Alkermes (ALKS) Q4 2025 Earnings Call Transcript

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DATE

Wednesday, Feb. 25, 2026 at 8 a.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — Richard F. Pops
• Chief Financial Officer — Joshua Reed
• Chief Commercial Officer — C. Todd Nichols
• Chief Operating Officer — Blair Jackson
• Vice President, Investor Relations — Sandra Coombs

TAKEAWAYS

• Total Revenues -- Nearly $1.5 billion reported for the year, with 9% proprietary product portfolio growth year over year.
• Proprietary Product Net Sales -- $1.2 billion in 2025, driven by VIVITROL ($468 million), ARISTADA ($370 million), and LEVOLVI ($347 million).
• Manufacturing and Royalty Revenues -- $291 million in 2025, including $131 million from VUMERITY and $110 million from long-acting Andega products.
• Key Expense Items -- 2025 cost of goods sold at $197 million (down from $245 million), R&D expenses at $324 million (up from $245 million), and SG&A at $702 million (up from $645 million).
• Profitability -- GAAP net income for 2025 was $242 million; EBITDA reached $286 million; adjusted EBITDA was $394 million.
• Ending Cash and Investments -- $1.3 billion on the balance sheet at year-end.
• Avadel Acquisition -- Closed in February 2026, funded by $775 million in cash and a $1.53 billion term loan due 2031.
• 2026 Total Revenue Guidance -- Range of $1.73 billion to $1.84 billion, including $1.52 billion to $1.6 billion in proprietary product net sales.
• 2026 Manufacturing and Royalty Revenue Guidance -- Range of $210 million to $240 million, reflecting scheduled Zeppelin royalty expirations in the second half of the year.
• VIVITROL 2026 Guidance -- Expected net sales of $460 million to $480 million.
• ARISTADA 2026 Guidance -- Net sales expected in the $365 million to $385 million range.
• LEVOLVI 2026 Guidance -- Forecasted net sales of $380 million to $400 million; gross-to-net adjustments projected to widen to the mid-thirties percent.
• LUMRIZE (Avadel) 2025 Performance -- Generated $279 million in net sales with approximately 3,500 patients on therapy (a roughly 40% year-over-year increase); 2026 revenue contribution projected at $350 million to $370 million.
• Cost of Goods Sold 2026 Guidance -- Expected in a $365 million to $385 million range, including approximately $150 million of Loomrise inventory step-up expense.
• 2026 R&D and SG&A Guidance -- R&D expected at $445 million to $485 million; SG&A at $890 million to $930 million, including $50 million in one-time transaction costs.
• Amortization and Interest Expense 2026 -- Amortization of intangible assets projected at $95 million to $105 million, net interest expense at $75 million to $85 million.
• 2026 GAAP Net Loss and EBITDA Guidance -- GAAP net loss expected in a $115 million to $135 million range due to acquisition accounting; adjusted EBITDA projected at $370 million to $410 million.
• First Quarter 2026 Guidance -- Proprietary product net sales expected at $310 million to $330 million; total revenues at $405 million to $450 million; Q1 adjusted EBITDA in the range of $30 million to $50 million.
• Elixorexant Clinical Milestones -- FDA breakthrough therapy designation received; Phase 3 Brilliance program in narcolepsy to initiate this quarter; end of Phase 2 meeting completed last week, solidifying registration plan.
• Orexin-2 Receptor Pipeline -- ALKS 7,290 Phase 1 in healthy volunteers with expected Phase 1b ADHD data and Phase 2 initiation in second half of year; ALKS 4,510 Phase 1 progressing toward Phase 2a study for neurodegenerative fatigue in 2026.
• Upcoming Clinical Data -- REVITALIZE Phase 3 study of LUMRIZE in idiopathic hypersomnia to read out in Q2, supporting possible sNDA submission and early 2028 launch if positive.
• Management Transition -- Richard F. Pops to step down as CEO, Blair Jackson to assume CEO role in summer while Pops continues as chairman.

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RISKS

• 2026 GAAP net loss is projected at $115 million to $135 million "reflecting accounting related to the transaction," as contrasted with expected positive adjusted EBITDA.
• 2026 manufacturing and royalty revenues forecast lower, in part, due to "scheduled expiration of certain Zeppelin royalties, which phase out on a country-by-country basis during the second half of the year."
• Management noted gross-to-net favorability ($27 million for VIVITROL and $14 million for ARISTADA) benefited 2025 results but explicitly stated these are "not expect to recur" in 2026, impacting reported growth rates.
• Joshua Reed stated, "GAAP results will be confounded by the accounting for the Avadel acquisition," indicating potentially less clarity for GAAP profitability visibility in 2026.

SUMMARY

Alkermes (NASDAQ:ALKS) reported substantial commercial expansion and executed the strategic Avadel acquisition, integrating LUMRIZE as a major new revenue stream with near-term synergies in sleep medicine. Management provided clear pipeline visibility with phase transitions for orexin-based candidates, detailed operational integration for Avadel, and outlined a precise clinical roadmap for elixorexant, now granted FDA breakthrough therapy designation. The company signaled major upcoming clinical catalysts in idiopathic hypersomnia and ADHD, while highlighting a robust cash position to support ongoing R&D and commercial investment through forecasted one-time transaction-driven GAAP losses.

• Elixorexant’s Phase 3 clinical studies will employ once-daily and split dosing regimens in narcolepsy, reflecting input from both FDA interactions and clinician feedback collected during Phase 2.
• Avadel's Loomrise generated $33 million in revenue in the first six weeks of 2026 prior to acquisition close, indicating accelerating demand in the narcolepsy market segment.
• Management specifically anticipates "pay down this debt quickly with cash flows from the business," citing a "strong cash flow positive profile in 2026" despite projected GAAP losses.
• Alkermes expects upcoming generic competition for VIVITROL but emphasized manufacturing complexity and readiness for multiple market-share scenarios beginning 2027.
• Phase 3 data for LUMRIZE in idiopathic hypersomnia are expected in Q2, potentially supporting a supplemental NDA and an early 2028 market launch if successful.
• Joshua Reed confirmed $50 million in one-time SG&A transaction costs in the 2026 guide, clarifying these will not persist beyond the year.
• Company will initiate clinical studies evaluating ALKS 7,290 for ADHD and ALKS 4,510 for fatigue associated with neurodegenerative conditions, with Phase 1 and 2 milestones expected in 2026.
• The transition of CEO responsibilities from Richard F. Pops to Blair Jackson will become official in summer, with Pops remaining as chairman to ensure continuity in strategic direction.

INDUSTRY GLOSSARY

• Gross-to-net adjustment: The difference between the list price of a pharmaceutical product and the actual realized price, after accounting for rebates, discounts, and other deductions.
• Orexin-2 receptor agonist: A class of drugs that selectively activate the orexin-2 receptor, targeting central sleep and attention disorders.
• Idiopathic hypersomnia (IH): A rare neurological disorder characterized by excessive daytime sleepiness unrelated to other known sleep disorders.
• Maintenance of Wakefulness Test (MWT): An objective measure of a patient’s ability to stay awake for a defined period under controlled conditions, commonly used in clinical trials for sleep disorders.
• Epworth Sleepiness Scale (ESS): A self-administered questionnaire used to assess a patient’s general level of daytime sleepiness.
• sNDA (Supplemental New Drug Application): A regulatory submission to the FDA for approval of a new indication, dosage, or formulation for an already approved drug.

Full Conference Call Transcript

Richard F. Pops, our CEO, Joshua Reed, our Chief Financial Officer, C. Todd Nichols, our Chief Commercial Officer, and Blair Jackson, 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 will 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 will open the call for Q&A. And now I will turn the call over to Richard for some opening remarks.

Richard F. Pops: Great. Thank you, Sandy, and 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. And the first is the commercial business. In 2026, we expect to generate revenues of more than $1,700,000,000 and adjusted EBITDA of more than $370,000,000, and we are 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 market and provides a highly functional commercial platform for the potential launch of elixirixib. Which brings me to the second element of our business. Elixorexant. Our most advanced orexin candidate. We plan to enter Phase 3 in narcolepsy this quarter, following the completion of a rigorous Phase 2 program and with recently granted FDA breakthrough therapy designation. We had our end of Phase 2 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 elixirixen has blockbuster potential and could advance the standard of care in central disorders of hypersomnia. Ready for Phase 3.

We are excited to get going. And third is the opportunity that extends beyond elixorexant in central disorders of hypersomnia. 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, and were leaders in advancing the frontiers of this pharmacology. Following a review with financials and the commercial performance and outlook, I will provide an update on where we are today and our plans to advance these development programs in 2026. So with that, I will turn it over to Joshua to review our financial performance and expectations.

Joshua Reed: 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 $1,500,000,000, driven primarily by our proprietary product portfolio, which grew 9% year over year and generated approximately $1,200,000,000 in net sales. For the year, we recorded VIVITROL net sales of $467,900,000, ARISTADA net sales of $370,000,000, and Livaldi net sales of $346,700,000. For the year, we recorded manufacturing and royalty revenues of $291,300,000, including revenues of $130,500,000 from VUMERITY and $109,600,000 from the long-acting Andega products. Turning to expenses.

Cost of goods sold were $196,500,000, which compared favorably to $245,300,000 for the prior year, primarily reflecting efficiencies following the sale of our Athlon-based manufacturing business last year. R&D expenses were $324,000,000 compared to $245,300,000 in the prior year, reflecting investments in the VIBERANCE Phase II studies of elixirexan across narcolepsy and idiopathic hypersomnia, and first-in-human studies and development efforts for our next orexin 2 receptor agonist candidates, ALKS 4,510 and ALKS 7,290. SG&A expenses were $701,500,000 compared to $645,200,000 in 2024, reflecting the expansion of our psychiatry field organization last year and promotional activities related to libality, 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 $241,700,000, EBITDA of $285,600,000, and adjusted EBITDA of $394,000,000 for the year. Turning to our balance sheet. We ended the year in a strong position, with $1,300,000,000 in cash and total investments. In order to fund the acquisition of Avadel, closed in February 2026, we used approximately $775,000,000 of cash from our balance sheet and entered into term loan totaling $1,525,000,000 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 Abadel 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 ten 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 $1,730,000,000 to $1,840,000,000, driven primarily by net sales from our proprietary products in the range of $1,520,000,000 to $1,600,000,000. Todd will provide more specific details on each of our proprietary products including expected LoomRise revenues for the remainder of the year.

For manufacturing and royalty revenues, we anticipate 2026 revenues in the range of $210,000,000 to $240,000,000. This outlook reflects the scheduled expiration of certain Zeppelin 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, and 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 the range of $365,000,000 to $385,000,000, reflecting the impact of purchase price accounting related to Loomrise inventory.

In connection with the closing of the acquisition, Loomrise inventory held by Avadol was marked to fair market value resulting in an increase of approximately $180,000,000 over its cost. Approximately $150,000,000 of this amount will be expensed as the inventory is sold in 2026. R&D expenses are expected to be in a range of $445,000,000 to $485,000,000. The increased investment reflects activities of the combined organization and development across the orexin portfolio. Later this quarter, we plan to initiate the Phase 3 Brilliance program for lixorexin 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 7,290 and ALKS 4,510 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 valroxabate in the early clinic. SG&A expenses are expected to be in the range of $890,000,000 to $930,000,000. This reflects consistent investments in our proprietary commercial portfolio, plus $50,000,000 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 Loomrise 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 the range of $95,000,000 to $105,000,000. Net interest expense for the year is expected to be in the range of $75,000,000 to $85,000,000, and we expect a net tax benefit of approximately $20,000,000. 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 $115,000,000 to $135,000,000 reflecting accounting related to the transaction contrasted by positive EBITDA in the range of $60,000,000 to $90,000,000 and adjusted EBITDA in the range of $370,000,000 to $410,000,000. As a reminder, adjusted EBITDA excludes share-based compensation and transaction-related expenses of $50,000,000 as well as the non-cash inventory step-up charge of $150,000,000 that I previously mentioned. Adjusted EBITDA is useful in that it is more reflective of cash flow to the business. As we look ahead, to support your modeling, I will 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 $310,000,000 to $330,000,000. 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 contribution from Lumerize. 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 $405,000,000 to $450,000,000.

On the expense side, we expect cost of goods sold in the first quarter of 2026 to increase by approximately $20,000,000 sequentially from the fourth quarter, primarily driven by the inventory fair value step up related to Loomrise. For the first quarter of 2026, we expect R&D expenses to increase sequentially from Q4 to a range of $110,000,000 to $125,000,000, primarily driven by activities related to the initiation of the elixiraxin Phase 3 program in narcolepsy and the integration of Avadel's ongoing R&D activities related to LUMRIZE and valroxabate.

We expect SG&A expenses in the first quarter to be in the range of $230,000,000 to $250,000,000, reflecting one-time transaction-related cost of approximately $40,000,000, the incorporation of Loomri's commercial activities in the latter half of the quarter, and consistent investment in promotional activities for Livaldi, ARISTADA, and VIVITROL. Taken altogether, we expect Q1 adjusted EBITDA in the range of $30,000,000 to $50,000,000. 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 Loomrise into our commercial model. We are well positioned for the year and committed to delivering shareholder growth. With that, I will now hand the call to Todd for a review of the commercial portfolio.

C. Todd Nichols: 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 $1,180,000,000. 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 well as our strategic priorities and expectations for 2026. Starting with VIVITROL.

In 2025, VIVITROL net sales were $467,900,000, 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. As a reminder, VIVITROL results in 2025 included approximately $27,000,000 of gross-to-net favorability that we do not expect to reoccur. As we look ahead to 2026, we expect VIVITROL net sales in the range of $460,000,000 to $480,000,000. 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. Has been highly successful. With our expanded footprint in place, we significantly increased call frequency to high priority prescriber targets across both Livaldi and ARISTADA throughout the year. This improved reach and frequency combined with strong execution in the field contributed a broader engagement and increased breadth of prescribers for both brands. For the ARISTADA product family, in 2025, net sales were $370,000,000, reflecting 7% growth year over year. Similar to VIVITROL, during the year, ARISTADA results included approximately $14,000,000 of gross-to-net favorability, which we do not expect to recur in 2026.

Throughout the year, leading indicators of underlying demand remain 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 $365,000,000 to $385,000,000. In 2025, net sales of Lebovy grew 24% year over year to $346,700,000. Underlying 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 LEVOLVI net sales in the range of $380,000,000 to $400,000,000, reflecting expectations of strong continued growth in demand and gross-to-net adjustments widening into the mid-thirties starting in Q1 of this year reflecting a strategic expansion of payer access to support broader adoption. We look ahead to 2026, we are excited to build on the 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 Loomrise, and the organization supporting the brand. First, for a few thoughts on Loomrise.

Launched in 2023, LUMRIZED 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. And Lumerize 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 and we intend to build on this momentum.

In 2025, Lumerai has generated approximately $279,000,000 in net sales, with approximately 3,500 patients on lumbrance therapy as of the 2025, a roughly 40% increase in number of patients from the 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 LUMRIZE. We are delighted to welcome the talented commercial team joining us from Avadel, and their integration to our organization is already underway.

Their expertise and deep relationships in sleep medicine will be critical to our success with Loomrise, and provide an opportunity for Alkermes to establish a strong presence in this community as we prepare for the potential future launch of orexin 2 receptor including our own elixirextin. We believe will be transformative in how narcolepsy is managed. We expect strong continued growth uptake of LUMRIZE as we integrate this commercial team and capabilities. We expect Lumerize total revenue the range of $350,000,000 to $370,000,000 for the full year. For the first six weeks of the year, the Avadel team was off to a strong start and generated revenue of approximately $33,000,000.

Following the recent completion of the acquisition, we expect that in 2026, Alkermes will generate an additional $315,000,000 to $335,000,000 in LUMRIZE net sales for the remainder of the year. We are truly excited about the opportunity for Lumerize 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 Loomrise, we enter 2026 with meaningful opportunities to drive growth and broaden the impact of our commercial business. With that, I will pass the call back to Rich.

Richard F. Pops: Great. Thank you, Todd. So as you have heard, the financial foundation of the business is strong, with a resilient commercial portfolio important growth potential. 2026 will be a year of execution across the elixorexant 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 2 meeting with FDA. This meeting followed the completion of a Phase 2 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 elements of our registrational program, we are in a strong position to initiate the Phase 3 later this quarter. So here is what it is going to look like. The global Brilliance Phase 3 program in narcolepsy will consist of three 12-week randomized, parallel-design, placebo-controlled studies. Two in narcolepsy type 1, and one in narcolepsy type 2. 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 four-arm study. 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 demonstrated robust efficacy in Phase 2. We expect that the option for once-daily dosing will continue to be a differentiating feature of elixirixa. We will also include split dosing regimens designed to drive wakefulness later into the evening hour. 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 Vibrin 3 Phase 2 study in idiopathic hypersomnia.

This study is expected to be completed in the fourth quarter. So for elixorexin, we have a clear path forward. We are capitalizing on our momentum for Phase 2, and we are excited to get started with the Phase III program later this quarter. We also expect to have data from the REVITALIZE Phase 3 study of lumirides 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. Now turning to our other orexin-2 receptor agonist development programs. ALKS 7,290, and ALKS 4,510.

Regarding the orexin pathway, with well-tolerated small molecule drugs is a rich area for pharmaceutical development. ALK 7,290 and 4,510 are both currently in Phase 1 studies in healthy volunteers. We expect to advance these candidates into patients this year. We plan to develop ALKS 7,290 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. It is frequently accompanied by impulsive behavior. Despite the availability of stimulant and nonstimulant treatment options. 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. OX7290 has demonstrated improved measures of attention, and task engagement and decreased behavioral impulsivity in validated preclinical models. We have 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 multidose Phase 1b study evaluating safety, tolerability, and efficacy in adult patients with ADHD. And we expect data from this translational study in the second half of the year. In parallel, we are planning for success.

Expect to initiate a Phase 2 study in the second half of the year. We plan to develop OX48510 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 one million patients in the U.S. with MS, and another million with Parkinson's. OX 4,510 went into its healthy volunteer Phase 1 study last year, and has completed several single and multiple ascending dose cohorts. We are planning to initiate a multidose Phase 2a study this year evaluating safety, tolerability, and efficacy in fatigue associated with MF and Parkinson's.

We see this as the beginning of a much more extensive fatigue in the future. So we have built a strong foundation for growth for value creation, both in the near term and for the future. With elixirac elixiracin moving to Phase 3, ALKS 7,290 and 4,510 moving to Phase 2, yes. I will at long last pass the CEO torch to Blair Jackson, who is our current Chief Operating Officer and my valued colleague for many years. We will 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 have summarized today.

Now is not the time for reflection. We have got too much important work to do over the next few months. But I will say what many of you know, which is that I am extremely proud of this company, its people, and all that we have 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 will 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 will turn the call over to Sandy for the Q&A.

Sandra Coombs: Okay. Thank you, Richard. We will now open the call for Q&A, please. Thank you. If you would like to ask a question, please press 1 on your telephone keypad. A confirmation tone will indicate your line is in the queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. 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: Hi there. Good morning. Thank you for taking my question, and it is always great to work together, 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 going to reduce AEs because you are splitting up the dose, or would it potentially also drive up AEs? How are you thinking about that? Thank you.

Richard F. Pops: Good morning, Joe. It is Rich. First of all, I think most important at the highest level is that the data so far for these orexin 2 receptor agonists in treatment of narcolepsy are they are generally quite well tolerated and very safe. So 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.

So I think that is the virtue of running such a big Phase 2 study where we can model the exposure wakefulness profile, we can select that split dose in order to maximize the later durations while minimizing side effects.

Sandra Coombs: Thank you. Our next question comes from the line of Lena Timosheth with RBC Capital Markets. Please proceed with your question.

Lena Timosheth: Hey, guys. Thanks for taking my question, and congrats, Richard, on a great career. 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 Salesforce between the psychiatry Salesforce and the potential sleep sales force? There is overlap in prescribers that can, you know, help fully both businesses and just generally how the onboarding of the Lumerai team has been. Thanks.

C. Todd Nichols: Yeah. 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 are off to a fast start this year. The beauty of this strategic integration is it is our first step into sleep medicine market. Right now, we do not see a lot of overlap between our current psychiatry sales force and the sleep medicine sales force. And so there is a beauty in that we can keep our psychiatry team excessively focused right now on driving Lavalvian Aristada.

So we think there will be some synergies eventually when we get to the place where we are prepared to launch elixirextin. And at that time, we will be building out that Salesforce to maximize the for both Loom Rides and Alixorexed.

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

Joon Lee: Hi. Thanks for the updates and for taking our questions. I think I understand the medical rationale for narcolepsy patients taking both oxbates and orexin agonist, but what sorts of evidence would you need to generate to convince the payers to reimburse for both premium priced drugs? Is especially since the patients from both fibrinase one and two seem to be doing well just on orfenac. Agonists in the long term extension after being washed out of oxalates. Just trying to understand why orexin agonist would not cannibalize the oxbate market. Thank you.

Richard F. Pops: Yeah. It is 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. And that may indeed be sufficient for many, many patients. As you know, most patients are not on oxybates right now. But the ones who are on oxybates are on them because of what they do on the other half 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 fragment of sleep at night.

It remains to be seen that the full range of doses what the complete effect is of an orexin 2 receptor agonist on reconsolidating nighttime sleep. But we know from talking patients over the last few years, there is a dedicated cadre of patients for whom the nighttime benefits of oxybate will continue to be valuable. And we will be the only company so far that has agents in both camps. So we will be motivated to actually generate some data for payers explaining for that verified cohort of patients why both medicines might be the most effective way of treating their disease.

Joon Lee: Thank you.

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

Luke Herrmann: Hi, team. I just wanted to extend my congratulations to both Richard and Blair. Thanks for taking the question. So thinking about the Lumris, Phase III in 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 F. Pops: 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. So when we acquired Avadel, we picked up this program essentially at the end of its development phase. And as we did the diligence on it, you know, what we found is that the randomized withdrawal study mimics exactly what was happening with XIAWAVE. So our expectation is that when we see the data in Q2, they will see a very similar profile for the once nightly medicine. With respect to key secondaries, I do not think I have the answer to that question right now.

As I just do not have that protocol committed to memory yet. We can get back to you on that.

Joshua Reed: Yeah. I will just add to that. Go ahead. Yes. So the primary is ESS, as Rich said. With the randomized withdrawal study. So our expectation is that it would mirror what we have seen in the market already with Xywav. Key secondaries are PGIC and IH, and our expectations, that would be similar to what we have seen for the current product in the market. I will just reinforce that it is 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 U.S., and it is a very low penetration right now with only one approved product. It is penetrated about 10% in the marketplace.

So this is something that we are looking forward to.

Sandra Coombs: Thank you. Our next question comes from the line of Rudy Lee with Wolfe Research. Please proceed with your question.

Rudy Lee: Hey, thanks for taking my question. Congrats reaching Bio for the Neuro. The question regarding the upcoming Phase III. So apparently, we are on track to start the trial for NT1 and NT2. I am just curious how have we discussed key factor for a Phase 3 trial in IH with FDA yet? Can you potentially start trial earlier? Would you really need to wait for the Vibrin 3 data? Thanks.

Richard F. Pops: Morning. Yeah. I think for IH, we will do exactly what we did for narcolepsy, which is get the Phase 2 data from the Vibrant study, have a, you know, formal end of Phase 2 meeting with FDA, and map out and agree on the Phase 3 program. So we will wait for those data to come later this year before we initiate that meeting with FDA.

Rudy Lee: K. Just a quick follow-up. Like, what is your current understanding on the dynamic here? Like NT1 versus NT2 in IH?

Richard F. Pops: The dynamic from a market perspective or from a regulatory—

C. Todd Nichols: Yeah. For the market?

Richard F. Pops: I think as Todd just said, the IH opportunity is a really interesting one because if you simply look at claims data, you would say that there is about 40,000 patients who are being treated for idiopathic hypersomnia today. But we think that pretty significantly underestimates the clinical need for a medicine that would deal with hypersomnolence that is not diagnosed as narcolepsy. So while we have a better sense of the narcolepsy numbers, i.e., about 200,000 patients in the U.S. prevalence, about 100,000 being diagnosed, about 80,000 being treated, we have a much more vague understanding of how big the IH market might be.

So as we have talked about before, the narcolepsy market by itself represents a very significant commercial opportunity given the unmet needs in that space. And IH, you know, I think that is the next step in the evolution of the elixirrhexin story. So we will wait for the Phase 2 data, conduct the Phase 3, and then hopefully launch into that well.

Rudy Lee: Yeah. Super helpful. Thanks.

Sandra Coombs: Thank you. Our next question comes from the line of Ami Fadia with Needham and Company. Please proceed with your question.

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

Richard F. Pops: Morning, Ami. Yeah. As I just was saying in the previous question, I think that there is a potential benefit for certain patients of dealing with the excessive daytime sleepiness with a wakefulness-promoting agent like elixirextin as well as consolidating fragmented nighttime sleep with an oxybate. That will not be the modal treatment. I think most patients will not opt for that polypharmacy. But for those patients that derive benefit from both sides of the equation, it could be a very, very powerful treatment approach. I can tell you during the even during the pendency of the Phase 2 studies, we were hearing from investigators an interest in testing both agents together in certain patients.

And we will be the only company that have agents in both camps. And so from our perspective, we see it less as a registrational pathway as more of an evidence-building pathway for the purpose of reimbursement. So I think you can expect to see more from us on that front in the weeks ahead.

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

Alice: Hi, good morning. This is Alice on for David. Thanks for taking our question. So now that you have LUMRIZE under your control, how are you thinking about the field force for the product, also bearing in mind that there will be another market entrance? Entrance by year end. And if an expansion is on the table, are you thinking about more from a breadth or a depth perspective? Thank you.

Joshua Reed: Yeah. Absolutely. So right now, we feel like the Salesforce is right-sized to really maximize the opportunity. I think context is important here. We have done a lot of work in this area. You know, our estimate is there is about 50,000 oxybate-eligible patients in the marketplace right now. And there is a dynamic segment of about 9,000 patients that are psyched. And so that is really the target for Lumerize. That is what the Salesforce is really lined up against. It is really this oxybate prescribers to maximize that dynamic segment. We are seeing very encouraging trends, obviously.

The team made some investments late last year with expanding the Salesforce slightly, also some commercial investments within our patient services area, and we are seeing benefits from that. So right now, we believe that we are right-sized. As Rich said, you know, we think this is a durable market. And so that patients will continue on oxybates. We will have to see at what how the year plays out with competitive entrants, but we clearly see this as a uniquely positioned product, and we think we are right-sized at this point.

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

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

Joshua Reed: Yeah. Let me talk about— Please talk to me. Know, SG&A. With respect to 2026, what you have impacting SG&A are a couple of things. You have got about $50,000,000 in one-time transaction costs that are impacting the year. So, clearly, those will not carry over into future periods. What you also have in 2026 compared to 2025, obviously, is taking on the commercial investments associated with LUMRIZE and, you know, typical increases that you might see in labor and benefits. You know, frankly, you exclude the impact of the transaction cost and the acquisition of Avadel, essentially, on our base business, our base company, SG&A is flat.

And so, you know, thinking certainly, we will look to about future periods, so 2027 and beyond, control spending and be disciplined on that front. And we will look to determine whether or we have got some synergies and opportunities to reallocate some of those costs of our business as it evolves. To increasing investment if necessary in our sleep medicine for elixiraxin, and for our—

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

Ashwani Verma: Hi. Thank you for taking my question, and congrats to both Richard and Blair. So just on Lumrise, there is a bit of a focus on the impact from the first generation full genetic market formation, some of the initial list prices coming in much above where the expectation was. And I know Jazz also talked about this last night, impact to Xywav in the second half. I think that like how are you thinking about that for LUMRISE, which is once nightly? Do you similar dynamic, what would apply to, like, an indirect pricing pressure and Zybee would also replicate on the rise, or does it have some sort of an advantage that the competitor might not have? Thanks.

Joshua Reed: Yeah, Ash. I will take that. We clearly think there is an advantage for Loomrise positioning. Again, it is the only once nightly oxybate, which is significant value to patients in HCP. So the positioning is clear. So strategically, we do believe there is a significant advantage. In terms of just the dynamics of the market, right now, I think just for context, you know, with generic multisource generics coming to the market, that is very specific to Xyrem. Very specific there. That is not specific to Lumerize. These products are not interchangeable. So 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 LUMRI. So we are not seeing any material changes at this point. Obviously, we are going to have to see how this plays out. Likely, if there is any impact, it would probably be second half of the year or a little bit later. And so we are going to watch that very closely. What we do know, what we hear from our sleep specialist is that they are committed to making sure that patients get access to Lumerize. They are, you know, sleep centers have the capabilities to support navigating market access hurdles, and they are committed to doing that.

So, again, we do not see any material changes at the beginning of the year. We will see how it plays out for the second half of the year.

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

Marc Goodman: Hey, good morning. Can you talk about valuelox that you inherited in the acquisition? Just the development plan and how excited you are about this product. You view it as a replacement strategy for Lumerize eventually. And just give us a sense of when you think in know, what do you have to do to get it to market, and how fast can you get it to market?

Blair Jackson: Blair, do you want to jump in on that one? Yeah. Hi, Marc. It is Blair. It is a good question. So actually valroxabate 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. And I think what we are looking to do there is try to move 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. So it is too early to say whether this would be a future replacement to Lumerize or an addition into the portfolio.

We will just see how the data plan pays out over the next year or so. This— bridging studies just you can do to get it to market? I mean, do you think you are going to have to do a full development plan, or is this—

Joshua Reed: That totally depends on the data that we get that we get early.

Blair Jackson: If we are able to match bioequivalents and things like that, then there is a much rapid path forward. If we need to do some additional studies, we will do that. This is an area we know really well. As you know, we are a formulation expert, and we have navigated these paths before. So we are early stages here, but it is now in our hands, and we are moving forward.

Marc Goodman: Thanks.

Sandra Coombs: Our next question comes from the line of Jason Matthew Gerberry with Jefferies. Please proceed with your question.

Anna Sejan: Hi. This is Anna Sejan for Akash. Just a couple questions about your ADHD study. Are you able to share any more details about that, and are you considering potentially enriching the population for a specific ADHD phenotypes?

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

Anna Sejan: Thanks.

Sandra Coombs: Our next question comes from the line of Benjamin Burnett with Wells Fargo. Please proceed with your question.

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

Richard F. Pops: So this is Rich. I think that we will not 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 are finding is that people are experiencing a quality wakefulness that they have not had before. They are very interested in certain situations of having that persist deeper into the hours of the evening.

So because of the modeling we have been able to do through our Phase 2 program, have a really good sense of how to administer two different doses, administer in time, to both extend that wakefulness and also minimize associated side effects. So that is proprietary information. And so we are going to keep that under wraps as long as we can. And I think that is going to, 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, think that will differentiate the product significantly commercially.

Sandra Coombs: Our next question comes from the line of Umer Raffat with Evercore ISI. Please proceed with your question.

Umer Raffat: Hi, guys. Thanks for taking my question. First, congratulations, Blair, on the expanded role. But my question, Richard, for you is, I have been tracking this from the days of eighty seven hundred and thirty eight thirty one, and I feel like pipeline finally is in a spot that it is never been in Alkermes' history. So I am just curious about the timing of your decision to give up the CEO role while saying chairman. And secondly, on your Phase 3 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 F. Pops: Good morning, Umer. You know, my theory all along has been the time to pass the baton—you recognize I have been doing this forever—is when the company is just in a demonstrably strong position. Past few years, we have had to basically change the business model from a royalty-based company based on formulation technology into a proprietary products company. And the last step in that transformation was getting our hands on what could be a potential blockbuster drug and its sequelae. And that is where we are right now. So, you know, Blair has been my partner through this for a long time. He is actually been at the helm for much of the transformation within the company.

And so it is a very logical time to do this. And, you know, I will say as chairman, I am extremely proud of where we are, and I think we are on this really exciting new trajectory, which I am going to be part of. On the Phase 3, we are going to include split doses in the NT1. And 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 have patients who want to extend this duration into the evening.

So, originally, our thought was that we would do this as a life cycle management post first approval, you know, adding what we were calling at the time a top up dose. But when we saw the NT2 data, 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 registration program. And I think that turned out to be a real blessing for their overall program because I think the competitive dynamic is going to swing significantly in our favor if we are successful with both the once-daily and the split dose regimens.

Joshua Reed: Thank you, Richard.

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

David Huang: Hi there. Good morning. Thanks for taking my questions, and congrats to both you, Richard and Blair. So with the Takeda potentially having a PDUFA date for oviporexant in Q3 and then q 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? And would their pricing inform how you think about the value proposition of elixirixen? Thanks so much.

Richard F. Pops: Hey, David. I will start, then I will turn it over to Todd. From my perspective, I think the most interesting unknown is going to be pricing. Because I think that is going to set the tone for the market's receptivity to the value that is being created with these NT1 drugs. So note that they are 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.

So I think that they are 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 successful with a much more broad product offering. But, Todd, your perspective.

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

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

Douglas Tsao: Hi. Good morning. Richard, congrats on your accomplishments at the company. We will miss you. Just a question on seventy two ninety in 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 nonstinulant ADHD drugs on the market right now. I guess I am 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. So I think that there would be sort of demand for better nonstimulants. Thank you.

Richard F. Pops: 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 nonstimulant drugs. And then in those model systems, the orexin system by itself as monotherapy looks incredibly important. There have been some recent publications about the actual effects of stimulants on ADHD, what the mechanistic basis of that is. And if you map that on to what is happened with the orexin pathway, the orexin pathway just anatomically and neuro obiologically, it is affecting many of these domains that are relevant to the idea of attention, focus, and vigilance and things like that.

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

Blair Jackson: 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 serial reaction test—it which is a highly translatable model to the clinic—is that we saw about equivalent efficacy across sort of the stimulants versus the orexin. And so we think as to Rich's point, think we are very confident about seeing a signal in the next study. And we will define that further as we get through the Phase 2 program.

Douglas Tsao: And 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 that currently marketed non stimulants? Thank you.

Blair Jackson: You know, I think it is too early to be 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. So, you know, we are going to be testing all of those part of this program.

Douglas Tsao: Okay. Great. Thank you very much.

Sandra Coombs: Thank you. Our next question comes from the line of Yuhi Eir with Mizuho Securities. Please proceed with your question.

Yuhi Eir: Thanks, guys. Congrats, Rich, to your accomplishment, and, Blair, congrats on your next role. So maybe just help us understand, that there is potential generic entry for the Viretrol in 2027. How you are thinking about the dynamic and you think, as far as you know, whether there is whether Teva has capability to manufacture generics at all at this point. Thanks.

Joshua Reed: Todd, do you want to go?

C. Todd Nichols: Yeah. Absolutely. So, know, our plan right now is to continue growth and expansion of VIVITROL similar to what we did in '25 and '26. So we see again strong demand for '26. We are preparing for multiple different scenarios. Could occur in 2027. You know, all the research that we have done continues to validate that this is a difficult product to commercialize, but it is really difficult to manufacture. So we know that, you know, as the company that is had this for so many years. And so we will have to see if there is a capability to do that, what the supply in the market looks like. We are prepared for that.

And if we do get competition in 2027, what that looks like, we will be prepared to compete, but we will also be prepared to execute a range of scenarios, which could include pulsing our spin differently.

Sandra Coombs: Thank you. Our further question this morning comes from the line of Paul Mitchell with Stifel. Please proceed with your question.

Julian: Hey. This is Julian on for Paul, and let me offer my congratulations on behalf of Paul and the rest of the team at Stifel. Just a couple really quick ones to you, Rich and Blair. When can we expect more detailed data on NT2? I am not sure if you have the open label extension is still ongoing, and disclose that, and when can we expect to get that data? And then for when you are talking about the Brilliance program, Rich, I think you mentioned that the primary endpoint in the NT2 Phase 3 study it is going to be MWT. I know it was a dual primary for the Phase 2.

So just curious know, thinking behind that or if there was always a plan to go ahead with MWT. Thanks.

Richard F. Pops: You are welcome. The DM—we have submitted the NT2 results for a series of presentations at Sleep in Baltimore in June. We should hear fairly soon. I expect those to be accepted. So you will see more of the complete dataset. You have seen a lot of it, but I think what I am really interested in, we have been talking internally about it, is trying even bring some more color to the quality efficacy that she sees in the NT2 population. Because I think looking at average MWT or average ESS does not really tell the whole story of the clinical benefit and the benefit of two receptor agonist in that more heterogeneous patient population.

I think that in the Phase 3 NT hierarchy. Now that we have the data from Phase 2 and we can model, we are comfortable with one. NT2 studies, we are referring to more the traditional— And I am looking around the table to make sure I am not misspeaking on this. Just we will have just a primary analysis on MWT, with key secondary, including ESF.

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

Sandra Coombs: Great. Thank you, everyone, for joining us on the call this morning and the questions. Please do not hesitate to reach out to us at the company if you have any follow-up questions you can be helpful with. Thank you.

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

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