressant treatment in adults with MDD who have had a partial response to standard antidepressant therapy. This randomized double-blind placebo-controlled study is designed to evaluate the safety and tolerability of ALKS 7290 over six weeks, while also assessing its effects on depressive symptoms as measured by change from baseline on the MADRS or CGI-S compared to placebo at week six. The study will enroll adults with and without excessive daytime sleepiness, which will allow us to evaluate the potential effects of ALKS 7290 in the overall MDD population, as well as in this important subgroup. Blair JacksonCEO at Alkermes00:19:24Turning to orexin biology and neurodegenerative disorders, we plan to initiate a randomized double-blind placebo-controlled phase II study evaluating ALKS 4510 in people with fatigue associated with multiple sclerosis or Parkinson's disease. Fatigue is one of the most common and consequential symptoms across a broad range of neurological and systemic diseases, yet effective treatment options remain limited. Fatigue associated with multiple sclerosis or Parkinson's disease are compelling initial areas for development with clearly defined patient populations, significant unmet need, and established clinical scales focused on fatigue. We believe these disease areas offer a tractable development pathway for establishing clinical proof of concept for orexin 2 receptor agonism in fatigue, while also representing meaningful commercial opportunities in these patient populations. Blair JacksonCEO at Alkermes00:20:20Importantly, this study is intended not only to evaluate the potential of ALKS 4510 in these specific disorders, but also to deepen our understanding of the role of orexin biology in fatigue more broadly. We believe these insights generated could help establish a foundation for evaluating additional disease areas where fatigue remains a significant source of patient burden and unmet need. Alixorexton in hypersomnolence disorders, ALKS 7290 in broader neuropsychiatric disorders, and ALKS 4510 in fatigue are components of a broader orexin portfolio development strategy that allows us to evaluate these distinct molecules across a range of patient populations and disease settings. As we advance and expand these development programs, we're also continuing to advance additional orexin compounds through preclinical development. We're just beginning to explore the potential clinical utility of orexin compounds, and Alkermes is at the leading edge of research for this emerging therapeutic class. Blair JacksonCEO at Alkermes00:21:22Our focus will remain in neuroscience applications, but with the potential to reach across a broad range of disorders. We believe the opportunity for this class is vast and will be the focus of significant research and development for years to come. Looking ahead, the next year will be a pivotal and data-rich period for Alkermes, with six important studies expected to read out across our orexin portfolio. We start with anticipated data from the Vibrance-3 phase II study of alixorexton in idiopathic hypersomnia in the coming months, followed by top-line results from all three Brilliance phase III studies in narcolepsy beginning in mid-2027. For ALKS 7290, we expect phase II data in ADHD next fall, and for ALKS 4510, phase II proof-of-concept data in fatigue toward the end of the year. Blair JacksonCEO at Alkermes00:22:14Taken together, these studies have the potential to significantly expand our understanding of where orexin-based therapies can make a meaningful difference for patients. Our focus remains on executing with urgency and discipline, generating the clinical evidence needed to unlock the potential of this novel class, and building what we believe can become a leading franchise, addressing some of the most significant unmet needs across sleep, neuropsychiatric, and neurological disorders. We plan to pursue these opportunities while continuing to deliver strong commercial performance and investing thoughtfully to support long-term growth and value creation. With that, I'll turn the call back to Sandy for the Q&A. Sandra CoombsSVP of Investor Relations and Corporate Affairs at Alkermes00:22:55Thanks, Blair. We'll now open the call for Q&A. Operator00:23:01Thank you. We will now be conducting a question-and-answer session. We ask that you limit yourselves to one question and one follow-up. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 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, while we poll for questions. Our first question comes from Leonid Timashev with RBC Capital Markets. Please go ahead. Leonid TimashevAnalyst at RBC Capital Markets00:23:41Hey, guys. Thanks for taking my question. Just wanted to ask one on IH and how you are thinking about what to expect there. Maybe can you talk us through when you see that data, how you will think about moving forward with the split dose, maybe with the once-daily doses, and maybe how you are thinking about what you could see on the relative magnitudes between those? Thanks. Blair JacksonCEO at Alkermes00:24:04Sure. Thanks for the question, Leo. It is Blair. I think when we look at the IH dataset that is coming out, there is a wealth of information that we are going to be getting from that trial. As you alluded to, first and foremost, we are going to be getting the once-daily dosing for that program. As we have spoken before, we see the IH population as somewhat similar to the NT2 population in that it is highly variable. These patients have a range of disease and different responses to orexin agonism. So we would expect something similar to that NT2 dataset. The main difference, though, being that with IH population, they do have one separate population, which is the long sleepers. Those long sleepers, we have less experience with. We expect that we will have a similar response within them, but this dataset will tell us more on that piece. Blair JacksonCEO at Alkermes00:24:56With regards to the split dosing, the split dosing, as you know, is an important component of our overall program in that it provides both flexibility for patients across NT1, NT2, and IH, but also could provide some additional efficacy for those patients who need it in the later afternoon. This will be the first opportunity we will be able to see that split dataset as part of a patient program. All this data will be coming out towards the end of the year, and we are pretty excited to see it. Sandra CoombsSVP of Investor Relations and Corporate Affairs at Alkermes00:25:38Okay, thanks. We will take the next question. Operator00:25:39Our next question. My apologies. Our next question comes from Paul Matteis with Stifel. Please go ahead. Analyst at Stifel00:25:48Hi, this is Emily on for Paul. We were just wondering, where do you think Takeda may price, and if there was a chance that they price on the lower end, do you think that you have the possibility to kind of adjust there with the different doses you plan to have available across sleep disorders? Thank you. Blair JacksonCEO at Alkermes00:26:13Thanks for the question. This is Blair. I think that Takeda's going to be pricing imminently, and we'll see that in the next few weeks. That'll set the range for the overall market. As you alluded to in your question, though, we have a lot of flexibility on our pricing moving forward, so we'll see where they price, and we'll adjust accordingly. Operator00:26:37Our next question comes from Graig Suvannavejh with Mizuho Securities. Please go ahead. Graig SuvannavejhAnalyst at Mizuho Securities00:26:45Good morning. Thanks for taking my question, and congrats on the progress in the quarter. Just on the pipeline and obviously on the orexin franchise, I was intrigued by the movement into major depressive disorder and psychiatry. Could you give us perhaps a little bit more of the rationale there, and can you give us maybe a sense of if there are other psychiatric indications beyond MDD that you think an orexin might make sense? Thanks so much. Blair JacksonCEO at Alkermes00:27:13Thanks for the question, Graig. We've looked extensively at other areas outside of hypersomnolence where you could apply orexin agonism, and we did some comprehensive preclinical work, really looking at the basic biology behind orexin agonism and identified a number of different domains where you could apply this, some of them being cognition, fatigue, mood, wakefulness, all these different areas. As part of that, we did some translational work in many of these areas. Within mood, some of the things we noticed is that we saw a really strong synergistic increase in serotonin in the prefrontal cortex when orexin agonism was given with SSRIs or SNRIs, and so synergistically. I think that's really telling that there's a benefit you could have here by having adjunctive therapy with orexin agonism. Blair JacksonCEO at Alkermes00:28:09We also did use a highly translational model as part of that early research, which is the chronic social defeat test, which is really a way of establishing rodents who have really a depressive phenotype, and then providing them with therapy and seeing how they respond to treatment. What we found is we found similar effects to what you'd see if those animals were dosed with ketamine or with fluoxetine. So we felt pretty strongly that there's a potential signal here, and so the desire to move into a patient population is something we've had for some time. Part of this study that we're looking at is exploratory in that we'll be looking at not only the full MDD population, but we'll also be looking at a subgroup of the population who also has some excessive daytime sleepiness. Blair JacksonCEO at Alkermes00:29:03That gives us an opportunity to really learn a lot as part of this program and really design our program going forward. To the first part of your question regarding other things, yes, we have a number of other areas that we're looking at within neuroscience, both neurodegenerative and neuropsychiatry, and we'll talk about those as we get closer to additional activity. Graig SuvannavejhAnalyst at Mizuho Securities00:29:30Thank you. Operator00:29:34Our next question comes from Akash Tewari with Jefferies. Please go ahead. Analyst at Jefferies00:29:40Hey, thanks so much. This is Albert on for Akash. Given that your ADHD program will likely need to demonstrate efficacy comparable to existing stimulants to be competitive, can you discuss the rationale for not modifying the trial design to target a specific patient type, and what gives you confidence that the current trial design can demonstrate a clinical meaningful treatment benefit? Blair JacksonCEO at Alkermes00:30:05Hi, Albert. Thanks for the question. First, I would like to correct a little bit of what you said there. I think there's a wide range of efficacy outcomes that are commercially attractive for a new entrant in the ADHD space, especially an entrant like an orexin agonist, which could bring broader response profiles over and above what you see with existing therapies that are there. I think for us, the goal moving forward is to establish that efficacy level, flush out some of those broader domains that we started to see in the phase I-B study, and show and demonstrate that this is a safe profile within this patient area. I think the early data that we saw in our phase I-B program support all of those goals. Blair JacksonCEO at Alkermes00:30:55One of the key things that we looked at through that phase I-B study was our dosage range, making sure we were at the right region of targeting those receptors and engaging that circuitry. What we found was exactly that yes, we are right in the range. We do not need to lower or raise our dose. We can use the doses that we have. We also found that we were seeing a really robust response early within treatment. I think there is no requirement for us to modify the study in any way, nor would it benefit from us, based on what we have seen, to look at individual subtypes. Operator00:31:39Our next question comes from Rudy Li with Wolfe Research. Please go ahead. Rudy LiAnalyst at Wolfe Research00:31:45Hey, thanks for taking my question. Just a quick follow-up question on 7290's MDD study. J&J showed good efficacy data in MDD for its orexin antagonist, but in patients with insomnia. Can you maybe talk about the rationale for orexin agonists for MDD? What will be the key difference in the study population, the trial design versus J&J, and what will be the key differentiator versus current standard of care? Thanks. Blair JacksonCEO at Alkermes00:32:15Thanks, Rudy. It is a good question, and I think it is important to recognize that using orexin agonism is a fundamentally different approach than using orexin antagonism. Orexin antagonism, what J&J was trying to do there was sort of address the sleep disorder and hoping it would have a knock-on effect on potential mood. This is very different, what we are doing. We believe that we directly impact centers of mood within the brain, and we are actually looking at treating the depressive symptoms directly. Because we are using a subgroup who has excessive daytime sleepiness, because we think we might be able to drive additional signal through that group, but this is a fundamentally different view than what J&J did with their orexin antagonist. Operator00:33:05Our next question comes from David Amsellem with Piper Sandler. Please go ahead. David AmsellemAnalyst at Piper Sandler00:33:12Thanks. Got a couple of LUMRYZ questions. Regarding the launch of Takeda's oveporexton, do you perceive any potential impact to LUMRYZ in terms of new starts next year in NT1? That is number one. Then looking longer term with the IH launch for LUMRYZ in 2028, how are you envisioning uptake? Do you think there is going to be a sizable switch market from XYWAV to LUMRYZ? Do you think you will be able to expand the overall oxybate footprint in IH, or is it a little bit of both? Thanks. Todd NicholsChief Commercial Officer at Alkermes00:33:56Yeah. Good morning, David. This is Todd. I appreciate the questions on LUMRYZ. Yeah, we are really excited and pleased with the performance of LUMRYZ this year, and specifically in Q2. Strong net sales, really strong patient demand, up to 4,100 patients. We are watching very closely and thinking very deeply about the impact of orexins. As you know, we are big believers in the mechanisms. We actually believe they are complementary, and we hear that pretty consistently from HCPs around the belief and the desire to use both mechanisms. So we think there is a long-term durability in the oxybate market and a lot of excitement with orexins. Initially, we are going to have to see how this plays out with Takeda's product entering the market. We think initially that will be a switch population for earlier lines of therapy, patients looking to switch. Todd NicholsChief Commercial Officer at Alkermes00:34:57But we hear pretty consistently from HCPs that patients that are on oxybate, specifically LUMRYZ, and that are stable, like to stay on the product overall. So we do believe that there will be an impact on oxybates, but we think it will be somewhat marginal at the beginning, and we think the category overall will be durable. In terms of IH, yeah, this is something we are really excited about. We did present the data recently at Sleep Europe. There is a lot of anticipation on the IH launch. If it is approved, we will be commercializing no sooner than March 1st of 2028. And there is a lot of anticipation there. This will be the second product potentially approved in the market. We think it is under-penetrated at this point right now. Todd NicholsChief Commercial Officer at Alkermes00:35:43We think that LUMRYZ actually will compete for new starts in IH, but also there will be a switch market, and that LUMRYZ will compete in that switch market. Operator00:35:57Our next question comes from Jessica Fye with JPMorgan. Please go ahead. Analyst at JPMorgan00:36:03Hi, this is [inaudible] from Jess. Thanks for taking our question. Any feedback from physicians regarding the ADHD dataset? Wonder if you could tell us how the placebo group did in the recent study, or when we could see more detailed data, including placebo response rates. Thank you. Blair JacksonCEO at Alkermes00:36:18Yeah, so we've had a lot of discussions with physicians with regards to the ADHD data, and I think there's a lot of excitement about the fact that we're able to move a number of these different tools using orexin agonism. I think in particular, folks were interested in the fact that you were seeing consistent response across these measures. So, not only the internal consistency between patient-reported outcomes, but also physician-reported outcomes, as well as objective measures. Just as a reminder, the study itself was a safety study that was designed to look at the wide therapeutic potential that we could have and the therapeutic window we would have with an orexin agonist, and I think that read out really, really well. As such, it's not really appropriate to have a placebo comparison. Blair JacksonCEO at Alkermes00:37:10What we rely on for that is the objective measures and the subjective measures that we included in that study that we shared in our press release. Analyst at JPMorgan00:37:19Thank you. Operator00:37:23Our next question comes from David Hoang with Deutsche Bank. Please go ahead. David HoangAnalyst at Deutsche Bank00:37:29Hi there. Thanks for taking my question. I wanted to ask, once you are post-Vibrance-3 data in IH, either year-end or early 2027, once that data is in hand, how quickly would you look to move into a phase III program for IH, and what would that study design potentially look like? Thank you. Blair JacksonCEO at Alkermes00:37:53Hi, David. Thanks for the question. I think we're going to want to move as quick as we can. Our goal is to get into the phase III following that dataset. What we would like to do, though, is meet with the agency first, and so that actually will probably be our rate-limiting step, is making sure we get that meeting, and we'll obviously hope that they'll be very responsive, because this is an important patient population. As for the size, our expectation is it's probably going to be a similar size to the NT2 study, but that'll obviously depend on the signal that we see in the phase II program, and so that'll help set that. But ballpark-wise, think of the phase II as for planning purposes. Sorry, think of NT2 for planning purposes. Operator00:38:40Our next question comes from Marc Goodman with Leerink Partners. Please go ahead. Marc GoodmanAnalyst at Leerink Partners00:38:45Yeah, just back on oxybate. Could you just give us a little sense behind the scenes what you thought happened in the quarter as far as, was it a normal quarter of just new patient starts, discontinuations, the pricing, just how the market dynamics have just shaken up since you've owned the asset? Is it generally kind of consistent with what you thought? Any major changes in the quarter? Todd NicholsChief Commercial Officer at Alkermes00:39:07Yeah, absolutely, Marc. This is Todd. I'll take that. Yeah, again, we were pleased with the quarter. We were assuming some seasonality, which you typically would during Q3, and I think we saw a little bit of seasonal dynamics. But overall, the growth in LUMRYZ was really driven by patient demand. We saw nice increases in overall patients for narcolepsy, 4,100 patients. That was driven by some of the sub-metrics that we watch very closely, which are new enrollments, conversions, and actually patient persistency. So all three of those dynamics, we believe, really contributed to the nice patient growth, and then also contributed to the net sales growth, which was 16% year-over-year. Marc GoodmanAnalyst at Leerink Partners00:39:55And pricing? Todd NicholsChief Commercial Officer at Alkermes00:39:58Yeah. We didn't see any significant pressures on pricing overall. The pricing was within our range of expectations. As we've said before, historically, LUMRYZ has a really strong market access profile. We didn't see any changing dynamics there as well, and we're not anticipating any strong changing dynamics as we head into the last part of the year. Marc GoodmanAnalyst at Leerink Partners00:40:24Thanks. Operator00:40:28Our next question comes from Joseph Thome with TD Cowen. Please go ahead. Analyst at TD Cowen00:40:34Hi, this is Jacob on the line for Joe. Thanks for taking my question. On the MDD study for ALKS 7290, I was actually just curious if we might expect any kind of pre-specified subgroup analysis by excessive daytime sleepiness or stratification by excessive daytime sleepiness, and whether we might expect powering to be sufficient to determine any differences between those patient populations, or whether we could have an endpoint like ESS, where we could see if the effects on mood were being mediated by sleepiness. Thanks. Blair JacksonCEO at Alkermes00:41:14Hi, Jacob. Thanks for the question. Yes, as I said in the prepared remarks, actually, we do have a pre-specified subgroup, which is a group that has excessive daytime sleepiness. Our goal here is to look at the two populations, both the all-comers MDD versus the group that has the excessive daytime sleepiness. One of the goals there is to see, do we see an enriched signal within that group? You may expect to see that, because as you look at the MADRS scale, for example, there's some questions there that specify or are highly related to sleep or the anhedonia associated or lack of urgency and things like that that people get. We want to see that, and we want to test that in this study, and then that'll allow us to then determine our development path moving forward. Operator00:42:09Our next question comes from Alex Nackenoff with Truist Securities. Please go ahead. Alex NackenoffAnalyst at Truist Securities00:42:16Hey, guys. Thanks for taking the question. Another one on ADHD. For the phase I-B portion, could you explain your rationale why you utilized an inpatient setting and possibly how that may have impacted, if at all, baseline characteristics, and if those baseline factors or the inpatient setting may have led to an outsized or suppressed treatment response? Just curious if you think you had a representative ADHD population where you believe the results will translate in future clinical studies. Thanks so much. Blair JacksonCEO at Alkermes00:42:45Yep. Thanks, Alex, for the question. As we looked at the ADHD program, we had two programs that are studies that we were running at the same time. We have, first and foremost, our large phase II outpatient study that we're running that is placebo-controlled, multiple doses, et cetera. What we wanted to do in the phase I-B study was to ensure that we had some information that we would inform on, one, what are some of the types of signals that we would see, and two, whether we were in the right dosage range overall. In order to do that, what we needed to do is learn a lot about how patients respond to orexin agonism, because remember, this is actually the first asset of this mechanism that's ever been tested outside of hypersomnia indications. Blair JacksonCEO at Alkermes00:43:35We needed to learn what we were doing, that meant we had to put a lot of different tools within the phase I program. In order to do that, if you tried to do that in an outpatient-type setting, that would be exhaustive for the patients. It would be very hard for you to operationalize that. So that's why we chose an inpatient setting. What it allows us to do is put those patients in a clinic, look at those different outcomes in a more staggered pace that's appropriate for the patients. We don't think that has any change on the overall baseline characteristics. I think overall, when we looked at the incoming baseline characteristics, that's consistent with what we see with other ADHD studies. Blair JacksonCEO at Alkermes00:44:15I think where inpatient settings tend to have an impact on some things is on your safety outcomes, because sometimes what you tend to see in inpatient settings is those patients talking about their side effects, that can sometimes amplify side effects here and there. Again, we saw a very good AE profile from this program, so I think all in all, we got exactly what we wanted from this study, and I think it validates the approach. As we've always said, the phase II study that's ongoing is going to be the one that's going to determine what's the characteristics or what's the signal size related to this drug treatment in this population. Alex NackenoffAnalyst at Truist Securities00:44:58Great. Thanks so much. Operator00:45:02Our next question comes from Umer Raffat with Evercore ISI. Please go ahead. Umer RaffatAnalyst at Evercore ISI00:45:08Morning, guys. Thanks for taking my question. I wanted to touch up on 7290 as well, and a couple of points. First, I saw you guys used split dosing when conducting the inpatient ADHD trial. Do you think split dosing could be driving placebo response, and are you intending to continue using split dosing only in your ongoing outpatient ADHD as well as the MDD trial? Secondly, the fact that you used up to 50 mg dose of 7290, what does that tell us about the potency relative to your narcolepsy program? Thank you very much. Blair JacksonCEO at Alkermes00:45:46Hi, Umer. It's nice to hear from you. I think on the first question on the split dosing, as we went into the ADHD study, one of the things we wanted to do as we're trying to learn on the signals is we didn't want to confound some of the PK differences of single-day dosing versus split dosing. We wanted to take that out of the equation. So we used split dosing just because it just allowed us to standardize. I think as you look at our ongoing phase II study, we're actually using both once daily and split dosing. Blair JacksonCEO at Alkermes00:46:21I think that's important because, as you know, in the ADHD population, it is a bit of a lifestyle drug in some respects in that patients have different needs according to whether they're working, whether they're students, what's happening in the evening, what happens in the morning, et cetera. I would envision that we'll probably introduce other dosing types, maybe PRN and other things in the future after original registration. But we're going to do both moving forward, single-day dosing as well as split dosing through the development program. With regards to the upper dose of 7290, it's actually, you can't really use that to relate to narcolepsy. This is fundamentally a different drug. It has a different potency, it has different pharmacological characteristics. Blair JacksonCEO at Alkermes00:47:08Also keep in mind that the pharmacologic dose level that you need to activate the ADHD circuit may be different than what you need to activate, say, a wakefulness circuit. There's a lot of dynamics that are going on there that don't really allow you to make that comparison. Operator00:47:30Our next question comes from Ash Verma with UBS. Please go ahead. Analyst at UBS00:47:35Hi. This is Lianan for Ash. Thank you for taking our question. For the IH study, is it fair to assume that the baseline ESS scores are similar to what you had in the NT2 study? Also, is it fair to assume that the placebo arm in this IH study could closely resemble how the placebo did in the NT2 study? Blair JacksonCEO at Alkermes00:47:59Yeah. I mean, look, we've established very similar entrance criteria as in IH versus NT2. Now, who ends up enrolling in the study depends on the study and which patients show up. So we'll know that as we look at the data moving forward. I think as we look at this area overall, I think we feel pretty good that we're controlling placebo. Obviously, with wakefulness, one of the things to keep in mind is you don't tend to see such a big placebo response like you see in neuropsychiatric indications. So you tend to actually It really depends more on the treatment arm than it depends on the placebo arm. But again, we do what we can to control that, and we've done that in this program by really trying to standardize how we do the tests, really making sure we have high quality control on our clinical sites. Analyst at UBS00:48:54Got it. Thank you. If I may have a follow-up, I think you alluded to the long-form IH patients earlier. Can you talk about roughly what percentage of your IH patients would be the long-form IH? Blair JacksonCEO at Alkermes00:49:08In our study, we haven't disclosed what that is. I think as we look at the general population, though, within IH, typically you see something in the order of around 25% of patients can be deemed long sleepers. Analyst at UBS00:49:22I see. Thank you so much. Blair JacksonCEO at Alkermes00:49:24You're welcome. Operator00:49:27Our next question comes from Ami Fadia with Needham & Company. Please go ahead. Ami FadiaAnalyst at Needham & Company00:49:33Hi, good morning. Thanks for taking my question. With regards to the upcoming IH study readout, I am trying to understand how you are thinking about the outcome of a result, especially in the split dosing arm. As we think about the trade-off between efficacy of having split dose and maybe potentially implications on safety, are there any guardrails in terms of those trade-offs beyond which you may decide not to pursue a split dosing? Secondly, is there some process within the study of determining which patients may be best suited for a split dosing versus not, that could inform your next clinical trial? Thanks. Blair JacksonCEO at Alkermes00:50:25Hey, Ami. Thanks for the questions. I think with the split dosing, we have a wide therapeutic range with this drug. We remember when we went into our programs before, we studied in the NT2 trial up to 18 mg. We have an ability to go higher if we want to. Split dosing, we do not see a safety question as to what is going to determine whether we move to split dosing. Now, obviously, the data will tell us that. When we look at the NT2 data, if we see something unexpected, we will adapt accordingly. A priori, we do not anticipate that being a gating factor. What we are really looking for with the split dosing is really a comparison to the once-daily dosing. In the subset of patients who require additional efficacy in the afternoon, do we see a difference? Blair JacksonCEO at Alkermes00:51:17If we do see that difference, that is going to add additional flexibility for physicians to provide that dosage option to the patients. Remember, in our NT2 study, we normalized, I would say, about 70% of the patients on the ESS scale using the once-daily dosing. So we anticipate even in IH that we are going to see a good response on both dosage forms. But we want to have that added flexibility and that added efficacy for patients, and that added flexibility that split dosing would provide. The second question was which again? Sorry. Ami FadiaAnalyst at Needham & Company00:52:01What I was trying to ask is there a way to learn from the study as to a priori which patients may be best suited for a split dosing? Blair JacksonCEO at Alkermes00:52:11Yeah, no, thank you. Ami FadiaAnalyst at Needham & Company00:52:12or not? Blair JacksonCEO at Alkermes00:52:12Thanks for the reminder. It's interesting. A priori what we don't know when patients come into the study is, would you be better on a split dose or would you be better on a single dose? And patients obviously in our study are going to be randomized randomly into those categories. We'll see if we learn anything from this study of whether or not there are any patient characteristics that drive that. I think it would be surprising. I think one of the challenges when you get into NT2 and IH populations is, the science underlying the etiology of the disease is a little unclear. In many ways, it's hard to You can't just use a standard biomarker to say a patient's going to be responsive or non-responsive or need an afternoon split dose. Blair JacksonCEO at Alkermes00:53:06Again, we'll learn in the NT2 study, and it may just be that after this study, doctors are going to have to empirically decide, see how their patients respond to the once-daily dose, and then move them on to split dose if it's required. But the data will tell us, and we'll adapt from there. Ami FadiaAnalyst at Needham & Company00:53:23Got it. Operator00:53:27Our next question comes from Andrea Newkirk with Goldman Sachs. Please go ahead. Analyst at Goldman Sachs00:53:33Hi, this is Morgan on for Andrea Newkirk. Thanks for taking our question. For ALKS 7290 in MDD, given antidepressants typically fail to address residual fatigue and anhedonia, what magnitude of difference on MADRS do you consider clinically meaningful for this novel mechanism? Thank you. Blair JacksonCEO at Alkermes00:53:55Yeah, it's interesting that as you look at the MADRS scores and you look at things that are out there, I think typically people see a change versus placebo of somewhere between two and five as being a meaningful difference on MADRS. In fact, the drug that's out now, AUVELITY, which only had a 3-point change, 3.5-point change or so relative to placebo, has strong uptake because it has unique characteristics. So it has, A, a different mechanism, and B, it has a rapid onset. I think as you look at the MDD space, there's a number of areas where you can provide improvement, cognition, anhedonia, fatigue, as you alluded to. We've seen things like cognition and fatigue benefits in some of our other trials. Blair JacksonCEO at Alkermes00:54:50I think the goal for us is to be able to show a statistical difference between placebo as part of MADRS, understand the domains of where we see response. If we can show something that is different, that provides a different, a broader profile than you see with the SSRIs, SNRIs, I think there is a lot of opportunity there. Because remember, this is adjunctive therapy. About 40% of these patients have an inadequate response. I think there is a lot of room for improvement for these patients. Analyst at Goldman Sachs00:55:23Thank you. Operator00:55:27Our next question comes from Jason Gerberry with Bank of America. Please go ahead. Analyst at Bank of America00:55:33Oh, hey. This is Chi on for Jason. Thanks for taking our question. I have a follow-up on the expectation for Vibrance-3. What do you expect to see from the data for advancing the program to phase III? Is it driven by whether the study meeting the primary endpoint? What do you want to see as differentiator relative to on-market offerings such as oxybate? Do you want to see sort of magnitude of benefit on ESS or IHSS for the IH study? Just quickly as a follow-up, on your earlier commentary around expecting to see a similar response as in the Vibrance-2 study, is that commentary related to QD dosing in ESS scale as we think about the overlapping elements between Vibrance-2 and Vibrance-3? Thanks so much. Blair JacksonCEO at Alkermes00:56:28Yeah, I mean, there's a lot in your question there. I think as you look at the Vibrance-3 study, as you look at it, obviously our endpoints are ESS and IHSS, and we want to be able to show a benefit within there. And for us, a phase II study, remember, is about trying to ensure and understand your signal. It's trying to understand your signal relative to your safety profile, and can you design your phase III trial in order to get over the line, show the statistical significance, show a benefit to those patients? Obviously, we want to hit statistical significance as part of our phase II study if we can. If we were to fall a little bit short, does that mean we would stop the program? No. Blair JacksonCEO at Alkermes00:57:10As long as we feel that we have an appropriate signal, that trial design would be able to overcome. That being said, when we look at our early treatment within this patient population, remember we had a once-daily dosing, similar to what we did with the NT2 population. We saw a similar effect size between NT2 and IH. So our hope is that we see something similar. We hope that we'll provide additional benefit through the split dosing, and that we'll be able to then design our phase III, meet with the agency, and then move that into our phase III program. With regards to my previous comment, with regards to Vibrance-2 versus Vibrance-3, what I'm really just trying to say is that there's a lot of heterogeneity in the patient populations, both in NT2 and IH. There's also a lot of overlap between diagnoses. Blair JacksonCEO at Alkermes00:58:05Patients move between an NT2 diagnosis and an IH diagnosis, sometimes frequently. So, I would expect that there's an overlap of population there, and that if you have a similar population, that the once-daily drug would perform similarly, with the caveats that I mentioned earlier, that you have this other patient group in there that we're going to be learning about, the long sleepers. So again, what I'm hoping is that we've designed the study in a way where we can learn what we need to from this program and move forward quickly into phase III. Analyst at Bank of America00:58:42Thank you. Operator00:58:46Our next question comes from Luke Herrmann with Baird. Please go ahead. Luke HerrmannAnalyst at Baird00:58:51Hi, team. Thanks for the question. Just to follow up on the orexin and oxybate dynamic, given the view that orexins and oxybates can be complementary by HCPs, and that's intuitively sound that they can be complementary, but I guess what is your early thinking on payer dynamics if a set of patients could theoretically be in position to step up from one to two branded therapeutics? Todd NicholsChief Commercial Officer at Alkermes00:59:14Yeah, Luke, this is Todd. I'll take that. We're spending a lot of time right now talking to payers overall. As you know, the access profile for oxybates and for LUMRYZ is quite strong at north of 80%, and we don't see that changing over time. There's a significant value to HCPs and to patients. I think a lot will be determined pretty quickly here when we see what the pricing dynamic looks like for the Takeda product overall. As you know, there's a lot that goes into pricing, and one of the considerations that we will be thinking through is not only just the overall value of alixorexton with a very broad label and how we plan to differentiate, but also making sure we take into consideration what the reimbursement profile looks like. Todd NicholsChief Commercial Officer at Alkermes01:00:11Our expectation is that we will put forward a profile and a pricing dynamic that will allow broad access to both products. Operator01:00:24Our next question comes from Douglas Tsao with H.C. Wainwright. Please go ahead. Douglas TsaoAnalyst at H.C. Wainwright01:00:31Hi, good morning. Thanks for taking the questions. On ALKS 7290 in MDD, I was curious, it sounds like you are looking into the drug's effect on some of the specific domains of the MADRS. I am curious, are you looking at things like SHAPS? Because I think there is a rationale to think that an orexin could have an effect on anhedonia, and obviously that is a more refined measure of looking at that specific aspect of the disease. Thank you. Blair JacksonCEO at Alkermes01:01:02Yeah, I mean, I think as we move forward in the program, we are going to be looking at a lot of different things. I think for the ongoing study right now, our primary is on the MADRS. Yes, are we looking at the individual domains? Of course we do, but we are designed to look at the overall response overall. So, our goal here is to really show whether or not we see an overall effect size, understand the patient population, and then as we move into the next phase of the program, we will dive deeper into some of the areas that we see. Operator01:01:34Okay. Our last question comes from Ben Burnett with Wells Fargo. Please go ahead. Analyst at Wells Fargo01:01:43Good morning, team. This is Orpheus on for Ben. Congrats on the progress. I had another question on oxybate plus orexins. You've described this as complementary, and we've also heard similar feedback from KOLs. With that in mind, could you remind us of your plans to generate data of an orexin agonist in combination with an oxybate? If you do run such a study, would your oxybate of choice be LUMRYZ or valiloxybate? Thank you. Blair JacksonCEO at Alkermes01:02:11I think it's a great question, and actually, we do want to generate a lot of data with oxybates and orexins together, because just like you're hearing, we're hearing from our patients that that would be desirable to be able to have a nighttime treatment with an oxybate and a daytime treatment with an orexin. We want to be able to support that. We want to support patients and doctors in how to use it, how to use it safely, and also to prepare, to support it and show those benefits. That being said, what we want to make sure is that we do those studies as we're further along in the registration program. We don't want to put our core registration program at risk, so it'll take a little time, and we will move to that. Of course, we will use LUMRYZ as the comparator. Blair JacksonCEO at Alkermes01:02:57We think that's the dominant drug moving forward, and that's what we'll want to show. Analyst at Wells Fargo01:03:04Thank you. Operator01:03:08We have reached the end of our question-and-answer session. I would now like to turn the floor back over to Sandra Coombs for closing comments. Sandra CoombsSVP of Investor Relations and Corporate Affairs at Alkermes01:03:16All right. Thanks, everyone, for joining us on the call today. If you have any follow-up questions, please do not hesitate to reach out to us at the company. Thank you. Operator01:03:28This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.Read moreParticipantsExecutivesSandra CoombsSVP of Investor Relations and Corporate AffairsBlair JacksonCEOTodd NicholsChief Commercial OfficerJoshua ReedCFOAnalystsLeonid TimashevAnalyst at RBC Capital MarketsAnalyst at StifelGraig SuvannavejhAnalyst at Mizuho SecuritiesAnalyst at JefferiesRudy LiAnalyst at Wolfe ResearchDavid AmsellemAnalyst at Piper SandlerAnalyst at JPMorganDavid HoangAnalyst at Deutsche BankMarc GoodmanAnalyst at Leerink PartnersAnalyst at TD CowenAlex NackenoffAnalyst at Truist SecuritiesUmer RaffatAnalyst at Evercore ISIAnalyst at UBSAmi FadiaAnalyst at Needham & CompanyAnalyst at Goldman SachsAnalyst at Bank of AmericaLuke HerrmannAnalyst at BairdDouglas TsaoAnalyst at H.C. WainwrightAnalyst at Wells FargoPowered by Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Alkermes Q3 2026 Earnings FAQ Did Alkermes beat earnings estimates for Q3 2026? Alkermes (NASDAQ:ALKS) reported earnings of $0.09 per share for Q3 2026, beating the consensus estimate of -$0.0818. The report was announced on Wednesday, November 4, 2026. What was Alkermes' revenue for Q3 2026? Alkermes reported revenue of $480.13 million for Q3 2026, against a consensus estimate of $463.48 million. Where can I read Alkermes' Q3 2026 earnings call transcript? The full Alkermes Q3 2026 earnings conference call transcript is published on this page, including prepared remarks and the analyst Q&A session, along with the participants who spoke on the call. Alkermes Earnings HeadlinesAlkermes Stock Earnings Estimates Lifted by HC WainwrightNovember 13 at 1:43 AM | americanbankingnews.comAlkermes plc (ALKS) - What Are Investment Firms Saying About This Stock?November 11, 2026 | americanbankingnews.comToday's free pick (on me)Elon Musk doesn't own the chip inside every Tesla, Starlink dish, and AI satellite - he licenses it from one lesser known company. With plans filed for 1,000,000 new satellites, that licensing fee could scale dramatically. Analyst Dylan says the stock could move by December 8th.November 15 at 1:00 AM | Behind the Markets (Ad)Analysts Have Conflicting Sentiments on These Healthcare Companies: Alkermes (ALKS), Nurix Therapeutics (NRIX) and Beam Therapeutics (BEAM)November 5, 2026 | theglobeandmail.comAlkermes plc 2026 Q3 - Results - Earnings Call PresentationNovember 5, 2026 | seekingalpha.comAlkermes Records Lower Q3 Profit At $16 Mln Despite Higher Product RevenuesNovember 4, 2026 | rttnews.comSee More Alkermes Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Alkermes? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Alkermes and other key companies, straight to your email. Email Address About AlkermesAlkermes (NASDAQ:ALKS) is a biopharmaceutical company focused on developing and commercializing medicines for neuroscience-related conditions, including serious mental illness and addiction. Founded in 1987, the company has operations in the United States and Ireland, with its corporate headquarters in Dublin and major U.S. operations in Massachusetts. Its marketed medicines include Vivitrol, an extended-release injectable formulation of naltrexone used to treat alcohol dependence and to prevent relapse to opioid dependence after detoxification; Aristada, an injectable treatment for schizophrenia in adults; and Lybalvi, a medicine for schizophrenia and bipolar I disorder in adults. Alkermes also conducts research and development in neuroscience, seeking to advance treatments for psychiatric and addiction-related disorders. 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PresentationSkip to Participants Operator00:00:00Greetings, and welcome to the Alkermes third quarter 2026 financial results conference call. My name is Dylan, and I will be your Operator for today's call. All participant lines will be placed on mute to prevent background noise. If you should require Operator assistance during the call, please press star zero from your telephone keypad. Please note, this conference is being recorded. I will now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, you may now begin. Sandra CoombsSVP of Investor Relations and Corporate Affairs at Alkermes00:00:32Welcome to the Alkermes plc conference call to discuss our financial results and business update for the quarter ended September 30th, 2026. With me today are Blair Jackson, our Chief Executive Officer, Todd Nichols, our Chief Commercial Officer, and Joshua Reed, our Chief Financial Officer. A slide presentation, along with our press release, related financial tables, and reconciliations of the GAAP to non-GAAP financial measures that we will discuss today are available on the Investors section of alkermes.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. Sandra CoombsSVP of Investor Relations and Corporate Affairs at Alkermes00:01:19Please see slide two of the accompanying presentation, our press release issued this morning, and our most recent annual report 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. I will now turn the call over to Blair for some opening remarks. Blair JacksonCEO at Alkermes00:01:51Thank you, Sandy. Good morning, everyone. On my first quarterly call as CEO of Alkermes, I would like to start with a few thoughts on the opportunity ahead and the priorities that will guide us. We have a clear strategy and a strong foundation. Our focus now is on execution. That means advancing our pipeline with rigor and urgency, driving strong commercial and financial performance, and allocating capital thoughtfully to our highest value opportunities. Our commercial business is an important element of our strategy and provides a strong financial foundation to invest in innovation. Our greatest opportunity for growth and value creation lies in our pipeline, particularly our leadership in orexin research and the potential of our orexin development portfolio to yield important new treatment options in neuropsychiatry. I will discuss the significant momentum across our development pipeline in more detail following the discussion of the quarterly results. Blair JacksonCEO at Alkermes00:02:46The combination of commercial strength, financial performance, and a differentiated pipeline positions Alkermes well for its next chapter and the potential for meaningful long-term value creation for shareholders. I am incredibly proud and honored to lead Alkermes at this important point in its evolution, and I am confident in our strategy, our people, and the opportunities ahead. With that, let's turn to the quarter, Todd. Todd NicholsChief Commercial Officer at Alkermes00:03:09Thank you, Blair. Good morning, everyone. I am pleased to report that we delivered strong performance across our commercial portfolio in the third quarter, reflecting contributions across addiction, psychiatry, and sleep medicine. Our teams remain focused on driving demand, broadening patient access, and building on the opportunities across our four proprietary products. In the third quarter, net sales from our proprietary product portfolio increased 31% year-over-year to $417.3 million, reflecting the addition of LUMRYZ and continued demand growth across our established commercial portfolio. Starting with VIVITROL, net sales in the third quarter were $127.6 million. VIVITROL continued to see strong demand driven by penetration in the alcohol dependence market. Net sales also benefited from approximately $8 million in gross-to-net favorability, primarily driven by favorable patient mix. For the full year, we continue to expect VIVITROL net sales in the range of $460 million-$480 million. Todd NicholsChief Commercial Officer at Alkermes00:04:20We remain confident in the strength and durability of our VIVITROL business and look forward to continuing our impact with this important medicine. Turning to our psychiatry franchise, third quarter net sales for ARISTADA product family were $103.9 million. ARISTADA continued to see demand growth driven by expansion in HCP adoption. Net sales also benefited from approximately $7 million of gross-to-net and inventory favorability. We are encouraged by ARISTADA's continued strong performance within this category. For the full year, we continue to expect ARISTADA net sales in the range of $365 million-$385 million. LYBALVI net sales were $95.9 million in the third quarter, with underlying TRX growth of 18% year-over-year, supported by new patient starts and broader prescriber adoption. Net sales also reflected approximately $2 million of inventory benefit. Todd NicholsChief Commercial Officer at Alkermes00:05:22Last quarter, we implemented a strategic expansion of the LYBALVI market access profile that we believe will position LYBALVI for long-term growth. Access now stands at approximately 80% of covered lives, and as a result, we have already seen positive trends on volume demand and prescription fulfillment. As expected, gross-to-net adjustments were approximately 42% during the third quarter. For the full year, we continue to expect LYBALVI net sales in the range of $380 million-$400 million. Looking ahead to next year, we expect gross-to-net adjustments for LYBALVI to be in the 45% range. We expect the benefits of expanded payer access to be reflected first in prescription volume, which we expect will continue to grow nearly 20% year-over-year, with an acceleration in net sales growth expected to follow. Beyond 2027, we expect volume growth and net sales growth to track more closely together again. Todd NicholsChief Commercial Officer at Alkermes00:06:23Turning to our sleep franchise. LUMRYZ net sales were $89.9 million in the third quarter. We reached approximately 4,100 patients on therapy at quarter end, reflecting strong underlying demand, broader prescriber adoption, and increased use among existing prescribers. Net sales also reflected the drawdown of approximately $7 million of inventory build that we highlighted in our second quarter results. Last month, we presented results from the positive phase III REVITALYZ study of LUMRYZ in idiopathic hypersomnia at the Sleep Europe meeting. IH is a fast-growing segment for the oxybate market. The REVITALYZ data will serve as the foundation for the sNDA submission for IH, with a potential launch in March 2028, if approved. IH represents an important potential growth opportunity for LUMRYZ, and we look forward to updating you on our progress. Todd NicholsChief Commercial Officer at Alkermes00:07:20For the full year, we continue to expect total LUMRYZ net sales of $350 million-$370 million, of which Alkermes expects to record $315 million-$335 million, reflecting the mid-February close of the Avadel transaction. Supporting LUMRYZ, we have an established sleep medicine platform that includes an experienced commercial and medical organization with a deep understanding of the market dynamics and HCP and patient journeys. This platform provides a strong foundation to support the potential launch of alixorexton and our broader ambition to become leaders in sleep medicine across multiple treatment modalities. Across our proprietary portfolio, we expect net sales to be in the range of $400 million-$420 million in the fourth quarter. We are pleased with what we have accomplished so far this year and remain focused on delivering against our 2026 objectives. Todd NicholsChief Commercial Officer at Alkermes00:08:15As we enter the final quarter, our priorities remain clear: drive demand for our medicines, expand patient access, and position our brands for continued growth. With that, I will pass the call to Joshua to review the financial results for the quarter. Joshua ReedCFO at Alkermes00:08:31Thank you, Todd. We delivered solid financial results in the third quarter, supported by the strength of our commercial portfolio and disciplined management of the business. Through the first nine months of the year, our financial position has provided the flexibility to advance our strategic priorities and invest in key opportunities that we believe will support our future growth. During the quarter, we generated total revenues of $480.1 million. As Todd outlined, our portfolio of proprietary products generated net sales of $417.3 million. These results reflect contributions from all four of our proprietary products and positive underlying demand trends across the commercial business. Manufacturing and royalty revenues were $62.9 million for the quarter, including $29.5 million from VUMERITY and $26.4 million from the long-acting INVEGA products. Joshua ReedCFO at Alkermes00:09:34Turning to expenses, cost of goods sold in the third quarter was $94.2 million, which includes the purchase price fair value accounting of LUMRYZ inventory that we described last quarter. This compared to $51.6 million in Q3 of the prior year. R&D expenses in the quarter were $121.1 million compared to $81.7 million in Q3 of the prior year, reflecting continued investment in our orexin development portfolio. Of note, our development activities during the quarter included the alixorexton phase III studies initiated earlier this year and clinical development activities to advance ALKS 7290 in ADHD and MDD, as well as ALKS 4510 in fatigue associated with Parkinson's disease or multiple sclerosis. Joshua ReedCFO at Alkermes00:10:30SG&A expenses were $208.5 million for the quarter compared to $171.8 million in Q3 of the prior year, with the addition of the Avadel commercial infrastructure as the primary driver of the year-over-year change. During the quarter, we also recorded amortization of acquired intangible assets of $19.7 million and net interest expense of $21.1 million. In Q3, we recorded GAAP net income of $16.3 million and EBITDA of $63 million. Adjusted EBITDA was $120.1 million, which we believe provides a useful measure of the underlying cash-generating performance of the business during the quarter. From a balance sheet perspective, we entered the third quarter in a strong position with approximately $787.6 million in cash and total investments. For the year, we are reiterating our 2026 financial expectations provided in July across all line items. Joshua ReedCFO at Alkermes00:11:43Our performance through the first nine months of the year positions us well to deliver against these expectations. Our 2026 financial performance and operating expenses reflect a number of Avadel transaction-related costs. As we look ahead to our 2027 operating expense profile, there are a few important dynamics to keep in mind, beginning with cost of goods sold. With the vast majority of the non-cash LUMRYZ inventory fair value step-up associated with the Avadel acquisition being recognized in 2026, we expect cost of goods sold to be lower in 2027, reflective of more normalized patterns. For SG&A, excluding the transaction-related costs recorded in early 2026, we expect a broadly similar expense profile for 2027. For R&D, our 2027 investment will reflect the growing number of programs across the portfolio and the broader level of clinical activity planned. Joshua ReedCFO at Alkermes00:12:48Importantly, we expect to deliver strong cash generation and adjusted EBITDA performance in 2027 while continuing to invest in the significant opportunities across our pipeline. We believe this balance demonstrates our ability to fund future growth drivers while maintaining financial discipline. We will provide our full 2027 expectations on our February call. With that, I will now hand the call to Blair. Blair JacksonCEO at Alkermes00:13:15As you've heard from Todd and Joshua, our commercial business continues to perform well, with the proprietary product portfolio expected to deliver net sales of nearly $1.6 billion in 2026. That foundation allows us to advance an increasingly broad pipeline, led by our portfolio of orexin 2 receptor agonists. We are in the early stages of understanding the full therapeutic potential of orexin biology. Over the past several years, we've been generating a substantial body of clinical evidence across central disorders of hypersomnolence, and we are now generating our first clinical datasets from our orexin portfolio in broader areas of neuroscience. Starting with alixorexton, our most advanced orexin candidate, we reached several important milestones across the development program during the quarter. Our phase III Brilliance studies in narcolepsy type 1 and narcolepsy type 2 are underway, and we are pleased with enrollment progress across the program. Blair JacksonCEO at Alkermes00:14:14We continue to expect top-line results from these studies beginning in mid-2027. In idiopathic hypersomnia, we completed enrollment in the Vibrance-3 phase II study, which enrolled approximately 130 participants and will represent the first multi-week clinical dataset of an oral orexin 2 receptor agonist in IH. The study is evaluating wakefulness and IH symptom severity with the Epworth Sleepiness Scale and Idiopathic Hypersomnia Severity Scale as primary and secondary endpoints, respectively. Beyond evaluating the safety, tolerability, and efficacy of alixorexton in patients with IH, we expect the study to provide important insights to inform a potential registration program, including dose selection, dosing regimen, and endpoint strategy. The study also includes our first evaluation of split dosing in a hypersomnolence disorder, which we believe could provide additional flexibility to address the diverse needs of patients. Blair JacksonCEO at Alkermes00:15:14We expect top-line results around year-end or in early 2027 and look forward to sharing those data. Hypersomnolence disorders represent a significant market opportunity, and this month, the first orexin 2 receptor agonist is expected to become commercially available for the subset of patients with narcolepsy type 1. As this new therapeutic category enters the commercial landscape, we believe that if approved, alixorexton's wide therapeutic range, dosing optionality, and broad anticipated utility across narcolepsy types 1 and 2, and potentially IH, will support a differentiated profile with the potential to provide an important new treatment option to providers and patients. While the commercial opportunity begins to take shape in hypersomnolence disorders, we are advancing our strategy to develop orexin 2 receptor agonists for a range of neuropsychiatric and neurodegenerative disorders. Last month, we reported the first clinical results for ALKS 7290 in adults with ADHD. Blair JacksonCEO at Alkermes00:16:17This was a 50-subject phase I-B proof-of-concept study designed primarily to evaluate safety and tolerability and to generate initial data characterizing the effects of ALKS 7290 across a range of established clinical scales for ADHD, CNS biomarkers, and objective cognitive performance tests. In the study, ALKS 7290 was generally well tolerated, with no serious treatment-emergent adverse events and no treatment discontinuations among participants who received ALKS 7290. Most treatment-emergent adverse events were mild and largely consistent with on-target effects for orexin 2 receptor agonists. Across the two doses evaluated, ALKS 7290 demonstrated dose-dependent, clinically meaningful improvements from baseline on exploratory endpoints evaluating established measures of ADHD symptoms and disease severity. We were pleased to observe improvements across both the inattentive and the hyperactivity-impulsivity subscales of the Adult ADHD Investigator Symptom Rating Scale, or AISRS, with effects emerging as early as the first assessment on day six. Blair JacksonCEO at Alkermes00:17:29ALKS 7290 also demonstrated clinically meaningful improvements from baseline in overall ADHD disease severity, as measured on the CGI-S scale. In addition, we observed treatment effects across objective measures related to processing speed, information processing, working memory, and attention. These findings provide the first clinical evidence of the effects of an orexin 2 receptor agonist in the treatment of adults with ADHD and further support the dose range selected for the ongoing phase II study. That phase II study is already enrolling adults with ADHD and is designed to evaluate once-daily and split-dose regimens of ALKS 7290, with change from baseline in AISRS total score compared with placebo at week four as the primary endpoint. We expect the ADHD phase II data in the second half of 2027. Blair JacksonCEO at Alkermes00:18:24Building our momentum in diseases outside of hypersomnolence, last week we announced the expansion of the ALKS 7290 development program into major depressive disorder, or MDD, with the initiation of a 150-patient phase II study evaluating ALKS 7290 as an adjunct to antidepressant treatment in adults with MDD who have had a partial response to standard antidepressant therapy. This randomized double-blind placebo-controlled study is designed to evaluate the safety and tolerability of ALKS 7290 over six weeks, while also assessing its effects on depressive symptoms as measured by change from baseline on the MADRS or CGI-S compared to placebo at week six. The study will enroll adults with and without excessive daytime sleepiness, which will allow us to evaluate the potential effects of ALKS 7290 in the overall MDD population, as well as in this important subgroup. Blair JacksonCEO at Alkermes00:19:24Turning to orexin biology and neurodegenerative disorders, we plan to initiate a randomized double-blind placebo-controlled phase II study evaluating ALKS 4510 in people with fatigue associated with multiple sclerosis or Parkinson's disease. Fatigue is one of the most common and consequential symptoms across a broad range of neurological and systemic diseases, yet effective treatment options remain limited. Fatigue associated with multiple sclerosis or Parkinson's disease are compelling initial areas for development with clearly defined patient populations, significant unmet need, and established clinical scales focused on fatigue. We believe these disease areas offer a tractable development pathway for establishing clinical proof of concept for orexin 2 receptor agonism in fatigue, while also representing meaningful commercial opportunities in these patient populations. Blair JacksonCEO at Alkermes00:20:20Importantly, this study is intended not only to evaluate the potential of ALKS 4510 in these specific disorders, but also to deepen our understanding of the role of orexin biology in fatigue more broadly. We believe these insights generated could help establish a foundation for evaluating additional disease areas where fatigue remains a significant source of patient burden and unmet need. Alixorexton in hypersomnolence disorders, ALKS 7290 in broader neuropsychiatric disorders, and ALKS 4510 in fatigue are components of a broader orexin portfolio development strategy that allows us to evaluate these distinct molecules across a range of patient populations and disease settings. As we advance and expand these development programs, we're also continuing to advance additional orexin compounds through preclinical development. We're just beginning to explore the potential clinical utility of orexin compounds, and Alkermes is at the leading edge of research for this emerging therapeutic class. Blair JacksonCEO at Alkermes00:21:22Our focus will remain in neuroscience applications, but with the potential to reach across a broad range of disorders. We believe the opportunity for this class is vast and will be the focus of significant research and development for years to come. Looking ahead, the next year will be a pivotal and data-rich period for Alkermes, with six important studies expected to read out across our orexin portfolio. We start with anticipated data from the Vibrance-3 phase II study of alixorexton in idiopathic hypersomnia in the coming months, followed by top-line results from all three Brilliance phase III studies in narcolepsy beginning in mid-2027. For ALKS 7290, we expect phase II data in ADHD next fall, and for ALKS 4510, phase II proof-of-concept data in fatigue toward the end of the year. Blair JacksonCEO at Alkermes00:22:14Taken together, these studies have the potential to significantly expand our understanding of where orexin-based therapies can make a meaningful difference for patients. Our focus remains on executing with urgency and discipline, generating the clinical evidence needed to unlock the potential of this novel class, and building what we believe can become a leading franchise, addressing some of the most significant unmet needs across sleep, neuropsychiatric, and neurological disorders. We plan to pursue these opportunities while continuing to deliver strong commercial performance and investing thoughtfully to support long-term growth and value creation. With that, I'll turn the call back to Sandy for the Q&A. Sandra CoombsSVP of Investor Relations and Corporate Affairs at Alkermes00:22:55Thanks, Blair. We'll now open the call for Q&A. Operator00:23:01Thank you. We will now be conducting a question-and-answer session. We ask that you limit yourselves to one question and one follow-up. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 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, while we poll for questions. Our first question comes from Leonid Timashev with RBC Capital Markets. Please go ahead. Leonid TimashevAnalyst at RBC Capital Markets00:23:41Hey, guys. Thanks for taking my question. Just wanted to ask one on IH and how you are thinking about what to expect there. Maybe can you talk us through when you see that data, how you will think about moving forward with the split dose, maybe with the once-daily doses, and maybe how you are thinking about what you could see on the relative magnitudes between those? Thanks. Blair JacksonCEO at Alkermes00:24:04Sure. Thanks for the question, Leo. It is Blair. I think when we look at the IH dataset that is coming out, there is a wealth of information that we are going to be getting from that trial. As you alluded to, first and foremost, we are going to be getting the once-daily dosing for that program. As we have spoken before, we see the IH population as somewhat similar to the NT2 population in that it is highly variable. These patients have a range of disease and different responses to orexin agonism. So we would expect something similar to that NT2 dataset. The main difference, though, being that with IH population, they do have one separate population, which is the long sleepers. Those long sleepers, we have less experience with. We expect that we will have a similar response within them, but this dataset will tell us more on that piece. Blair JacksonCEO at Alkermes00:24:56With regards to the split dosing, the split dosing, as you know, is an important component of our overall program in that it provides both flexibility for patients across NT1, NT2, and IH, but also could provide some additional efficacy for those patients who need it in the later afternoon. This will be the first opportunity we will be able to see that split dataset as part of a patient program. All this data will be coming out towards the end of the year, and we are pretty excited to see it. Sandra CoombsSVP of Investor Relations and Corporate Affairs at Alkermes00:25:38Okay, thanks. We will take the next question. Operator00:25:39Our next question. My apologies. Our next question comes from Paul Matteis with Stifel. Please go ahead. Analyst at Stifel00:25:48Hi, this is Emily on for Paul. We were just wondering, where do you think Takeda may price, and if there was a chance that they price on the lower end, do you think that you have the possibility to kind of adjust there with the different doses you plan to have available across sleep disorders? Thank you. Blair JacksonCEO at Alkermes00:26:13Thanks for the question. This is Blair. I think that Takeda's going to be pricing imminently, and we'll see that in the next few weeks. That'll set the range for the overall market. As you alluded to in your question, though, we have a lot of flexibility on our pricing moving forward, so we'll see where they price, and we'll adjust accordingly. Operator00:26:37Our next question comes from Graig Suvannavejh with Mizuho Securities. Please go ahead. Graig SuvannavejhAnalyst at Mizuho Securities00:26:45Good morning. Thanks for taking my question, and congrats on the progress in the quarter. Just on the pipeline and obviously on the orexin franchise, I was intrigued by the movement into major depressive disorder and psychiatry. Could you give us perhaps a little bit more of the rationale there, and can you give us maybe a sense of if there are other psychiatric indications beyond MDD that you think an orexin might make sense? Thanks so much. Blair JacksonCEO at Alkermes00:27:13Thanks for the question, Graig. We've looked extensively at other areas outside of hypersomnolence where you could apply orexin agonism, and we did some comprehensive preclinical work, really looking at the basic biology behind orexin agonism and identified a number of different domains where you could apply this, some of them being cognition, fatigue, mood, wakefulness, all these different areas. As part of that, we did some translational work in many of these areas. Within mood, some of the things we noticed is that we saw a really strong synergistic increase in serotonin in the prefrontal cortex when orexin agonism was given with SSRIs or SNRIs, and so synergistically. I think that's really telling that there's a benefit you could have here by having adjunctive therapy with orexin agonism. Blair JacksonCEO at Alkermes00:28:09We also did use a highly translational model as part of that early research, which is the chronic social defeat test, which is really a way of establishing rodents who have really a depressive phenotype, and then providing them with therapy and seeing how they respond to treatment. What we found is we found similar effects to what you'd see if those animals were dosed with ketamine or with fluoxetine. So we felt pretty strongly that there's a potential signal here, and so the desire to move into a patient population is something we've had for some time. Part of this study that we're looking at is exploratory in that we'll be looking at not only the full MDD population, but we'll also be looking at a subgroup of the population who also has some excessive daytime sleepiness. Blair JacksonCEO at Alkermes00:29:03That gives us an opportunity to really learn a lot as part of this program and really design our program going forward. To the first part of your question regarding other things, yes, we have a number of other areas that we're looking at within neuroscience, both neurodegenerative and neuropsychiatry, and we'll talk about those as we get closer to additional activity. Graig SuvannavejhAnalyst at Mizuho Securities00:29:30Thank you. Operator00:29:34Our next question comes from Akash Tewari with Jefferies. Please go ahead. Analyst at Jefferies00:29:40Hey, thanks so much. This is Albert on for Akash. Given that your ADHD program will likely need to demonstrate efficacy comparable to existing stimulants to be competitive, can you discuss the rationale for not modifying the trial design to target a specific patient type, and what gives you confidence that the current trial design can demonstrate a clinical meaningful treatment benefit? Blair JacksonCEO at Alkermes00:30:05Hi, Albert. Thanks for the question. First, I would like to correct a little bit of what you said there. I think there's a wide range of efficacy outcomes that are commercially attractive for a new entrant in the ADHD space, especially an entrant like an orexin agonist, which could bring broader response profiles over and above what you see with existing therapies that are there. I think for us, the goal moving forward is to establish that efficacy level, flush out some of those broader domains that we started to see in the phase I-B study, and show and demonstrate that this is a safe profile within this patient area. I think the early data that we saw in our phase I-B program support all of those goals. Blair JacksonCEO at Alkermes00:30:55One of the key things that we looked at through that phase I-B study was our dosage range, making sure we were at the right region of targeting those receptors and engaging that circuitry. What we found was exactly that yes, we are right in the range. We do not need to lower or raise our dose. We can use the doses that we have. We also found that we were seeing a really robust response early within treatment. I think there is no requirement for us to modify the study in any way, nor would it benefit from us, based on what we have seen, to look at individual subtypes. Operator00:31:39Our next question comes from Rudy Li with Wolfe Research. Please go ahead. Rudy LiAnalyst at Wolfe Research00:31:45Hey, thanks for taking my question. Just a quick follow-up question on 7290's MDD study. J&J showed good efficacy data in MDD for its orexin antagonist, but in patients with insomnia. Can you maybe talk about the rationale for orexin agonists for MDD? What will be the key difference in the study population, the trial design versus J&J, and what will be the key differentiator versus current standard of care? Thanks. Blair JacksonCEO at Alkermes00:32:15Thanks, Rudy. It is a good question, and I think it is important to recognize that using orexin agonism is a fundamentally different approach than using orexin antagonism. Orexin antagonism, what J&J was trying to do there was sort of address the sleep disorder and hoping it would have a knock-on effect on potential mood. This is very different, what we are doing. We believe that we directly impact centers of mood within the brain, and we are actually looking at treating the depressive symptoms directly. Because we are using a subgroup who has excessive daytime sleepiness, because we think we might be able to drive additional signal through that group, but this is a fundamentally different view than what J&J did with their orexin antagonist. Operator00:33:05Our next question comes from David Amsellem with Piper Sandler. Please go ahead. David AmsellemAnalyst at Piper Sandler00:33:12Thanks. Got a couple of LUMRYZ questions. Regarding the launch of Takeda's oveporexton, do you perceive any potential impact to LUMRYZ in terms of new starts next year in NT1? That is number one. Then looking longer term with the IH launch for LUMRYZ in 2028, how are you envisioning uptake? Do you think there is going to be a sizable switch market from XYWAV to LUMRYZ? Do you think you will be able to expand the overall oxybate footprint in IH, or is it a little bit of both? Thanks. Todd NicholsChief Commercial Officer at Alkermes00:33:56Yeah. Good morning, David. This is Todd. I appreciate the questions on LUMRYZ. Yeah, we are really excited and pleased with the performance of LUMRYZ this year, and specifically in Q2. Strong net sales, really strong patient demand, up to 4,100 patients. We are watching very closely and thinking very deeply about the impact of orexins. As you know, we are big believers in the mechanisms. We actually believe they are complementary, and we hear that pretty consistently from HCPs around the belief and the desire to use both mechanisms. So we think there is a long-term durability in the oxybate market and a lot of excitement with orexins. Initially, we are going to have to see how this plays out with Takeda's product entering the market. We think initially that will be a switch population for earlier lines of therapy, patients looking to switch. Todd NicholsChief Commercial Officer at Alkermes00:34:57But we hear pretty consistently from HCPs that patients that are on oxybate, specifically LUMRYZ, and that are stable, like to stay on the product overall. So we do believe that there will be an impact on oxybates, but we think it will be somewhat marginal at the beginning, and we think the category overall will be durable. In terms of IH, yeah, this is something we are really excited about. We did present the data recently at Sleep Europe. There is a lot of anticipation on the IH launch. If it is approved, we will be commercializing no sooner than March 1st of 2028. And there is a lot of anticipation there. This will be the second product potentially approved in the market. We think it is under-penetrated at this point right now. Todd NicholsChief Commercial Officer at Alkermes00:35:43We think that LUMRYZ actually will compete for new starts in IH, but also there will be a switch market, and that LUMRYZ will compete in that switch market. Operator00:35:57Our next question comes from Jessica Fye with JPMorgan. Please go ahead. Analyst at JPMorgan00:36:03Hi, this is [inaudible] from Jess. Thanks for taking our question. Any feedback from physicians regarding the ADHD dataset? Wonder if you could tell us how the placebo group did in the recent study, or when we could see more detailed data, including placebo response rates. Thank you. Blair JacksonCEO at Alkermes00:36:18Yeah, so we've had a lot of discussions with physicians with regards to the ADHD data, and I think there's a lot of excitement about the fact that we're able to move a number of these different tools using orexin agonism. I think in particular, folks were interested in the fact that you were seeing consistent response across these measures. So, not only the internal consistency between patient-reported outcomes, but also physician-reported outcomes, as well as objective measures. Just as a reminder, the study itself was a safety study that was designed to look at the wide therapeutic potential that we could have and the therapeutic window we would have with an orexin agonist, and I think that read out really, really well. As such, it's not really appropriate to have a placebo comparison. Blair JacksonCEO at Alkermes00:37:10What we rely on for that is the objective measures and the subjective measures that we included in that study that we shared in our press release. Analyst at JPMorgan00:37:19Thank you. Operator00:37:23Our next question comes from David Hoang with Deutsche Bank. Please go ahead. David HoangAnalyst at Deutsche Bank00:37:29Hi there. Thanks for taking my question. I wanted to ask, once you are post-Vibrance-3 data in IH, either year-end or early 2027, once that data is in hand, how quickly would you look to move into a phase III program for IH, and what would that study design potentially look like? Thank you. Blair JacksonCEO at Alkermes00:37:53Hi, David. Thanks for the question. I think we're going to want to move as quick as we can. Our goal is to get into the phase III following that dataset. What we would like to do, though, is meet with the agency first, and so that actually will probably be our rate-limiting step, is making sure we get that meeting, and we'll obviously hope that they'll be very responsive, because this is an important patient population. As for the size, our expectation is it's probably going to be a similar size to the NT2 study, but that'll obviously depend on the signal that we see in the phase II program, and so that'll help set that. But ballpark-wise, think of the phase II as for planning purposes. Sorry, think of NT2 for planning purposes. Operator00:38:40Our next question comes from Marc Goodman with Leerink Partners. Please go ahead. Marc GoodmanAnalyst at Leerink Partners00:38:45Yeah, just back on oxybate. Could you just give us a little sense behind the scenes what you thought happened in the quarter as far as, was it a normal quarter of just new patient starts, discontinuations, the pricing, just how the market dynamics have just shaken up since you've owned the asset? Is it generally kind of consistent with what you thought? Any major changes in the quarter? Todd NicholsChief Commercial Officer at Alkermes00:39:07Yeah, absolutely, Marc. This is Todd. I'll take that. Yeah, again, we were pleased with the quarter. We were assuming some seasonality, which you typically would during Q3, and I think we saw a little bit of seasonal dynamics. But overall, the growth in LUMRYZ was really driven by patient demand. We saw nice increases in overall patients for narcolepsy, 4,100 patients. That was driven by some of the sub-metrics that we watch very closely, which are new enrollments, conversions, and actually patient persistency. So all three of those dynamics, we believe, really contributed to the nice patient growth, and then also contributed to the net sales growth, which was 16% year-over-year. Marc GoodmanAnalyst at Leerink Partners00:39:55And pricing? Todd NicholsChief Commercial Officer at Alkermes00:39:58Yeah. We didn't see any significant pressures on pricing overall. The pricing was within our range of expectations. As we've said before, historically, LUMRYZ has a really strong market access profile. We didn't see any changing dynamics there as well, and we're not anticipating any strong changing dynamics as we head into the last part of the year. Marc GoodmanAnalyst at Leerink Partners00:40:24Thanks. Operator00:40:28Our next question comes from Joseph Thome with TD Cowen. Please go ahead. Analyst at TD Cowen00:40:34Hi, this is Jacob on the line for Joe. Thanks for taking my question. On the MDD study for ALKS 7290, I was actually just curious if we might expect any kind of pre-specified subgroup analysis by excessive daytime sleepiness or stratification by excessive daytime sleepiness, and whether we might expect powering to be sufficient to determine any differences between those patient populations, or whether we could have an endpoint like ESS, where we could see if the effects on mood were being mediated by sleepiness. Thanks. Blair JacksonCEO at Alkermes00:41:14Hi, Jacob. Thanks for the question. Yes, as I said in the prepared remarks, actually, we do have a pre-specified subgroup, which is a group that has excessive daytime sleepiness. Our goal here is to look at the two populations, both the all-comers MDD versus the group that has the excessive daytime sleepiness. One of the goals there is to see, do we see an enriched signal within that group? You may expect to see that, because as you look at the MADRS scale, for example, there's some questions there that specify or are highly related to sleep or the anhedonia associated or lack of urgency and things like that that people get. We want to see that, and we want to test that in this study, and then that'll allow us to then determine our development path moving forward. Operator00:42:09Our next question comes from Alex Nackenoff with Truist Securities. Please go ahead. Alex NackenoffAnalyst at Truist Securities00:42:16Hey, guys. Thanks for taking the question. Another one on ADHD. For the phase I-B portion, could you explain your rationale why you utilized an inpatient setting and possibly how that may have impacted, if at all, baseline characteristics, and if those baseline factors or the inpatient setting may have led to an outsized or suppressed treatment response? Just curious if you think you had a representative ADHD population where you believe the results will translate in future clinical studies. Thanks so much. Blair JacksonCEO at Alkermes00:42:45Yep. Thanks, Alex, for the question. As we looked at the ADHD program, we had two programs that are studies that we were running at the same time. We have, first and foremost, our large phase II outpatient study that we're running that is placebo-controlled, multiple doses, et cetera. What we wanted to do in the phase I-B study was to ensure that we had some information that we would inform on, one, what are some of the types of signals that we would see, and two, whether we were in the right dosage range overall. In order to do that, what we needed to do is learn a lot about how patients respond to orexin agonism, because remember, this is actually the first asset of this mechanism that's ever been tested outside of hypersomnia indications. Blair JacksonCEO at Alkermes00:43:35We needed to learn what we were doing, that meant we had to put a lot of different tools within the phase I program. In order to do that, if you tried to do that in an outpatient-type setting, that would be exhaustive for the patients. It would be very hard for you to operationalize that. So that's why we chose an inpatient setting. What it allows us to do is put those patients in a clinic, look at those different outcomes in a more staggered pace that's appropriate for the patients. We don't think that has any change on the overall baseline characteristics. I think overall, when we looked at the incoming baseline characteristics, that's consistent with what we see with other ADHD studies. Blair JacksonCEO at Alkermes00:44:15I think where inpatient settings tend to have an impact on some things is on your safety outcomes, because sometimes what you tend to see in inpatient settings is those patients talking about their side effects, that can sometimes amplify side effects here and there. Again, we saw a very good AE profile from this program, so I think all in all, we got exactly what we wanted from this study, and I think it validates the approach. As we've always said, the phase II study that's ongoing is going to be the one that's going to determine what's the characteristics or what's the signal size related to this drug treatment in this population. Alex NackenoffAnalyst at Truist Securities00:44:58Great. Thanks so much. Operator00:45:02Our next question comes from Umer Raffat with Evercore ISI. Please go ahead. Umer RaffatAnalyst at Evercore ISI00:45:08Morning, guys. Thanks for taking my question. I wanted to touch up on 7290 as well, and a couple of points. First, I saw you guys used split dosing when conducting the inpatient ADHD trial. Do you think split dosing could be driving placebo response, and are you intending to continue using split dosing only in your ongoing outpatient ADHD as well as the MDD trial? Secondly, the fact that you used up to 50 mg dose of 7290, what does that tell us about the potency relative to your narcolepsy program? Thank you very much. Blair JacksonCEO at Alkermes00:45:46Hi, Umer. It's nice to hear from you. I think on the first question on the split dosing, as we went into the ADHD study, one of the things we wanted to do as we're trying to learn on the signals is we didn't want to confound some of the PK differences of single-day dosing versus split dosing. We wanted to take that out of the equation. So we used split dosing just because it just allowed us to standardize. I think as you look at our ongoing phase II study, we're actually using both once daily and split dosing. Blair JacksonCEO at Alkermes00:46:21I think that's important because, as you know, in the ADHD population, it is a bit of a lifestyle drug in some respects in that patients have different needs according to whether they're working, whether they're students, what's happening in the evening, what happens in the morning, et cetera. I would envision that we'll probably introduce other dosing types, maybe PRN and other things in the future after original registration. But we're going to do both moving forward, single-day dosing as well as split dosing through the development program. With regards to the upper dose of 7290, it's actually, you can't really use that to relate to narcolepsy. This is fundamentally a different drug. It has a different potency, it has different pharmacological characteristics. Blair JacksonCEO at Alkermes00:47:08Also keep in mind that the pharmacologic dose level that you need to activate the ADHD circuit may be different than what you need to activate, say, a wakefulness circuit. There's a lot of dynamics that are going on there that don't really allow you to make that comparison. Operator00:47:30Our next question comes from Ash Verma with UBS. Please go ahead. Analyst at UBS00:47:35Hi. This is Lianan for Ash. Thank you for taking our question. For the IH study, is it fair to assume that the baseline ESS scores are similar to what you had in the NT2 study? Also, is it fair to assume that the placebo arm in this IH study could closely resemble how the placebo did in the NT2 study? Blair JacksonCEO at Alkermes00:47:59Yeah. I mean, look, we've established very similar entrance criteria as in IH versus NT2. Now, who ends up enrolling in the study depends on the study and which patients show up. So we'll know that as we look at the data moving forward. I think as we look at this area overall, I think we feel pretty good that we're controlling placebo. Obviously, with wakefulness, one of the things to keep in mind is you don't tend to see such a big placebo response like you see in neuropsychiatric indications. So you tend to actually It really depends more on the treatment arm than it depends on the placebo arm. But again, we do what we can to control that, and we've done that in this program by really trying to standardize how we do the tests, really making sure we have high quality control on our clinical sites. Analyst at UBS00:48:54Got it. Thank you. If I may have a follow-up, I think you alluded to the long-form IH patients earlier. Can you talk about roughly what percentage of your IH patients would be the long-form IH? Blair JacksonCEO at Alkermes00:49:08In our study, we haven't disclosed what that is. I think as we look at the general population, though, within IH, typically you see something in the order of around 25% of patients can be deemed long sleepers. Analyst at UBS00:49:22I see. Thank you so much. Blair JacksonCEO at Alkermes00:49:24You're welcome. Operator00:49:27Our next question comes from Ami Fadia with Needham & Company. Please go ahead. Ami FadiaAnalyst at Needham & Company00:49:33Hi, good morning. Thanks for taking my question. With regards to the upcoming IH study readout, I am trying to understand how you are thinking about the outcome of a result, especially in the split dosing arm. As we think about the trade-off between efficacy of having split dose and maybe potentially implications on safety, are there any guardrails in terms of those trade-offs beyond which you may decide not to pursue a split dosing? Secondly, is there some process within the study of determining which patients may be best suited for a split dosing versus not, that could inform your next clinical trial? Thanks. Blair JacksonCEO at Alkermes00:50:25Hey, Ami. Thanks for the questions. I think with the split dosing, we have a wide therapeutic range with this drug. We remember when we went into our programs before, we studied in the NT2 trial up to 18 mg. We have an ability to go higher if we want to. Split dosing, we do not see a safety question as to what is going to determine whether we move to split dosing. Now, obviously, the data will tell us that. When we look at the NT2 data, if we see something unexpected, we will adapt accordingly. A priori, we do not anticipate that being a gating factor. What we are really looking for with the split dosing is really a comparison to the once-daily dosing. In the subset of patients who require additional efficacy in the afternoon, do we see a difference? Blair JacksonCEO at Alkermes00:51:17If we do see that difference, that is going to add additional flexibility for physicians to provide that dosage option to the patients. Remember, in our NT2 study, we normalized, I would say, about 70% of the patients on the ESS scale using the once-daily dosing. So we anticipate even in IH that we are going to see a good response on both dosage forms. But we want to have that added flexibility and that added efficacy for patients, and that added flexibility that split dosing would provide. The second question was which again? Sorry. Ami FadiaAnalyst at Needham & Company00:52:01What I was trying to ask is there a way to learn from the study as to a priori which patients may be best suited for a split dosing? Blair JacksonCEO at Alkermes00:52:11Yeah, no, thank you. Ami FadiaAnalyst at Needham & Company00:52:12or not? Blair JacksonCEO at Alkermes00:52:12Thanks for the reminder. It's interesting. A priori what we don't know when patients come into the study is, would you be better on a split dose or would you be better on a single dose? And patients obviously in our study are going to be randomized randomly into those categories. We'll see if we learn anything from this study of whether or not there are any patient characteristics that drive that. I think it would be surprising. I think one of the challenges when you get into NT2 and IH populations is, the science underlying the etiology of the disease is a little unclear. In many ways, it's hard to You can't just use a standard biomarker to say a patient's going to be responsive or non-responsive or need an afternoon split dose. Blair JacksonCEO at Alkermes00:53:06Again, we'll learn in the NT2 study, and it may just be that after this study, doctors are going to have to empirically decide, see how their patients respond to the once-daily dose, and then move them on to split dose if it's required. But the data will tell us, and we'll adapt from there. Ami FadiaAnalyst at Needham & Company00:53:23Got it. Operator00:53:27Our next question comes from Andrea Newkirk with Goldman Sachs. Please go ahead. Analyst at Goldman Sachs00:53:33Hi, this is Morgan on for Andrea Newkirk. Thanks for taking our question. For ALKS 7290 in MDD, given antidepressants typically fail to address residual fatigue and anhedonia, what magnitude of difference on MADRS do you consider clinically meaningful for this novel mechanism? Thank you. Blair JacksonCEO at Alkermes00:53:55Yeah, it's interesting that as you look at the MADRS scores and you look at things that are out there, I think typically people see a change versus placebo of somewhere between two and five as being a meaningful difference on MADRS. In fact, the drug that's out now, AUVELITY, which only had a 3-point change, 3.5-point change or so relative to placebo, has strong uptake because it has unique characteristics. So it has, A, a different mechanism, and B, it has a rapid onset. I think as you look at the MDD space, there's a number of areas where you can provide improvement, cognition, anhedonia, fatigue, as you alluded to. We've seen things like cognition and fatigue benefits in some of our other trials. Blair JacksonCEO at Alkermes00:54:50I think the goal for us is to be able to show a statistical difference between placebo as part of MADRS, understand the domains of where we see response. If we can show something that is different, that provides a different, a broader profile than you see with the SSRIs, SNRIs, I think there is a lot of opportunity there. Because remember, this is adjunctive therapy. About 40% of these patients have an inadequate response. I think there is a lot of room for improvement for these patients. Analyst at Goldman Sachs00:55:23Thank you. Operator00:55:27Our next question comes from Jason Gerberry with Bank of America. Please go ahead. Analyst at Bank of America00:55:33Oh, hey. This is Chi on for Jason. Thanks for taking our question. I have a follow-up on the expectation for Vibrance-3. What do you expect to see from the data for advancing the program to phase III? Is it driven by whether the study meeting the primary endpoint? What do you want to see as differentiator relative to on-market offerings such as oxybate? Do you want to see sort of magnitude of benefit on ESS or IHSS for the IH study? Just quickly as a follow-up, on your earlier commentary around expecting to see a similar response as in the Vibrance-2 study, is that commentary related to QD dosing in ESS scale as we think about the overlapping elements between Vibrance-2 and Vibrance-3? Thanks so much. Blair JacksonCEO at Alkermes00:56:28Yeah, I mean, there's a lot in your question there. I think as you look at the Vibrance-3 study, as you look at it, obviously our endpoints are ESS and IHSS, and we want to be able to show a benefit within there. And for us, a phase II study, remember, is about trying to ensure and understand your signal. It's trying to understand your signal relative to your safety profile, and can you design your phase III trial in order to get over the line, show the statistical significance, show a benefit to those patients? Obviously, we want to hit statistical significance as part of our phase II study if we can. If we were to fall a little bit short, does that mean we would stop the program? No. Blair JacksonCEO at Alkermes00:57:10As long as we feel that we have an appropriate signal, that trial design would be able to overcome. That being said, when we look at our early treatment within this patient population, remember we had a once-daily dosing, similar to what we did with the NT2 population. We saw a similar effect size between NT2 and IH. So our hope is that we see something similar. We hope that we'll provide additional benefit through the split dosing, and that we'll be able to then design our phase III, meet with the agency, and then move that into our phase III program. With regards to my previous comment, with regards to Vibrance-2 versus Vibrance-3, what I'm really just trying to say is that there's a lot of heterogeneity in the patient populations, both in NT2 and IH. There's also a lot of overlap between diagnoses. Blair JacksonCEO at Alkermes00:58:05Patients move between an NT2 diagnosis and an IH diagnosis, sometimes frequently. So, I would expect that there's an overlap of population there, and that if you have a similar population, that the once-daily drug would perform similarly, with the caveats that I mentioned earlier, that you have this other patient group in there that we're going to be learning about, the long sleepers. So again, what I'm hoping is that we've designed the study in a way where we can learn what we need to from this program and move forward quickly into phase III. Analyst at Bank of America00:58:42Thank you. Operator00:58:46Our next question comes from Luke Herrmann with Baird. Please go ahead. Luke HerrmannAnalyst at Baird00:58:51Hi, team. Thanks for the question. Just to follow up on the orexin and oxybate dynamic, given the view that orexins and oxybates can be complementary by HCPs, and that's intuitively sound that they can be complementary, but I guess what is your early thinking on payer dynamics if a set of patients could theoretically be in position to step up from one to two branded therapeutics? Todd NicholsChief Commercial Officer at Alkermes00:59:14Yeah, Luke, this is Todd. I'll take that. We're spending a lot of time right now talking to payers overall. As you know, the access profile for oxybates and for LUMRYZ is quite strong at north of 80%, and we don't see that changing over time. There's a significant value to HCPs and to patients. I think a lot will be determined pretty quickly here when we see what the pricing dynamic looks like for the Takeda product overall. As you know, there's a lot that goes into pricing, and one of the considerations that we will be thinking through is not only just the overall value of alixorexton with a very broad label and how we plan to differentiate, but also making sure we take into consideration what the reimbursement profile looks like. Todd NicholsChief Commercial Officer at Alkermes01:00:11Our expectation is that we will put forward a profile and a pricing dynamic that will allow broad access to both products. Operator01:00:24Our next question comes from Douglas Tsao with H.C. Wainwright. Please go ahead. Douglas TsaoAnalyst at H.C. Wainwright01:00:31Hi, good morning. Thanks for taking the questions. On ALKS 7290 in MDD, I was curious, it sounds like you are looking into the drug's effect on some of the specific domains of the MADRS. I am curious, are you looking at things like SHAPS? Because I think there is a rationale to think that an orexin could have an effect on anhedonia, and obviously that is a more refined measure of looking at that specific aspect of the disease. Thank you. Blair JacksonCEO at Alkermes01:01:02Yeah, I mean, I think as we move forward in the program, we are going to be looking at a lot of different things. I think for the ongoing study right now, our primary is on the MADRS. Yes, are we looking at the individual domains? Of course we do, but we are designed to look at the overall response overall. So, our goal here is to really show whether or not we see an overall effect size, understand the patient population, and then as we move into the next phase of the program, we will dive deeper into some of the areas that we see. Operator01:01:34Okay. Our last question comes from Ben Burnett with Wells Fargo. Please go ahead. Analyst at Wells Fargo01:01:43Good morning, team. This is Orpheus on for Ben. Congrats on the progress. I had another question on oxybate plus orexins. You've described this as complementary, and we've also heard similar feedback from KOLs. With that in mind, could you remind us of your plans to generate data of an orexin agonist in combination with an oxybate? If you do run such a study, would your oxybate of choice be LUMRYZ or valiloxybate? Thank you. Blair JacksonCEO at Alkermes01:02:11I think it's a great question, and actually, we do want to generate a lot of data with oxybates and orexins together, because just like you're hearing, we're hearing from our patients that that would be desirable to be able to have a nighttime treatment with an oxybate and a daytime treatment with an orexin. We want to be able to support that. We want to support patients and doctors in how to use it, how to use it safely, and also to prepare, to support it and show those benefits. That being said, what we want to make sure is that we do those studies as we're further along in the registration program. We don't want to put our core registration program at risk, so it'll take a little time, and we will move to that. Of course, we will use LUMRYZ as the comparator. Blair JacksonCEO at Alkermes01:02:57We think that's the dominant drug moving forward, and that's what we'll want to show. Analyst at Wells Fargo01:03:04Thank you. Operator01:03:08We have reached the end of our question-and-answer session. I would now like to turn the floor back over to Sandra Coombs for closing comments. Sandra CoombsSVP of Investor Relations and Corporate Affairs at Alkermes01:03:16All right. Thanks, everyone, for joining us on the call today. If you have any follow-up questions, please do not hesitate to reach out to us at the company. Thank you. Operator01:03:28This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.Read moreParticipantsExecutivesSandra CoombsSVP of Investor Relations and Corporate AffairsBlair JacksonCEOTodd NicholsChief Commercial OfficerJoshua ReedCFOAnalystsLeonid TimashevAnalyst at RBC Capital MarketsAnalyst at StifelGraig SuvannavejhAnalyst at Mizuho SecuritiesAnalyst at JefferiesRudy LiAnalyst at Wolfe ResearchDavid AmsellemAnalyst at Piper SandlerAnalyst at JPMorganDavid HoangAnalyst at Deutsche BankMarc GoodmanAnalyst at Leerink PartnersAnalyst at TD CowenAlex NackenoffAnalyst at Truist SecuritiesUmer RaffatAnalyst at Evercore ISIAnalyst at UBSAmi FadiaAnalyst at Needham & CompanyAnalyst at Goldman SachsAnalyst at Bank of AmericaLuke HerrmannAnalyst at BairdDouglas TsaoAnalyst at H.C. WainwrightAnalyst at Wells FargoPowered by