Alkermes - Q4 2025

Transcript

Operator (participant)

Greetings, and welcome to the Alkermes' Fourth Quarter 2025 Financial Results Conference Call. My name is Melissa, 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 on your telephone keypad. Please note that this conference is being recorded. I will now turn the call over to Sandy Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, please go ahead.

Sandy Coombs (SVP of Investor Relations and Corporate Affairs)

Good morning. Welcome to the Alkermes plc conference call to discuss our financial results and business update for the quarter and year ended 31 December, 2025. With me today are Richard Pops, our CEO, Iain Brown, our Chief Financial Officer, Todd Nichols, our Chief Commercial Officer, and Blair Jackson, our Chief Operating Officer, who will join us for the Q&A. A slide presentation, along with our press release, related financial tables and reconciliations of the GAAP to non-GAAP financial measures that we'll discuss today, are available on the 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 and quarterly reports filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements. We undertake no obligation to update or revise the information provided on this call or in the accompanying presentation as a result of new information or future results or developments. After our prepared remarks, we'll open the call for Q&A. Now I'll turn the call over to Richard for some opening remarks.

Richard Pops (CEO)

Great. Thank you, Sandy, good morning, everyone. Well, we clearly had a strong and eventful 2025. As we enter 2026, there are three elements of the business to understand and to value, the first is the commercial business. In 2026, we expect to generate revenues of more than $1.7 billion and adjusted EBITDA of more than $370 million. We're continuing to build this business with the recently completed acquisition of Avadel. Adding Avadel represents an important milestone and strategic step in the company's transformation. The acquisition adds an important new revenue stream and growth opportunity to our portfolio of commercial products. Strategically, it accelerates our entry into the commercial sleep medicine markets and provides a highly functional commercial platform for the potential launch of alixorexton.

Which brings me to the second element of our business, alixorexton, our most advanced orexin candidate. We plan to enter phase III in narcolepsy this quarter, following the completion of a rigorous phase II program and with recently granted FDA Breakthrough Therapy designation. We had our end-of-phase II meeting with FDA last week, which solidified our registration plan and reaffirmed for us the benefit of consistent interactions with the reviewing division. We believe alixorexton has blockbuster potential and could advance the standard of care in central disorders of hypersomnolence. We're ready for phase III. We're excited to get going.

Third is the opportunity that extends beyond alixorexton in central disorders hypersomnolence orexin 2 receptor agonist candidates represent an entirely new potential vertical of growth and expansion in multiple disease areas beyond sleep medicine. We identified this early on, we're leaders in advancing the frontiers of this pharmacology. Following a review of the financials and the commercial performance and outlook, I'll provide an update on where we are today and our plans to advance these development programs in 2026. With that, I'll turn it over to Joshua to review our financial performance and expectations.

Joshua Reed (CFO)

Thank you, Richard. Alkermes' economic engine is underpinned by a diverse portfolio of commercial products. These revenue streams provide the resources to advance our exciting pipeline of development programs while generating strong cash flow. In 2025, we generated total revenues of nearly $1.5 billion, driven primarily by our proprietary product portfolio, which grew 9% year-over-year and generated approximately $1.2 billion in net sales. For the year, we recorded VIVITROL net sales of $467.9 million, ARISTADA net sales of $370 million, and LYBALVI net sales of $346.7 million.

For the year, we recorded manufacturing and royalty revenues of $291.3 million, including revenues of $130.5 million from VUMERITY and $109.6 million from the long-acting Invega products. Turning to expenses. Cost of goods sold were $196.5 million, which compared favorably to $245.3 million for the prior year, primarily reflecting efficiencies following the sale of our Athlone-based manufacturing business last year. R&D expenses were $324 million, compared to $245.3 million in the prior year, reflecting investments in the Vibrance phase II studies of alixorexton across narcolepsy and idiopathic hypersomnia, and first in human studies and development efforts for orexin two receptor agonist candidates, ALKS 4510 and ALKS 7290.

SG&A expenses were $701.5 million, compared to $645.2 million in 2024, reflecting the expansion of our psychiatry field organization last year and promotional activities related to LYBALVI, as well as certain legal and transaction-related expenses incurred in 2025. The investments we have made in the expansion of our psychiatry sales force have generated a strong return, and we expect to continue to build on that momentum going forward. Our performance generated strong profitability, resulting in GAAP net income of $241.7 million, EBITDA of $285.6 million, and adjusted EBITDA of $394 million for the year. Turning to our balance sheet. We ended the year in a strong position with $1.3 billion in cash and total investments.

In order to fund the acquisition of Avadel, which closed in February 2026, we used approximately $775 million of cash from our balance sheet and entered into term loans totaling $1.525 billion, due in 2031. We expect to pay down this debt quickly with cash flows from the business. In 2026, we plan to continue to manage the business with disciplined operational execution to deliver strong profitability and cash flow, while continuing to invest in the opportunities we believe will drive long-term shareholder value. With the Avadel acquisition now closed, our commercial platform is meaningfully strengthened, and we are allocating capital to the highest potential growth drivers across the business, including the advancement of our Orexin portfolio.

Our 2026 financial expectations were outlined in the press release issued this morning and reflect the combined organization, including 10 and a half months of contribution from Avadel and certain transaction expenses and related accounting adjustments that were outlined in the press release that we issued earlier this month upon closing of the acquisition. Starting with the top line, we expect total revenues for 2026 to be in the range of $1.73 billion-$1.84 billion, driven primarily by net sales from our proprietary products in the range of $1.52 billion-$1.6 billion. Todd will provide more specific details on each of our proprietary products, including expected LUMRYZ revenues for the remainder of the year.

For manufacturing and royalty revenues, we anticipate 2026 revenues in the range of $210 million to $240 million. This outlook reflects the scheduled expiration of certain XEPLION royalties, which phase out on a country-by-country basis during the second half of the year. For VUMERITY, we completed our manufacturing obligations in 2025. Going forward, VUMERITY revenues will be solely driven by the royalty on worldwide net sales without any associated costs. Turning to expenses. Cost of goods sold are expected to be in a range of $365 million to $385 million, reflecting the impact of purchase price accounting related to LUMRYZ inventory. In connection with the closing of the acquisition, LUMRYZ inventory held by Avadel was marked to fair market value, resulting in an increase of approximately $180 million over its cost.

Approximately $150 million of this amount will be expensed as the inventory is sold in 2026. R&D expenses are expected to be in a range of $445 million to $485 million. The increased investment reflects activities of the combined organization and development across the orexin portfolio. Later this quarter, we plan to initiate the phase III Brilliance program for alixorexton in narcolepsy. We expect to complete the recently expanded phase II study in IH in the fourth quarter. In addition, we will continue to advance our ongoing phase I work for ALKS 7290 and ALKS 4510, with phase II programs expected to begin in the second half. In terms of the Avadel R&D portfolio, we plan to complete the phase III program in IH in the first half and to continue to advance Valiloxybate in the early clinic.

SG&A expenses are expected to be in the range of $890 million to $930 million. This reflects consistent investments in our proprietary commercial portfolio, plus $50 million of transaction costs related to the acquisition of Avadel, which closed earlier in the first quarter, and the incorporation of Avadel's commercial infrastructure supporting LUMRYZ for the remainder of the year. In connection with the acquisition, we will also begin to record amortization of intangible assets. In 2026, we expect this will be in a range of $95 million to $105 million. Net interest expense for the year is expected to be in the range of $75 million to $85 million, and we expect a net tax benefit of approximately $20 million.

While GAAP results will be confounded by the accounting for the Avadel acquisition, we expect to maintain a strong cash flow positive profile in 2026. We expect a GAAP net loss in the range of $115 million to $135 million, reflecting accounting related to the transaction, contrasted by positive EBITDA in the range of $60 million to $90 million and adjusted EBITDA in the range of $370 million to $410 million. As a reminder, adjusted EBITDA excludes share-based compensation and transaction-related expenses of $50 million, as well as the non-cash inventory step-up charge of $150 million that I previously mentioned. Adjusted EBITDA is useful and that is more reflective of cash flow to the business.

As we look ahead to support your modeling, I'll provide some additional context on our expectations for the first quarter of the year. In the first quarter of 2026, we expect net sales from our proprietary commercial product portfolio to be in the range of $310 million to $330 million. This reflects our expectation of less pronounced inventory fluctuations during the first quarter, typical patient co-pay and deductible reset dynamics, and historical demand patterns, as well as six weeks of contributions from LUMRYZ. Royalty and manufacturing revenues will reflect the annual reset of the royalty tiers on the remaining long-acting Invega products and typical Q1 end market demand patterns. We expect these factors will drive a sequential decrease compared to Q4 2025, to a range of $40 million to $45 million.

On the expense side, we expect cost of goods sold in the first quarter of 2026 to increase by approximately $20 million sequentially from the fourth quarter, primarily driven by the inventory fair value step-up related to LUMRYZ. For the first quarter of 2026, we expect R&D expenses to increase sequentially from Q4 to a range of $110 million to $125 million, primarily driven by activities related to the initiation of the alixorexton phase III program in narcolepsy and the integration of Avadel's ongoing R&D activities related to LUMRYZ and Valiloxybate.

We expect SG&A expenses in the first quarter to be in the range of $230 million to $250 million, reflecting one-time transaction-related costs of approximately $40 million, the incorporation of LUMRYZ commercial activities in the latter half of the quarter, and consistent investment in promotional activities for LYBALVI, ARISTADA, and VIVITROL. Taken altogether, we expect Q1 adjusted EBITDA in the range of $30 million to $50 million. As we close out 2025, we do so from a position of financial strength. Our commercial portfolio delivered another year of solid performance, providing a profitable foundation that enables continued investment in our strategic priorities.

With the Avadel transaction now closed, we enter 2026 with expanded commercial capabilities and a broader platform from which to grow. Across the organization, we remain focused on operational discipline, efficient capital allocation, and investing in the opportunities we believe will drive long-term value, including the advancement of our orexin portfolio and the integration of LUMRYZ into our commercial model. We are well-positioned for the year and committed to delivering shareholder growth. With that, I'll now hand the call to Todd for a review of the commercial portfolio.

Todd Nichols (Chief Commercial Officer)

Thank you, Joshua, and good morning, everyone. 2025 was another strong year of disciplined execution against our commercial strategy. I am pleased that we delivered at the high end of the increased guidance ranges we provided in October for our proprietary products, driven by strong performance across all three brands. For the full year, proprietary product sales totaled $1.18 billion. The commercial investments we made throughout 2025 have already generated strong returns and strengthen our foundation for growth as we enter 2026. Joshua has taken you through the top-line results, so for my remarks, I will focus on the underlying demand trends as well as our strategic priorities and expectations for 2026. Starting with VIVITROL. In 2025, VIVITROL net sales were $467.9 million, reflecting 2% growth year-over-year.

Vivitrol performance continued to be driven by growth in the alcohol dependence market and our ability to capitalize on highly localized market dynamics in certain states and payer systems. A reminder, Vivitrol results in 2025 included approximately $27 million of gross to net favorability that we do not expect to reoccur. We look ahead to 2026, we expect Vivitrol net sales in the range of $460 million to $480 million. We continue to expect Vivitrol to contribute meaningfully to our revenue and profitability profile over the coming years. Turning to our psychiatry franchise. The expansion of our psychiatry sales force in early 2025 was a key strategic initiative designed to enhance our competitive share of voice, it has been highly successful.

With our expanded footprint in place, we significantly increased call frequency to high-priority prescriber targets across both LYBALVI and ARISTADA throughout the year. This improved reach and frequency, combined with strong execution in the field, contributed to broader engagement and an increased breadth of prescribers for both brands. For the ARISTADA product family, in 2025, net sales were $370 million, reflecting 7% growth year-over-year. Similar to VIVITROL, during the year, ARISTADA results included approximately $14 million of gross to net favorability, which we do not expect to recur in 2026. Throughout the year, leading indicators of underlying demand remained solid.

We continue to see expanding prescriber breadth, healthy persistency, and strong new to brand prescriptions, reflecting effective execution by the field team. For the full year 2026, we expect ARISTADA net sales in the range of $365 million to $385 million. In 2025, net sales of LYBALVI grew 24% year-over-year to $346.7 million. Underlying TRX growth was 24% year-over-year, driven by sustained momentum in new patient starts and continued expansion in prescriber breadth. Throughout the year, improvements in payer access supported broader utilization and reinforced the durability of demand. gross to net adjustments were approximately 29% in 2025.

Looking ahead for 2026, we expect LYBALVI net sales in the range of $380 million to $400 million, reflecting expectations of strong continued growth in demand and gross to net adjustments widening into the mid-30s, starting in Q1 of this year, reflecting a strategic expansion of payer access to support broader adoption. As we look ahead to 2026, we are excited to build on this strong foundation. This year also marks our entry into the commercial sleep medicine market, accelerated by the recently closed acquisition of Avadel, which brings a number of valuable new assets into our business, including Avadel's commercial product, LUMRYZ, and the organization supporting the brand. First, for a few thoughts on LUMRYZ. Launched in 2023, LUMRYZ is a once-at-bedtime sodium oxybate for the treatment of narcolepsy.

The features of this product are differentiated and address a significant unmet need in the treatment landscape for narcolepsy. Intended to consolidate the fragmented sleep, sodium oxybates are an important option in the treatment paradigm for narcolepsy. LUMRYZ is the only once-at-bedtime option available, avoiding the need for patients to wake up in the middle of the night for a second dose. The Avadel team has done exceptional work launching this product. We intend to build on this momentum. In 2025, LUMRYZ generated approximately $279 million in net sales, with approximately 3,500 patients on LUMRYZ therapy as of the end of 2025, a roughly 40% increase in number of patients from the fourth quarter of 2024.

With an estimated 50,000 oxybate-eligible patients with narcolepsy, we believe there is a significant opportunity to continue to expand the number of patients on LUMRYZ. We are delighted to welcome the talented commercial team joining us from Avadel, and their integration into our organization is already underway. Their expertise and deep relationships in sleep medicine will be critical to our success with LUMRYZ and provide an opportunity for Alkermes to establish a strong presence in this community as we prepare for the potential future launch orexin 2 receptor agonists, including our own alixorexton, which we believe will be transformative in how narcolepsy is managed. We expect strong continued growth of uptake of LUMRYZ as we integrate this commercial team and capabilities. We expect LUMRYZ total revenue in the range of $350 million to $370 million for the full year.

For the first 6 weeks of the year, the Avadel team was off to a strong start and generated revenue of approximately $33 million. Following the recent completion of the acquisition, we expect that in 2026, Alkermes will generate an additional $315 million to $335 million in LUMRYZ net sales for the remainder of the year. We are truly excited about the opportunity for LUMRYZ, which we believe will continue to play an important role in the treatment paradigm. With the momentum across our existing brands and the addition of LUMRYZ, we enter 2026 with meaningful opportunities to drive growth and broaden the impact of our commercial business. With that, I'll pass the call back to Rich.

Richard Pops (CEO)

Good. Thank you, Todd. As you've heard, the financial foundation of the business is strong, with a resilient commercial portfolio with important growth potential. 2026 will be a year of execution across the alixorexton development program. As I mentioned in my opening comments, last week, we completed an important milestone in the development program with our end of phase II meeting with FDA. This meeting followed the completion of a phase II program developed in consultation with the agency. The interaction was detailed and constructive and helped confirm key design elements of the pivotal program. With Breakthrough Therapy designation and clarity regarding the necessary elements of our registrational program, we're in a strong position to initiate the phase III later this quarter. Here's what it's going to look like.

The Global Brilliance phase III program in narcolepsy will consist of three, 12-weeks, randomized, parallel design with placebo-controlled studies, two in narcolepsy type one and one in narcolepsy type two. In NT1, each study will include three arms and will enroll approximately 150 patients. The primary endpoint will be change in mean sleep latency on the Maintenance of Wakefulness Test, or MWT, with weekly cataplexy rates and the Epworth Sleepiness Scale, or ESS, as key secondary endpoints. The Brilliance NT2 study will be a 4-arm study and is planned to enroll approximately 180 patients, again, with MWT as a primary endpoint and ESS a key secondary. Each program will have as an anchor, a once daily dose that demonstrates robust efficacy in phase II. We expect that the option for once daily dosing will continue to be a differentiating feature of alixorexton.

We'll also include split dosing regimens designed to drive wakefulness later into the evening hours. Along with the once daily option, split dosing may add another strong element to the product profile. Our first clinical trial from the split dose regimens will be from the ongoing Vibrance-3 phase II study in idiopathic hypersomnia. This study is expected to be completed in the fourth quarter. For alixorexton, we have a clear path forward. We're capitalizing on our momentum from phase II, and we're excited to get started with the phase III program later this quarter. We also expect to have data from the REVITALYZ phase III study of LUMRYZ in patients with idiopathic hypersomnia in the second quarter. This 14-week randomized withdrawal study enrolled approximately 150 patients.

If positive, we expect these data would serve as the basis for an sNDA submission, with a potential launch in early 2028, if approved. Turning to our orexin 2 receptor agonist development programs, ALKS 7290 and ALKS 4510. Targeting the orexin pathway with well-tolerated small molecule drugs is a rich area for pharmaceutical development. ALKS 7290 and 4510 are both currently in phase I studies in healthy volunteers. We expect to advance these candidates into patients this year. We plan to develop ALKS 7290 for ADHD, moving quickly to generate proof-of-concept data in patients this year. ADHD is characterized by persistent difficulty in maintaining attention and concentration, and it's frequently accompanied by impulsive behavior. Despite the availability of stimulant and non-stimulant treatment options, there's a significant unmet need in this space, and an orexin agonist targeting the wakefulness and attention circuitry could be a major advance.

With approximately 15.5 million adults and 6.5 million children in the U.S. with a current ADHD diagnosis, this represents a significant potential opportunity. ALKS 7290 has demonstrated improved measures of attention and task engagement and decreased behavioral impulsivity in validated preclinical models. We've already shared these compelling data with you. Our single and multiple ascending dose cohorts in healthy volunteers are underway. As we progress through the multiple ascending dose cohorts, we plan to initiate a multi-dose phase Ib study evaluating safety, tolerability, and efficacy in adult patients with ADHD. We expect data from this translational study in the second half of the year. In parallel, we're planning for success and expect to initiate a phase II study in the second half of the year.

We plan to develop ALKS 4510 for fatigue associated with neurodegenerative disorders, starting with fatigue associated with multiple sclerosis and Parkinson's disease. Fatigue is one of the most common and burdensome symptoms affecting these patients. Patient populations here are significant, with approximately 1 million patients in the U.S. with MS and another 1 million with Parkinson's. ALKS 4510 went into its healthy volunteer phase I study last year and has completed several single and multiple ascending dose cohorts. We're planning to initiate a multi-dose phase IIa study this year, evaluating safety, tolerability, and efficacy in fatigue associated with MS and Parkinson's. We see this as the beginning of a much more extensive of fatigue in the future. We've built a strong foundation for growth and for value creation, both in the near term and for the future.

With alixorexton moving to phase III, ALKS 7290 and ALKS 4510 moving to phase II, LUMRYZ in phase III for IH, and Valiloxybate, a sodium-free, once-nightly oxybate candidate early in the clinic. This company has an unusual combination of assets: a profitable neuroscience business, a late-stage potential blockbuster product in development, and leadership in one of the most exciting new areas of neuroscience. Lastly, this morning, we announced that I will, at long last, pass the CEO torch to Blair Jackson, who's our current Chief Operating Officer and my valued colleague for many years. We'll make the transition official this summer, and I will continue as chairman. The timing is good. The company is in the strongest position it has ever been in my 35 years, for reasons that we've summarized today. Now is not the time for reflection.

We've got too much important work to do over the next few months. I will say what many of you know, which is that I'm extremely proud of this company, its people, and all that we've accomplished. Thousands of patients have benefited from our medicines, developed in a culture defined by scientific curiosity, integrity, and deep commitment to patients and families. I have great confidence that we'll continue to build on the momentum we have right now. Alkermes is on a whole new growth path. It took us some time to get here, but we did, and the road ahead looks extraordinarily promising. With that, I'll turn the call over to Sandy for the Q&A.

Sandy Coombs (SVP of Investor Relations and Corporate Affairs)

Okay, thank you, Richard. We'll now open the call for Q&A, please.

Operator (participant)

Thank you. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd 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. To allow for as many questions as possible this morning, we ask that you each keep to one question. Thank you. Our first question comes from the line of Joseph Thome with TD Cowen. Please proceed with your question.

Joseph Thome (Managing Director)

Hi there. Good morning. Thank you for taking my question, and, always great to work together, Rich, so best of luck to both of you on this next step. Maybe when thinking about the phase III trial design and start going into the split dosing for some of these candidates, how should we think about the AE profile associated with that? Obviously, hoping to boost some efficacy. Is that also gonna reduce AEs because you're splitting up the dose, or would you potentially also drive up AEs? How are you thinking about that? Thank you.

Richard Pops (CEO)

Morning, Joe. It's Rich. First of all, I think the most important at the highest level is that. The data so far orexin 2 receptor agonists, in treatment narcolepsy, are they're generally quite well tolerated and very safe. The baseline AE profile is quite favorable. The way we model the split doses is in order to drive those later hours of wakefulness for those patients who want an extended duration of wakefulness with a very similar AE profile. I think that's the virtue of running such a big phase two study, where we can model the exposure wakefulness profile, and we can select that split dose in order to maximize the later durations while minimizing side effects.

Operator (participant)

Thank you. Our next question comes from the line of Leonid Timashev with RBC Capital Markets. Please proceed with your question.

Leonid Timashev (Biotechnology Analyst)

Hey, guys. Thanks for taking my question, and congrats, Richard, on a storied career. I guess I wanted to ask on now that the Avadel deal is closed, whether you can speak a little more about the potential synergies across the sales force between the psychiatry sales force and the potential sleep sales force, just overlap in prescribers that can helpfully both businesses and just generally how the onboarding of the LUMRYZ team is going. Thanks.

Todd Nichols (Chief Commercial Officer)

Absolutely. We are really excited about the integration of the Avadel commercial team. As I said in my prepared remarks, that team has done just an exceptional job, and they're off to a fast start this year. The beauty of this strategic integration is it's our first step into the sleep medicine market. Right now, we don't see a lot of overlap between our current psychiatry sales force and the sleep medicine sales force. There's a beauty in that we can keep our psychiatry team excessively focused right now on driving LYBALVI and ARISTADA. We think there will be some synergies eventually when we get to the place when we're prepared to launch alixorexton, and at that time, we'll be building out that sales force to maximize the opportunity for both LUMRYZ and alixorexton.

Operator (participant)

Thank you. Our next question comes from the line of Joon Lee with Truist Securities. Please proceed with your question.

Joon Lee (Managing Director)

Hi, thanks for the updates and for taking our questions. I think I understand the medical rationale for narcolepsy patients taking both oxybates and orexin agonists, but what sorts of evidence would you need to generate to convince the payers to reimburse for both premium price drugs, especially since the patients from both NT1 and NT2 seem to be doing well just on orexin agonist in the long-term extension after being washed out of oxybates? Just trying to understand why orexin agonists wouldn't cannibalize the oxybate market. Thank you.

Richard Pops (CEO)

Yeah, it's a really good question. This is Rich. I think that the way we think about it is that the orexin agonists are working on the wakefulness side of the equation, that may indeed be sufficient for many, many patients. As you know, most patients aren't on oxybates right now, the ones who are on oxybates are on them because of what they do on the other half of the day, which is the fragmented sleep piece of it. We think there will be a cohort of patients for whom both sides of the equation are going to be important, their daytime wakefulness, as well as consolidating the fragmented sleep at night. It remains to be seen at the full range of doses, what the complete effect is orexin 2 receptor agonist on reconsolidating nighttime sleep.

We know from talking to patients over the last few years, there's a dedicated cadre of patients for whom the nighttime benefits of oxybates will continue to be valuable, and we'll be the only company so far that has agents in both camps. We'll be motivated to actually generate some data for payers, explaining for that rarefied cohort of patients why both medicines might be the most effective way of treating their disease.

Joon Lee (Managing Director)

Thank you.

Operator (participant)

Thank you. Our next question comes from the line of Luke Herrmann with Baird. Please proceed with your question.

Luke Herrmann (Research Analyst)

Hi, team. I just wanted to extend my congratulations to both Richard and Blair, and thanks for taking the question. Thinking about the LUMRYZ phase III and IH, can you help us understand your internal bar for ESS that would give you confidence ahead of a potential launch, and maybe the degree of importance of key secondaries in the eyes of prescribers? Thanks.

Richard Pops (CEO)

This is Rich. I think that the IH study mirrors very much what was done for the previous oxybate program that was approved by the FDA. When we acquired Avadel, we, you know, we picked up this program essentially at the end of its development phase. As we did the diligence on it, you know, we found is that the randomized withdrawal study mimics exactly what was happening with XYWAV. Our expectation is that when we see the data in Q2, it will see a very similar profile for the once nightly medicine. With respect to key secondaries, I don't think I have the answer to that question right now because I just don't have that protocol committed to memory yet, but we can get back to you on that.

Todd Nichols (Chief Commercial Officer)

Yeah, I'll just add.

Richard Pops (CEO)

Go ahead.

Todd Nichols (Chief Commercial Officer)

Yes, the primary is ESS, as Rich said, with the randomized withdrawal study. Our expectation is that it would mirror what we've seen in the market already with XYWAV. Key secondaries are PGIC and IHSS, and our expectations, that would be similar to what we've seen for the current product in the market. I'll just reinforce that, it's really a significant opportunity here. As you kind of heard us in the past, the eligible population is about 40,000, our estimate in the US, and it's a very low penetration right now, with only one approved product, it's penetrated about 10% in the marketplace. This is something that we are looking forward to.

Operator (participant)

Thank you. Our next question comes from the line of Rudy Li with Wolfe Research. Please proceed with your question.

Rudy Li (Director)

Thanks for taking my question. Congrats, Rich and Blair, for the new role. The question regarding the upcoming phase three. Apparently, we're on track to start the trial for NT1 and NT2. I'm just curious, have you discussed key factor for a phase three trial in IH with FDA yet? Can you potentially start the trial earlier, or do we need to wait for the Vibrance-3 data? Thanks.

Richard Pops (CEO)

Morning. I think for IH, we'll do exactly what we did for narcolepsy, which is get the phase II data from the Vibrance study, have a, you know, formal end of phase II meeting with FDA and map out and agree on the phase III program. We'll wait for those data to come later this year before we initiate that meeting with FDA.

Rudy Li (Director)

Thanks. Just a quick follow-up. Like, what's your current understanding on the dynamic here, like NT1 versus NT2 and IH?

Richard Pops (CEO)

The dynamic from a market perspective or from a regulatory perspective?

Rudy Li (Director)

Yes.

Richard Pops (CEO)

I think as Todd Nichols just said, the IH opportunity is a really interesting one because if you simply look at claims data, you would say that there's about 40,000 patients who are being treated for idiopathic hypersomnia today. We think that pretty significantly underestimates the actual clinical need for a medicine that would deal with hypersomnolence that is not diagnosed as narcolepsy. While we have a better sense of the narcolepsy numbers, i.e., about 200,000 patients in the US prevalence, about 100,000 being diagnosed

About 80,000 being treated, we have a much more vague understanding of how big the IH market may be. As we've talked about before, the narcolepsy market by itself represents a very significant commercial opportunity, given the unmet needs in that space. IH, you know, I think that's the next step in the evolution of the alixorexton story. We'll wait for the phase two data, conduct the phase III, and then hopefully launch into that as well.

Rudy Li (Director)

Yeah. Super helpful. Thanks.

Operator (participant)

Thank you. Our next question comes from the line of Ami Fadia with Needham & Company. Please proceed with your question.

Ami Fadia (Managing Director)

Hi, good morning. Thanks for taking my question. With LUMRYZ now in your portfolio, what are your plans to study alixorexton along with an oxybate together to explore the synergistic effect of a patient being treated with both, outside of, you know, the information that we already have, based on anecdotal evidence? Thank you.

Richard Pops (CEO)

Morning, Ami. As I just was saying in the previous question, I think that there's a potential benefit for certain patients of dealing with the excessive daytime sleepiness with the wakefulness-promoting agent like alixorexton, as well as consolidating fragmented nighttime sleep with oxybate. That will not be the modal treatment, i.e., I think most patients will not opt for that polypharmacy. For those patients that derive benefit from both sides of the equation, I think it could be a very powerful treatment approach.

I can tell you, even during the pendency of the phase two studies, we were hearing from investigators an interest in testing both agents together in certain patients. We'll be the only company that have agents in both camps. From our perspective, we see it less as a registrational pathway, as more of an evidence-building pathway for the purpose of reimbursement. I think you can expect to see more from us on that front in the weeks ahead.

Ami Fadia (Managing Director)

Thank you.

Operator (participant)

Thank you. Our next question comes from the line of David Amsellem with Piper Sandler. Please proceed with your question.

Alice Avanian (Supervisory Analyst)

Hi, good morning. This is Alice on for David. Thanks for taking our question. Now that you have LUMRYZ under your control, how are you thinking about the field force for the product, also bearing in mind that there will be another market entrant by year-end? If an expansion is on the table, are you thinking about it more from a breadth or a depth perspective? Thank you.

Todd Nichols (Chief Commercial Officer)

Yeah, absolutely. Right now we feel like the sales force is right-sized to really maximize the opportunity. I think context is important here. We've done a lot of work in this area. You know, our estimate is there's about 50,000 oxybate-eligible patients in the marketplace right now, and there's a dynamic segment of about 9,000 patients that are cycling. That's really the target for LUMRYZ. That's what the sales force is really lined up against, is really those oxybate prescribers to maximize that dynamic segment. We're seeing very encouraging trends.

Obviously, the team made some investments late last year with expanding the sales force slightly, also some commercial investments within our patient services area, and we're seeing benefits from that. Right now we believe that we are right-sized. As Rich said, you know, we think this is a durable market. That patients will continue on oxybate. We'll have to see how the year plays out with competitive entrants. We clearly see this as a uniquely positioned product, and we think we're right-sized at this point.

Operator (participant)

Thank you. Our next question comes from the line of Jason Gerberry with Bank of America. Please proceed with your question.

Jason Gerberry (Managing Director)

Hey, guys. thanks for taking my questions. My question is just how to think about the kind of SG&A, underlying SG&A spend beyond 2026. If you can outline in the 2026 guide for the full year, sort of what's the embedded 1-time transaction costs? 'cause as I look ahead beyond 2026, I assume that there's redundant G&A spend between Avadel and Alkermes, and then with the VIVITROL LOE in 2027, I imagine there's opportunity to harvest that brand for profit, unless the decision internally is to just reallocate that spend towards other brands, with longer tails. Kind of curious if you can just outline some of those puts and takes in the SG&A, kind of beyond 2026. Thanks.

Blair Jackson (COO)

Yeah, let me talk about, you know, SG&A. With respect to 2026, what you have impacting SG&A are a couple things. You've got about $50 million in one-time transaction costs that are impacting that year. Clearly, those won't carry over into future periods. What you also have in 2026 compared to 2025, obviously, is us taking on the commercial investments associated with Lumryz and, you know, typical increases that you might see in labor and benefits. You know, frankly, if you exclude the impact of the transaction costs and the acquisition of Avadel, essentially, on our base business, our base company, SG&A is flat.

You know, thinking about future periods, so 2026 and beyond, certainly we'll look to control spending, and be disciplined on that front. We will look to determine whether or not we've got some synergies and opportunities to reallocate some of those costs of our business as it evolves to increasing investment, if necessary, for alixorexton, and for our sleep medicine.

Operator (participant)

Thank you. Our next question comes from the line of Ashwani Verma with UBS. Please proceed with your question.

Ashwani Verma (Research Analyst)

Hi, thanks for taking my question, and congrats to both Richard and Blair. Just on LUMRYZ, there's a bit of a focus on the impact from the first generation full generic market formation, some of the initial list prices coming in much above where the expectation was. I know Jazz also talked about this last night, impact to XYWAV in this in the second half. Like, how are you thinking about that for LUMRYZ, just once nightly? Do you think that similar dynamic, what would apply to, like, an indirect, pricing pressure on XYWAV would also replicate on LUMRYZ, or does it have some sort of an advantage that the competitor might not have? Thanks.

Todd Nichols (Chief Commercial Officer)

Ash, I'll take that. We clearly think there's an advantage for LUMRYZ positioning. Again, it's the only once-nightly oxybate, which is significant value to patients and HCPs. The positioning is clear. Strategically, we do believe there's a significant advantage. In terms of just the dynamics of the market right now, I think just for context, you know, with multi-source generics coming to the market, that's very specific to Xyrem, very specific there. That is not specific to LUMRYZ. These products are not interchangeable. Our view right now and what we see in the marketplace with our discussions with payers is payer access is strong. Over 90% of commercial payers or commercial patients have access to LUMRYZ. We're not seeing any material changes at this point.

Obviously, we're gonna have to see how this plays out. Likely, if there's any impact, it would probably be second half of the year or a little bit later. We're gonna watch that very closely. What we do know, what we hear from, you know, from our sleep specialists, is that they're committed to making sure that patients get access to Lumryz. Their, you know, sleep centers have the capabilities to support navigating market access hurdles, and they're committed to doing that. Again, we don't see any material changes at the beginning of the year. We'll see how it plays out for the second half of the year.

Operator (participant)

Thank you. Our next question comes from the line of Marc Goodman with Leerink Partners. Please proceed with your question.

Marc Goodman (Senior Research Analyst)

Hey, good morning. Can you talk about the Valiloxybate that you inherited in the acquisition, just the development plan and how excited you are about this product? Do you view it as a replacement strategy for Lumryz eventually? Just give us a sense of when you're thinking, what do you have to do to get it to market, and how fast can you get it to market?

Sandy Coombs (SVP of Investor Relations and Corporate Affairs)

Sir, do you wanna hop in on that one?

Blair Jackson (COO)

Hi, Marc, it's Blair. It's a good question. Actually, Valoxalate is a really interesting asset that came over as part of the Avadel transaction. It has an opportunity to play in really the low to no sodium space. I think what we're looking to do there is try to move the program forward as quickly as possible, trying to really look through the PK profile of that and leverage some of our formulation capabilities to advance that rapidly through the clinic. It's too early to say whether this would be a future replacement to LUMRYZ or an addition into the portfolio. We'll just see how the data plans pays out over the next year or so.

Marc Goodman (Senior Research Analyst)

I mean, do you think you're gonna have to do a full development plan, or there's bridging studies you can do to get it to market?

Blair Jackson (COO)

That totally depends on the data that we get, that we get early. If we're able to match bioequivalence and things like that, then there's a much rapid path forward. If we need to do some additional studies, we'll do that. This is an area we know really well. As you know, we're a formulation expert, and we've navigated these paths before. We're early stages here, but it's now in our hands, and we're moving forward aggressively.

Marc Goodman (Senior Research Analyst)

Thanks.

Operator (participant)

Thank you. Our next question comes from the line of Akash Tewari with Jefferies. Please proceed with your question.

Anya John (Research Associate)

Hi, this is Anna St. John for Akash Tewari. Just a couple questions about your ADHD study. Are you able to share any more details about that? Are you considering potentially enriching the population for any specific ADHD phenotypes?

Richard Pops (CEO)

Yes, Rich. No, we're not going to enrich for any particular phenotype or chronotype. What we're excited about for ADHD is very similar in many ways to what we did in narcolepsy, in that we think in a reasonably short period of time, in a reasonably small cohort of patients, we should be able to discern dose response and efficacy signal. We're going to move quickly into that translational study.

Anya John (Research Associate)

Thanks.

Operator (participant)

Thank you. Our next question comes from the line of Ben Burnett with Wells Fargo. Please proceed with your question.

Ben Burnett (Senior Equity Analyst)

Hey, thank you. I wanted to ask about the split dosing program and split dosing the alixorexton program. Just color on the protocol, like, when is the second dose taken? I guess, is it given that this is a split dose, is it possible you could get away from having any sort of food restrictions?

Richard Pops (CEO)

This is Rich. I think that we won't give a whole lot of specificity on the split dose strategy other than to say what its objective is, which is to drive additional wakefulness in the later hours of the day for patients who might want to extend that wakefulness duration. What we're finding is that people are experiencing a quality of wakefulness that they've not had before, and they're very interested in certain situations of having that persist deeper into the hours of the evening.

Because of the modeling we've been able to do through our phase II program, we have a really good sense of how to administer two different doses administered in time to both extend that wakefulness and also minimize associated side effects. That's proprietary information, and so we're gonna keep that under wraps as long as we can. I think that's gonna, at the end of the day, if we can have a sort of an anchor once daily dose available to all patients as well as this option for split doses, I think that'll differentiate the product significantly commercially.

Operator (participant)

Thank you. Our next question comes from the line of Umer Raffat with Evercore ISI. Please proceed with your question.

Umer Raffat (Senior Managing Director)

Hi, guys. Thanks for taking my question. First, congratulations, Blair, on the expanded role. My question, Richard, for you is, I've been tracking this from the days of ALKS 8700 and ALKS 3831, and I feel like pipeline finally is in a spot that it's never been in Alkermes' history. I'm just curious about the timing of your decision to give up the CEO role while staying chairman. Secondly, on your phase III design strategy that you laid out, could you remind us if it includes split dosing, both in NT1 and in NT2? Thank you very much.

Richard Pops (CEO)

Morning, Umer. You know, my theory all along has been the time to pass the baton, you recognize I've been doing this forever, is when the company is just in a demonstrably strong position. The past few years, we've had to basically change the business model from a royalty-based company, based on formulation technology into a proprietary products company. The last step in that transformation was getting our hands on what could be a potential blockbuster drug and its sequelae, and that's where we are right now. You know, Blair's been my partner through this for a long time. He's actually been at the helm for much of the transformation within the company. It's a very logical time to do this.

You know, I'll say, as the chairman, I'm extremely proud of where we are, and I think we're on this really exciting new trajectory, which I'm going to be part of. On the phase III, we are going to include split doses in the NT1. The history of that is through the NT1 study, notwithstanding the fact that we had this really beautiful efficacy once daily that we presented at World Sleep. Along the way, we heard from clinicians, we have patients who want to extend this duration into the evening. Originally, our thought was that we would do this as a lifecycle management post first approval, you know, adding, what we were calling at the time, a top-up dose.

When we saw the NT2 data, where it was so clear that for most patients or many patients, they would benefit from a second dose to lift those later at time points, we decided to incorporate it into the, into the registrational program. I think that turned out to be a real blessing for the overall program because I think the competitive dynamic is going to swing significantly in our favor if we're successful with both the once daily and the split dose regimens.

Umer Raffat (Senior Managing Director)

Thank you, Richard.

Operator (participant)

Thank you. Our next question comes from the line of David Huang with Deutsche Bank. Please proceed with your question.

David Huang (Director)

Hi there. Good morning. Thanks for taking my questions and congrats to both you, Richard and Blair. With Takeda potentially having a PDUFA date for soticlestat in Q3 and then potentially being on the market by the end of the year, what learnings do you think you could take away from their commercial launch, if any? Would their pricing inform how you think about the value proposition of alixorexton? Thanks so much.

Richard Pops (CEO)

I'll, hey, David, I'll start, and then I'll turn it over to Todd. From my perspective, I think the most interesting unknown is going to be pricing. I think that's going to set the tone for the market's receptivity to the value that's being created with these NT1 drugs. Note that they're going to come to market in NT1. In NT1, this is a true orphan indication where we have a disease-modifying therapy conferring benefits from a wakefulness perspective that have not been seen before in this patient population. I think that they're entering the market with a premium product, with this degree of medical benefit to patients is a great thing for us, because I think that we come second, if we're successful, with a much more broad product offering. Todd, your perspective?

Todd Nichols (Chief Commercial Officer)

Absolutely. Yeah. I would say, you know, there's the basic things that'll be interesting, which is just the positioning of a product like this, whether it's really positioned for market expansion or for switch. That's clearly something that we'll be watching. I think Rich really put on the really key thing that we're going to be watching, which is really the pricing dynamic in the market. That's going to be very interesting for us. It'll be something for us to pay close attention to, and it will absolutely fold into what our pricing strategy, market access strategy looks like.

Operator (participant)

Thank you. Our next question comes from the line of Douglas Tsao with H.C. Wainwright & Co. Please proceed with your question.

Douglas Tsao (Managing Director)

Hi. Good morning. Thank you very much. Richard, congrats on, you know, your accomplishments at the company. We'll miss you. Just a question on ALKS 7290 and ADHD. If I remember from the presentations that you gave at the Orexin Day in 2024, you showed preclinical data showing a profile that looked better than the non-stimulant ADHD drugs on the market right now. I guess I'm curious, is that the benchmark, or do you have a sense how ultimately this might compare to the stimulants on the market, which have continued to have very significant disruption on the market and real challenges for availability? I think that there would be sort of demand for a better non-stimulant. Thank you.

Richard Pops (CEO)

Yeah, good morning. I think what struck us about that preclinical program was that our going-in hypothesis was that the orexin pathway might be a really nice complement to the non-stimulant drugs. In those model systems, the orexin system by itself, as monotherapy, looks incredibly important. There's been some recent publications about the actual effects of stimulants on ADHD, what the mechanistic basis of that is. If you map that onto what's happening with the orexin pathway, the orexin pathway just anatomically and neurobiologically, it's affecting many of these domains that are relevant to the idea of attention and focus and vigilance and things like that.

I don't think we necessarily have an a priori sense of how to compare it to a stimulant or compare it to a non-stimulant. What we think is that the phenomenon that we'll see in the clinic could be very, very specific to that of orexin 2 receptor agonist in this disease setting. We'll be keeping our eyes wide open for the clinical signs that emerge from the study. We go in with some very strong preclinical expectations that we'll have a benefit. Blair, I don't know if you have any additional thoughts on that.

Todd Nichols (Chief Commercial Officer)

No, I guess just to add, I think as you look at the preclinical data, one of the things we saw in this, five choice, Five-Choice Serial Reaction Time Task, which is a highly translatable model to the clinic, is that we saw about equivalent efficacy across sort of the stimulants versus the orexin. So we think, as to Rich's point, I think we're very confident about seeing a signal in the next study, and we'll define that further as we get through the phase II program.

Douglas Tsao (Managing Director)

If I can, just a quick follow-up. Do you think that you might have sort of a different effect on different domains of ADHD than stimulants, as well as sort of the currently marketed non-stimulants? Thank you.

Todd Nichols (Chief Commercial Officer)

You know, I think it's too early to tell. I think right now, our best data is that the early test that I mentioned earlier, and we actually had efficacy across all the domains in ADHD, both on concentration and impulsivity. You know, we're going to be testing all of those as part of this program.

Douglas Tsao (Managing Director)

Okay, great. Thank you very much.

Operator (participant)

Thank you. Our next question comes from the line of Yiyi with Mizuho Securities. Please proceed with your question.

Yiyi Chen (Equity Research Analyst)

Thanks, guys. congrats, Rich, to your accomplishment, and Blair, congrats on your next role. Maybe just help us understand, given that there's potential generic entry for VIVITROL in 2027, how you're thinking about the dynamic, and do you think, as far as you know, whether there's whether Teva has capability to manufacture generics at all at this point? Thanks.

Richard Pops (CEO)

Todd, you want to go?

Todd Nichols (Chief Commercial Officer)

Yeah, absolutely. You know, our plan right now is to continue the growth and expansion of VIVITROL, similar to what we did in 2025 into 2026. We see, again, strong demand for 2026. We're preparing for multiple different scenarios that could occur in 2027. You know, all the research that we've done continues to validate that this is a difficult product to commercialize, but it's really difficult to manufacture. We know that, you know, as the company that's had this for so many years. We'll have to see if there's a capability to do that, what the supply in the market looks like. We're prepared for that. If we do get competition in 2027, what that looks like, we'll be prepared to compete, but we'll also be prepared to execute a range of scenarios, which could include pulsing our spend differently.

Operator (participant)

Thank you. Our final question this morning comes from the line of Paul Matteis with Stifel. Please proceed with your question.

Julian Pino (Biotechnology Equity Research)

Hey, this is Julian on for Paul, let me offer my congratulations on behalf of Paul and the rest of the team at Stifel to you, Rich and Blair. Just a couple of really quick ones. When can we expect more detailed data on NT2? I'm not sure if you've disclosed that. The open label extension is still ongoing, and when can we expect to get that data? For when you were talking about the Brilliance program, Rich, I think you mentioned that the primary endpoint in the NT2 phase III study is going to be MWT. I know it was a dual primary for the phase II, so just curious, you know, thinking behind that or, you know, if it was always a plan to go ahead with MWT. Thanks.

Richard Pops (CEO)

You're welcome. We've submitted the NT2 results for a series of presentations at SLEEP in Baltimore in June, so we should hear fairly soon. I expect those to be accepted, so you'll see more of the complete data set. You've seen a lot of it, but I think what I'm really interested in, and we've been talking internally about, is trying to even bring some more color to the quality efficacy that you see in the NT2 population. Because I think looking at average MWT or average ESS doesn't really tell the whole story of the clinical benefit and the benefit orexin 2 receptor agonist in that more heterogeneous patient population.

I think that in the phase III NT1, NT2 studies, we're reverting to more the traditional hierarchy. Now that we have the data from phase II, and we can model what we're comfortable with, and I'm looking around the table to make sure I'm not misspeaking on this. We'll have just a primary analysis on MWT, with key secondary, including ESS.

Operator (participant)

Thank you. Ladies and gentlemen, this concludes our question and answer session. I'll turn the floor back to Sandy for final comments before we close out.

Sandy Coombs (SVP of Investor Relations and Corporate Affairs)

Great. Thank you, everyone, for joining us on the call this morning and for the questions. Please don't hesitate to reach out to us at the company, if you have any follow-up questions we can be helpful with. Thank you.

Operator (participant)

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