Q3 2025 Alkermes PLC Earnings Call

Speaker #2: Greetings and welcome to Alkermes' Third Quarter 2020 Financial Results conference call. My name is Rob, and I'll be your operator for today's call.

Operator: Greetings. Welcome to the Alkermes plc third quarter 2025 financial results conference call. My name is Rob, and I'll be your operator for today's call. All participant lines will be placed on mute to prevent background noise. If you should require operator assistance during the call, please press star zero from your telephone keypad. Please note that this conference is being recorded. I will now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandra, you may now begin.

Speaker #2: All participant lines will be placed on mute to prevent background noise. If you should require operator assistance during the call, please press Star Zero from your telephone keypad.

Speaker #2: Please note that this conference is being recorded. I will now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs.

Speaker #2: Sandy, you may now begin.

Speaker #6: Thanks , Rob . Welcome to the Alkermes PLC conference call to discuss our financial results and business update for the quarter ended September 30th , 2025 .

Sandra Coombs: Thanks, Rob. Welcome to the Alkermes plc conference call to discuss our financial results and business update for the quarter ended September 30, 2025. With me today are Richard Pops, our CEO, Blair Jackson, our Chief Operating Officer, Todd Nichols, our Chief Commercial Officer, and Joshua Reid, our Chief Financial Officer. A slide presentation along with our press release, related financial tables, and reconciliations of the GAAP to non-GAAP financial measures that we'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.

Speaker #6: With me today are Richard Pops , our CEO Blair Jackson , our chief Operating Officer , Todd Nichols . Our Chief Commercial Officer , and Joshua Reed , our chief financial officer .

Speaker #6: A slide presentation , along with our press release . Related financial tables and reconciliations of GAAP to non-GAAP financial measures that will discuss today are available on the investor section of Alchemy's .

Speaker #6: Comm . We believe the non-GAAP financial results , in conjunction with the results , are useful in understanding the ongoing economics of our business .

Speaker #6: 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 .

Sandra Coombs: 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. Now I'll turn the call over to Richard for some opening remarks.

Speaker #6: Our press release issued this morning and our most recent annual and quarterly reports filed with the SEC contain important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements.

Speaker #6: 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 .

Speaker #6: After our prepared remarks , we will open the call for Q&A . And now I'll turn the call over to Richard for some opening remarks .

Speaker #7: That's great Sandy . Thank you . Good morning everyone . So Alchemy's delivered a strong third quarter . It was marked by solid commercial execution , significant progress in our development pipeline , robust financial performance and continued execution across our strategic priorities .

Richard Pops: That's great, Sandy. Thank you. Good morning, everyone. Alkermes plc delivered a strong third quarter. It was marked by solid commercial execution, significant progress in our development pipeline, robust financial performance, and continued execution across our strategic priorities. Today, we're raising our financial expectations for 2025, reflecting our confidence in the momentum of the business. Before we dive into the results for the quarter and our increased expectations for the remainder of 2025, I'd like to take a moment on the announcement we made last week regarding our proposed acquisition of Avadel Pharmaceuticals. This transaction is an important step forward in Alkermes' strategic evolution for three compelling reasons. First, we gain an FDA-approved medicine with significant growth potential. Lumryz is the first and only FDA-approved once-at-bedtime oxybate for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.

Speaker #7: Today , we're raising our financial expectations for 2025 , reflecting our confidence in the momentum of the business . Before we dive into the results for the quarter and our increased expectations for the remainder of 2025 , I'd like to take a moment on the announcement we made last week regarding our proposed acquisition of Avadel Pharmaceuticals .

Speaker #7: This transaction is an important step forward in alchemy , strategic evolution for three compelling reasons . First , we gain an FDA approved medicine with significant growth potential .

Speaker #7: Lumryz is the first and only FDA approved once at bedtime oxybate for the treatment of cataplexy , or excessive daytime sleepiness in patients seven years or older with narcolepsy .

Speaker #7: It has already shown strong market uptake since launch in 2025. It's expected to generate between $265 million and $275 million in net revenue once the transaction is complete.

Richard Pops: It has already shown strong market uptake since launch. In 2025, it's expected to generate between $265 million and $275 million in net revenue. Once the transaction is complete, it will immediately diversify our commercial portfolio and strengthen our profitability. Second, the acquisition will accelerate our commercial entry into the sleep medicine market. It will provide a well-established foundation for the potential launch of Elixerextan, our promising orexin-2 receptor agonist in development for narcolepsy and idiopathic hypersomnia. Avadel Pharmaceuticals is a recognized leader in sleep medicine and has successfully built and scaled a high-performing commercial organization. With positive phase 2 data for Elixerextan in narcolepsy type 1 now in hand, data from Vibrance II and NT2 that we expect to report in November, and plans to initiate a global phase 3 program early next year, we've reached a new level of conviction in the potential of our orexin platform.

Speaker #7: It will immediately diversify our commercial portfolio and strengthen our profitability . Second , the acquisition will accelerate our commercial entry into the sleep medicine market .

Speaker #7: It will provide a well-established foundation for the potential launch of Elixir in our promising orexin 2 receptor agonist in development for narcolepsy and idiopathic hypersomnia.

Speaker #7: Avadel is a recognized leader in sleep medicine and has successfully built and scaled a high-performing commercial organization with positive Phase 2 data for orexin in narcolepsy type one.

Speaker #7: Now in hand data from vibrance two and Nt2 that we expect to report in November and plans to initiate a global phase three program early next year .

Speaker #7: We've reached a new level of conviction in the potential of our orexin platform . And third , the financial strength of the combined company will enhance our ability to support a diversified development strategy in sleep disorders .

Richard Pops: Third, the financial strength of the combined company will enhance our ability to support a diversified development strategy in sleep disorders. This will include Elixerextan, as well as our additional orexin-2 receptor agonist candidates, AUX4510 and AUX7290, which recently entered the clinic. Avadel Pharmaceuticals' development pipeline also has the potential to broaden our offerings for the sleep community with an ongoing phase 3 study of Lumryz in idiopathic hypersomnia and valioxabate, a no-salt oxabate candidate in early-stage development. The proposed acquisition reinforces our commitment to neuroscience. It gives us additional scale and builds on our legacy of innovation in complex psychiatric and neurological disorders. The transaction is a compelling opportunity to accelerate our growth trajectory and is squarely aligned with our financial and strategic priorities. Upon closing, which we currently expect in Q1, we'll be able to provide more color on our expectations for the combined business.

Speaker #7: This will include a orexin as well as our additional two receptor agonist candidates . Alks 4005 and 7290 , which recently entered the clinic development pipeline , also has the potential to broaden our offerings for sleep , community with an ongoing phase three study of lumryz in idiopathic hypersomnia and oxybate , a no salt oxybate candidate in early stage development .

Speaker #7: The proposed acquisition reinforces our commitment to neuroscience . It gives us additional scale and builds on our legacy of innovation in complex psychiatric and neurological disorders .

Speaker #7: The transaction is a compelling opportunity to accelerate our growth trajectory and is squarely aligned with our financial and strategic priorities. Upon closing, which we currently expect in Q1, we'll be able to provide more color on our expectations for the combined business.

Speaker #7: So with that as an intro , I'll turn it over to Joshua , who will walk through our third quarter financial results .

Richard Pops: With that as an intro, I'll turn it over to Joshua, who will walk through our third quarter financial results.

Speaker #8: Thank you . Richard . I'm pleased to join you today for my first earnings call as Chief Financial Officer of Alchemy's . I'm excited to be part of a company with a strong financial foundation , a clear strategic vision and a deep commitment to delivering value for shareholders while advancing innovative medicines that have the potential to make a meaningful difference for patients .

Joshua Reid: Thank you, Richard. I'm pleased to join you today for my first earnings call as Chief Financial Officer of Alkermes plc. I'm excited to be part of a company with a strong financial foundation, a clear strategic vision, and a deep commitment to delivering value for shareholders while advancing innovative medicines that have the potential to make a meaningful difference for patients. Since joining, I spent time getting to know our team, our operations, and our financial priorities. I've been impressed by the discipline and focus that drive our performance, and I look forward to building on that momentum. Now, turning to our financial results. Our third quarter results were strong, reflecting continued commercial and operational execution. Financially, the year's tracking ahead of our expectations, and based on our performance through the first nine months, we are raising our full-year 2025 guidance today.

Speaker #8: Since joining , I spent time getting to know our teams , our operations and our financial priorities . I've been impressed by the discipline and focus that drive our performance , and I look forward to building on that momentum .

Speaker #8: Now turning to our financial results . Our third quarter results were strong , reflecting continued commercial and operational execution . Financially , the years tracking ahead of our expectations and based on our performance through the first nine months , we are raising our full year 2025 guidance today .

Speaker #8: For the third quarter , we generated total revenues of $394.2 million , driven primarily by our portfolio of proprietary products , which generated net sales of $317.4 million , reflecting 16% year over year growth .

Joshua Reid: For the third quarter, we generated total revenues of $394.2 million, driven primarily by our portfolio proprietary products, which generated net sales of $317.4 million, reflecting 16% year-over-year growth. These results were driven by strong underlying demand, which Todd will address in his remarks, and gross-to-net favorability, primarily related to Medicaid utilization rates, which drove a one-time gross-to-net benefit of approximately $8 million for Vivitrol and approximately $5 million for Aristada. As we move into the fourth quarter, we expect Q4 net sales from this portfolio in the range of $300 to $320 million. Manufacturing and royalty revenues were $76.8 million for the third quarter, including revenues of $35.6 million from Lumryz and $30.2 million from the long-acting Invega products.

Speaker #8: These results were driven by strong underlying demand , which Todd will address in his remarks and gross net favourability primarily related to Medicaid utilization rates , which drove a one time gross net benefit of approximately $8 million for Vivitrol and approximately $5 million for Aristada .

Speaker #8: As we move into the fourth quarter , we expect Q4 net sales from this portfolio in the range of 300 to $320 million .

Speaker #8: Manufacturing and royalty revenues were $76.8 million for the third quarter , including revenues of $35.6 million from rumored and $30.2 million from the long acting and Vega products .

Speaker #8: Turning to expenses , cost of goods sold were $51.6 million , which compared favorably to $63.1 million for Q3 last year , primarily reflecting efficiencies .

Joshua Reid: Turning to expenses, cost of goods sold were $51.6 million, which compared favorably to $63.1 million for Q3 last year, primarily reflecting efficiencies following the sale of our Athlone-based manufacturing business last year. R&D expenses were $81.7 million compared to $59.9 million for Q3 last year, reflecting investments in the vibrant phase 2 studies of Elixerextan across narcolepsy and idiopathic hypersomnia, and first-in-human studies and development efforts for our next orexin-2 receptor agonist candidates, AUX4510 and AUX7290. SG&A expenses were $171.8 million compared to $150.4 million for Q3 last year, reflecting the expansion of our psychiatry field organization earlier this year and promotional activities related to Lybalvi. In Q4, we expect a modest increase in SG&A, primarily reflecting activities related to the Avadel transaction. This performance generated strong profitability of GAAP net income of $82.8 million, EBITDA of $96.9 million, and adjusted EBITDA of $121.5 million in the third quarter.

Speaker #8: Following the sale of our Athlone-based manufacturing business last year, R&D expenses were $81.7 million, compared to $59.9 million for Q3 last year. This reflects investments in the vibrant Phase 2 studies of Elixir Exton across narcolepsy and idiopathic hypersomnia, as well as first-in-human studies and development efforts.

Speaker #8: For our next orexin two receptor agonist candidates . Alex , 45 , ten , and Alex , 7290 . SG&A expenses were $171.8 million , compared to $150.4 million for Q3 last year , reflecting the expansion of our psychiatry field organization earlier this year .

Speaker #8: And promotional activities related to Lowballed in Q4. We expect a modest increase in SG&A, primarily reflecting activities related to the Avadel transaction.

Speaker #8: This performance generated strong profitability of GAAP net income of $82.8 million , EBITDA of $96.9 million , and adjusted EBITDA of $121.5 million in the third quarter .

Speaker #8: As we look ahead, based on our strong commercial performance and momentum through the first nine months of the year, we are on track to deliver record revenues from our portfolio of proprietary products in 2025.

Joshua Reid: As we look ahead, based on our strong commercial performance and momentum through the first nine months of the year, we are on track to deliver record revenues from our portfolio of proprietary products in 2025. As a result, we are raising our 2025 full-year guidance to reflect our current expectations of total revenues of $1.43 to $1.49 billion, GAAP net income of $230 to $250 million, EBITDA of $270 to $290 million, and adjusted EBITDA of $365 to $385 million. Our full expectations are outlined in the press release issued this morning. Turning to our balance sheet, we entered the quarter in a strong position with $1.14 billion in cash and total investments. For the acquisition of Avadel, we will use cash from our balance sheet in conjunction with bank debt to finance the transaction.

Speaker #8: As a result, we are raising our 2025 full-year guidance to reflect our current expectations of total revenues of $1.43 to $1.49 billion.

Speaker #8: GAAP net income of 230 to $250 million . EBITDA of 270 to $290 million , and adjusted EBITDA of 365 to $385 million .

Speaker #8: Our full expectations are outlined in a press release issued this morning . Turning to our balance sheet , we ended the quarter in a strong position with $1.14 billion in cash and total investments for the acquisition of Avadel .

Speaker #8: We use cash from our balance sheet in conjunction with bank debt to finance the transaction . As we close the transaction and finalized the financing , we will be in a position to provide more details .

Joshua Reid: As we close the transaction and finalize the financing, we will be in a position to provide more details. Taking a step back, Alkermes plc is one of the few biopharmaceutical companies that has successfully transitioned into a fully integrated, profitable commercial organization with an exciting development pipeline. I step into this role at a time when the company is operating from a position of financial strength, with a clear growth trajectory and near-term opportunities with the potential to drive meaningful value for shareholders. I'm energized by the opportunity to help shape that next phase of our growth, working closely with the rest of the leadership team to support our strategic priorities and drive long-term value creation. I look forward to engaging with many of you in the weeks ahead and to contributing to the continued success of Alkermes plc.

Speaker #8: Taking a step back . Alkermes is one of the few biopharmaceutical companies that has successfully transitioned into a fully integrated , profitable commercial organization with an exciting development pipeline .

Speaker #8: I step into this role at a time when the company is operating from a position of financial strength, with a clear growth trajectory and near-term opportunities.

Speaker #8: With the potential to drive meaningful value for shareholders, I'm energized by the opportunity to help shape that next phase of our growth.

Speaker #8: Working closely with the rest of the leadership team to support our strategic priorities and drive long-term value creation. I look forward to engaging with many of you in the weeks ahead and to contributing to the continued success of Alkermes.

Speaker #8: With that, I will turn the call to Todd for a review of the proprietary portfolio.

Joshua Reid: With that, I will turn the call to Todd for a review of the proprietary portfolio.

Speaker #9: Thank you . Joshua , and good morning , everyone . In the first three quarters of the year , we executed with discipline against our targeted growth initiatives .

Todd Nichols: Thank you, Joshua. Good morning, everyone. In the first three quarters of the year, we executed with discipline against our targeted growth initiatives. The focus drove strong, consistent performance across our three proprietary brands, underscoring the strength of our commercial strategy and our capabilities. We're encouraged by the momentum we've built and remain confident in our ability to carry it forward. In the third quarter, we recorded net sales from our proprietary product portfolio of $317.4 million, reflecting 16% year-over-year growth. We drove strong in-market demand across Vivitrol, Aristada, and Lybalvi. Starting with Vivitrol, net sales in the third quarter were $121.1 million. Vivitrol performance continued to be driven by growth in the alcohol dependence indication market and our ability to capitalize on highly localized market dynamics in certain states and payer systems.

Speaker #9: The focus drove strong , consistent performance across our three proprietary brands , underscoring the strength of our commercial strategy and our capabilities . We're encouraged by the momentum we've built and remain confident in our ability to carry it forward .

Speaker #9: In the third quarter , we recorded net sales from our proprietary product portfolio of $317.4 million , reflecting 16% year over year growth .

Speaker #9: We drove strong in-market demand across Vivitrol, Aristada, and Lybalvi. Starting with Vivitrol, net sales in the third quarter were $121.1 million.

Speaker #9: Vivitrol performance continued to be driven by growth in the alcohol dependence indication market and our ability to capitalize on highly localized market dynamics in certain states and payer systems.

Speaker #9: For the full year 2025 , we now expect Vivitrol net sales in the range of 460 to $470 million , compared to our prior expectation of 440 to $460 million .

Todd Nichols: For the full year 2025, we now expect Vivitrol net sales in the range of $460 to $470 million, compared to our prior expectation of $440 to $460 million. Turning to our psychiatry franchise, the expansion of our psychiatry sales force earlier this year was a key strategic initiative designed to enhance our competitive share of voice. With our expanded footprint, we have been able to significantly increase the frequency of our call volume for high-priority prescriber targets across Lybalvi and Aristada. This increased share of voice, along with strong execution, has driven increased breadth of prescribers for both brands. For the Aristada product family, in the third quarter, net sales were $98.1 million. Leading indicators related to underlying demand were encouraging, with increased prescriber breadth and strong new-to-brand prescriptions during the quarter.

Speaker #9: Turning to our psychiatry franchise , the expansion of our psychiatry sales force earlier this year was a key strategic initiative designed to enhance our competitive share of voice with our expanded footprint , we have been able to significantly increase the frequency of our call volume for high priority prescriber targets across Lybalvi and Aristada .

Speaker #9: This increased share of voice , along with strong execution , has driven increased breadth of prescribers for both brands . For Aristada product family in the third quarter , net sales were $98.1 million , leading indicators related to underlying demand were encouraging , with increased prescriber breadth and strong new to brand prescriptions during the quarter .

Speaker #9: For the full year 2025 , we now expect Aristada net sales in the range of 360 to $370 million . Compared to our prior expectation of 335 to $355 million .

Todd Nichols: For the full year 2025, we now expect Aristada net sales in the range of $360 to $370 million, compared to our prior expectation of $335 to $355 million. Turning to Lybalvi, net sales grew 32% year-over-year to $98.2 million. Underlying TRX growth was 25% year-over-year, driven by new patient starts and prescriber breadth. Gross-to-net adjustments were approximately 28% in the third quarter. For the full year, we now expect Lybalvi net sales in the range of $340 to $350 million, compared to our prior expectation of $320 to $340 million. Across the portfolio, we are pleased with our performance through the first three quarters of the year and entered the final stretch of the year with strong momentum and a clear focus on delivering against our full-year objectives. With that, I will pass the call back to Rich.

Speaker #9: Turning to Lybalvi, net sales grew 32% year over year to $98.2 million. Underlying growth was 25% year over year, driven by new patient starts and prescriber breadth. Gross to net adjustments were approximately 28% in the third quarter.

Speaker #9: For the full year, we now expect net sales in the range of $340 to $350 million, compared to our prior expectation of $320 to $340 million across the portfolio.

Speaker #9: We are pleased with our performance through the first three quarters of the year and enter the final stretch of the year with strong momentum in a clear focus on delivering against our full year objectives .

Speaker #9: With that , I'll pass the call back to Rich .

Speaker #7: Thank you Todd . Well done . I think you can see from the results that the company's performing well across each of the key aspects of our business during the quarter , our commercial teams delivered strong operational and financial performance , and our R&D teams made major strides in advancing our expanding development pipeline .

Richard Pops: Thank you, Todd. Well done. I think you can see from the results that the company is performing well across each of the key aspects of our business. During the quarter, our commercial teams delivered strong operational and financial performance, and our R&D teams made major strides in advancing our expanding development pipeline. I want to make comments about both aspects of the business. First, commercial. We entered the final quarter of the year ahead of plan and with good momentum into year-end. Over many years, we've developed capabilities necessary to operate in challenging payer and policy environments. By design, we manufacture our proprietary products in the U.S., and we do not commercialize these products outside the U.S. We are growing our business by growing demand based on the clear clinical attributes of our medicines and maintaining a disciplined contracting strategy consistent with our view of their significant value.

Speaker #7: So I want to make comments about both aspects of the business . First , commercial . We enter the final quarter of the year ahead of plan and with good momentum into year end .

Speaker #7: Over many years , we have developed capabilities necessary to operate in challenging payer and policy environments by design , we manufacture our proprietary products in the United States , and we do not commercialize these products outside of the US .

Speaker #7: We are growing our business by growing demand based on the clear clinical attributes of our medicines and maintaining a disciplined , contracting strategy consistent with our view of their significant value .

Speaker #7: Now , R&D , our portfolio of orexin two receptor agonists is advancing rapidly , led by orexin , the first phase two data set of orexin was presented at World Sleep in September in the vibrance , one study , elixir Rexton , demonstrated compelling therapeutic benefits in patients with narcolepsy .

Richard Pops: Now, R&D. Our portfolio of orexin-2 receptor agonists is advancing rapidly, led by Elixerextan. The first phase 2 data set of Elixerextan was presented at World Sleep in September. In the Vibrance I study, Elixerextan demonstrated compelling therapeutic benefits in patients with narcolepsy type 1, with a profound effect on excessive daytime sleepiness and cataplexy, along with a generally well-tolerated safety profile. Taken together with the clinically meaningful improvements in fatigue and cognitive function demonstrated in the study, we believe Elixerextan has the potential to transform the treatment of NT1. At World Sleep, the competitive positioning for Elixerextan in NT1 also came clearly into focus. In this large, randomized, double-blind, multi-week study, Elixerextan administered once daily across a range of doses demonstrated new potential best-in-class features.

Speaker #7: Type one with a profound effect on excessive daytime sleepiness and cataplexy , along with a generally well-tolerated safety profile . Taken together with the clinically meaningful improvements in fatigue and cognitive function demonstrated in the study , we believe elixir has the potential to transform the treatment of nt1 at World Sleep , the competitive positioning for elixir and Nt1 also came clearly into focus in this large , randomized , double blind , multi-week study .

Speaker #7: Elixir administered once daily across a range of doses demonstrated new potential best in class features with data from this rigorous phase two study now in hand , we're confident in the profile of Elixir Rexton in Nt1 , and we're moving rapidly to initiate the phase three Registrational program in the first quarter of next year .

Richard Pops: With data from this rigorous phase 2 study now in hand, we're confident in the profile of Elixerextan in NT1, and we're moving rapidly to initiate the phase 3 registrational program in the first quarter of next year. We expect to be first to market narcolepsy type 2 and idiopathic hypersomnia. We completed enrollment in Vibrance II in patients with narcolepsy type 2 toward the end of the summer, and we expect to report top-line data in November. In idiopathic hypersomnia, Vibrance III is enrolling well, and we expect data from that study in mid-2026. Like Vibrance I, these are both large, well-powered phase 2 studies designed to provide substantial data sets informing potential phase 3 development. We are building a significant body of clinical data that deepens our understanding of orexin biology and its therapeutic potential in central orders of hypersomnolence and beyond.

Speaker #7: We expect to be first to market narcolepsy type two and idiopathic hypersomnia . We completed enrollment in vibrance two . In patients with narcolepsy type two toward the end of the summer , and we expect to report top line data in November in idiopathic hypersomnia .

Speaker #7: Vibrance three is enrolling well , and we expect data from that study in mid 2026 . Like vibrance one . These are both large .

Speaker #7: Well-powered Phase 2 studies designed to provide substantial data sets informing potential Phase 3 development. We are building a significant body of clinical data that deepens our understanding of orexin biology and its therapeutic potential in central disorders of hypersomnolence and beyond.

Speaker #7: Equally important , the phase two studies are yielding key learnings related to study design and implementation that we believe will be invaluable for phase three and help support elixir competitive position in narcolepsy beyond Elixir Exton and sleep disorders .

Richard Pops: Equally important, the phase 2 studies are yielding key learnings related to study design and implementation that we believe will be invaluable for phase 3 and help support Elixerextan's competitive position in narcolepsy. Beyond Elixerextan in sleep disorders, additional candidates from our portfolio of orexin-2 receptor agonists are advancing well. AUX4510 is in the clinic and progressing quickly through single and multiple ascending dose studies in healthy volunteers. We expect to complete this phase 1 work early next year and move quickly into proof-of-concept studies in the disease areas that we plan to pursue. For AUX7290, we have filed the IND and recently initiated our first in-human study. Across our orexin development programs, we have demonstrated in clinical or preclinical models that orexin-2 receptor agonists may have powerful effects not only on wakefulness but also across domains related to fatigue, cognition, attention, and mood.

Speaker #7: Additional candidates from our portfolio of orexin two receptor agonists are advancing well . Alks 4510 is in the clinic and progressing quickly through single and multiple ascending dose studies in healthy volunteers .

Speaker #7: We expect to complete this phase one work early next year and move quickly into proof of concept studies in the disease areas that we plan to pursue .

Speaker #7: For ALK 7290 , we have filed the IND and recently initiated our first in human study across our development programs . We have demonstrated in clinical or pre-clinical models that orexin two receptor agonists may have powerful effects not only on wakefulness , but also across domains related to fatigue , cognition , attention and mood .

Speaker #7: We look forward to sharing more on both of these candidates next year as they complete their Phase 1 healthy volunteer studies. So, to wrap up, the third quarter was a clear demonstration of Alchemy's strong execution.

Richard Pops: We look forward to sharing more on both of these candidates next year as they complete their phase 1 healthy volunteer studies. To wrap up, the third quarter was a clear demonstration of Alkermes plc's strong execution, commercial momentum, and scientific leadership. We continue to operate from a position of financial strength as we advance our pipeline and generate a growing body of data and insights that inform our strategy and reinforce our conviction in the opportunities ahead. With disciplined focus and a commitment to innovation in the patients we serve, we're well-positioned to deliver long-term value for our shareholders. We look forward to sharing our progress. With that, I'll turn the call back to Sandy to manage the Q&A.

Speaker #7: Commercial momentum , and scientific leadership . We continue to operate from a position of financial strength as we advance our pipeline and generate a growing body of data and insights that inform our strategy and reinforce our conviction in the opportunities ahead with disciplined focus and a commitment to innovation in the patients we serve , we're well positioned to deliver long term value for our shareholders .

Speaker #7: So we look forward to sharing our progress . With that , I'll turn the call back to Sandy to manage the Q&A .

Speaker #6: Thanks , Rich Robb . We'll open the call for Q&A . Please .

Sandra Coombs: All right. Thanks, Rich. Rob, we'll open the call now for Q&A, please.

Speaker #2: Thank you . Sandy . We'll now be conducting a question and answer session . We ask you to please limit yourself to one question and one follow up to allow as many as possible to ask questions .

Operator: Thank you, Sandy. We'll now be conducting a question and answer session. We ask that you please limit yourself to one question and one follow-up to allow as many as possible to ask questions. If you'd like to ask a question at this time, please press star one from your telephone keypad, and 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 who are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Thank you. Our first question is from the line of Mark Goodman with Leerink Partners. Please proceed with your questions.

Speaker #2: If you'd like to ask a question at this time , please press Star one from your telephone keypad and a confirmation tone will indicate your line is in the question queue .

Speaker #2: You may press star 2. 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.

Speaker #2: Thank you . And our first question is from the line of Mark Goodman with Leerink Partners . Please proceed with your questions .

Speaker #10: Yeah . Can you talk about Lybalvi just a little bit ? Seem to be a lot stronger than expected . And the gross to net seemed to be a little lower than expected .

[Analyst 1]: Yeah. Can you talk about Lybalvi just a little bit? It seemed to be a lot stronger than expected, and the gross-to-net seemed to be a little lower than expected. We were expecting that to kind of creep up some. Just give us a sense of what's happening with the product and just how you're thinking about gross-to-nets, you know, into the next year.

Speaker #10: We were expecting that to kind of creep up . Some just give us a sense of what's happening with the product and just how you're thinking about gross to net , you know , into the next year .

Speaker #9: Yeah , absolutely . Mark , this is Todd . Yeah , we're really pleased with performance for Q3 . As I said in my prepared remarks , extension of our psychiatry footprint really drove a strong share of voice in the quarter .

Todd Nichols: Yeah, absolutely, Mark. This is Todd. Yeah, we're really pleased with performance for Q3. As I said in my prepared remarks, the extension of our psychiatry footprint really drove a strong share of voice in the quarter. We were able to significantly increase our call volume, which was our strategic plan. We did that in Q3. We believe that that momentum will carry into Q4. The result of that is we saw year-over-year TRX growth of about 25%. What's even more encouraging is we saw new patients start year-over-year MBRX increase almost 16%. The underlying demand is really encouraging, and we believe that's a really direct reflection of the expansion of our sales force. For context, breadth of prescribing over the quarter increased 7%. That's two consecutive quarters, Q2 and Q3. We saw strong breadth of prescribing.

Speaker #9: We were able to significantly increase our call volume , which was our strategic plan . We did that in Q3 . We believe that that momentum will carry into Q4 .

Speaker #9: And so the result of that is we saw year over year growth of about 25% . But what's even more encouraging is we saw new patients start year over year , NBR has increased almost 16% .

Speaker #9: So the underlying demand is really encouraging. And we believe that's a direct reflection of the expansion of our sales force.

Speaker #9: So for context , breadth of prescribing over the quarter increased 7% . So that's two consecutive quarters Q2 and Q3 . We saw strong breadth of prescribing .

Speaker #9: To your question on gross to net gross to net was a little bit lower in the quarter than , than than from Q2 .

Todd Nichols: To your question on gross-to-net, gross-to-net was a little bit lower in the quarter than from Q2. That's the result of just as deductible resets throughout the year, lower copay utilization, some small little dynamics like that actually had a lower gross-to-net for the quarter.

Speaker #9: That's the result of just as as deductible resets throughout the year . Lower copay utilization , some small little dynamics like that actually had a lower , lower gross to net for the quarter .

Speaker #7: And Mark , it's rich . I'll just I'll just add and Todd can expand on it . But the story about Lybalvi over time in the marketplace , other than just our strong commercial execution , is its efficacy .

Richard Pops: Mark, it's Rich. I'll just add, and Todd can expand on it. The story about Lybalvi over time in the marketplace, other than just our strong commercial execution, is its efficacy. That efficacy message is resonating, and I think it's supported now by multi-year data in the real world.

Speaker #7: And that efficacy message is resonating . And I think it's supported now by multiyear data in the real world .

Speaker #10: How do we think about gross into next year ?

[Analyst 1]: Why don't we think about gross-to-net favorability into next year?

Speaker #9: So we're not going to provide any guidance today , Mark , for next year . We we do expect that going into Q4 that the typical seasonal patterns would , would , would , would show up .

Todd Nichols: We're not going to provide any guidance today, Mark, for next year. We do expect that going into Q4 the typical seasonal patterns would show up. We do expect a little bit of expansion of gross-to-net in Q4. We'll give you a full-year guide in February.

Speaker #9: So we do expect a little bit of expansion of gross to net in Q4 , but we'll give you a full year guide in February .

Speaker #10: Okay . Thanks .

[Analyst 1]: Okay. Thanks.

Speaker #2: Our next question is from the line of David Hwang with Deutsche Bank . Please proceed with your question .

Operator: Our next question is from the line of David Huang with Deutsche Bank. Please proceed with your question.

Speaker #11: Hi . Thanks for taking the question . So I just wanted to ask about , I guess , expectations . Once the Nt2 Elixir Rexetin data are in hand , how does that inform the next steps with the FDA ?

[Analyst 1]: Hi, Eric. Thanks for taking the question. I just wanted to ask about expectations once the NT2 Elixerextan data are in hand. How does that inform the next steps with the FDA? When will we know more about the phase 3 program and design? Maybe just a follow-up on Vivitrol, just kind of the expectations heading into Q4 for that product. Thank you.

Speaker #11: And when will we know more about the phase three program and design ? And then maybe just a follow up on Vivitrol just kind of the expectations heading into Q4 for that , that product .

Speaker #11: Thank you . Thank you .

Speaker #7: David , I'll take the first and then tuck and answer on Vivitrol . So we expect that we're on track for data from the NTT study in November .

Richard Pops: David, it's Rich. I'll take the first and then Todd can answer on Vivitrol. We expect that we're on track for data from the NT2 study in November. As we've said all along, when we get those data in hand, that coupled with the Vibrance I NT1 data will comprise the package for our end-of-phase student meeting with FDA. We'll request that meeting as soon as we get the NT2 data. We'll have that meeting, and we'll launch the phase 3 program as our expectation early next year. Go ahead, Todd.

Speaker #7: And as we've said all along , when we get those data in hand , that coupled with the vibrance one Nt1 data will comprise the package for our end of phase two meeting with FDA .

Speaker #7: So we'll request that meeting as soon as we get the Nt2 data. We'll have that meeting, and then we'll launch the Phase 3 program as our expectation early next year.

Speaker #7: Go ahead .

Speaker #9: Yeah . In terms of vivitrol for the fourth quarter , I think the basis of that is what we saw in Q3 . We saw strong ad demand , ad sales continue to drive the substantial majority of the brand .

Todd Nichols: Yeah. In terms of Vivitrol for the fourth quarter, I think the basis of that is what we saw in Q3. We saw strong AD demand. AD sales continue to drive the substantial majority of the brand. We hear very encouraging feedback from the market from HCPs and patients. Our expectation is that we would continue to see AD growth going into the fourth quarter. I think it's also just important to keep in mind that this is a mature product. We think it will perform like a mature product, but our focus is really driving AD sales in Q4.

Speaker #9: We hear very encouraging feedback from the market , from HCPs and patients . So our expectation is that we would continue to see ad growth going into the fourth quarter .

Speaker #9: I think it's also just important to keep in mind that this is a mature product. So we think it will perform like a mature product, but our focus is really driving ad sales in Q4.

Speaker #2: Our next question comes from the line of Umar Rafat with Evercore ISI . Pleased to see you . Three questions .

Operator: Our next question comes from the line of Umar Rafat with Evercore ISI. Please proceed with your questions.

Speaker #12: Hi , guys . Thanks for taking my question . I just wanted to dial in on the Nt2 study a little bit . Could you perhaps lay out for us your expectation of how much of an benefit is reasonable to expect , knowing there's a bit of tachyphylaxis off of single dose work in phase one ?

[Analyst 2]: Hi guys. Thanks for taking my question. I just wanted to dial in on the NT2 study a little bit. Could you perhaps lay out for us your expectation of how much of an MWT benefit is reasonable to expect, knowing there's a bit of tachyphylaxis off of single-dose work in phase 1? On the flip side, patients are starting off at 10 to 12 minutes at baseline. How much MWT improvements are you expecting? Also, any broad parameters around what do you know as of right now on blinded safety for NT2? Thank you very much.

Speaker #12: But on the flip side, patients are starting off at 10 to 12 minutes at baseline. So how much more improvements are you expecting?

Speaker #12: And then also any broad parameters around what do you know as of right now on blinded safety for Nt2? Thank you very much.

Richard Pops: I'm Rich. I won't comment on any of the blinded data. We'll get the full data set here just in a matter of weeks. We'll look at the data in the aggregate. In a large multi-week randomized placebo-controlled study, the blinded information is not particularly useful to us. We'll look forward to seeing the whole data set right away. Our expectation is that, based on the phase 1B study, we know that orexin-2 receptor agonists from that study can drive wakefulness in patients with narcolepsy type 2 and idiopathic hypersomnia. We really don't have a numerical threshold at the outset because we also expect a lot more variability in the patient population. From a phase 2 perspective, what we're looking for is we've identified a range of doses like we did in the narcolepsy type 1 study.

Speaker #7: I won't comment on any of the blinded data . We'll get the full data set here just in a matter of weeks . So we'll , we'll we'll look at the data in the aggregate in a large multi week randomized , placebo controlled study .

Speaker #7: You know , the blinded information is only is not particularly useful to us . So we'll look forward to seeing the whole data set right away .

Speaker #7: Our expectation is that based on the phase one study is that we know the direction two receptor agonists from that study can drive wakefulness in patients with Nt2 and NIH .

Speaker #7: But we really don't have a numerical threshold at the outset , because we also expect a lot more variability in the patient population .

Speaker #7: So from a Phase 2 perspective, what we're looking for is we've identified a range of doses like we did in the NT1 study.

Speaker #7: What we'd like to see is , is the safety tolerability profile across that range of doses . And clear evidence of efficacy across the various efficacy parameters , all to inform our dose selection for phase three .

Richard Pops: What we'd like to see is the safety tolerability profile across that range of doses and clear evidence of efficacy across the various efficacy parameters, all to inform our dose selection for phase 3. That's the goal. If we can come out of the narcolepsy type 2 study with clear evidence of safety tolerability and efficacy and a design for phase 3, we think we're going to be the first to market in narcolepsy type 2. The same thing applies for idiopathic hypersomnia. This is the virtue, by the way, of running these large phase 2 studies. When you're talking about cohorts of 90 patients or so over multiple weeks, remember it's not just the six-week or five-week double-blind period or eight-week double-blind period. It's also the extension period where we have dose variability and selection for patients.

Speaker #7: So that's the goal . If we can come out of the Nt2 study with clear evidence of safety , tolerability and efficacy , and a design for phase three , we think we're going to be the first to market in Nt2 .

Speaker #7: And the same thing applies for I . And this is the virtue , by the way , of running these large phase two studies .

Speaker #7: You know , when you're talking about cohorts of 90 patients or so over multiple weeks . And remember , it's not just the six week or five week double blind or eight week double blind period .

Speaker #7: It's also the extension period where we have dose variability and selection for patients . So between these two phases , we just tremendous amount about about patient preference as well as dose response .

Richard Pops: Between these two phases, we just learn a tremendous amount about patient preference as well as dose response. That all goes into the calculus for phase 3.

Speaker #7: And that all goes into the calculus for phase three .

Speaker #13: Thank .

Speaker #13: Thank .

Operator: Thank you. Our next question comes from the line of Paul Matisse with Stifel. Please proceed with your questions.

Speaker #14: So much for taking my questions. Just to piggyback off that, can you confirm what details you'll give learned a us in the top-line release?

[Analyst 3]: Hey, thanks so much for taking my questions. Just to piggyback off that, can you confirm what details you'll give us in the top-line release? Will we know the actual effect size, or are you going to be saving some of this for a medical meeting? On the safety point, how are you thinking now looking ahead as to whether you might employ some sort of titration to try to attenuate certain side effects, given that in the OLE and the NT1 study, we weren't really seeing much in the way of new onset visual AEs or things like that? Thanks so much.

Speaker #14: Will we know the actual effect size , or are you going to be saving some of this for a medical meeting ? And then on on the safety point , how are you thinking now ?

Speaker #14: Looking ahead as to whether you might employ some sort of titration to try to attenuate certain side effects , given that in the Ol and the Nt1 study , we weren't really seeing much in the way of new onset visual aids or things like that .

Speaker #14: Thanks so much .

Speaker #7: Morning , Paul . So yeah , we have a good sense of how we're going to provide the top line data . You'll see that in the next few in the next few weeks .

Richard Pops: Good morning, Paul. Yeah, we have a good sense of how we're going to provide the top-line data. You'll see that in the next few weeks. What you learned from the Vibrance I probably is that there's a lot of data that comes out of these studies. As soon as we get the data, we'll start submitting the abstracts for the various medical meetings as they roll into 2026. You can expect a fair amount of data coming out of it. The top line, we have a good sense of the structure of it, and you'll see that in relatively short order. We have made a lot of decisions following Vibrance I about the structure of the dosing in phase 3. We're going to keep most of that proprietary right now because we feel like there were some real learnings.

Speaker #7: What you learn from the vibrance one probably is that there's a lot of data that comes out of these studies . So what we'll do is as soon as we get the data , we'll start submitting the abstracts for the various medical meetings as they roll into 2026 .

Speaker #7: But you can expect a fair amount of data coming out of it. But the top line, we have a good sense of the structure of it, and you'll see that in relatively short order.

Speaker #7: We have made a lot of decisions following vibrance . One about the structure of the dosing in phase three , we're going to keep most of that proprietary right now because we feel like there are some real learnings .

Speaker #7: Some of them probably you can think through and derives from the comment that you made is that we really saw very , very little incidence of new onset adverse events for patients who had already been exposed to elixir in the double blind period .

Richard Pops: Some of them probably you can think through and derive from the comment that you made is that we really saw very, very little incidence of new onset adverse events for patients who had already been exposed to Elixerextan in the double-blind period. All that information from Vibrance I has been put into our modeling, and I think we've settled on our phase 3 design, and you'll see that when that study gets underway.

Speaker #7: So all that information from vibrance one has been has been put into our modeling . And I think we've settled on our our phase three design .

Speaker #7: And you'll see that when we when that study gets underway .

Speaker #14: Great . Thank you .

[Analyst 3]: Great. Thank you.

Speaker #2: Next question is from the line of Akash Tiwari with Jefferies . Please proceed with your questions .

Operator: The next question is from the line of Akash Towari with Jefferies. Please proceed with your questions.

Speaker #15: Hey , this is for Argus . Just two questions . When you release the top line , vibrance to data . Will you be releasing data points over time ?

[Analyst 4]: Hey, this is Manoj for Agas. Just two questions. When you release the top-line Vibrance II data, will you be releasing data points over time, like four weeks and eight weeks? Because both TAAC994 and 861 NT2 data showed some deterioration of efficacy, primarily in MWT, going from four weeks to eight weeks. Do you see any biological rationale for this, or is it just like a noise related to a small number there? Do you expect a dose response in Vibrance II in terms of ESS? Lastly, what kind of PK profile do you look for the next-gen orexin agonist? Thank you.

Speaker #15: Like four weeks and eight weeks ? Because both track nine , nine , four and 86 192 data showed some deterioration of efficacy , primarily in MWD , going from four weeks to eight weeks .

Speaker #15: Do you see any biological rationale for this , or is it just like a noise related to the small number ? There ? And also , do you expect a dose response in vibrance to in terms of SS ?

Speaker #15: And also, lastly, what kind of PK profile do you look for in the next generation? Thank you.

Speaker #7: So . On the on the point about the the tachyphylaxis that you refer to are referred to as well , we don't see based on previous data , the significant evidence of Tachyphylaxis or degradation in efficacy signal between 4 and 8 weeks , or even eight and 12 weeks , in other data sets .

Richard Pops: On the point about the tachyphylaxis that you referred to or Umar referred to as well, we don't see, based on previous data, significant evidence of tachyphylaxis or degradation in efficacy signal between four and eight weeks or even eight and twelve weeks in other data sets. At the top line, I wouldn't expect all the detailed data of time course, but I just want to let you know at the outset that's not our pretest hypothesis that we expect to see a degradation. To the extent that one did, one way that you could overcome it is with a range of doses. We've always thought that having a range of doses could be a real competitive advantage in this category. We're hopeful to see dose response across the various efficacy measures, but we won't know until we see the data.

Speaker #7: So at the top line, I would expect all the detailed data of the time course, but I just want to let you know at the outset that that's not our pretest hypothesis that we expect to see a degradation.

Speaker #7: Now , to extent that one did . One way that you could overcome it is with with a range of doses . And we've always thought that having a range of doses could be a real competitive advantage in , in this , in this category , we we're hopeful to see dose response across the various efficacy measures .

Speaker #7: But we won't know until we see the data . The three doses that we modeled for Nt2 were designed to give us a spectrum of of of of dose response .

Richard Pops: The three doses that we modeled for narcolepsy type 2 were designed to give us a spectrum of dose response, but we won't know until we see the final data set. The PK profile of, I think you asked about the next orexin-2 receptor agonist. We're really not going to disclose any of those particular attributes of the next wave of molecules coming in. I wouldn't necessarily describe them as next generation because I don't feel like they're improving necessarily on deficiencies that Elixerextan has. They're just different, and so they're designed for different patient populations in different clinical settings. As such, they share common features of potency and selectivity. We think that's essential for interrogating this circuitry in the brain, but they will be different.

Speaker #7: But we won't know until we see the final data set . And the PK profile of . I think you asked about the next orexin agonist .

Speaker #7: We we're really not going to disclose any of the any of this particular attributes of of the next wave of , of molecules coming in .

Speaker #7: I wouldn't necessarily describe them as next generation because I don't feel like they're improving necessarily on deficiencies that orexin has there , just different .

Speaker #7: And so they're they're designed for different patient populations in , different clinical settings . And as such they share common features of potency and selectivity .

Speaker #7: And we think that's , you know , essential for for interrogating this circuitry in the brain . But they will be different .

Speaker #15: Thank you .

[Analyst 4]: Thank you.

Speaker #2: Thank you. Our next question is from the line of Joseph Thome with TD Cowen. Please proceed with your questions.

Operator: Thank you. Our next question is from the line of Joseph Tome with TD Cowen. Please proceed with your questions.

Speaker #16: Hi there . Good morning and thank you for taking my questions . Maybe for the Nt2 data set . Can you talk a little bit about the importance of also showing the benefit on the the SS is , is this important for both the FDA or is this more of a European measure ?

[Analyst 5]: Hi there. Good morning, and thank you for taking my question. Maybe for the NT2 data set, can you talk a little bit about the importance of also showing the benefit on the ESS? Is this important for both the FDA, or is this more of a European measure? If you can put that into context a little bit. For the phase 3 programs, can you talk a little bit about your expectation for ocular monitoring on one side of it? I could see that it would be helpful if you do see some early visual disturbances to say that this was not impactful. Obviously, on the flip side, it would probably make the phase 3 a little bit more complicated. Your latest thoughts on that would be helpful. Thank you.

Speaker #16: If you can kind of put that into context a little bit. And then for the Phase 3 programs, can you talk a little bit about your expectation for ocular monitoring?

Speaker #16: On one side of it , I could see that it would be helpful . If you do see some early visual disturbances to kind of , you know , say that this was not impactful .

Speaker #16: But obviously , on the flip side , it would probably make the phase three a little bit more , you complicated . So kind of your latest thoughts on that would be helpful .

Speaker #16: Thank you .

Speaker #7: Yeah . Morning Joe . Yeah we think in the Nt2 study both M1 and SS or Epworth Sleepiness Scale are primary endpoints . And they capture different things .

Richard Pops: Yeah. Morning, Joe. Yeah, we think in the NT2 study, both MWT and ESS, or Epworth Sleepiness Scale, are primary endpoints. They capture different things. The virtue of the MWT is it's sort of a numeric, quantitative assessment of the sleep latency. ESS captures the patient experience, their self-described degree of sleepiness. They both, I think they both are quite important. In phase 2, you know, we're interested in looking at where the sensitivity is, where what scales move the most reliably across the doses. That includes, I'll throw, cognition, fatigue, narcolepsy severity scale, global impressions, all the endpoints that we're looking at in phase 2 because that informs your phase 3 structure and design. We're hoping to see signs of efficacy across all those various parameters. Phase 3, it's too hard to say.

Speaker #7: The virtue of the MWD is its sort of a numeric quantitative assessment of the sleep latency, and SS captures the patient experience.

Speaker #7: There self-described degree of sleepiness and they both I think they both are quite important . And in phase two you know we're interested in looking at where the sensitivity is , where where what what scales move the most reliably across the doses .

Speaker #7: And that includes I'll throw cognition fatigue , narcolepsy severity scale , Global impressions . You know , all the endpoints that we're looking at phase two because that informs your phase three .

Speaker #7: Structure in design . So we're hoping to see signs of efficacy across all those various parameters . Phase three it's it's too early to say just recounting .

Richard Pops: Just recounting, I think that in Vibrance I, what we saw was really generally very mild, one moderate, and one severe ocular in the form of blurred vision. It was generally very well tolerated. That, along with the rigorous ophthalmic exams that were conducted in all the patients, I think really answered the question about are there any structural issues that derive from using an orexin-2 receptor agonist. I don't know the answer yet whether we'll have to do any monitoring in the phase 3 study. We're hopeful that we don't. To the extent that we do, it's quite mild. I think in some ways, that'll be more of a discussion with the regulators.

Speaker #7: I think that that in vibrance one , what we saw was , was really generally mild . One moderate and one severe ocular in the form of of blurred vision .

Speaker #7: And so it was generally very well tolerated . And that , that along with the rigorous ophthalmic exams that were conducted in all the patients , I think really answered the question about are there any structural issues that that derive from using an orexin two receptor agonist ?

Speaker #7: And so I don't know the answer yet whether we'll have to do any monitoring in the phase three study . We're hopeful that we don't or the extent that we do .

Speaker #7: It's quite it's quite mild . But I think in some ways that'll be more of a discussion with the regulators .

Speaker #17: Thank you .

[Analyst 4]: Thank you.

Speaker #2: Our next question comes from the line of David Amsellem with Piper Sandler . Please proceed with your questions .

Operator: Our next question is coming from the line of David M. Salem with Piper Sandler. Please proceed with your questions.

Speaker #18: Thanks . Just a couple of quick ones on the . Additional orexins that are going into the clinic . And no , Richard , you've talked about properties in mood and attention .

[Analyst 1]: Thanks. Just a couple of quick ones on the additional orexins that are going into the clinic. I know, Richard, you talked about properties in mood and attention. Is it safe to say that at least one additional disease setting is going to be in a psychiatric setting once you move into proof-of-concept studies next year? Maybe elaborate a little more on how you're thinking about that. Secondly, I don't know if this has been asked, but any thoughts on Elixerextan outside of the U.S. and what kind of discussions, if any, have you had with European regulators there? Thank you.

Speaker #18: So is it safe to say that the at least one additional disease setting is going to be in a psychiatric setting once you move into proof of concept studies next year , maybe elaborate a little more on how you're thinking about that , and then secondly , I don't know if this has been asked , but any thoughts on orexin outside of the United States and what kind of discussions , if any , have you had with European regulators there ?

Speaker #18: Thank you .

Speaker #7: Good morning . David . Yeah , I think we've said about the next candidates that we're interested in in three broad domains psychiatry , neurology , and interestingly , certain , certain rare neuro neurodevelopmental or neurodegenerative settings where we think a significant part of the clinical presentation is excessive daytime sleepiness and atonia fatigue , depressed mood , things like that .

Richard Pops: Morning, David. Yeah, I think we've said about the next candidates that we're interested in three broad domains: psychiatry, neurology, and interestingly, certain rare neurodevelopmental or neurodegenerative settings where we think a significant part of the clinical presentation is excessive daytime sleepiness, anhedonia, fatigue, depressed mood, things like that. We won't be more specific than that right now. As I mentioned in the earlier remarks, our goal is as we get through the SAD/MAD to move right into those types of patient-focused studies to get signal early on. I'm hopeful that by the end of 2026, people see how this program has expanded well beyond narcolepsy. The essential prerequisite of that is getting these two candidates through their SAD/MAD, credentialing them as bona fide development candidates for these indications. That's well underway. We're quite excited about how that's going to mature in 2026. The second question was Elixerextan in.

Speaker #7: So we won't be more specific than , than , than that right now . But as I mentioned in the earlier remarks , our goal is as we get through the sad mad to move right into those types of of of patient focused studies to get signal early on .

Speaker #7: And you'll what I'm hopeful is that by the end of 2026 , people see how this program has expanded well beyond narcolepsy and essential prerequisite of that is getting these two candidates through their sad , mad credentialing them as bona fide development candidates for these these indications .

Speaker #7: That's well underway . So we're quite excited about how that's going to mature in 2026 . The second question with elixir and in ex-US , we're developing an ex-US and we're running clinical trials in Europe and in Asia .

Sandra Coombs: XUS.

Richard Pops: We're developing an XUS. We're running clinical trials in Europe and in Asia. There's a strong demand, I think, for this type of product for patients around the world. Given the state of pharmaceutical pricing discussions across the world, I think we can say comfortably we wouldn't expect to bring Elixerextan to patients outside the U.S. at significantly lower prices than in the U.S. Our goal is to bring this product to patients in the U.S., in Europe, as well as in Asia.

Speaker #7: And there's a strong demand , I think , for for this type of product for patients around the world . So , you know , given the state of of of pharmaceutical pricing discussions across the world , I think it's it's we can say comfortably we wouldn't expect to bring Alexa Rexton to patients outside the US at significantly lower prices than in the US .

Speaker #7: But our goal is to bring this patient to to patients in the US , in Europe as well as in Asia .

Speaker #2: Our next question is from the line of Ash Verma with UBS . Please see with your questions .

Operator: Our next question is from the line of Ash Varma with UBS. Please proceed with your questions.

Speaker #19: Hi . This is for ash . Thanks for taking our question for Mt2 . How are you thinking about these patients ? Hypersensitive hypersensitivity to exogenous orexin .

[Analyst 6]: Hi. This is Hoyanon for Ash. Thanks for taking our question. For NT2, how are you thinking about these patients' hypersensitivity to exogenous orexin? What's the most concrete evidence that you see why this hypersensitivity could be lower in NT2 patients versus the NT1?

Speaker #19: What's the most concrete evidence that you see ? Why this hypersensitivity could be lower in nt2 patients versus the nt1 ?

Speaker #7: Yeah , I wouldn't describe it as hypersensitivity . I think it's the other direction . I think nt2 patients , based on the data are less sensitive to orexin agonists administered exogenously .

Richard Pops: Yeah, I wouldn't describe it as hypersensitivity. I think it's the other direction. I think NT2 patients, based on the data, are less sensitive to orexin agonists administered exogenously. NT1, recall, is the disease is a deficiency of orexin. In NT1 patients, small doses are driving significant efficacy benefits. As low as 1 milligram in our hands with Elixerextan, we've shown meaningful changes in wakefulness. Whereas in the NT2 patients, and we know this from our phase 1B study, you can drive higher doses in order to elicit more wakefulness, as well as they tolerate higher doses before you see adverse events. The basic hypothesis going into the NT2 and IH studies is that there's a frame shift. There's a dose response curve shift to the right so that you need more Elixerextan in order to drive wakefulness, and patients will tolerate more Elixerextan before seeing adverse events.

Speaker #7: So nt1 recall is the disease is a deficiency of orexin . So an ent1 patients small doses are driving significant efficacy benefits as low as one milligram in our hands with orexin .

Speaker #7: And we've shown meaningful changes in wakefulness . Whereas in nt2 patients . And we know this from our phase one study , you can drive higher doses in order to to to elicit more wakefulness as well as they tolerate higher doses .

Speaker #7: Before you see adverse events . So the basic hypothesis going into the nt2 NIH studies is if there's a frameshift , there's a dose response curve shift to the right .

Speaker #7: So that you need more elixir in order to drive wakefulness . And patients will tolerate more elixir before seeing adverse events .

Speaker #20: Thank you .

[Analyst 6]: Thank you.

Speaker #2: Thank you . The next question is from the line of Leonid Timashev with RBC Capital Markets . Please see you for your questions .

Operator: Thank you. The next question is from the line of Leonid Timashev with RBC Capital Markets. Please proceed with your questions.

Speaker #21: Hey, thanks for taking my question. I just wanted to ask, how are you thinking about the Nt2 versus I.h populations and sort of the differences in your ability to actually accurately capture them?

[Analyst 2]: Hey. Thanks for taking my question. I just want to ask how you're thinking about the narcolepsy type 2 versus idiopathic hypersomnia populations and the differences in your ability to actually accurately capture them in separate trials, what you're hearing from physicians on how those are diagnosed and bucketed. Ultimately, whether these are differences that are meaningful in the real world and how that may impact how you're thinking about the relative opportunities of narcolepsy type 2 versus idiopathic hypersomnia. Thanks.

Speaker #21: In separate trials , sort of what you're hearing from physicians on how those are diagnosed and bucketed . And then ultimately , whether these are differences that are meaningful in the real world and how that may impact how you're thinking about the relative opportunities of nt2 versus I.h .

Speaker #21: Thanks .

Speaker #7: I think it's an important question. I think we won't really know the answer till we complete the two studies. And I think there are differences.

Richard Pops: I think it's an important question. I think we won't really know the answer until we complete the two studies. I think there's differences, you know, based on our learnings in multiple discussions with clinicians and patient groups in the U.S. and Europe. There could be regional differences too in the way that the differential diagnosis is made. What's interesting, though, Leonid, is the hypothesis, there's no pretest hypothesis that suggests there might be a difference in the response between the IH, NT2 diagnosis, or the subcategorization within those two diagnoses. As you know, within IH, there are long sleep IH patients. There are shorter sleep IH patients. They have different phenotypes that they present. What we know from our phase 1B study, albeit small, was that just taking all comers with NT2 and IH, we were able to show changes in wakefulness and a well-tolerated profile.

Speaker #7: You know , based on on our learnings in multiple discussions with clinicians and patient groups in the US and Europe , there could be regional differences , too , in the way that the differential diagnosis is made .

Speaker #7: What's interesting , though , is the the hypothesis , there's no pretest hypothesis that suggests there might be a difference in the response between the T2 diagnosis or the subcategorization within those two diagnoses .

Speaker #7: As you know , within NIH , there are long sleep by age patients . There are shorter sleep i.h. patients . They have different phenotypes that present well , we know from our phase one study , albeit small , was that just taking all comers with Nt2 NIH , we were able to show changes in wakefulness , well , profile .

Speaker #7: So I think this is de novo clinical research . No one's ever tested an M2 receptor agonist at these doses . In these patient populations .

Richard Pops: I think this is de novo clinical research. No one's ever tested an orexin-2 receptor agonist at these doses in these patient populations. I think the whole community is going to be fascinated to see what the distribution looks like, what the variability looks like, and what the overall effect of various doses in these patients. I think with that information, we can better design phase 3 too. Are there ways of tuning up or focusing that response in the phase 3 studies? A priori, we're enrolling patients without any discrimination between the differential diagnosis. Interestingly, in NT2s, you tend to use MWT as an endpoint, whereas that's not used in IH. They use the idiopathic hypersomnia severity scale and Epworth. It will be interesting to see how the two patient populations look when we're finished with the studies.

Speaker #7: So I think the whole community is going to be fascinated to see what the what the distribution looks like , what the variability looks like and what the overall effect of various doses in these patients .

Speaker #7: And then I think with that information, we can better design Phase 3 to see if there are ways of tuning up or focusing that response in the Phase 3 studies.

Speaker #7: But a priori we're enrolling patients without any discrimination between the differential diagnosis in interestingly , in entities you tend to use NWT as an endpoint , whereas that's not used in I.h.

Speaker #7: . They use the idiopathic hypersomnia Severity Scale and Epworth . So it's it will be interesting to see how the two patient populations look when we're finished with the studies .

Speaker #2: Our next question comes from the line of Luke Hermann with Baird . Please see with your questions .

Operator: Our next question comes from the line of Lou Kerman with Baird. Please proceed with your questions.

Speaker #22: Hey guys . Congrats on the quarter and thanks for the question . Just a couple timeline questions on the earlier pipeline for the next gen Orexins .

[Analyst 1]: Hey, guys. Congrats on the quarter and thanks for the question. Just a couple of timeline questions on the earlier pipeline. For the next-gen orexins, are you expecting to share phase 1 data from AUX4510 next year? Do you think there's a possibility of AUX7290 first in human data reading out next year as well? I know it's sensitive right now before deal close, but in general, do you see a possibility of some new data on the low salt oxybate next year?

Speaker #22: Are you expecting to share phase one data from 4510 next year ? And do you think there's a possibility of 72 and 91st in human data ?

Speaker #22: Reading out next year as well ? And then similarly , I know it's sensitive right now before deal close , but in general , do you see a possibility of some new data on the low salt oxybate next year ?

Speaker #7: Yeah , the the 45 , ten and 7290 , I think . I can't say right now whether we'll show you data quote unquote , per se from the sad man .

Richard Pops: Yeah. The AUX4510 and AUX7290, I think I can't say right now whether we'll show you "data" per se from the SAD/MAD. I think it's more of the gating, the go-decision to say if we're through SAD/MAD at doses we think are targeting, gauging, and therapeutically relevant, then you'll know that we're moving into the patient-focused studies. The timing of the readout of those translational studies remains to be disclosed. I think we're getting a sense of it right now, but it just depends on how fast we move into those translational studies and how quick the readout is. Give us some time to give a little bit more refinement about that as we move into 2026. Our goal is to finish SAD/MAD for AUX4510 first and move right into some translational studies. Same thing with AUX7290.

Speaker #7: I think it's more the gating the go decision to say if we're if we're through sad mad at doses , we think are targeting , Gagan and therapeutically relevant , then we're going to you'll know that we're moving into the patient focused studies .

Speaker #7: The timing of the of the readout of those translational studies remains to be disclosed . I think we're getting a sense of it right now , but it just depends on how fast we move into those translational studies and how quick the readout is .

Speaker #7: So, give us some time to provide a little more refinement about that as we move into 2026. But our goal is to finish SAD MAD for 4510 first and move right into some translational studies.

Speaker #7: Same thing with 7290 . Get through the sad , mad and then go right into a different set of translational studies . We're we're obviously quite interested in in the no salt once daily .

Richard Pops: Get through the SAD/MAD and then go right into a different set of translational studies. We're obviously quite interested in the no salt once-daily development program within Avadel Pharmaceuticals. As we complete the merger or the acquisition, what we'll do is we'll give you more sense of in our hands what we'll be doing with that program. We think it's a very logical extension to the business that Lumryz has built.

Speaker #7: Development program within within Avadel . And as we as we complete the the the the merger , we will or the acquisition , what we'll do is we'll give you more sense of our in our hands , what we'll do with that program .

Speaker #7: But we think it's a very logical extension to the business that has built .

Speaker #22: Great . Thank you .

[Analyst 1]: Great. Thank you.

Speaker #2: The next question is from the line of Ami Fadia with Needham Company , please to see you for your questions .

Operator: The next question is from the line of Amy Fadia with Needham Company. Please proceed with your questions.

Speaker #23: Hi . Good morning . Thanks for taking my question . With regards to impact on nighttime sleep . Can you talk about the two mechanisms orexin versus oxybate and how you're thinking about the two mechanisms being complementary and how you intend to study that further going forward .

[Analyst 6]: Hi. Good morning. Thanks for taking my question. With regards to impact on nighttime sleep, can you talk about the two mechanisms, orexin versus oxybate, and how you're thinking about the two mechanisms being complementary and how you intend to study that further going forward? Just separately, with regards to Aristada, can you talk about where you expect the gross-to-net to land for the full year? Thank you.

Speaker #23: And just separately with regards to Aristada , can you talk about where you expect the gross to net to land for the full year ?

Speaker #23: Thank you .

Speaker #7: Good morning Amy . It's rich . Yeah I think I think your question about nighttime sleep is , is going to be a very fertile one for additional clinical research .

Richard Pops: Good morning, Amy. It's Rich. I think your question about nighttime sleep is going to be a very fertile one for additional clinical research. What we've heard from clinicians, and you've probably heard the same thing, is notwithstanding the powerful daytime wakefulness that orexin agonists are driving, there is still some interest in understanding how that coexists with consolidation of sleep at night for certain patients. Recognizing that most patients don't take oxybates, but the ones who do see real benefit from it, I think there's a real opportunity for some clinical research now to understand how the two can coexist, particularly in once-nightly and once-daily forms that we would control both. That's an exciting area for further research for patients and I think for the full field because I think that the full effect of an orexin agonist on nighttime sleep architecture is still yet to be learned.

Speaker #7: What we've heard from clinicians , you've probably heard the same thing is , notwithstanding the the powerful daytime wakefulness that orexin agonists are driving , there is still some interest in understanding how that coexists with consolidation of sleep at night .

Speaker #7: For certain patients . Recognizing the most patients don't take oxybates , but the ones who do see real benefit from it . I think there's a real opportunity for some clinical research now to to understand how the two can coexist , particularly in once nightly and once daily forms that we would control both .

Speaker #7: So that's an exciting area for for further research , for for patients . And I think for the for the full field , because I think that the full effect of an orexin agonist on nighttime sleep architecture is still yet to be to be learned .

Speaker #7: We're developing those data in our phase two program with extensive polysomnography . So we'll be analyzing that data as we complete the vibrance program .

Richard Pops: We're developing those data in our phase 2 program with extensive polysomnography. We'll be analyzing that data as we complete the Vibrance program. In the meantime, I think that we see that there's a place for the oxybates on a going-forward basis for the patients who really benefit from them, and we want to further elaborate that. Todd, do you want to talk about the GTN?

Speaker #7: But in the meantime , I think that there's there's a we see that there's a place for the oxybates on a going forward basis for the patients who really benefit from them .

Speaker #7: And we want to further elaborate that . Todd , you want to talk about the GCN ?

Speaker #9: Yep , absolutely . For Aristada , for the full year , we expected to follow the consistent historical patterns , which should be approximately 53% .

Todd Nichols: Absolutely. For Aristada, for the full year, we expected to follow the consistent historical patterns, which should be approximately 53%.

Speaker #23: Got it . Thank you .

[Analyst 6]: Got it. Thank you.

Speaker #2: Our next question is from the line of you ior with Mizuho . Please proceed with your questions .

Operator: Our next question is from the line of Euir with Mizuho. Please proceed with your questions.

Speaker #24: Hey guys , congrats on the quarter . So maybe just a quick question on the gross and net favorability . And you know , you benefit from the last quarter and this quarter for both Aristotle , for Aristotle and Vivitrol .

[Analyst 2]: Hey, guys. Yeah, congrats on the quarter. Maybe just a quick question on the gross-to-net favorability. You know, you benefit from the last quarter and this quarter for both Aristada and Vivitrol. Just wondering, could you maybe just help us understand whether there's more benefit going forward? What is being, yeah, help us understand why these adjustments. Secondly, in the quarter, could you also sort of speak about inventory, whether it's, is there any stocking or is that normal level? Thanks.

Speaker #24: Just wondering , could you maybe just help us understand whether there's more benefit going forward , like what is being like ? Yeah , help us understand why these adjustments and secondly , in the quarter , could you also sort of speak about inventory , whether it's is there any stocking or is that normal level ?

Speaker #24: Thanks .

Speaker #9: Yeah , absolutely . Yeah . As we said in our prepared remarks , we did see a benefit for Vivitrol and Aristada with and in relation to Medicaid utilization going forward .

Todd Nichols: Yeah, absolutely. As we said in our prepared remarks, we did see a benefit for Vivitrol and Aristada in relation to Medicaid utilization. Going forward, we're not assuming or planning for any additional gross-to-net favorability within Medicaid. I think it's important just to note that the Medicaid volume, the absolute volume for Medicaid patients, is stable. This is just related to the percentage of Medicaid across our overall channel mix. That's the favorability. In terms of inventory, there's always seasonal patterns during the fourth quarter.

Speaker #9: We're not assuming or planning for any additional gross net favorability within Medicaid . I think it's important just to note that that the Medicaid volume , the absolute volume for Medicaid patients , is stable .

Speaker #9: This is just related to the percentage of Medicaid across our overall channel mix . That was that's the favorability in terms of of inventory .

Speaker #9: There's always seasonal patterns during the fourth quarter , and it can be a little bit difficult to predict , but we are expecting a little bit smoother of a pattern from Q4 of this year into Q1 of next year .

[Company Representative]: be a little bit difficult to predict, but we are expecting a little bit smoother of a pattern from Q4 of this year into Q1 of next year.

Speaker #24: Okay . Thanks .

[Company Representative]: Okay. Thanks.

Speaker #9: Sure .

[Company Representative]: Sure.

Speaker #2: The next question is from the line of Ben Burnett with Wells Fargo . Please see with your questions .

[Company Representative]: The next question is from the line of Ben Burnett with Wells Fargo. Please proceed with your questions.

Speaker #25: Hey, good morning. I wanted to see if you could just maybe talk about some of the Phase 3 scenarios for Elixir.

[Unknown Speaker]: Hey, good morning. I wanted to see if you could just maybe talk about some of the phase 3 scenarios for Alkermes plc. I think we're assuming sort of two phase 3s would be needed. I guess, number one, do you agree with that? If so, would a phase 3 NT2 study maybe be sufficient, along with an NT1 phase 3 to get approval in both of those indications?

Speaker #25: And I think we're assuming sort of two phase threes would be needed . I guess number one , I guess . Do you agree with that ?

Speaker #25: And then if so , like would a phase three N2 study maybe be sufficient along with an nt1 phase three to get approval in both of those indications ?

Speaker #7: Hey , Ben , it's Richard , that's our assumption right now . But we'll confirm that obviously with FDA , our expectation is that we'll seek labeling for Alexa , orexin for the treatment of narcolepsy .

[Unknown Speaker]: Hey, Ben. It's Richard. That's our assumption right now, but we'll confirm that with FDA. Our expectation is that we'll seek labeling for Alkermes plc for the treatment of narcolepsy, and the phase 3 program will be a well-controlled phase 3 study for narcolepsy type 1 on a standalone basis and a similar study in narcolepsy type 2.

Speaker #7: And the Phase 3 program will be a well-controlled Phase 3 study for NT1 on a standalone basis, and a similar study in NT2.

Speaker #2: Thank you. The next question is from the line of Douglas Suits with H.C. Wainwright. Please repeat your question.

[Company Representative]: Thank you. The next question is from the line of Douglas Sowell with A.T. Wainwright. Please proceed with your questions.

Speaker #26: Hi . Good morning . Congrats on the progress and thanks for taking questions . I guess I know it's early , Richard , and a lot of uncertainty , but just given the fact that you're you're always so thoughtful on public policy issues , I'm just curious if you've thought much about the potential impact of sort of lapse on ACA subsidies and what it could have for your commercial business in the near term ?

Operator: Hi. Good morning. Congrats on the progress and thanks for taking the questions. I guess I know it's early, Richard, and a lot of uncertainty, but just given the fact that you're always so thoughtful on public policy issues, I'm just curious if you've thought much about the potential impact of sort of the lapse on ACA subsidies and what it could have for your commercial business in the near term. Thank you. I have a follow-up.

Speaker #26: Thank you. And I have a follow-up.

Speaker #7: Yeah , it's a good question . Doug . And I think everybody's watching that . I think my sense is that there's a there's a strong political virtue to continuing the ACA subsidies at some at some level .

[Unknown Speaker]: Yeah. It's a good question, Doug. I think everybody's watching that. I think my sense is that there's a strong political virtue to continuing the ACA subsidies at some level. You recall that in reconciliation and the one big beautiful bill, what we were able to make sure is that patients in our population, i.e., patients with serious mental illness and addiction, are treated differently. They're the ones who are the explicit target of programs like Medicaid because if these patients are not treated, they end up in the emergency rooms, in the criminal justice system, and in the community. The price points of our medicines treating these patients are lower, and the gross-to-net favorability is high. They're not breaking the bank.

Speaker #7: And recall that in reconciliation in the in the the one big beautiful bill , what we were able to make sure is that patients in our population , i.e. patients with serious mental illness and addiction , are , are treated differently .

Speaker #7: You know , they they're the ones who are the explicit target of of programs like Medicaid . Because if these patients are not treated , they end up in the rooms and in the in the criminal justice system .

Speaker #7: And in , in the community . So the price points of medicines treating these patients are lower . And the gross nets are high .

Speaker #7: So they're not breaking the bank . So our view from a policy perspective is that there's a reasonable there's a there's a political reason to keep ACA subsidies in place , A and B , to the extent that we have changes that are focused on Medicaid population , particular serious mental illness and addiction patients , we're going to continue to fight to have them carved out .

[Unknown Speaker]: Our view from a policy perspective is that there's a political reason to keep ACA subsidies in place, A, and B, to the extent that we have changes that are focused on the Medicaid population, in particular serious mental illness and addiction patients, we're going to continue to fight to have them carved out.

Speaker #26: And I guess just to follow up on the ball , the I'm just curious , just given the sex , you had with the sort of additional promotion and detailing the product , do you have the sense was it physicians just weren't writing and they just needed that consistent reminder ?

Operator: Just to follow up on the ball, I'm just curious, just given the success you had with the sort of additional promotion and detailing the product, do you have a sense was it physicians just weren't writing and they just needed that consistent reminder, or was there just sort of some extent lack of awareness of the product and its attributes? Thank you.

Speaker #26: Or was there just sort of some extent of lack of awareness of the product and its attributes? Thank you.

Speaker #9: Yeah . In terms of lybalvi , I think the the first thing is over the last several years , we've had a really strong .

[Company Representative]: Yeah. In terms of Lybalvi, I think the first thing is over the last several years, we've had a really strong focus strategically on building awareness around the efficacy profile. That's really resonating. It resonates every single quarter. That's a big driver. It's just the underlying value of the product. It's also important to remember that Lybalvi has a broad label, right? We have a broad addressable population. We're seeing strong growth with schizophrenia and bipolar. The mix is still roughly about 50/50, but new patient starts are definitely growing more towards the bipolar population. I think with the strong efficacy, along with our commercial execution, and then also the resourcing that we've put behind the brand, we actually really saw a very positive quarter. Our expectation is that, and our focus is really growing that demand going into the fourth quarter as well.

Speaker #9: Focus strategically on building awareness around the efficacy profile . And and that is that's really resonating . It resonates every single quarter . So that's a big driver is just the underlying value of the product .

Speaker #9: It's also important to remember that Laval has a broad label . Right . So we have a broad addressable population . So we're seeing we're seeing strong growth with schizophrenia and bipolar .

Speaker #9: The mix is still roughly about 50 over 50 . But new patients starts are definitely growing more towards the bipolar population . And so I think with the with the strong efficacy along with our commercial execution and then also the resourcing that we've put behind the brand , we actually really saw a very positive quarter in our expectation is that in our focus is really growing that demand going into the fourth quarter as well .

Speaker #26: But I guess just sort of was what was driving it . Did you do you think some clinicians just weren't familiar that you had the breadth of label for bipolar and the efficacy , or was it just , you know , those are competitive markets and you just constantly need to stay in front of reps .

Operator: I guess just sort of what was driving it? Did you think some clinicians just weren't familiar or that you had the breadth of label for bipolar and the efficacy, or was it just, you know, those are competitive markets and you just constantly need to stay in front of that? Thank you.

Speaker #26: Thank you .

Speaker #9: Yeah , yeah . It's a great it's a good point . The competitive landscape is fierce as we know . And so you know we're very practical with this to make sure that we're putting resources in our highest growth drivers .

[Company Representative]: Yeah. Yeah. It's a good point. The competitive landscape is fierce, as we know. We're very practical with this to make sure that we're putting resources in our highest growth drivers. We felt and the data showed us that we needed a stronger share of voice. Number two is physician research tells us that HCPs need experience. Once they get experience with one patient type, schizophrenia or bipolar, in general, patients are having a good experience. They're more open to expanding their breadth of prescribing. We're very pleased. As I said earlier, breadth of prescribing has expanded by approximately 7% for two consecutive quarters, and we're seeing encouraging trends with that. It's really those two things. It's our commercial investment, but it's also the experience of the HCP and the positive experience they're hearing from patients.

Speaker #9: So we we felt and the data showed us that we needed a stronger share of voice . But number two is physician research tells us that hcp's need experience .

Speaker #9: So once they get experience with one patient type , schizophrenia or bipolar in general , patients are having a good experience . They're more open to expanding their breadth of prescribing .

Speaker #9: And so we're very pleased , as I said earlier , you know , breadth of prescribing has expanded by approximately 7% for two consecutive quarters .

Speaker #9: And we're seeing encouraging trends with depth . So it's really those two things . It's our commercial investment , but it's also the experience of the HCP and the positive experience they're hearing from patients .

Speaker #26: Okay great . Thank you .

Operator: Okay. Great. Thank you.

Speaker #2: Thank you . Our last question is from the line of Jason Gerberry with Bank of America . Please see with your questions .

[Company Representative]: Thank you. Our last question is from the line of Jason Gerber with Bank of America. Please proceed with your questions.

Speaker #27: Hey this is key on for Jason . Thanks for taking our questions . I want to follow up on the virtual Echo commentary earlier for veterans .

Sandra Coombs: Hey. This is Chi over at Jason. Thanks for taking our questions. I want to follow up on the virtual AE commentary earlier for Vibrance One. The commentary that I heard was that most virtual AEs were mild, and there was one moderate and one severe case. Can you contextualize one constituent as severe vision blur, and how long did that AE last? Secondarily, is there a dose-response relationship with that with the virtual AE in Vibrance One? When I look back at the Vibrance One AE table, there was a severe case of AE of any cause in a 4-milligram dose and two severe cases of AE of any cause in an 8-milligram dose. Can you clarify which dose level did that one moderate case of virtual AE and which dose level did the one severe virtual AE case occur in? Thanks so much.

Speaker #27: One commentary that I heard was that most virtual cases were mild, and there was one moderate and one severe case. Can you contextualize what constitutes a severe vision blur?

Speaker #27: And how long did that last? And secondarily, is there a dose-response relationship with that with the visual aid environments? One, when I look back at the vibrance, on one echo table, there was a severe case of echo of any cause in the four milligram dose.

Speaker #27: And two severe cases of echo of any cause . An eight milligrams dose . Can you clarify which dose level did that one moderate case of visual and which dose level did the one severe visual echo case occurred in ?

Speaker #27: Thanks so much .

Speaker #7: Yeah , the the the vast preponderance of the visual . They were actually reported as blurred vision were mild cases . There was one moderate that became a mild after four days , I believe .

[Unknown Speaker]: Yeah. The vast preponderance of the visual AEs, they were actually reported as blurred vision, were mild cases. There was one moderate that became a mild after four days, I believe. There was one that was categorized as severe, but that was part of a constellation of symptoms that led to an early termination of that patient after the third day, I believe, in the study. There was dose response. We saw more at the 8-milligram dose than at the 4 and the 6. Interestingly, in the extension period, after patients had been in the double-blind period and could choose their dose, if patients had been on a previous dose of Alkermes plc and then moved to the 8 milligrams, we saw no new incidence of visual AEs, of blurred vision. We think that there is dose response.

Speaker #7: And there was one that was categorized as severe . But that was part of a constellation of , of of symptoms that led to an early termination of that patient .

Speaker #7: After the third day . I believe , in the study . So there was dose response . We saw more at the eight milligram dose than at the four .

Speaker #7: And the six . But interestingly , in the in the in the extension period , after patients had been in the double blind period and could choose their dose if patients had been on a previous dose of elixir , and then moved to the eight milligram , we saw no new incidence of of of of visual AES of blurred vision .

Speaker #7: So we think that there there is dose response . We think the phenomena is largely mild , meaning it's noted by the patient but doesn't affect them .

[Unknown Speaker]: We think the phenomenon is largely mild, meaning it's noted by the patient but doesn't affect them, and largely occurred in the first week and are largely transient as well. We'll see now in the NT2 dataset what that looks like in the IHs as well. As we build a bigger and bigger dataset, the overall conclusion I think you have to draw from this class so far is that they're largely generally well tolerated, and the side effects are generally mild to moderate and transient. The top of the list of the AEs that are on target, you're going to see with these drugs are insomnia and polycythemia, which is urinary frequency.

Speaker #7: And largely occurred in the first week and are largely transient as well . But we'll see now in . The T2 data set , what that looks like in the eyes as well .

Speaker #7: But as we build a bigger and bigger data set , that overall conclusion , I think you have to have to draw from from this class so far is that they're largely , generally well tolerated .

Speaker #7: And the side effects are generally mild to moderate . And transient . In the top of the list of the AES that are on target , you're going to see with these drugs are insomnia .

Speaker #7: And pollakiuria , which is urinary frequency .

Speaker #27: Okay . Thanks .

Operator: Okay. Thanks.

Speaker #2: Thank you . That will conclude our question and answer session . I'll turn the floor back to management for closing comments .

[Company Representative]: Thank you. That will conclude our question and answer session. I'll turn the floor back to management for closing comments.

Speaker #6: All right . Thanks everyone for joining us on the call today . Please don't hesitate to reach out to us at the company if there are any follow up questions .

Richard Pops: All right. Thanks, everyone, for joining us on the call today. Please don't hesitate to reach out to us at the company if there are any follow-up questions.

[Company Representative]: Thank you. This will conclude today's conference. Let me disconnect your lines at this time and have a wonderful day.