Alkermes plc. (ALKS) Q2 2026 Earnings Call Transcript

Greetings. Welcome to Alchemy's second quarter 2026 Financial Results Conference Call. My name is Sherry. I will be your operator for today's call. All participants will be pleased to unmute to prevent any 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.

Good morning. Welcome to the Alchemist PLC conference call to discuss our financial results and business update for the quarter ended June 30, 2026. With me today are Richard Pops, our CEO, Joshua Reed, our Chief Financial Officer, Todd Nichols, our Chief Commercial Officer, and Blair Jackson, our Chief Operating Officer and incoming CEO. A slide presentation along with our press release, related financial tables, and reconciliations reconciliations of the GAAP to non-GAAP financial measures that we'll discuss today are available on the Investor 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. Please 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 statement. 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 development. After our prepared remarks, we'll open the call for Q&A. Now, let's turn the call over to Richard for some opening remarks.

That's great. Thank you, and good morning, everyone. So a few months ago, we announced that I would be handing the CEO reins to Blair while continuing to serve as chairman. That transition becomes official next week, making this my final earnings call as CEO. When we made that announcement in February, it reflected my confidence in the strength of Alkermy's leadership team and how effective we've been in positioning the company for its next major phase of growth. At the time, we had a strong sense of what the coming months could bring, and I'm pleased to say that many of our most optimistic expectations have become reality. So what does that mean in practical terms? I think most notably, Alkermy's leadership position in orexin development is now quite clear. While our initial focus is on disorders of hypersomnoense, such as narcolepsy and idiopathic hypersomnia, we increasingly see orexin as a platform with the potential to address a broad range of serious conditions where this neurocircuitry plays an important role, such as ADHD, fatigue, and other potential psychiatric, neurodevelopmental, and neurodegenerative diseases. Elexorexin is at the leading edge of that opportunity. It remains the only Erexin-2 receptor agonist to have demonstrated efficacy and tolerability across both narcolepsy type 1 and narcolepsy type 2 in large phase 2 studies. Importantly, its clinical profile has shown benefit beyond improvements in excessive daytime sleepiness, with evidence of meaningful effects on cognition and fatigue as well. We've continued to share these findings, presenting the first Phase II data set in narcolepsy type 2 at the sleep meeting in June, and most recently, the top-line results of an interim analysis of our elixorexin long-term extension study in NT1 and NT2, which demonstrated sustained improvement in wakefulness and other measures for up to nine months of treatment. Today, we're actively enrolling patients in our Phase III narcolepsy program, which remains on track for expected completion next year. At the same time, we're advancing elixir-rextrin in idiopathic hypersomnia in our Vibrance III Phase II study. Vibrance III adds a new element to the program with a split-dose arm. The split-dose regimen is designed to extend the pharmacodynamic effects of elixir-rextrin later into the day and expand our competitive profile as we seek to meet the spectrum of needs of individual patients. We've now introduced two additional Erexin compounds into clinical development, each exploring a new avenue of potentially significant commercial and medical opportunity. AUC 7290 is currently enrolling adults with ADHD, with initial Phase 1B clinical data expected by the end of the third quarter. ADHD represents one of the largest and most compelling potential applications of Erexin biology, and we look forward to getting our first insights into its activity in this population. In addition, AUX 4510 is planned to enter Phase II in fatigue later this year, initially focused on patients with multiple sclerosis or Parkinson's disease. Fatigue remains one of the most debilitating and poorly treated symptoms across a number of neurological disorders, and we expect initial data from this program next year. Our advantageous competitive position has become increasingly evident. Today, Alchemist is setting the pace in orexin biology, with a robust and expanding foundation of clinical evidence in narcolepsy, and now generating new data sets across a number of development candidates in disease states. The result is an R&D pipeline with both depth and momentum, and we enter the second half of the year with a series of meaningful clinical readouts ahead of us. But there's more to Alchemist than the pipeline. We've built a significant commercial business that serves hundreds of thousands of patients, generates substantial cash flow, and provides a foundation that allows us to invest for the future. And here, too, a number of important developments have unfolded, largely as we anticipated they The first relates to Libalvi, or oral antipsychotic medicine. For several years, we've been pursuing a deliberate strategy of steadily expanding access while carefully balancing the economics of our gross to net profile. This past quarter marked an important milestone in that effort. Through new contracting arrangements that we believe will help drive increased uptake of Libalvi, we expanded access strategically with three of the largest Part D plans, where Libalvi is now on formula. With this expansion, Libalvi is now covered for more than 80% of insured lives. That level of access means that patients who may benefit from Libalvi have a better chance of getting it, and importantly, provides a strong platform for continued prescription growth in the years ahead. The second relates to Vivitrol, our longstanding medicine for the treatment of alcohol and opioid dependence. Given its unique clinical profile and the distinct treatment settings in which it's used, we have always believed that Vivitrol would have a long commercial life. Today, more than two decades after its launch, Vivitrol continues to grow. So, earlier this month, we announced the termination of our agreement with Amnil for an authorized generic of Vivitrol. So, we can say now conclusively that there will be no AG for Vivitrol in 2027. As we've discussed many times before, Vivitrol's manufacturing requires specialized sterile facilities and formulation expertise. This has created meaningful barriers to entry, as evidenced by the fact that today there remains only one approved ANDA. And as we look ahead to 2027, the actual timing of that generics market entry remains uncertain. So we see Vivitrol continuing to be a strong contributor to our commercial business in the years ahead. The third major development has been the acquisition and integration of Avidel and the LoomRise brand. As reflected in today's results, the integration of the Avidel team and the LoomRise business has proceeded exceptionally well. In fact, as we've gained experience with the medicine and the impact it can have on patients, our enthusiasm for its long-term potential has only increased. Importantly, last quarter we reported positive Phase III results for LUMRISE in idiopathic hypersomnia, positioning us to pursue an SNDA submission and, if approved, a launch in that indication in March 2028. Taken together, these developments underscore how substantially Alchemist has evolved. From a standing start in sleep only a few years ago, we've become one of the leading companies in hypersomnolence disorders, with both a growing commercial presence in narcolepsy and a differentiated research and development platform. More broadly, we believe the biology underlying sleep and wakefulness represents one of the most compelling frontiers in neuroscience, with opportunities that may extend well beyond today's approved therapies and well beyond narcolepsy. We expect this to remain a fertile area for innovation and drug development for many years So as I reflect on where the company stands today, I would say that much of what we had hoped to accomplish has begun to take shape. Our commercial business is strong. Our pipeline is advancing. Our scientific leadership has never been more apparent. It's exciting. So I'll end my prepared remarks from my last earnings call on a note of great optimism and appreciation for the remarkable opportunity this company has provided me. And with that, I'll turn the call over to Todd for a review of the commercial results.

Thank you, Rich, and good morning, everyone. I'm pleased to report another quarter of strong commercial execution. During the second quarter, our teams remain focused on supporting patient access, driving demand for our commercial products, and delivering strong performance across addiction, psychiatry, and sleep medicine. In the second quarter, net sales from our proprietary product portfolio increased 34% year-over-year to $411.7 million, reflecting solid demand across our psychiatry and addiction portfolios and our first full quarter of commercial contribution from Loom Rise. Starting with Vivitrol, net sales in the second quarter were $124.5 million, reflecting solid year-over-year performance. Results were driven by growth in underlying demand in the alcohol dependence market, as well as approximately $4 million of gross-to-net favorability, primarily related to favorable patient mix. For the full year, we continue to expect Vivitrol net sales for 2026 in the range of $460 to $480 million. We remain confident in the strength and the durability of our Vivitrol business and look forward to expanding our impact with this important medicine. For our psychiatry franchise, in the second quarter, net sales for the Aristotle product family were $96.7 million. Results reflected solid underlying demand, as well as approximately $4 million of growth to net favorability, primarily related to favorable patient mix. We are encouraged by recent growth trends in the long-acting injectable antipsychotic space and Aristotle's performance in that market. For the full year, 2026, we continue to expect Aristotle net sales in the range of $365 to $385 million. The evolving net sales grew 12% year-over-year to $94 million. Underlying TRX growth was 18% year-over-year, driven by sustained momentum in new patient starts and continued expansion in prescriber breadth. Gross to net adjustments were approximately 36% during the second quarter. This quarter marked a meaningful step forward in the evolution of our long-term access strategy for Libavi. We significantly expanded Lubavi's access position during the quarter, with coverage now exceeding 80% of all insured lives, with notable access enhancements, particularly in the Part D channel. These access gains improve our competitive position and represent a strategic investment in the brand's long-term growth potential. We expect growth to nets to expand in the second half of the year, and for the full year, we now expect GTN adjustments in the high 30s. Underlying demand has remained strong, and we are maintaining our full-year guidance of LeBalbi net sales in the range of $380 to $400 million. Turning to our sleep franchise, Q2 marked the first full quarter following our acquisition of Avidel and the LumeRise brand. During the quarter, the team delivered strong performance and generated LumeRise net sales of $96.6 million. We exited the quarter with approximately 3,900 patients on therapy. Our strategic focus is on providing a strong access profile and driving adoption among prescribers while providing extensive patient support services. In addition to strong underlying demand, our Q2 results included approximately $7 million of benefit related to timing of wholesaler inventory shipments at quarter end. I'll discuss how we expect that to impact Q3 in a moment. For the full year, we continue to expect LoomRise to generate total net sales in the range of $350 to $370 million. Of this, we expect Alkermes to record $315 to $335 million, reflecting the mid-February close of the transaction. In sleep medicine, we have the unique opportunity to both grow the Lumerize brand while preparing for the potential future launch of Elixir-Rextin. We believe the combination of our commercial capabilities, deep expertise in central disorders of hypersomulants, in a differentiated portfolio encompassing both oxabate and orexin mechanisms uniquely positioned to Alkermes as a leader in sleep medicine. Looking ahead to the third quarter, excluding the GTM benefits for Aristotel and Vivitrol and the $7 million inventory fluctuation for LumeRise mentioned earlier, we expect net sales from the four proprietary products to be generally similar to Q2 levels in the range of $390 to $410 million. dollars. As we enter the second half of the year, we remain focused on discipline execution, supporting patient access to our medicines, and delivering sustained commercial performance across the portfolio. With a seizing commercial organization, a growing presence in sleep medicine, and significant opportunities ahead, we believe we are well positioned to drive growth and to create long-term value. With that, I will pass the call to Joshua to review the financial results for the quarter.

Thank you, Todd. In the second quarter, we delivered strong financial results driven by continued growth across our proprietary product portfolio, a full quarter of contribution from Loomrise, and disciplined execution across the business. Our diversified commercial portfolio and strong operating performance continue to generate meaningful cash flow and to provide flexibility to invest in our expanding development pipeline. Turning to our financial results, during the quarter, we generated total revenues of $496 These results reflect solid performance for our portfolio of commercial products and the first full quarter of financial contribution from Loomrise following the acquisition of Avidal. As Todd outlined, our portfolio of proprietary products generated net sales of $411.7 million. Manufacturing and royalty revenues were $84.3 million for the quarter, including $30.6 million from Vumerity, $27.5 million from the long-acting Envega products, and manufacturing revenue of $20.9 million related to risk at all consta. This represents the majority of our expected manufacturing revenues for CONSTA for 2026, and as such, we do not expect meaningful revenues from CONSTA for the remainder of the year. As we move into the third quarter, we expect Q3 total revenues in the range of $450 to $470 million. Turning to expenses. Costs of goods sold in the second quarter were $98.1 million, dollars, which includes the purchase price fair value accounting of Bloomrise inventory that we described last quarter. This compared to $49.5 million in Q2 of the prior year prior to the acquisition of Avidel. In the third quarter, we expect costs to be in the range of $85 to $95 million. R&D expenses in the quarter are $112.9 million compared to $77.4 million in Q2 of the prior year, reflecting continued advancement of our Erexin portfolio. That program has expanded to include a number of ongoing studies, including the Phase III Elixirexin Brilliance studies in narcolepsy, the Vibrance III Phase II study in idiopathic hypersomnia, and the ALCS 7290 Phase I-B study in ADHD and preparations for the Phase II study in ADHD, as well as clinical development activities supporting ALCS4510 as we prepare to enter into Phase II and fatigue later this year. In the third quarter, we expect R&D expenses to be in the range of $120 to $130 million. SG&A expenses were $217.6 million to the quarter compared to $170.8 million in Q2 of the prior The year-over-year increase primarily reflects the addition of the Avidel commercial infrastructure. As we look ahead to the third quarter, we expect SG&A expense to be fairly flat in the range of $215 to $225 million. We also recorded amortization of intangibles of $22.6 million and net interest expense of $20.6 million. In addition, we recorded a change in the fair value of contingent consideration of $26.4 million related to the CVR milestone associated with our acquisition of Avidel, which we deemed more likely to be achieved following the recently announced positive Phase 3 results for Loom Rise and IH. In Q2, we recorded GAP net income of $0.5 million and EBITDA of $49 million. dollars. Adjusted EBITDA was $139.2 million, which we believe is more representative of cash generated by the business during the quarter. Looking ahead to the third quarter, we expect adjusted EBITDA to be in the range of $80 to $100 million. For the year, we are reiterating our financial expectations across all line items, with the exception of gap net loss and EBITDA, which are impacted by the change in fair value of the contingent consideration that I mentioned earlier. We now expect gap net loss in the range of $95 to $115 million and positive EBITDA in the range of $75 to $95 million. Turning to our balance sheet, we ended the second quarter in a strong position with approximately $690 million in cash and total investment. Overall, we are pleased with our performance in the first half of the year. Our diversified commercial portfolio, strong balance sheet, and ability to generate meaningful cash flow provide flexibility to invest in our growing development pipeline while maintaining disciplined financial management. We remain focused on executing against our strategic priorities and believe we are well positioned to deliver on our objectives for the remainder of 2026. With that, I'll now hand the call to Blair.

Thank you, Joshua. As you've heard, we entered the second half of 2026 with strong commercial and financial momentum and continued execution across our development portfolio. During the first half of the year, we delivered important clinical and operational milestones that further strengthen our long-term growth profile. Starting with LUMRISE, as Richard mentioned, in May, we announced positive top-line results from the Phase 3 revitalized study in idiopathic hypersomnia. Based on these results, we plan to submit an SNDA for Lumerize in IH by year-end. If approved, this would expand Lumerize's growth opportunity into an additional area of significant unmet need, with a potential launch as early as March 2028. Turning to elixirextin, in June we presented detailed results from the Vibrance 2 study at the annual sleep meeting. This marked the first positive phase 2 data set for an orexin 2 receptor agonist in narcolepsy type 2 and one of the few studies conducted exclusively in this patient population. Importantly, it also provided the first look at the impact of orexin signaling on fatigue and cognition in patients with normal physiological levels of orexin. We were encouraged not only by the treatment effects observed across wakefulness, fatigue, cognition, and other patient-reported outcomes, but also by the response from the sleep medicine community to these findings. Collectively, the data broadened our understanding of the potential role of orexin biology in patients with normal orexin tone. Building on these data, earlier this month, we reported in-term results from the ongoing elixarexin long-term extension study, or LTE. This is the first long-term study of an orexin 2 receptor agonist to demonstrate sustained clinically meaningful improvements from baseline in wakefulness and excessive daytime sleepiness across both NT1 and NT2. We view these data as highly clinically relevant, and there are a number of important elements to this data set. First, we observe durable improvements in wakefulness, cognition, and fatigue for up to nine months of treatment with sustained effects over time. Given that narcolepsy is a lifelong disease, durability is a critical attribute for any potential long-term therapy. Second, the magnitude of benefit remained impressive with up to nine months of treatment. Overall, across measures of wakefulness, cognition, and fatigue, most participants were severely symptomatic at baseline. At week 24 of the LTE, most patients across all doses had cognitive functioning scores within the normal or mild range, and mean fatigue scores were within the normal range. Across all dose groups in both NT1 and NT2, elixirexin sustained clinically meaningful improvements from baseline in mean wakefulness. We believe this is one of the most compelling aspects of the Elixarexin Profos. Finally, data from week 24 of the LTE generally demonstrated further improvement in mean wakefulness on the maintenance of wakefulness tests and Epsworth sleepiness scale relative to the results observed during the randomized phase 2 studies. During the first four weeks of the LTE, dose adjustment was permitted, providing flexibility to meet individual needs across narcolepsy patients. This has important potential implications for clinical practice. Narcolepsy is a heterogeneous disorder with a spectrum of disease severity and sensitivity to Erexin-2 receptor agonists. In a real-world setting, we believe providing a range of dose options would give physicians flexibility to tailor treatment to individual patients and would be an important element of Elexorexin's competitive profile. Taken together with the general safe and well-tolerated profile demonstrated in this interim analysis of the extension study, these data strengthen our confidence in elixerexin's potential to become a cornerstone treatment for narcolepsy. As the body of evidence continues to grow, we believe elixerexin is well-positioned to help transform the treatment of narcolepsy and address significant unmet needs for patients living with NT1 and NT2. Operationally, we've continued our strong focus on clinical execution. The Brilliance Phase III studies in NT1 and NT2 are active and enrolling, and we are pleased with the progress across the program. In idiopathic hypersomnia, enrollment in the once-daily dosing cohorts of Vibrance III has been completed, and the split-dose cohort is actively enrolling. We continue to expect completion of that study in the fourth quarter. Turning to ALK7290 and adult ADHD, we have made substantial progress in our Phase 1B study, and we now expect top-line results by the end of the third quarter. This randomized, placebo-controlled study is designed to enroll approximately 50 adult patients to establish initial clinical proof of concept for ALK7290 in ADHD. PhD. Participants will receive two weeks of treatment with ELK 7290 or placebo. This study will assess the safety and tolerability of ELK 7290 along with the effects of treatment on translational measures including quantitative EEG and certain neuropsychological performance measures. These assessments are designed to evaluate sustained attention, vigilance and impulse control in a short duration study. While the study is not powered for statistical significance, we will also assess changes from baseline on established clinical ADHD scales, including the Adult ADHD Investigator Symptom Rating Scale, or AISRS. Importantly, we expect these data will represent the first clinical evaluation of an orexin-2 receptor agonist in patients with ADHD. In parallel, we continue preparations for a larger Phase 2 study and expect to begin enrollment in that study this quarter. Finally, turning to ELKS 4510, fatigue represents another potentially significant opportunity for orexin biology. Our initial strategy is to evaluate fatigue in well-defined patient populations where symptom burden is substantial and meaningful unmet needs remain. Our first Phase 2A study will enroll participants with fatigue associated with multiple sclerosis or Parkinson's disease, providing an important opportunity to evaluate the impact of Erexin signaling in these disease states. In this placebo-controlled randomized double-blind study, we plan to enroll approximately 175 participants with multiple sclerosis or Parkinson's for four weeks of treatment. As we look for signal and prepare for later stage clinical studies, the Phase 2a represents an important opportunity to evaluate a number of established fatigue scales, including the Modified Fatigue Impact Scale, or MFIS, which is commonly used in patients with MS, the Parkinson's Disease Fatigue Scale, or PFS16, the Fatigue Severity Scale, as well as the PROMIS Fatigue Scale that we implemented in the Elixir-Rextin Narcolepsy Development Program. As we advance into this area of development, we also plan to engage with the FDA regarding study design and a development pathway. More broadly, we believe fatigue represents a large and underserved category where meaningful innovation is needed, and we are excited to begin exploring the potential of this mechanism in that setting. We've built the industry's most comprehensive portfolio of orexin-2 receptor agonists and are now advancing that science across multiple indications where meaningful unmet need remains. The progress we've made over the past year has increased our confidence, not only in Elexorexin, but in the broader opportunity to leverage Elexorexin biology beyond narcolepsy. So as I prepare to take on the responsibilities of the CEO role next week, my objective is Deliver on the tremendous opportunities ahead of us, focusing on what matters most, operating with discipline and executing with excellence. Under Richard's leadership, Alcremis has grown into a company that has profoundly impacted the lives of countless patients, a company of which we are all immensely proud. As the continuing chairman of our board of directors and a trusted advisor, I'm grateful for Richard's ongoing contributions to the company and know he will continue to play an important role in supporting our future success. With that, I'll turn the call back to Sandy for the Q&A.

We'll now turn the call over for Q&A. Thank you. If you would like to ask a question please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. And for participants using speaker equipment it may be necessary to pick up your handset before pressing the star keys. We ask that you please limit to one question and one follow-up question. One moment while we poll for questions. Our first question is from Omer Rufa with Evercore ISI. Please proceed.

Hi, guys. Thanks for taking my question. I just wanted to focus on ADHD for today's question. And specifically, here's the couple things I want to touch up on. One, I think you've mentioned it's 50 adult patients in an ongoing study that's going to be reporting later this year. How are you thinking about the translatability from adults over to pediatrics. My understanding is pediatrics is a must for any ADHD drug development. So that's one. Secondly, I think you also mentioned it'll be like a two-week endpoint. And I'm just trying to think about, I know tachyflaxis was something that you were definitely able to overcome in the narcolepsy setting. I'm just trying to think about the ADHD endpoints and whether two weeks and translatability six weeks given the and Mechanism Act and how you're thinking about that and whether there will be a follow-up. And then finally, is it safe to assume that among the neuropsych performance measures you're evaluating, we will have AISRS for adults in there as well?

Morning, Amir. This is Blair. Thanks for the questions. Yeah, look, I think as you look at the market as a whole, pediatrics is obviously very important. What we do, though, is start with adults, and we'll do the first part of the program in the adult population. That's highly translatable into adolescents and children, and the way you typically handle that is by doing some bridging PK, and then you move into your later stage programs, including those patient populations. So we have that well in hand, and we'll move forward once we have the dose ranging figured out for the adult populations. And remember, we'll get the dose ranging predominantly from our larger Phase II study that will come out from next year. The study that we get this year will be our translational study, our Phase I-B study that we'll have by the end of the third quarter. With regards to the endpoints, you're exactly right. The two-week endpoint that we have in the Phase I-B study is shorter than you'd typically have in a dose ranging study. And that just really reflects the fact that this is predominantly a safety and a translation study. And so what we'll be doing is looking at a lot of different markers, both from EEG, behavioral markers, as well as some of the typical tools that you see. And we will include AISRS as part of that. So, we'll be able to really get a comprehensive sense of whether or not we're engaging the target, you know, sort of some of the effect size, but we're also looking for dimensionality of the response. Are we seeing things other than what you see with the typical assets that have been tested in this space using this new mechanism? So, we're really excited to see what learnings we can bring from this study.

Thank you, Blair.

Our next question is from Paul Matias with Stiefel. Please proceed.

Hey, thanks for taking my questions, and Richard, congrats on the transition, and Blair, congrats to you as well. Another one on ADHD, can you maybe just talk a little bit about how you selected the doses for this study? You know, obviously, you can't look at, like, receptor occupancy, so how confident are you that you're in the right sort of range here in the 50-patient POC study? And then, as you think about other non-sleep indications, like something like MS fatigue, fatigue, you know, where are we with establishing the regulatory path there? And what are some of the kind of different endpoints you're kicking around that you think the FDA could be receptive to? Thank you.

Sure. Hey, Paul. I think on the selection of doses, so as you mentioned, 7290 is a new asset. So it's a molecule that stands on its own. It's been through a full SADMAD program. And we took a similar path to selecting doses that we did with the original work with elixir extin, whereby we used EEG and target engagement as a way of assessing what range we wanted to be in. That gives us a pretty good sense of where we're engaging the system. I think what's unknown still is a little bit of the response and the pharmacology related to attention versus what we see with, say, wakefulness in an elixir-extin system. So part of our strategy here is if we see that we're slightly high or slightly low in the range out of the 1B study, we'll have an opportunity to tuck in additional doses on the higher or lower end. We think we've got it in a good range, but we have that flexibility if need be. With regards to our other areas, specifically MS fatigue and 4510, as I said in the prepared remarks, I put in some of the endpoints or some of the tools that we're using as part of that study, and that's really getting at what you were asking about, which is establishing a regulatory pathway with the agency, and what we're trying to do here is make sure that we can find a scale that best represents how fatigue is described by patients across multiple areas, such as multiple sclerosis or Parkinson's disease, and align with the FDA on that tool moving forward for the regulatory path. So this 4510 study is going to be important in establishing that.

Our next question is from Leonid Timoshev with RBC Capital Markets. Please proceed.

Hey, guys. Thanks for taking my question. I just wanted to ask sort of how you're viewing the orexin commercial landscape and specifically maybe what your latest thinking is on pricing and how much of that strategy might be driven by, you know, how the competition evolves versus sort of what you're seeing as the intrinsic value of the molecule as sort of you continue to develop it in NT1, NT2, and IH. Thanks.

Yeah, I think as the market evolves, you know, pricing is one of the things that we're going to learn over the next little while. With Takeda coming into the marketplace first, I think they'll be definitely establishing a price corridor for the class. And as you know, this is a mechanism where we've seen really outside effects relative to the current standard of care. So it's really meaningful impacts to patients and their lives potentially. And so So we'll see where Takeda ends up pricing, and then, you know, based on that, we'll look to establish our own price strategy as we complete our program. As we've said before, I think we're going to bring a lot of potential options to the table with the program that we're developing with Elixirextin, multiple doses, a range of doses that patients can use according to their own individual needs, but also a split-dose option, which will allow for flexibility in dosing commercially as well. And then, assuming the data comes through, that will be across all different hypersomnia indications, NT1, NT2, and idiopathic hypersomnia. So I think all of that will go into our determination of price moving forward, but we think from a patient perspective, we're in a really good place of delivering a lot of value over the next few years.

Our next question is from Akash Tawari with Jeffries. Please proceed.

Hey, thanks so much. And congrats, Richard. It was really great working with you. So any lessons from the TRISCRL for their once-nightly low sodium oxybate, do you feel like you'd be able to file on PK data? And where do you currently stand with your program? And then maybe stepping back, Richard, can you talk a bit about what's going on with Globe and Guard and the impact it could have on MidCap Biotech? Is the perception that there's limited dialogue with these companies in the administration true? And do you think these programs will ultimately get implemented. Thank you.

Why don't I start with the Vox question and then I'll turn it to Rich on the second question. I think as we look at our low to no salt option that we're developing, which we call our Vox program, we're taking an approach where we're taking multiple formulations into the clinic and looking at them this year. And the goal here is to establish a bioequivalence pathway if possible. That'll be our fastest path to market potentially. If we're able to do that, then that would allow us to do a PK bridging study and move forward with a broad label. I don't think that the TRS-CRL really impacts that in any way. I think TRS has its own idiosyncratic safety and efficacy questions that it needs to answer. I think for us, it's a pretty straightforward path if we're able to achieve bioequivalence. We have a robust package with the LUMRISE data set that we can leverage, and I think the molecule that we're using on the Vox program looks really good. So we'll see how that data comes out, and we'll give you guys some information on that once that's available.

And Akash, it's Rich. You know, briefly on Globe and Guard, these are the CMMI demonstration projects that are currently in front of the OMB, with an expectation of perhaps a final rule fairly soon. Both of them are ways of essentially building in reference pricing to foreign markets into the Medicare and Medicaid programs. They're probably directly in violation of the existing statute. So I think there's a lot of energy in the Congress and also just direct lobbying with HHS and the administration about modifying these or not proceeding to the final rule. To the extent there's a final rule issued, I think there's still a fair amount of litigation that will go forward. For midsize companies, it's actually quite important because many of the big companies have a large portfolio that they can sort of craft deals around, whereas many of the midsize companies depend on one or two products only. And to the extent they have a foreign reference price, it can be really important for their And I think policymakers have been very receptive to that message. Just to be clear, for Alkermes, we don't have foreign reference pricing. We don't sell our drugs at a lower price outside the U.S., so it's not an issue for us. But for the industry writ large, it's actually something people are paying a lot of attention to.

Our next question is from Joseph Thume with TD Callen. Please proceed.

Hi there. Thank you for taking my questions and adding my best wishes to Rich and Blair on the upcoming transition. Maybe switching to IH for Alex Rexton, I guess, what should we think about as the goal for later this year? Is it getting patients to below 10 on ESS? Maybe how can we extrapolate the results that you saw in the NT2 population over to IH, given that there is some similarities in this population, but also you have the incorporation of the BID dosing? And then maybe your competitor, Takeda, has indicated some expectations on scheduling for their compound. I guess, how are you thinking about scheduling of elixiraxin and maybe what studies have you done to support that?

I'll start then. Blair and Todd can jump in. I think our expectations for the IAH are informed by the success that we had with NT2, given the fact that two populations overlapped to some extent. They're both characterized by a lot of variability. So, what we want to see in the Vibrance 3 study is a couple of things. We want to see evidence of the activity of elixiraxin in this diverse patient population as measured primarily by ESS and IHSS. We're using MWT simply as another marker because we've used it in other studies, recognizing that it's not used as an approval endpoint in IH, but it also gives us a tool to look at the benefits of the split dose, and so we're testing the split dose in the IH population to see whether we can see just numerical changes in the IH-MWT by splitting the dose one in the morning and one later in the day. So what we're hoping to see, and our expectation is to see evidence of activity, a sense of dose, so we can design and size the Phase III program. With respect to CADA, they've been talking publicly about potential scheduling at Schedule IV, which is within our planning scenario, and that won't be a commercial impediment at all. So, Blair, Todd, yeah.

Yeah, as Rich said, I think IH is a really interesting market overall, and I think, you know, to the extent that we can have an effect within that patient population, I think that's going to be really, really important to that group. There's really only one approved product there right now on a branded basis, and I think bringing orexin into that class is going to be very, very attractive. And as Rich said, our whole focus here is about identifying the signal to design our phase three to get the most robust label possible, and that's what we'll be looking for.

Great, thank you. As Rich said, all of our research points to HTPs don't see this as a barrier to entry for a product.

Our next question is from David Amasalem with Piper Sandler. Please proceed.

Thanks. So a bigger picture question on orexins. When Lily bought Sintessa, they talked very clearly about multi-indication potential. Obviously, you have a lot of irons in the fire, but can you talk about how you're thinking about even more indications for your orexins and when we can get more updates on potential additional clinical programs? So that's number one. And then number two on Vivitrol, do you think that any generic competition whatsoever will materialize next year? I've noticed on the FDA website that Teva's generic is listed as, quote, discontinued. So just wondering, I know, Richard, you alluded to it being a fluid situation, but are you expecting any generic competition, any entrance on Vivitrol whatsoever next year, given that?

Hey, David, it's Rich. You know, it's so interesting, and I referred to it in my opening comments, is that things are playing out largely the way that we would have hoped that they would have played out in both the orexin space and in the Vivitrol space. So I think it's really gratifying to see Lily and others talking about the potential breadth of applications of the orexins. Because remember, when we started this a couple of years ago, that was a gleam in people's We're still trying to figure out the pharmacology, the tolerability, the overall efficacy levels. And now I think it's almost taken as a matter of proven science that these drugs are quite effective in driving wakefulness in patients with and without orexin tone in their brain. We are, as you know, active in ADHD and fatigue in multiple domains, and we're not going to describe at this moment some of the other areas that we're going, but we do have a number of other ideas as well as other compounds in development. With respect to Vivitrol, you know, Vivitrol has always been a bearer of a product to manufacture. It requires unit operations that most generic companies just don't have. There's a sterile processing of microspheres and sterile filling of dry powders and so on. We terminated the amineal deal earlier this year, so there won't be an authorized generic next year. And at this moment, we don't plan on a generic entering in 2027. We don't have perfect visibility in everything, but in terms of the way we're going to plan our business for 2027, we're not anticipating a generic.

Our next question is from David Huang with Deutsche Bank. Please proceed.

Hi there. Congrats on the transition, the upcoming transition, and thanks for taking my questions. So I just wanted to ask first on, I guess, latest thoughts, maybe around the relative market size and opportunity for NT1, NT2, and IH? And I think, you know, the thinking is maybe the IH market is perhaps bigger than, you know, some of the epidemiology historically has suggested. And, you know, would you agree with that? And then in terms of LUM rise, if you could just talk about some of the, you know, the underlying maybe patient demand trends that you're seeing there. Thanks so much.

Yeah, David, hi. I'll take that one. We would agree with your statement. Significant unmet need, NT1, NT2, but also all of our research really points to significant unmet need with NIH. As we've said in the past, there's about 40,000 patients right now. We think that's actually likely undersized, and there's only one approved product on the marketplace. And when we do our research with HCPs and patients, we see a really significant unmet need there, which provides a great opportunity eventually for LumRise and also for Elixir-Rex, and so something that we're excited about. LumRise had a great quarter. Q2 was really strong, as you saw in the results. Overall, 3,900 patients on therapy, which is a really nice growth trend, quarter over quarter, year over year. In fact, year over year, that's a 25% growth in patients, and that's really being driven by HCP TRX breadth. We continue to see expanding breadth. In fact, HCP breadth year-over-year grew by 24%, and it's really driven by strong patient mix, and so it's a really diverse profile. It's new to Oxabate patients. It's switched patients coming back into the mix overall, and so we're really encouraged with the underlying demand and the metrics that are supporting that.

Our next question is from Oye Iyar with Motsuho Securities. Please proceed.

Hey, guys. Yeah, thanks for taking our questions. And Rich, congrats on making the transition. and maybe just help us sort of understand potentially the implication from the CADA readout that we expect this year. Would you be able to, you know, I guess if our understanding is that it's twice, it's BID dosing, and if the readout for NT2 is positive or NIH is positive, how should we kind of perhaps interpret what that means with respect to your split dosing program and the IH readout later this year? Thanks.

Rich, I don't know if I completely understand the question, but I'll give you my interpretation of what you're asking. Takeda is going to get approved for only NT1 for a drug 8.6.1 that is dosed at the 2.2 dose as their anchor dose. And that's the extent of the commercial launch that will happen this year. They have other drugs in development. We've not seen any data on those and they're way behind what we're doing. We're range of doses from once daily to split doses to provide the flexibility that we know patients will want as they introduce this, as they get introduced to this new pharmacology. So I think one of the things that's happened over the last year is that our leadership position in the disease of hypersomnolence has become more clear. I think at this time last year there was still speculation about other players, are they going to be faster or slower than us, what their data were going to look like now. Takeda is going to come first, and we're going to come next with a broader offering. So anything that comes behind us is going to have to figure out how to compete with our profile. And our profile, we think, is the best in class right now, and it's the most advanced.

Our next question is from Jessica Frye with J.P. Morgan. Please proceed.

Thanks for taking our questions. This is Jose on for Jess. I have to do an ADHG. I'm curious about how you're applying learnings from narcolepsy and your other programs to design an ADHD detration strategy, particularly given that standard ADHD therapies are used across a wide range of doses in dosing schedules. And second, how do you think class effects such as polycuria would play out in this patient population? Thank you.

This is Blair. Thanks for the question. I think as you go into ADHD, it has many of the similar characteristics that we see within diseases of hypersomalance with regards to a need for long-acting dose options, dose options that will last throughout the day, as well as opportunities for some flexibility for patients. And I think there's a lot of learnings that we take from the work that we've done in NT2 and NT1 that will inform on that. I think from the wide safety profile that we've seen and the wide therapeutic window, we don't anticipate that a titration is going to be required for any sort of safety reason. Remember, we saw in our NT2 study that the drug in this mechanism was tolerated really well with patients who had an intact orexan tone, which is what we see as kind of the platform that we'll be launching into in all of these other indications outside of diseases of hypersomnolence. So it then comes down to just sort of normal drug development in sort of looking at what other AEs you bring to the table. I think, as you said, polychuria is something that we've seen in our hypersomnolence program, and that comes with a certain engagement of the Rexin system. We're not sure if that will come into play at the levels of dosing that we're going to need for ADHD. We'll assess that as we go forward. What we've seen, though, at least in all of our clinical programs, is that the polychorea that we see is really an increased frequency of urination that's noticed by the patient. It's usually mild. It can be moderate, but it doesn't tend to lead to discontinuation or dissatisfaction. to action. So I think all in all, if we see a similar profile to what we've seen in our existing programs in ADHD, we'll be quite happy. But the data will speak for itself when we get it.

Thank you.

Our next question is from Rudy Lee with Wolf Research. Please proceed.

Thanks for taking my question. Just a quick follow-up for the Lumerize growth trajectory. Can you provide additional color on the key growth drivers across different patient segments and regarding potential impact of oorexin entry and maybe talk about recent market research and pair discussions for potential combo use of oorexin plus oxibate? Thanks.

Yeah, sure. So, yeah, again, overall, Q2 was really driven by addition of new patients. Total patients on therapy, 3900. That's a net add of about 300, quarter-over-quarter, which is a strong indicator going into the Q2. And it's really based on contribution from returning patients, new-to-oxabate patients, and switch patients. Actually, the strongest growth segment right now is new-to-oxabate, which we view as very encouraging, because that's the highest portion of the dynamic impact of the market overall. So we feel really good about that. We're going to be watching closely just the impact of the launch of Takeda's program, potentially sometime this year going into next year. I think you know we are really big believers in orexin biology. We believe that there's significant unmet need and that elixir-rexin has the potential to fill a very big gap in the marketplace. All of our research, all of our HCP research continues to support durability of the oxabate class, and there's a lot of interest in Oxabate plus Erexin, and so we believe we have the chance to be really the leaders in sleep right now. In terms of payer research, that's ongoing. We're watching it very closely, the pricing that will happen with the CATIS program. We believe we have a competitive advantage based upon the profile of Elixir Erexin and also the breadth of the indications.

And this is Blair, just to talk on the combination element for a second. I mean, we do get a lot of interest from patients and physicians about the ability to use both the rexins and the oxabates together. And a lot of that actually is generated by some of those that use oxabates now. They're getting a tremendous benefit. And what they'd like to do is augment that with the rexin molecules. And so I think as a company that has both, it's on us to start to generate some data that we can provide both to the treatment community as well as to the payer community. And that's something we'll be looking at doing over the next few years.

Very helpful. Thank you.

Our next question is from Ben Burnett with Wells Fargo. Please proceed.

Good morning, Tim. This is Ophios on for Ben. Thank you for sharing some call on Libalby and the party expansion. Would you expect to see the impact on this expansion this year, or will that be more visible in 2007? And perhaps more broadly, how do you expect Lubavis' growth dynamics to unfold over the coming quarters? Thank you.

Yeah, absolutely. In terms of Lubavis, as Rich and I both said in our prepared remarks, it was a really strong quarter overall for Lubavis' performance with demand, but we're really pleased with the strategic move in expanding access. Lubavis access across all channels is now approximately 80%. We view that as a long-term strategic investment in the durability of the brand. We think that all of the underlying metrics support that right now, which is TRX growth, HCP breadth of prescribing continues to expand in persistency. And so we believe that improving access will enable stronger volume. That's the reason why we've enhanced the access profile and gone into new agreements. The short-term impact is going to be expanded growth to net, which I said earlier that will happen later this year, but we believe that's going to support long-term growth over the next several years.

Perfect.

Thank you very much.

Our next question is from Ami Fada with Needham & Company. Please proceed.

Good morning. Thanks for taking my question. I wanted to get your latest thoughts on how you're looking to generate, potentially generate any data in patients that are using both an Octobate and an Orexin, and if there is a way to differentiate in this market with, you know, say, some sort of combination data. Thank you.

I mean, why don't I start, then I'll turn it over to the others. I think one of the biggest takeaways I had coming from the sleep conference in Baltimore was the interest in this combination therapy, given the fact that narcolepsy is a 24-hour disease. And we're going to address the wakefulness side of it incredibly aggressively with the erexins. But in talking to patients, patient advocacy groups, and clinicians, the consolidation of nighttime sleep, particularly as it relates to consolidation of slow wave nighttime sleep, is a benefit that's not entirely captured in the current labels for Oxabate. So I think we came away from that as we've gotten more experience with LUMRIZE, the idea that this Oxabate biology is under-scienced at this point. So with Elixir-Rexin moving so aggressively in Phase 3, we're not going to disrupt that program. We're going to finish the Brilliance program. We're going to file with a safety data set that's consistent with the Brilliance program. Around that time, though, we'll start feathering in the idea of creating some studies to look at both sides of the equation. And we'll do that probably not for registrational purposes, but more for support for clinicians and for payers. But it's an area that's got a lot of energy right now. No, I think that's a great question.

Our next question is from Ash Firma with UBS. Please proceed.

Hi. This is Hoi Anan for ASH. Thanks for taking our questions. I guess our first question is, so as we get closer to the potential launch of Takeda's overparexin in M2.1, what is your base case assumption on where the annualized list and net pricing per patient might shake out? And the second is, what is your assumption around how ORX 750 asset may change in the hands of Lilly? We saw that Phase II has expanded materially from 96 patients to 248 patients, and now includes more frequent or regular follow-ups on the endpoints. How could that change the data generation, in your view? Thank you.

I think as you look at Takeda's launch, as we said earlier, they'll be determining the overall price. And as you know, this class generates a tremendous amount of value for these patients, and they're going to be limited to the NT1 population. So I'd expect them to price kind of in the range of a typical orphan drug, and obviously they're in the process of working through that now as they prepare for their PDUFA, which we expect to see in kind of the August to December timeframe. So we'll learn more then as to where they end up. As for Lilly, I think, and the orexin 750 program or ORX 750 program, I think you're exactly right. Lily's widened their Phase II program, and they've done that because they needed to sort of backfill some of the work that was done by Sentessa earlier. I think that wasn't a very thorough dose ranging. I think they were being very exploratory in their program to try to show people what they could potentially do. Lilly is taking a traditional and responsible drug development approach. They're doing a proper dose ranging so they can understand what they really have and how it's going to play. And I think Rich characterized it really well earlier, which is we're well ahead of our competitors as we think of NT2 and IH. And I think across all indications, we think we have a really robust profile that's going to be difficult to differentiate from. And I think Lilly is going to be looking to see how could they differentiate as they come into the market after us.

Thank you so much.

Our next question is from Douglas So with H.C. Wainwright. Please proceed.

Hi, good morning. Thanks for taking the questions. Just one follow-up. I think you made the comment at the beginning of the call that you had become sort of more optimistic or, you know, sort of enthusiastic about the Avidel transaction in Lumarize. And I'm just curious what in particular, you know, is sort of driving or sort of drove that enthusiasm, you know, because obviously you felt good enough about the asset to do the deal originally. Thank you. Todd, why don't you start?

Yeah, absolutely. The transaction has gone exceptionally well with the integration. Approximately, you know, we're coming up on six months right now, and so we feel really good about that. Gaining the commercial infrastructure that Avidel had was a really big strategic advantage for us and something that we have in our long-term plan. We believe that it's going to allow us to obviously get into the market much sooner in the sleep community, and that evidence is playing out right now. We believe that Lumerize is the best-in-class Oxabate. We're seeing that really strong growth trends across patient segments. It's being supported by HCP research and just the capabilities that the team brings to the market, such as patient services, our established capabilities and market access is also supporting that right now. So, you know, we weren't surprised by the Q2 results, and we believe that there's a really long-term durable opportunity for loom rise and then addition when Elixir-Extrin comes to the market.

Let me just add that on the human side, culture in these companies is so critical, and we ask a lot of our teams, and the team at Avidel is just a superb team, and they've just integrated into Alkermy's culture so seamlessly, and they've taught us a lot about this Oxabate It's interesting to observe it from the outside, but once you're actually dealing with patients and providers and the whole reimbursement system and understanding the value of these medicines confer to individual patients, it's hard not to get more excited about it. Then coupled with the idea of combining the pharmacology, and we just see a lot of white space here to improve the overall quality of life for patients with diseases of hypersomnose.

Our last question is from Mark Goodman with Learing Partners. Please proceed.

Yeah, good morning, guys. And, Rich, it's been a fun journey working with you all these years. So, my question is kind of just on orexin, big picture strategy. You've got three products now. One is obviously focused on fatigue. You've talked about different areas. It's the strategy to take that product, and that's the fatigue product, and you'll just continue to work through that. One of them will be ADHD. And then, do you have other plans, you know, other orexin molecules behind that to go into other indications, or do you feel like three is enough to kind of take it into all the different areas? And I'm just curious, Joshua, as we think about the R&D spend for these programs, specifically, you know, obviously, Arexin, which is where most of the spend is, should we be thinking that the R&D numbers, you know, go up dramatically here, or is this going to kind of level out in the 500, 600 spending, you know, per year range over the next couple of years as narcolepsy kind of comes down and all these other indications, you know, kind of come up and spend?

Well, this is Blair, Mark. Why don't I start, and then Joshua can tell you how we're going to pay for it all. I think as you look at the expanding pipeline in Erexin, as you said, fatigue is a really interesting drug in that we're starting in multiple sclerosis fatigue and PD-associated fatigue. And then the goal is to expand it outwards from there into broader areas. As you know, fatigue sort of impacts a number of different diseases around neuroscience, and we think this can be a really interesting opportunity. That being said, we have a number of indications that we're looking at within neuroscience that are both extensions of some of the programs that we already have, the molecules that we already have, and we also have additional molecules in development, which would allow us to go after different things and perhaps with different characteristics as well. So we have a pretty comprehensive strategy. We'll start to reveal more of that as we move forward and we get closer to the clinic on a couple things. But, you know, our goal is to press our advantage here. We've been talking about these diseases in orexin biology for a number of years now, and it's great to see it now finally getting to the point where we're starting to generate data around that. And, Mark, a few things from my perspective.

You know, first off, we'll always exercise discipline financial management, but as Blair pointed out, I mean, we've got a tremendous opportunity here in Erexin, and we'll appropriately invest to capitalize on that opportunity. But with all that said, you're thinking about this appropriately, right? We're in phase three on Elixir Erexin, so as those programs wind down, we'll start to reinvest in our pipeline. And you can imagine that we'll leverage that investment in the erexin space.

And Mark, just one last thought on this, it looks at the analogy and hopefully this plays out to the GLP-1 space where there's plenty of molecules, you need plenty of molecules because the pharmacology also begins to expand. You start with GLP-1, you add GLP, you add GP, you add glucagon, you start getting triples and adding this pharmacology into other established pharmacologic pathways in CNS indications is really exciting. So I think we're just at the beginning of this all.

That will conclude our question and answer session. I would like to turn the call back over to Sandy for closing remarks.

Thanks, everyone, for joining us on the call this morning. Please don't hesitate to reach out to us at the company if there are any follow-up questions we can be helpful with. Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.