Q1 2024 Alkermes PLC Earnings Call

May 1, 2024

Yes.

Maria: Thank you for watching. Thank you. Thank you. Thank you. Thank you. Greetings, and welcome to the Alkermes First Quarter 2024 Financial Results Conference Call. My name is Maria, and I'll be the operator for today's call. All participant lines will be placed on mute to prevent background noise.

Maria: Greetings and welcome to the Alkermes first quarter 2024 financial results Conference call. My name is Maria and I'll be the operator for today's call. All participants lines will be placed on mute to prevent background noise you should require operator assistance during the call. Please press star zero on your telephone keypad.

Maria: If you should require operator assistance during the call, please press star zero on your telephone keypad. Please note that this conference is being recorded. I'll now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, you may begin.

Maria: Please note that this conference is being recorded I'll now turn the call over to Sandra Coombs Senior Vice President of Investor Relations and corporate Affairs Sandy you may begin.

Sandra Coombs: Good morning. Welcome to the Alkermes Plc conference call to discuss our financial results and business update for the quarter ended March 31, 2024. With me today are Richard Pops, our CEO; Blair Jackson, our Chief Operating Officer; and Todd Nichols, our Chief Commercial Officer. During today's call, we will be referencing slides. These slides, 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 in the Investors section of Alkermes.com.

Sandra Coombs: Good morning, welcome to the Alkermes plc conference call to discuss our financial results and business update for the quarter ended March 31, 2024 with me today are Richard Pops, Our CEO Blair Jackson, our Chief operating Officer, and Todd Nichols, Our Chief commercial officer. During today's call, we will be referencing slides. These slides along with our press release.

Sandra Coombs: The related financial tables, and reconciliation of the GAAP to non-GAAP financial measures that we'll discuss today are available on the investors section of Alkermes Dot Com, we believe the non-GAAP financial results in conjunction with the GAAP results are useful in understanding the ongoing economics of our business.

Sandra Coombs: We believe the non-GAAP financial results, in conjunction with the GAAP results, are useful in understanding the ongoing economics of our business. However, our discussions during this conference call will include forward-looking statements, and actual results could differ materially from these forward-looking statements.

Sandra Coombs: Please see slide 2 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 in this call or in the accompanying presentation as a result of new information or future results or developments. After our prepared remarks, we'll open the call for Q&A, and now we'll turn the call over to Blair for a review of our quarterly financial results. Thank you, Sandy.

Sandra Coombs: Our discussions during this conference call will and look forward that will include forward looking statements actual results could differ materially from these forward looking statements. Please see slide two of the accompanying presentation. Our press release issued this morning, and our most recent annual and quarterly reports filed with the SEC for important risk factors that could cause our actual results to differ materially.

Sandra Coombs: Really 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 development. After our prepared remarks, we'll open the call for Q&A and now I'll turn the call over to Blair for a review of our quarterly financial results.

Blair C. Jackson: Thank you Sandy.

Blair C. Jackson: Over the past two years, we've been executing a plan to streamline our business and drive the growth of our proprietary products, our pipeline, and our profitability. We entered 2024 as a pure play neuroscience company with a top line driven by Vivitrol, Aristotle, and LaBalva. Our 2024 financial expectations provided in February assumed Q1 seasonality followed by growth in the second quarter and beyond.

Blair C. Jackson: Over the past two years, we've been executing a plan to streamline our business and drive the growth of our proprietary products our pipeline and our profitability. We entered 2024 as a pure play neuroscience company with a top line driven by Vitriol Harriss, daughter in law Bobby.

Blair C. Jackson: Our 2024 financial expectations provided in February assumed Q1 seasonality followed by growth in the second quarter and beyond this continues to be our expectation and today, we are reiterating our 2024 financial guidance.

Blair C. Jackson: This continues to be our expectation, and today we are reiterating our 2024 financial guidance. Our first quarter performance reflects continued year-over-year growth of our proprietary product portfolio. Investment in Lebalvi and the advancement of the ALCS 2680 Development Program, as well as our ongoing focus on efficient management of our cost structure to drive profitability. We're in a strong financial position and confident in the growth opportunities ahead of us. For the first quarter, we generated total revenues of $350.4 million, driven by our proprietary product portfolio, which grew 9% year over year.

Blair C. Jackson: Our first quarter performance reflects continued year over year growth of our proprietary product portfolio net sales investment in the body and advancement of the <unk> 2680 development program as well as our ongoing focus on efficient management of our cost structure to drive profitability.

Blair C. Jackson: In a strong financial position and confident in the growth opportunities ahead of us.

Blair C. Jackson: For the first quarter, we generated total revenues of $354 million driven by our proprietary product portfolio, which grew 9% year over year.

Blair C. Jackson: This top line result also reflected the impact of a combined $10.2 million drawdown of inventory in the channel for our three proprietary products. Starting with Vivitrol, net sales in the quarter were $97.7 million, driven primarily by the Alcohol Dependence Indicator, compared to $96.7 million in the same period last year. For the Aristotle product family, net sales were $78.9 million for the first quarter compared to $80.1 million for the same period last year.

Blair C. Jackson: This top line result, also reflected the impact of a combined $10 $2 million drawdown.

Blair C. Jackson: Inventory in the channel for our three proprietary products.

Blair C. Jackson: Starting with pivotal net sales in the quarter were $97 $7 million driven primarily by the alcohol dependence indication <unk>.

Blair C. Jackson: Paired to $96 7 million in the same period last year.

Blair C. Jackson: For the <unk> product family net sales were $78 9 million for the first quarter compared to $80 1 million for the same period last year.

Blair C. Jackson: For Livaldi, consistent with the expectations we outlined in February, net sales during the quarter were fairly flat sequentially at $57 million, which represented 50% year-over-year growth. Gross TIN-ED adjustments were stable sequentially. Moving on to our Manufacturing and Royalty. In the first quarter, we recorded manufacturing and royalty revenues of $116.8 million, compared to $72.9 million for Q1 last year.

Blair C. Jackson: For the baldy consistent with the expectations, we outlined in February net sales during the quarter were fairly flat sequentially at $57 million, which represented 50% year over year growth.

Gross to net adjustments were stable sequentially.

Blair C. Jackson: Moving on to our manufacturing and royalty business.

Blair C. Jackson: In the first quarter, we recorded manufacturing and royalty revenues of $116 8 million compared.

Blair C. Jackson: Compared to $72 9 million for.

For Q1 last year.

Blair C. Jackson: Revenues from the long-acting and vega products were $62.7 million compared to $13.6 million for Q1 last year. Reflecting the reinstatement of royalties related to these products in the second quarter of 2023. Revenues from Brumerity were $31.3 million compared to $28.9 million for Q1 last year.

Blair C. Jackson: Revenues from the long acting and Vega products were $62 7 million compared to $13 6 million for Q1 last year.

Blair C. Jackson: Reflecting the reinstatement of royalties related to these products in the second quarter of 2023.

Blair C. Jackson: Revenues from <unk> were $31 3 million compared to $28 9 million for Q1 last year.

Blair C. Jackson: Turning to expenses, following the separation of our oncology business last year, expenses associated with the oncology business are considered discontinued operations. Today I'll focus on results from continuing operations as those results are more relevant to the financial profile of the company going forward. Our first quarter results reflect slightly elevated operating expenses, driven by the phasing of certain investments in clinical development, commercial support activities, and other activities. Labor-related costs and recognition of certain share-based compensation. We expect that total operating expenses will decrease sequentially throughout the remaining quarters of the year. Cost of goods sold of $58.6 million was flat compared to $58.2 million for Q1 last year.

Blair C. Jackson: Turning to expenses following the separation of our oncology business last year expenses associated with the oncology business are considered discontinued operations today I'll focus on results from continuing operations as those results are more relevant to the financial profile of the company going forward.

Blair C. Jackson: R&D expenses were $67.6 million compared to $63.8 million for Q1 last year. This reflects focused investments in our neuroscience development program, primarily related to the ALCS 2680 Clinical Program and support activities for our proprietary commercial products. We expect R&D expense to decrease by approximately $10 million in Q2, and then remain relatively steady at that level through the end of the year. SG&A expenses were $179.7 million, compared to $167.8 million for Q1 last year, primarily reflecting continued investment in the launch of Lebalda.

Blair C. Jackson: Our first quarter results reflect slightly elevated operating expenses driven by the phasing of certain investments in clinical development commercial support activities labor related costs and recognition of certain share based compensation expenses. We expect the total operating expenses will decrease sequentially throughout the remaining quarters of the year.

Blair C. Jackson: Cost of goods sold.

Blair C. Jackson: $8 $6 million were flat compared to $58 2 million for Q1 last year.

Blair C. Jackson: R&D expenses were $67 6 million compared to $63 8 million for Q1 last year. This.

Blair C. Jackson: This reflects focused investments in our neuroscience development programs, primarily related to the <unk> 2680 clinical program and support activities for our proprietary commercial products.

Blair C. Jackson: We expect R&D expense to decrease by approximately $10 million in Q2.

And then it remained relatively steady at that level through the end of the year.

Blair C. Jackson: SG&A expenses were $179 $7 million.

Blair C. Jackson: Compared to $167 8 million for Q1 last year, primarily reflecting continued investment in the launch of <unk>.

Blair C. Jackson: Looking ahead, we expect phased investments in selling and marketing initiatives to remain fairly consistent in the second quarter, followed by decreases in the second half of the year, reflecting the timing and mix of promotional activities. Within our non-cash expenses across R&D and SG&A, we recorded $3.2 million and $6.2 million, respectively, of non-recurring share-based compensation expenses during the first quarter related to the achievement of certain performance award criteria. We continue to focus on driving profitability, and during the first quarter, we delivered GAP net income from continuing operations of $38.9 million.

Blair C. Jackson: Within our noncash expenses across R&D and SG&A, we recorded $3 2 million and $6 2 million, respectively of nonrecurring share based compensation expenses during the first quarter related to the achievement of certain performance award criteria.

Blair C. Jackson: We continue to focus on driving profitability and during the first quarter, we delivered GAAP net income from continuing operations of $38 $9 million non.

Blair C. Jackson: Non-Gap Net Income from continuing operations of $76.2 million and EBITDA from continuing operations of $51.5 million, reflected significantly enhanced profitability year over year, primarily driven by the growth of our proprietary commercial product portfolio. Turning to our balance sheet, we ended the first quarter in a strong financial position with $807.8 million in cash and total investments, and Total Debt Outstanding of $290.1 million. Additionally, we expect to close the sale of our Athlone Ireland manufacturing facility to Novo Nordisk within the next day or two. In connection with the closing, Alkermes will receive a one-time cash payment of approximately $91 million.

Blair C. Jackson: non-GAAP net income from continuing operations of $76 2 million and EBITDA from continuing operations of $51 5 million.

Blair C. Jackson: Reflecting significantly enhanced profitability year over year, primarily driven by the growth of our proprietary commercial product portfolio. The separation of the oncology business completed during the fourth quarter of 2023, and our continued focus on operational efficiencies and disciplined expense management.

Blair C. Jackson: Turning to our balance sheet. We ended the first quarter in a strong financial position with $807 $8 million in cash and total investments and total debt outstanding of $290 1 million.

Blair C. Jackson: Additionally, we expect to close the sale of our Athlone, Ireland manufacturing facility to Novo Nordisk within the next day or two in connection with the closing alkermes will receive a onetime cash payment of approximately $91 million.

Blair C. Jackson: This transaction represents a significant element of our multi-year program to drive operational efficiency and further align our infrastructure and cost framework with the anticipated needs of our businesses. Taking a step back, our first quarter results were largely consistent with our expectations and we believe they provide a solid foundation for growth through the rest of the year. We expect top-line growth to accelerate into the second quarter and are pleased with our trajectory thus far. We remain focused on disciplined management of our expenses and expect enhanced profitability as we move through the remaining quarters of the year. With that, I'll now hand the call to Todd. Great. And thank you, Blair.

Blair C. Jackson: This transaction represents a significant element of our multiyear program to drive operational efficiency and further align our infrastructure and cost framework with the anticipated needs of our business.

Taking a step back our first quarter results were largely consistent with our expectations and we believe provide a solid foundation for growth through the rest of the year, we expect topline growth to accelerate into the second quarter and are pleased with our trajectory thus far.

Blair C. Jackson: We remain focused on disciplined management of our expenses and expect enhanced profitability as we move through the remaining quarters of the year.

Unknown Attendee: With that I'll now hand, the call to Todd Great and thank you Blair and good morning, everyone. In the first quarter net sales from our proprietary product portfolio grew 9% year over year, even with a meaningful reduction in inventory in the channel for all three products.

Unknown Attendee: Good morning, everyone. In the first quarter, net sales from our proprietary product portfolio grew 9% year-over-year, even with meaningful reductions in inventory in the channel for all three products. As we enter the second quarter, we are reiterating our 2024 financial expectations for each of our three proprietary products, Libalvi, Aristata, and Vivitrol, starting with Livalvi. During the fourth quarter, we generated net sales of $57 million, which was relatively flat sequentially compared to the third quarter, consistent with our expectations.

Todd Great: As we enter the second quarter, we are reiterating our 2024 financial expectations for each of our three proprietary products the ball the ARISTOTLE individual.

Todd Great: Starting with <unk> during the fourth quarter, we generated net sales of $57 million, which was relatively flat sequentially compared to the fourth quarter.

Todd Great: System with our expectations.

Unknown Attendee: Total prescriptions of approximately 49,600 during the quarter reflect underlying prescription growth of 6% sequentially and 50% year-over-year, as well as continued expansion of prescriber breadth. This growth in demand was partially offset by a decrease in inventory in the channel equal to approximately $2.3 million.

Todd Great: Total prescriptions of approximately 49600 during the quarter reflect underlying prescription growth of 6% sequentially and 50% year over year as well as continued expansion of prescriber breadth.

Todd Great: This growth in demand was partially offset by a decrease in inventory in the channel equal to approximately $2 3 million.

Unknown Attendee: During the first quarter, Le Balby continued to be the fastest-growing oil brand in the market on a prescription basis. Optimizing Libavi's access profile is an important element of our long-term growth strategy for the brand. Payer coverage across Medicare and Medicaid is established, with most patients having a pathway to access. For the Commercial Payer Channel, our disciplined contracting strategy is playing out as we seek to maximize net sales of Libalvi while expanding patient access. We recently enhanced the access profile for Livalvi through selective contracting with a large pharmacy benefit manager to improve formulary positioning. However, this contracting is not expected to significantly impact our anticipated gross to net adjustments this year.

Todd Great: During the first quarter lowball, the continue to be the fastest growing oral brand in the market on a prescription basis.

Optimizing the ball because access profile is an important element of our long term growth strategy for the brand payer coverage across Medicare and Medicaid is established with most patients having a pathway to access.

Todd Great: For the commercial payer channel our disciplined contracting strategy is playing out as we seek to maximize net sales of leave all the while expanding patient access.

Todd Great: We recently enhanced the access profile for laboratory through selective contracting with a large pharmacy benefit manager to improve formulary positioning.

Todd Great: This contracting is not expected to significantly impact our anticipated gross to net adjustments this year.

Unknown Attendee: We have additional opportunities to further enhance commercial payer access for patients and believe we are well positioned to continue to execute our strategy. For the full year, we continue to expect evolving net sales in the range of $275 to $295 million. Turning to the Aristotle product family, net sales in the first quarter were $78.9 million, reflecting pronounced seasonality and prescriptions and a substantial decrease in inventory in the channel, equal to approximately $3.6 million.

Todd Great: We have additional opportunities to further enhance the commercial payer access for patients and believe we are well positioned to continue to execute our strategy.

Todd Great: For the full year, we continue to expect <unk> net sales in the range of $275 million to $295 million.

Turning to the ARISTOTLE product family net sales in the first quarter were $78 $9 million, reflecting.

Todd Great: Reflecting pronounced seasonality in prescriptions in a substantial decrease of inventory in the channel equal to approximately $3 $6 million, we expect inventory levels to approach more normal levels in the second quarter. We continued to focus on highlighting aerostat as differentiated features and supporting clinical data for the full year we.

Unknown Attendee: We expect inventory levels to approach more normal levels in the second quarter. We continue to focus on highlighting Aristotle's differentiated features in supporting clinical data. For the full year, we continue to expect Aristata net sales in the range of $340 to $360 million.

Todd Great: We expect <unk> net sales in the range of $340 million to $360 million.

Unknown Attendee: Moving to Vivitrol, net sales in the first quarter were $97.7 million, reflecting normal seasonal trends and patient flow and a decrease in inventory in the channel equal to approximately $4.3 million. Vivitrol performance continues to be largely driven by the opportunity for the alcohol dependence indication, which currently accounts for approximately 75% of Vivitrol volume. Alcohol dependence is an important growth opportunity, and our team is energized about driving awareness and uptake in that underserved disease area. Looking ahead to the full year, we continue to expect Vivitrol net sales in the range of $410 to $430 million. We're in the first quarter now, and that's behind us.

Todd Great: Moving to <unk> net sales in the first quarter were $97 $7 million, reflecting normal seasonal trends in patient flow and a decrease in inventory in the channel equal to approximately $4 $3 million Vishal performance continues to be largely driven by the opportunity to alcohol dependence indication, which currently accounts for approximately.

Todd Great: 75% of the vitriol volume.

Alcohol dependence is an important growth opportunity and our team is energized about driving awareness and uptake in that underserved disease area.

Todd Great: Looking ahead to the full year, we continue to expect Vivek Shah of net sales in the range of $410 million to $430 million.

Todd Great: For the first quarter now behind Us with a solid foundation for growth into the second quarter and the second half of the year for all three of our products inventory levels have started to rebound in recent weeks and prescription growth has been in line with our Q2 expectations. Our commercial team is focused on execution across our portfolio and we look forward.

Unknown Attendee: We have a solid foundation for growth into the second quarter and the second half of the year. For all three of our products, inventory levels have started to rebound in recent weeks, and prescription growth has been in line with our Q2 expectations. Our commercial team is focused on execution across our portfolio, and we look forward to sharing our progress. With that, I will pass the call to Richard. Richard Pops Good

Todd Great: To sharing our progress with that I will pass the call to Richard.

Richard F. Pops: Thank you, Todd. Good morning, everybody. Alkermes is now a profitable pure play neuroscience company with an advancing pipeline. This profile drives our objectives for 2024, commercial execution, advancing ALCS2680 in the clinic, and expanding our development pipeline. Blair and Todd covered the financial and commercial elements.

Richard F. Pops: Thank you Todd Good morning, everybody Alkermes is now a profitable pure play neuroscience company with an advancing pipeline.

Richard F. Pops: This profile drives our objectives for 2024 commercial execution advancing <unk> 2006, <unk> in the clinic and expanding our development pipeline.

Blair and Todd covered the financial commercial elements I'm going to spend a few minutes on recent developments within our R&D pipeline, particularly out to 2006 to 80.

Richard F. Pops: I'm going to spend a few minutes on recent developments within our R&D pipeline, particularly ALCS 2680, our novel, once daily, oral erection to receptor agonist in development for narcolepsy, starting with our progress in narcolepsy type 1, or NT1. Based on biology, the core of the ALK2680 development program is in NT1, which is associated with an absence or significant deficiency of orexin levels. We are moving quickly in this indication. Last year, we generated important proof of concept data in patients with NT1.

Richard F. Pops: <unk> our novel once daily oral Orexin two receptor agonist in development for narcolepsy.

Richard F. Pops: Based on the compelling initial data from our first four patients, we made the decision to accelerate the Phase II plan. Toward year end, the data from the full NT1 cohort of 10 patients reinforced our conviction in that decision. So we entered 2024 with work well underway to finalize the Phase II protocol, manufacture clinical supplies of the Phase II dose strengths, and interact with FDA and clinical study sites and investigators. These activities culminated in the recent initiation of VIBRANCE-1, a Phase 2, randomized placebo-controlled multinational study, which we announced last week.

Richard F. Pops: Starting with our progress in narcolepsy type one or in Q1 based on the biology of the core of the <unk> 2680 development program is in tier one which is associated with an absence of significant deficiency interaction levels. We.

Richard F. Pops: Vibrance 1 is planned to enroll approximately 80 subjects, randomized to single daily doses of either 4, 6, or 8 mg of ALK2680 or placebo over a 6 week double-blind treatment period. Data from this study will further characterize the safety and efficacy profile of ALCS2680, utilizing well-established efficacy endpoints, including the Maintenance of Wakefulness Test, or MWT, Epworth Sleepiness Scale, and Weekly We expect the study will take approximately one year to fully enroll.

We are moving quickly in this indication last year, we had generated important proof of concept data in patients with <unk> one.

Richard F. Pops: Just on the compelling initial data from our first four patients we made the decision to accelerate the phase II planning toward year end the data from the full N T. One cohort of 10 patients reinforced our conviction in that decision. So we entered 2024 with work well underway to finalize the phase II protocol manufactured clinical supplies of the phase two dose.

Richard F. Pops: Strengths interaction with FDA and clinical study sites and investigators. These activities culminated in the recent initiation of <unk>, one a phase II randomized placebo controlled multinational study, which we announced last week.

Richard F. Pops: Vibrance one is planned to enroll approximately 80 subjects randomized a single daily doses of either four six or eight milligrams of <unk> 2680, or placebo over a six week double blind treatment period.

Richard F. Pops: Data from this study will further characterize the safety and efficacy profile of <unk> 2680.

Richard F. Pops: Utilizing well established efficacy endpoints, including the maintenance of wakefulness test or M. WT Epworth, sleepiness scale and weekly cataplexy rates.

Richard F. Pops: We expect this study will take approximately one year to fully enrolled as we gain more experience with clinical site initiations and patient enrollment trends will look to put a finer point on the timelines.

Richard F. Pops: As we gain more experience with clinical site initiations and patient enrollment trends, we'll look to put a finer point on the timeline. As we launch this Phase 2 study, we're also looking forward to sharing additional data from the full NT1 cohort from the Phase 1B study with the clinical community at the Sleep 2024 meeting in June. These data will include safety, tolerability, and MWT improvements for the full cohort of 10 patients, as well as our first presentation of improvements in subjective levels of sleepiness, as measured by the Karolinska Sleepiness Scale. Narcolepsy Type 2, or NT2, represents another significant potential opportunity for ALS2680.

Richard F. Pops: As we launched this phase II study. We're also looking forward to sharing additional data from the full <unk> one cohort from the phase <unk> study with the community clinical community at the sleep 2024 meeting in June.

Richard F. Pops: These data will include safety Tolerability and M. WT improvements for the full cohort of 10 patients as well as our first presentation of improvements in subjective levels of sleepiness as measured by the Karolinska sleepiness scale or ksf's.

Richard F. Pops: Narcolepsy type two or <unk> represents another significant potential opportunity for our 2680 <unk>.

Richard F. Pops: Last month, we announced positive top-line data from the Phase 1b cohorts in NT2 and idiopathic hypersomnia. In these cohorts, participants were randomized in a four-way crossover design in which each participant received single oral doses of 5, 12, and 25 milligrams of Alx26 and placebo with washout periods between each treatment. Alkis 2680 was generally well tolerated and resulted in clinically meaningful and statistically significant improvements in weight gain, as measured by MWT sleep latency scores at all doses tested. I will refer you to the press release we issued on April 9th for more details related to the safety, tolerability, and efficacy observed in these cohorts in the 1B study.

Richard F. Pops: Last month, we announced positive top line data from the phase <unk> cohorts in NTT, <unk> and Youll Pathic hypersomnia.

Richard F. Pops: In these cohorts participants were randomized in a four way crossover design, which in which each participant received single oral doses of 512, and 25 milligrams of <unk> thousand 680, and placebo with washout periods between each treatment.

2680 was generally well tolerated and resulted in clinically meaningful and statistically significant improvements in wakefulness as measured by M. WT sleep leave scores at all doses tested.

Richard F. Pops: We will refer you to the press release, we issued on April 9th for more details related to the safety Tolerability and efficacy observed in these cohorts in the <unk> study.

Richard F. Pops: Importantly, the data show dose-dependent effects in a pharmacodynamic profile that supports advancement into a planned Phase 2 study in NT2 patients, which will be known as Vibrance 2. We recently finalized our dose selection for that phase 2 study and plan to move forward with 10, 14, and 18 mg doses of Alpha-26A. Alex2680 is currently the only orexin 2 receptor agonist moving into later stage clinical evaluation for narcolepsy type 2.

Richard F. Pops: Importantly, the data showed dose dependent effects and a pharmacodynamic profile that supports advancement into a planned phase II study in <unk> patients, which will be known as <unk> two <unk>.

We recently finalized our dose selection for that Phase II study and plan to move forward with 10, 14, and 18 milligram doses of <unk> 2068.

Richard F. Pops: <unk> is currently the only orexin two receptor agonists moving into later stage clinical evaluation in narcolepsy type two we are working to initiate vibrance to as quickly as possible, which we expect to be in the second half of 2024.

Richard F. Pops: We are working to initiate Vibrance 2 as quickly as possible, which we expect to be in the second half of 2024. Data from the 1B cohort. validate our hypothesis that an erection agonist with appropriate pharmaceutical properties has the potential to provide clinical benefits for both NT1 and NT2 patient populations. Importantly, the data also demonstrate that orexin-2 receptor agonists, such as ALX2680, may have utility in treating other disorders in patients without known orexin deficiency.

Richard F. Pops: The data from the <unk> cohort validate our hypothesis in Orexin agonist with appropriate pharmaceutical properties has the potential to provide clinical benefits for both <unk> and NTT patient populations importantly, the data also demonstrated orexin two receptor agonists such as Alex 20, <unk> may have utility in treating other disorders.

Richard F. Pops: In patients without known Orexin deficiency.

Richard F. Pops: This represents a significant opportunity to evaluate expansion into broader disorders where excessive daytime sleepiness is a feature. To explore these opportunities, we continue to advance our portfolio of preclinical orexin 2 receptor agonists and recently nominated our next candidate, which is now in IND enabling studies. We look forward to sharing additional details about our plans in this space later this year. So, four months into the year, we're continuing to execute against our strategic priorities.

Richard F. Pops: This represents a significant opportunity to evaluate expansion into broader disorders, where excessive daytime sleepiness is a feature to explore these opportunities. We continue to advance our portfolio of preclinical Orexin two receptor agonist and recently nominated our next Kennedy, which is now in <unk>.

Richard F. Pops: IND, enabling studies.

Richard F. Pops: Look forward to sharing additional details about our plans in this space later this year.

Richard F. Pops: So four months into the year, we're continuing to execute against our strategic priorities across the commercial business. The team is focused on delivering growth and strong financial performance. The 2680 development program is well on track and represents a potentially transformative opportunity for our business and consistent with the capital allocation framework.

Richard F. Pops: Across the commercial business, the team is focused on delivering growth and strong financial performance. The 2680 Development Program is well on track and represents a potentially transformative opportunity for our business. And consistent with the capital allocation framework we unveiled earlier this year, we continue to evaluate opportunities for external business development and to return capital to shareholders. We'll look forward to sharing our progress with you, and now that I've done that, I'll turn it back to Sandy to run the Q&A. Thanks, Rich.

Richard F. Pops: Unveiled earlier this year, we continue to evaluate opportunities drug external business development and to return capital to shareholders. We look forward to sharing our progress with you and now with that I'll turn it back to sandy to run the Q&A.

Thanks Rich.

Sandra Coombs: Maria, could you please hold the audience for questions? Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue.

Sandy: Could you please poll the audience for questions.

Maria: We ask that you limit your questions to one and a follow-up so that others may have an opportunity to ask questions. You may re-enter the queue by pressing star 1. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question call comes from Charles Duncan with Cantor Fitzgerald. Please proceed with your question. Hey, good morning, Rich and team.

Sandy: Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate that your line is in the question queue. You May Press Star two if you would like to remove your question from the queue. We ask that you limit your question.

Charles Cliff Duncan: Congratulations on a good quarter of progress. I had a couple of pipeline questions. Thanks for taking them.

Sandy: So wanted to follow up so that others may have an opportunity to ask questions. You may reenter the queue by pressing star one.

Sandy: Participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.

Sandy: Our first question comes from Charles Duncan with Cantor Fitzgerald. Please proceed with your question.

Blair C. Jackson: And that is primarily around 2680. I think it was mentioned that R&D is coming down by $10 million. And, and despite all of the progress that you're making in the clinic, I'm trying to reconcile that. In addition, I had a question on Vibrance too, but I'll hold that for the first answer. Hi, Charles. This is Blair.

Charles Cliff Duncan: Hey, Yeah, good morning, Richard and team Congrats on a good quarter of progress I had a couple of pipeline questions. Thanks for taking them.

Charles Cliff Duncan: And that is primarily around 26 80, I think it was mentioned that R&D is coming down by $10 million and despite all of the progress that you're making in the clinic I'm trying to reconcile that in addition, I had a question on <unk>, two but I'll hold that for the first name Sir.

Blair C. Jackson: I hope you're doing well. Thanks for the question. With regard to R&D, there are a couple dynamics associated with the spend this year. One is that we have a number of non-recurring expenses in the first quarter that apply to the R&D group that include payroll taxes and things like share-based comp.

Charles Cliff Duncan: Hi, Charles This is Blair I hope Youre doing well.

Charles Cliff Duncan: Thanks for the question with regards to R&D. There is a couple of dynamics associated with the spend this year. One is that we have a number of nonrecurring expenses in the first quarter that apply to the R&D group that implies payroll taxes and things like share based comp those won't recur and so you would expect declines from that through the course of.

Charles Cliff Duncan: The year and then also there's a phasing of the payments associated with the programs as you know with with Alex 2680, we had a lot of activity and closing out our phase <unk> program in NT 192, NIH and we had expenses associated with that and then as we kick off the phase two program.

Blair C. Jackson: Those won't recur, and so you'd expect declines from that through the course of the year. And then there's also a phased out of the payments associated with the programs. As you know, with ELKS 2680, we had a lot of activity in closing out our Phase 1B program in NT1 and NT2 and IH, and we had expenses associated with that. And then as we kick off the Phase 2 program, there's a lot of contractually dictated spend, and that leads to some phasing over the course of the year. Sounds like that's the case.

Charles Cliff Duncan: There's a lot of contractual dictated spend and that leads to some phasing over the course of the year Charles the only I'll add is from a capital allocation perspective, 2680 gets what it needs. We're not we're not throwing that back at all on the contrary, we're leaning into that one as aggressively as we can.

Blair C. Jackson: Regarding NT2, I'm not sure if I've misheard it, but you're moving in, or yeah, Vibrance2, you're moving into NT2 specifically. Wondering if you have further thoughts on I8, or is that perhaps an indication that is better suited for a second candidate? And can you provide any color on the target product profile for that second candidate in terms of differentiating from 2680? Thank you.

Speaker Change: Sounds like that's the case regarding two I'm not sure if I misheard, it, but youre moving in or Yeah, hi, Brian So you're moving into and Pete two specifically wondering if you have further thoughts on the I H or is there, perhaps an indication that is better suited.

Brian: For a second candidate and can you provide any color on.

Brian: Target product profile for that second candidate in terms of differentiating from 26 80. Thank you.

Richard F. Pops: We were really pleased with those IH data, and taking it in whole with the NT1, NT2, IH, you just see this very consistent profile for Alpha-2680 in driving wakefulness, almost irrespective of the erection tone in the underlying disease. Clearly, the most aggressive path to first approval is in narcolepsy, that indication. That's why we're prioritizing NT1, NT2, Vibrance1, Vibrance2, and going as fast as we can. We are very interested in the IH population as a disease indication itself, but also as it reads on to other indications that might be characterized by excessive daytime sleepiness with erection tone in the brain.

Speaker Change: Yes, it's a great question, we're really pleased with those IH data.

Speaker Change: <unk> taken in whole with the N T. One NTT IH you just see this very consistent profile for <unk> 2006 city in driving wakefulness, almost irrespective of the orexin tone in the underlying.

Speaker Change: And the underlying disease that clearly the most aggressive path to first approval was in narcolepsy that indication and that's why we're prioritizing and do you want NTT <unk> to go as fast as we can we are very interested in the IH population as a as a disease indication itself, but also as it reads on.

Speaker Change: Two other indications that might be characterized by excessive daytime sleepiness with orexin tone in the brain. It may be something we would do subsequent with 2680 or it may be indeed, something with an additional compound I'm not going to give you specifics necessarily on the backup or the next generation compounds because I there is some competitive aspects.

Richard F. Pops: It may be something we would do subsequent to 2680, or it may be indeed something with an additional compound. I'm not going to give you specifics necessarily on the backup or the next generation compounds, because there are some competitive aspects to the profiles that we're working on, but I expect you'll hear more about that later this year. Thanks, Charles.

Speaker Change: The profiles that we're working on but I would.

Speaker Change: Expect you'll hear more about that later this year.

Speaker Change: Thanks Charles.

Maria: Maria, can we take the next question, please? Our next question comes from David Amsellem with Piper Sandler. Please proceed with your question. Hey, thanks.

Speaker Change: Can we take the next question please.

Speaker Change: Our next question comes from David <unk> from.

David: With Piper Sandler. Please proceed with your question.

David A. Amsellem: So, one question on the orexins and one on Liz Baldy. First, on the orexins: there's a number of these agents that are kicking around. I think recently Harmony is in license, the preclinical stage, orexin receptor agonists, and there are certainly others. So, Richard, maybe help us understand, you know, how you're thinking about the extent to which multiple orexins can coexist, maybe not just in narcolepsy, but as you're thinking about IH and other disorders where hypersomnolence is a hallmark symptom.

David: Hey, Thanks, So one question on the erections and one on the first on the erections.

David: There is a number of these agents that are kicking around I think recently harmony.

David: License the preclinical stage Orexin two receptor agonist and there are certainly others. So so Richard maybe help us understand how you're thinking about the extent to which.

David: Multiple orexin can coexist.

Maybe not just in narcolepsy, but as you're thinking about IH and other.

David: Disorders, where hypersomnia lines, there was a hallmark symptoms. So just wanted to get your high level thoughts there.

Speaker Change: Then secondly on <unk>.

Speaker Change: Also a high level question as it relates to the availability of car X T.

Speaker Change: And the noise in the marketplace.

Speaker Change: Do you perceive any noise.

Speaker Change: And how you think that could.

Speaker Change: Impact new starts on laboratory as we move through 2025. Thank you.

Richard F. Pops: So, just wanted to get your high-level thoughts there. And then, secondly, on libalvi, also a high-level question as it relates to the availability of CAR-XT and the noise in the marketplace, if you perceive any noise, and how you think that could impact new starts on libalvi as we move through 2025. Thank you. Good morning, David.

Speaker Change: Good morning, David.

Richard F. Pops: Yeah, I'll start with the erection and give you my thoughts on Ebola V2, then I'll ask Todd to give you his perspective from the front lines on it. The one thing we've learned about this orexin space, if we've learned anything, is that each of these molecules is quite different when they get into the clinic. And we anticipated that, you know, if you recall the slide that we presented multiple times, which shows the various optimization parameters that one needs to consider when developing an oral small molecule GPCR agonist that gets into the brain.

David: Yeah, I'll start on the erection and give you a thought on the evolving to you then I'll ask Todd to give you his perspective from the front lines on it but.

David: The one thing we've learned about this erection space. If we've learned anything is at each of these molecules is quite different when they get into the clinic and we anticipated that and if you recall the slide that we presented multiple times, which shows the various observation parameters that one needs to consider when developing an oral small molecule <unk>.

David: <unk> agonist that gets into the brain.

Richard F. Pops: And what we saw from competitive programs is that the molecules, when they get into humans, separate pretty distinctively. So to your question... It presupposes that there are multiple co-existing commercial erection agonists that are similar in profile. I just don't believe that's going to be the case.

David: And what we saw from competitive programs is that the programs that the molecules when they get into humans separate pretty distinctively so to your question.

David: Presupposes that theres multiple co existing commercial orexin agonist that are that are similar in the profile I. Just don't believe that's going to be the case now that will yield the data of course, but I think that in our case, we're focused on developing a once daily very well tolerated orexin agonist.

Richard F. Pops: Now, that will yield data, of course, but I think that in our case, we're focused on developing a once-daily, very well-tolerated erection agonist that is approved for narcolepsy NT1, NT2, and so far, we're right on track for that. With respect to the development, I think the first approval for CAR-XT we expect will be in schizophrenia. And remember that Livolvi is competing in a broader market, which is both schizophrenia and bipolar.

David: If approved for narcolepsy, and <unk> and so far we're right on track for that.

David: With respect to the ballgame.

David: Yeah, I think I think the the first approval for a car T. We expect will be in schizophrenia and.

David: And remember that the ball is competing in a broader market, which is both schizophrenia and bipolar and most of the big oral brands in this space need multiple indications to really drive sales across multiple patient populations with that said and the focus in in schizophrenia.

Richard F. Pops: And most of the big oral brands in this space need multiple indications to really drive sales across multiple patient populations. With that said, in the focus on schizophrenia, I think that our differentiating feature in schizophrenia is the efficacy of Livolvi. And if physicians and patients are talking about efficacy, that's a good setup for Livolvi. Todd, what's your thought?

David: I think that that are differentiating feature in schizophrenia is the efficacy of the Baltimore and if physicians and patients are talking about about efficacy.

David: It's a good setup for the ball Todd what's your thought yes, I would I would agree with that I think it's important to remember when you look at the category overall.

Unknown Attendee: Yeah, I would agree with that. But I think it's important to remember when we look at the category overall, there's a very large category for Livolvi in general, I'm speaking about, bipolar I, and schizophrenia. The dynamics of the market are changing. So this is a changing market, so you have to be able to compete within the changing market. Car XT coming out in the market, the first indication, as Rich said, is going to be schizophrenia. This is obviously a market that we know very well, but the core attribute has to be efficacy. And Livalvi is very well positioned.

Todd: Large large category for laboratory in general I'm speaking about bipolar one and schizophrenia the dynamics of the market. Our switch. So this is a this is a switch market. So you have to be able to compete within the switch market.

Todd: Car T coming out in the market. The first indications rich said is going to be schizophrenia. This is obviously a market that we know very well, but the core of the core attribute has to be efficacy and lobotomy is very well positioned to all of our research.

Unknown Attendee: Through all of our research, HCPs continue to tell us that the core value proposition for Livalvi is efficacy, but you have to have a good balance of tolerability and safety as well. We believe Livalvi is extremely well positioned now and in the future, even with new products coming into the marketplace. Our next question comes from Joel Beatty with Baird. Please proceed with your question. Hi, thanks for taking the questions. The first one's on 2680.

Todd: <unk> content continue to tell us that the core value proposition for la <unk> efficacy, but you have to have a good balance of Tolerability and safety as well. So we believe <unk> is extremely well positioned now and in the future even with new products coming into the marketplace.

Todd: Okay.

Speaker Change: Okay. Thanks, David.

Speaker Change: Our next question comes from Joel Beatty with Baird. Please proceed with your question.

Unknown Attendee: With the recent NT to IH data, do you think visual disturbance is on or off target? And if it's on target, why hasn't it been seen with other agents such as Takeda's? Well, as I said earlier, I think that each of these agents is quite different. This is because 26A is a very potent, very selective molecule. Just to be clear, when we talk about visual disturbance, what we've observed in patients so far is very mild, very transient, and very infrequent. We saw no visual disturbances in patients with NT1 methotoxin.

Unknown Attendee: Hi, Thanks for taking my questions. The first one's on 26 80.

Unknown Attendee: Lisa <unk> to instead of using visual disturbances on or off target.

Unknown Attendee: Why isn't it.

Unknown Attendee: <unk> seen with other agents such as what is the cadence.

Lisa: Well as I said earlier I think that each of these agents is quite different and this is 26 days is a very potent selective molecule in the clinic just to be clear when we talk about visual disturbances, what we've observed in patients. So far is very mild and very transient very infrequent.

Lisa: Saw no visual disturbances in patients with <unk> at the doses tested and we saw one event in patients within Q1 and one in patients with IH, both were mild transient self limiting single occurrences and just understanding what the parlance is with respect to adverse event characterization when something is characterized as mark.

Richard F. Pops: And we saw one event in patients with NT1 and one in patients with IH. Both were mild, transient, self-limiting, single occurrences. And just to understand what the terminology is with respect to adverse event characterization, when something is characterized as mild, it means that it's noticeable by the patient, but it's easily tolerated and doesn't impact their activities. So to the extent that it may be on target, we'll need more data across a wide dose range. Great, and then for LaValvie, what's the outlook for the DTHC campaign? Does it seem to be having the impact you were hoping for? Yeah, I'll take that one.

<unk> it means that it's noticeable by the patient, but it's easily tolerated and doesn't impact their activities. So to the extent that it may be on target you will need more data across a wide dose range to know that for sure but the profile as currently configured we're very comfortable with it.

Speaker Change: Great and then sort of evolving.

Speaker Change: Let's say outlook for the CD campaign doesn't seem to be having more impact you were hoping for.

Speaker Change: Yes.

Unknown Attendee: I would say right now that we're really pleased with our DTC program. We've been executing the program over the last couple quarters as planned. The lead indicators, the trends are positive, as we've discussed in the past, such as website visits and branded searches. In fact, they're significantly up year over year.

Speaker Change: Yes, I'll take that one.

Speaker Change: I would say right now we're really pleased with our DTC program, we've been executing the program over the last couple of quarters as planned.

Speaker Change: The leading indicators the trends are positive as we've discussed in the past such as website visits branded searches and.

Speaker Change: In fact, they're significantly up year over year.

Akash Tewari: And our early indicators, our early analysis shows that the overall program, which is TV and digital, is contributing to TRX growth. So our data actually shows that there is a meaningful contribution, so our plan is to continue to execute that program throughout the year. Thank you. Our next question comes from Akash Tewari with Jeffreys. Please proceed with your question. Hi, this is Kathy on behalf of Akash.

Speaker Change: And our early indicators are early our early analysis shows that the overall program, which is a which is television and digital.

Speaker Change: Is contributing to T. Rx growth. So our data actually shows that there is a meaningful contribution to our plan is to continue to execute that program throughout the year.

Speaker Change: Thank you.

Cash Story: Our next question comes from a cash story with Jefferies. Please proceed with your question.

Richard F. Pops: I just have a couple of questions. So, when TAC presents full data on sleep in June, what data points are you looking for that will give you confidence that OX2 won't need to be combined with sodium oxidate? And then also, what measurements do you think are the most important regarding sleep architecture?

Cash Story: Hi, this is kathy on for our costs.

Kathy: Just a couple of questions. So one tak present full data at sleep in June what data points are you looking for that will give you confidence ox you won't need to be combined with sodium <unk> and then also what measurements do you think are the most important regarding sleep architecture and then finally for NTT study will you require any type of thing.

Richard F. Pops: And then finally, for your NT2 study, will you require any driving restrictions? Thank you. Yeah, I mean, we'll look forward to seeing Takeda's presentation of data at SLEAP in Houston in June because there we should see the results of the randomized phase 2 study at multiple doses, dosed twice a day for that drug, both safety as well as efficacy. So we'll look forward to seeing what they present, and obviously, we don't know at this point what they will present. With respect to the effect of erectin agonists on sleep architecture, I think that's yet to be fully characterized.

Speaker Change: Makes sense. Thank you.

Speaker Change: Yeah, I mean, we will look forward to seeing caters presentation of data at sleep in Houston in June because there we should see the results of the randomized phase II study in multiple doses dosed twice a day for that drug both safety as well as efficacy. So we'll look forward to seeing what you presented obviously, we don't know at this point.

Speaker Change: They will present with respect to the effective orexin agonist and sleep architecture I think that's that's yet to be fully characterize perhaps we'll see some data in June that begin to describe that but I think that the.

Richard F. Pops: Perhaps we'll see some data in June that begin to describe that. But I think that the theory is that with a full day of wakefulness, sleep should be consolidated and resume a more normal architecture. But that needs to be proven in the lab. We'll be doing that in our Phase 2 study looking at polysomnography in our Phase 2 study for both Vibrance 1 and Vibrance 2. No, there's no need for any driver driving restrictions in New York State.

Speaker Change: Theory is that with.

Speaker Change: Full day of wakefulness.

Speaker Change: Sleep should be consolidated resume more normal architecture, but that needs to be proven in the lab, we will be doing that in our phase II study looking at Polycom nagra fee in our phase II study for both fiber and Swan environment too.

Speaker Change: Ken.

Speaker Change: No theres no need for any driver driving restrictions in New York City.

Richard F. Pops: Okay, great. Thank you so much. Our next question comes from Paul Matteis with Steeple. Please proceed with your question. Hey, this is James. I'm on behalf of Paul.

Okay, great. Thank you so much.

Thanks.

Speaker Change: Our next question comes from Paul Mckenzie with Stifel. Please proceed with your question.

Paul Andrew Matteis: Thanks for taking our question. I just have one question around kind of like margins going forward and specifically on EBITDA. I guess, you know, as you look ahead and as some of these royalties kind of start to peel off, I guess, do you think this kind of current kind of EBITDA margin profile is sustainable kind of in the midterm or beatable? I guess just kind of, what do you see as kind of your goal kind of looking forward? And then, in that context, how are you thinking about, you know, investing in R&D or looking at business development opportunities? Thanks. Maybe I'll start with the margins first.

Speaker Change: Hey, this is James on for Paul Thanks for taking our question.

I just had one question around kind of like margins going forward and specifically on EBITDA.

James: Yes, as you look ahead and as some of these royalties kind of starts.

James: To Peel off I guess do you think the kind of the current kind of EBITDA margin profile is sustainable kind of in the mid term or beatable I guess, just kind of what do you see as kind of your goal kind of looking forward and then I guess in that context, how are you thinking about.

James: Investing in R&D are looking at BD opportunities. Thanks.

Blair C. Jackson: This is Blair, and then I'll ask Rich to give some context on our future strategy on BD and things. I think with regard to margins, as you said, we have a healthy margin going forward. We expect to generate significant cash for the business. We plan to continue to operate the business at a profitable level in this sort of range moving forward, but it still allows for significant investment both in the portfolio and in our commercial business.

Speaker Change: Maybe I'll start with the margins as Blair and then I'll ask rich to give some context on our future strategy on BD and things I think with regards to margins.

As you said, we have a healthy margin going forward, we expect to generate significant cash for the business we.

Speaker Change: We plan to continue to operate the business at a profitable level.

Speaker Change: In this sort of range moving forward and but still up that allows for significant investment both in the portfolio and in our commercial business and and that's our overall plan for the business.

Blair C. Jackson: And that's our overall plan. [inaudible] with a growing top line. And so that accommodates both expansion and R&D spending as well as potential return to capital of the shareholder. And maintaining significant profitability. So we think we can do all this at the same time.

Speaker Change: Rich did you want to comment on all I'm just curious if you look at if you look at our long range plan, what you see as you see as we're indicating you see growing profitability with.

Rich: With a growing top line and so that a.

Rich: Accommodates both expansion and R&D spending as well as potential return of capital to shareholders, while maintaining significant profitability. So we think we can we can do all of this at the same time.

Speaker Change: And it's all driven by that advancing topline.

Speaker Change: Alright. Thanks.

Blair C. Jackson: And it's all driven by that advancing top line. All right, thanks. Our next question comes from Umer Raffat, Evercore ISI. Please proceed with your question. Hi guys. Thanks for taking my question. Maybe a boring question and then a less boring question.

Speaker Change: Our next question comes from Nomura.

Speaker Change: Evercore ISI. Please proceed with your question.

Speaker Change: Hi, guys. Thanks for taking my question, maybe a boring question and then a less boring question.

Umer Raffat: So the boring question is, Part D reform, how much of an impact do you expect on your top line and APS into next year? And I realize this could be relevant, so I'd be curious. On the second one, on Norexin, I just wanted to look into its potency a little more. I know you've shown some very good data previously. I think it was at World Sleep where it was in CHO cells, and I'm assuming it was the IP1 assay where 2680 was about 10 times more potent than the native orexin.

Speaker Change: So the boring question as part D reform, how much of an impact do you expect on your topline and EPS into next year and I realize this could be relevant so I'd be curious on on the second one on Rex and I just wanted to look into the potency a little more I know you've shown some very good data previously I think it was up.

Speaker Change: I'll sleep, where it was and chose cells and I'm, assuming it was the I P. One assay, where 26 80 was about 10 times more potent than the native orexin, but other data seems to also suggest native orexin underperforms in IP one assays.

Richard F. Pops: But other data seems to also suggest native orexin underperforms in IP1 assays. So my question is, how does your potency look versus native orexin in a Flipper assay? Good morning. Those are both boring questions.

Speaker Change: So my question is how does your potency look versus native Orexin Flipper assay.

Speaker Change: Yeah.

Richard F. Pops: So Part D is interesting because we are one of the companies that qualifies for the phase. So that phase-in, just to orient folks, as companies take on more liability in the catastrophic phase of Part D, that for certain companies that qualify, that begins a very gradual phase-in. So the exposure in 2025 is 1%. So it's, it's, you know, it's a small step, but it's a ramp toward full participation in the program at the end of the decade or so. So it won't have much of an impact on 2025.

Good morning.

Speaker Change: Those are both boring questions.

Speaker Change: So the.

Speaker Change: The part D is interesting because we are one of the companies that qualifies for the season.

Speaker Change: So that phasing and just to Orient folks as companies take on more liability and the catastrophic phase in part D that that for certain companies with it qualify it becomes a very gradual phasing. So the exposure in 2025, 1%. So it's it's you know it's a small.

Speaker Change: But it's a it's a ramp toward a full participation in the program at the end of the decade or so so it won't have much impact on 2025.

Richard F. Pops: I have to smile about potency because, you know, the potency that matters is actually the human potency. And I think that we're way ahead of everybody else in demonstrating the high potency of ALK2680 in the form of doses in 4, 6, 8, 10, 14, and 18 in NT1 and NT2, where we're driving meaningful efficacy. So we can talk all day about various in vitro systems, about both selectivity and potency. But I would say they're necessary but absolutely insufficient to determine the actual potency as it relates to the medicine. So the answer to your question, I don't actually know what our Flipper values are because we're so far beyond that now in our development program that it's essentially irrelevant.

Speaker Change: I have to smile about the potency because I mean, the potency that matters is actually the human potency and I think that we're way ahead of everybody else and demonstrating the high potency of our 2680 in the form of doses in 468, 10, 14, and 18 and N T. One and T two where we're driving meaningful efficacy.

Speaker Change: So we can talk all day about various in vitro systems about both productivity and potency, but I would say there isn't there necessary, but absolutely insufficient and determine the actual potency as it relates to it as a medicine. So the answer because I don't actually know what our flipper values are because we're so far beyond that now in our development program.

Speaker Change: It's essentially irrelevant at this point.

Richard F. Pops: And, sorry, Richard, just to clarify, on the D-point that you made, you said there's a phase-in, obviously. Whatever the max impact is by 2030, how much of the max is in by 2025? Is it a quarter of that or a tenth of that?

Speaker Change: And sorry, Richard just to clarify on the point that you made.

You said Theres a phase then obviously.

Speaker Change: Whatever the Max impact is by 2030, how much of the Max is in by 2025 is it a quarter of that or a 10th of that 225, 1% literally nominal.

Richard F. Pops: No, no, 2025 is 1%. Literally, it's the absolute value of a 1% participation in that catastrophic event. Okay, got it. Thank you very much. But you know, that's from zero; we have zero right now.

Speaker Change: Absolute values of 1% participation that catastrophic with it.

Speaker Change: Okay got it thank you very much.

Richard F. Pops: So we add 1%, and then it scales over the next several years until it ultimately hits the full level. But it's a specific carve out for companies that are smaller companies with dependence on that Part D population as a significant source of income.

Speaker Change: From zero, we have zero right now so we add 1% and then it scales over the over the next several years until it ultimately.

Speaker Change: Yeah.

Speaker Change: The full level, but it's a it's a specific carve out for companies that are that are smaller companies with <unk>.

Speaker Change: Pendants on that part D population as a significant source of income and it was.

Richard F. Pops: And it was specifically targeted by the policymakers to make sure that companies like ours weren't devastated by going from zero exposure in a catastrophe to a 10 or 20 percent exposure in a catastrophe. Correct. Thank you very much. So it's 1% of the max 20%, correct? It's not 20, 30, 500, 20, 30, 20. It's not 1% of 20%; it's 1% absolute.

Speaker Change: Specifically oriented by by the policymakers to make sure that companies like ours weren't devastated by going from zero exposure and quite catastrophic to a 10 or 20% exposure in Caddo struggle.

Speaker Change: Correct. Thank you very much so it's 1% of the Max 20% correct its not 20.

Speaker Change: It's not 1% or 20 percentage, 1% absolute.

Speaker Change: 1% absolutely Okay got it thank you very much.

Richard F. Pops: Okay, got it. Thank you very much. If you have any questions, call us, Umer, because we can take you through that whole phase-in if you want. I know you just did a big thing yesterday on it, which is smart. So give us a ring, and we can take you through the phase-in in particular if you have any specific questions. Thank you, Ashwani.

Speaker Change: If you have any color root cause we can take you through that whole phasing. If you want I know you just did a big thing yesterday on it which is smart. So it makes you give us a range. We can take you through the phasing in particular, if you have any specific questions.

Speaker Change: Thank you rich.

Jason Matthew Gerberry: Our next question comes from Jason Gerberry with Bank of America. Please proceed with your question. Hey guys, I've got a couple of questions as well.

Speaker Change: Our next question comes from Jason <unk> with Bank of America. Please proceed with your question.

Richard F. Pops: I'll be the judge of that, Jason. Yeah, on your comments about the Lebalvy PBM contract not impacting 2024, I'm just sort of curious about 2025 plus, like directionally, you know, how we think about these high 20% growth nets and, you know, as you move towards a more commercial contracted basis, directionally, how that looks, and then, you know, just a follow up on the CAR T impact: is your bipolar schizophrenia mix still 50-50, I know with the DTC. The thought was that you might activate more bipolar patients, and that makes the shift might actually grow more towards bipolar. Yeah, hey, Jason. Good morning. This is Todd.

Jason: Hey, guys.

Jason: I've got a couple of boring questions as well.

I'll be the judge of that Jason.

Jason: Yeah.

Jason: On your comments about the lowball the P. B M contract not impacting 2024, I'm just sort of curious about 2025 plus like Directionally.

Speaker Change: You know, how we think about these high 20% gross to net and does you know as you move towards a more commercial contracted basis.

Speaker Change: Directionally, how that looks and then you know just a follow up on the car T impact is your bipolar schizophrenia mix still 50, 50 or or has that shifted more to bipolar I know with the DTC.

Speaker Change: The thought was that you might activate more bipolar patients and that mix shift might actually even grow more towards bipolar.

Unknown Attendee: I'll take that, For gross to net, yeah, we're really pleased that we were actually able to continue to execute on our strategy, our commercial contracting strategy. So, as I said in the prepared remarks, we did enter into a new agreement with a really large PBM that we're really pleased with to improve the formulary positioning and get more patients access. For the full year, we still expect Rose Tonette to be in the high 20s.

Speaker Change: Yeah, Hey, Jason Good morning. This is Todd I'll take that four for gross to net we were really pleased.

Todd: They were actually able to continue to execute on our strategy our commercial contracting strategy.

Todd: So as I said in the prepared remarks, we did enter into a new agreement with a really large P. B M that we're really pleased with improve the formulary positioning and get more patient access.

Todd: Till evolve even with that you know for for 2024, we had a range of scenarios for gross to net plus net sales so that fits perfectly in the range that we've outlined for the full year, we still expect gross to net to be in that high twenty's going into 'twenty five and beyond we're not we're not guiding to 25 and beyond.

Unknown Attendee: Going into 25 and beyond, we're not guiding to 25 and beyond, but that may widen a little bit as we continue to execute our strategy and get more access for patients on formula for commercial. In terms of the mix overall for schizophrenia and bipolar, the mix for TRXs is still approximately 50% for schizophrenia and bipolar. We continue to see new patients start skewing more towards bipolar I, which again was part of our strategy.

Todd: But that may widen a little bit as we continue to execute our strategy and get more access for patients on formulary for commercial.

Todd: In terms of the mix overall for schizophrenia and bipolar the mix for <unk> is still approximately 50% for schizophrenia and bipolar we continue to see new patient start skew more towards bipolar one which again was part of our strategy. So.

Unknown Attendee: So it's approaching a little north of 55% for new patient starts, and the volume growth overall, most of the volume growth we're seeing within the brand right now is coming from bipolar I. So we think that's a combination of, obviously, growing breadth of prescribing and also the activation we have with patients right now.

Todd: It's approaching a little north of 55% for new patient starts and the volume growth overall most of the volume growth were seeing within the brand right now is coming from bipolar. One. So we think that's a combination of obviously of growing breadth of prescribing and also the activation we have of patients right now.

Speaker Change: Great. Thanks, guys.

Yes.

Uy Sieng Ear: Thanks, guys. Our next question comes from Uy Ear with Mizzou Securities. Please proceed with your question. Hey, guys. Yeah, thanks for taking my question. Just high level.

Speaker Change: Our next question comes from Lee here with Mizuho Securities. Please proceed with your question.

Lee: Hey, guys yeah. Thanks.

Lee: Thanks for taking my question.

Hi leveling.

Richard F. Pops: Curious, um, you know, given the recent, uh, in licensing by harmonies of an erection, um, to agonist, uh, you know, the deal was kind of strange, you know, it just went from one company to the next and curious, um, to see what the landscape is like is, is an erection molecule, um, this rare, or is it, uh, you know, is it, um, easily, I guess, can be generated, maybe just provide a little color on the ability to have access to one of these molecules. Thanks. I think, I think it's actually, Relatively rare.

Lee: Just curious you know given the recent in licensing by harmony an erection.

Speaker Change: <unk> two agonist.

Speaker Change: The deal was kind of strange.

Speaker Change: Went from one company to the next and curious to see what the landscape is like is in Orexin molecule. This rare or is it.

Speaker Change: You know is it.

Speaker Change: Easily I guess.

Speaker Change: <unk> can be generated maybe just provide a little color on the the the ability to to have access to one of these molecules.

Speaker Change: I think I think it's actually.

Richard F. Pops: I think that's why people have had such difficulty coming up with chemical diversity in this space. These are. [inaudible] yet cross the blood-brain barrier, and once they've done that, they need to bind to a G-protein coupled receptor as an agonist. And so it drives signaling in the brain and the target neurons of choice. And do all that with a pharmacokinetic profile, a concentration profile over time that's consistent with the normal sleep-wake cycle, so people can wake up in the morning and go to sleep. So it's really quite difficult to do.

Speaker Change: Relatively rare I think that's why people have had such difficulty coming up with chemical diversity in this space.

Speaker Change: These are as you've heard me say AD Nauseum. These are these are complicated molecule to make because they have to be orally bio available yet.

Speaker Change: Yet cross the blood brain barrier and once they've done that they need to bind to a G protein coupled receptor as an agonist and so drive signaling in the brain and the target neurons.

Of choice and do all that with a pharmacokinetic profile of concentration profile over time, that's consistent with the normal sleep wake cycle. So people can wake up in the morning go to sleep at night. So it's really it's really quite difficult to do and that's why I think even with this much of a commercial and medical promise you see.

Richard F. Pops: And that's why, even with this much of a commercial medical promise, you see a very small number of products in the clinic right now. I contrast that with other, you know, systemically available kinase inhibitors or other types of drugs where there's a lot of chemical diversity that can be brought to bear. Even small molecules from, ranging from small molecules to large molecules.

Speaker Change: A very small number of products in the clinic right now are contrasted to other systemically.

Speaker Change: We available kinase inhibitors or other types of drivers where theres a lot of chemical diversity of that can be brought to bear.

Speaker Change: Even small molecules from ranging from small molecules to large molecules, but here. It's a really really constricted area. So I think that one can find molecules to license the questions are they good molecules.

Richard F. Pops: But here it's a really, really constricted area. So I think that one can find molecules to license. The question is, are they good?

Richard F. Pops: Just to follow up on that, could you maybe also speak a bit about the number of molecules that you perhaps have in-house, if you can share that, and what is it about your platform that gives you an advantage, I guess? I think our platform derives from a sensibility from the outset when we began medicinal chemistry about what the features that needed to be integrated rather than... So you'll hear a lot of people talking about potency. Potency is absolutely important, but it's absolutely insufficient. So we began our screening and medicinal chemistry efforts based on optimizing across all of these different domains, and it yielded chemical structures that we think are separate from others.

Speaker Change: Just to follow up on that could you maybe also speak a bit about the number of molecules that you perhaps have in house. If you can share that in and what is it about your platform that gives you an advantage I guess thanks.

Speaker Change: I think our platform derives from from a sensibility from the outset. When we began the medicinal chemistry and about what features that needed to be an integrated rather than so you'll hear a lot of people talking about potency potency is absolutely important but it is absolutely insufficient. So we began our screening and missile Kevin.

History efforts based on optimizing across all of these different domains.

Speaker Change: And it yielded chemical structures that we think separate from others, but even in our in our patent suite. There's a limited number of structures that could that can confirm all of these attributes. So our patents are critical to the foundation of this within that patents, we can generate a multitude of compounds.

Richard F. Pops: But even in our patent suite, there is a limited number of structures that can confer all these attributes, so our patents are critical to the foundation of this. Within that patent suite, we can generate a multitude of compounds. And so our job, pre-clinically, is to try to stratify those into ones that map best onto the particular indications that we're thinking about for... The core of the bullseye is narcolepsy. This is the most simple embodiment of the idea of replacing a deficient neurotransmitter in a disease, NT1, with a small molecule analog.

Speaker Change: And so our job pre clinically is to try to stratify those into ones that Matt burst onto that particular indications that we're thinking about pursuing the core of the bull's eye as narcolepsy. This is the most simple embodiment of the idea of replacing a deficient neurotransmitter in disease and T. One with a small molecule analog.

Richard F. Pops: And that's why it's such a great place to start with this whole chemistry and this whole biology. But if we're indeed interrogating the circuitry in the brain that drives wakefulness... That has implications beyond our control. Thank you. The next question comes from Jessica Fye with J.P. Morgan. Please proceed with your question. Hey guys, good morning.

Speaker Change: And that's why it's such a great place to start with this whole come up with this whole chemistry and this whole biology, but if we are indeed interrogating the circuitry in the brain that drives wakefulness.

Speaker Change: That has implications beyond narcolepsy.

Speaker Change: Thank you.

Speaker Change: Our next.

Speaker Change: Comes from Jessica Fye with J P. Morgan. Please proceed with your question.

Jessica Macomber Fye: Thanks for taking my questions. Chris, did you see any impact on volumes from the ChangeHealth cyber attack in the first quarter? And separately on orexin, I think for the recent NT2 and IH update, the description of AEs was just listing those that happened in more than one participant. And I think it left some investors wondering about the rates that you saw. For example, if that just meant some of these occurred in only two patients versus more than that. So, curious if there's any color you can provide there.

Hey, guys. Good morning, Thanks for taking my question I'm curious did you see any impact to volumes from the change health cyber attack in the first quarter.

Jessica Macomber Fye: And separately on the Orexin I think for that reason.

And due to an HFC description on Aes was just listing those that happened in more than one participant and I think some investors are wondering about the rates that you saw for example, if that just meant some of these occurred in only two patients versus more than that.

Speaker Change: So curious if theres any color you can provide there. Thank you.

Unknown Attendee: Transcripts provided by Transcription Outsourcing, LLC, for HCP offices, pharmacies, and hospitals about processing claims. The biggest impact overall for the market overall was really with processing of co-pay cards and co-pay claims. Our three brands with our co-pay cards had no impact.

Speaker Change: Joe do you want to yes, absolutely Jessica Yeah in terms of change healthcare there were a lot of reports in the marketplace about operational issues for HCP offices pharmacies and hospitals about processing claims.

Joe: The biggest impact overall for the for the for the market overall was really with processing of co pay cards co pay claims.

Our three co pay our three brands with our Copay card had no impact. So we didn't see any impact at all from the change healthcare cyber attack.

Richard F. Pops: So we didn't see any impact at all from the Chained Health Care cyber attack. And Jess, I don't have the AE tables in front of me, but remember, we were very pleased with the AE profile in the NT2IH cohort and remember that across all the doses, it was observed to be generally well tolerated. The treatment emergent adverse events assessed as related to the study drug were mild transient resolve without treatment. No severe or serious AEs were reported, and there were no AEs that led to study drug discontinuation.

Joe: And just I don't have I don't have the AE tables in front of me, but remember we were very pleased with the AE profile in the <unk> cohort and remember that across all the doses. It was observed to be generally well tolerated the treatment emergent adverse events assessed as related to study drug where mild trans.

Joe: And resolved without treatment no severe or serious aes were reported and there were no aes that led to the study drug discontinuation. So we'll provide the full data tables when we when we present the data later this year, but the overall profile is just as I described.

Richard F. Pops: So we'll provide the full data tables when we present the data later this year, but the overall profile is just as I described. Our next question comes from Mark Goodman with SVB Securities. Please proceed with your question. Hi, thanks for taking my question. This is Rudy on the line from Merck.

Okay. Thank you.

Joe: Our next question comes from Marc Goodman with FCB Securities. Please proceed with your question.

Joe: Alright, Thanks for taking my question. This is Rudy on the line for Mark. So you mentioned increased breadth for Bobby prescribed worse. So what percentage of these 20000 prescribers have you reached and what is your strategy to increase the breadth and depth and prescribe Bruce moving forward.

Marc Harold Goodman: So you mentioned increased breadth for Lybali prescribers. So what percentage of these 20,000 prescribers have you reached, and what is your strategy to increase the breadth and depth of prescribers moving forward? Thanks. Yeah, absolutely. I'll take that.

Thanks, Yes.

Unknown Attendee: So we, with our sales force, overall, we target about 22,000 prescribers. There's a really meaningful impact there in terms of breadth and depth of prescribing. Overall, for the quarter, you know, we saw approximately 6,600 prescribers in Q1. That's a growth year over year of about 34%, which we're, we're really encouraged by. And our, you know, a lot of this is just timing. We continue to bring on new prescribers every single week and every single month, and a lot of that is being driven by just the utility of the brand. We hear this consistently with HCPs, that efficacy is the differentiator, and it provides broad utility across Schizophrenia and Bipolar 1.

Speaker Change: Yes, absolutely I'll take that so with our sales force overall, we target about 22000 prescribers, there's a really meaningful we've had a really meaningful impact there.

Speaker Change: A breadth and depth of prescribing overall for the quarter.

Speaker Change: We saw it we see approximately 6600 prescribers in Q1, that's a that's a growth year over year of about 34%, which where we're really encouraged with and are you know a lot of this is just timing we continue to bring on new prescribers every single week and every single month and a lot of that is being driven by just the utility of the brand we hear this.

Speaker Change: Sisterly with HCP is that efficacy is the differentiator.

Speaker Change: And it provides a broad utility across schizophrenia and bipolar one. Additionally in some of our most recent market research about 90% of Hep's report that they can they they plan to continue to prescribe an increased prescribing over the next over the next calendar year. So we think that's a very encouraging trend.

Unknown Attendee: Additionally, in some of our most recent market research, about 90% of HCPs report that they can, that they plan to continue to prescribe and increase prescribing over the next, you know, the next calendar year. So we think that's a very encouraging trend to continue to drive breadth but also depth of prescribing. Thanks.

Speaker Change: To continue to drive breadth, but also depth of prescribing.

Speaker Change: Got it thanks.

Douglas Dylan Tsao: Our next question comes from Douglas Tsao with HC Wainwright. Please proceed with your question. Hi, good morning.

Speaker Change: Our next question comes from Douglas Tsao of H C. Wainwright. Please proceed with your question.

Douglas Dylan Tsao: Thanks for taking the question. Just first, on the ball, I'm just curious as a follow-up to that last question. I mean, do you see the bigger opportunity in improving the depth of prescribing with individual prescribers, or is it just expanding the universe of Ryder? Yeah, actually, it's both.

Douglas Dylan Tsao: Hi, good morning, Thanks for taking the questions just first on the ball. The I'm just curious as a follow up that last question I mean, do you see the bigger opportunity in improving the depth of prescribing with individual prescribers or is it just expanding the universe of of writers.

Unknown Attendee: But, you know, overall, we're still in the early stages, I would say of our launch. And so prescriber breath is obviously primary job number one. Prescriber deaths every single quarter is actually improving.

Speaker Change: Yeah actually its both but.

Speaker Change: Overall, we are still in the early stages I would say of our launch and so prescriber breadth has obviously been primary job number one.

Speaker Change: Prescriber deaths every single quarter actually is improving so we continue to see that and we've done a lot of research with that and and really the key insight is once in HCP.

Unknown Attendee: So we continue to see that, and we've done a lot of research with that. And really, the key insight is once an HCP has a positive experience with Livalvi, whether it's schizophrenia or bipolar disorder, they tend to expand utilization pretty rapidly. So we're really pleased with that.

Speaker Change: It has a positive experience with the ball, whether it's schizophrenia or bipolar they tend to expand utilization pretty rapidly. So we're really we're really pleased with that so that the.

Unknown Attendee: So the overall profile of the product for a broad population with schizophrenia and bipolar will ultimately, over time, cause a lot of death. But primarily, job number one right now is continuing to drive prescribers to breath. And we think we're still really early with that. And just as a quick follow-up on that, just how long does it take, you know, in terms of sort of accruing that experience to accumulate, you know, to feel confident in terms of individual docs to start writing more? Thank you. Yeah, yeah.

Speaker Change: Overall profile of the product for a broad population with schizophrenia and bipolar will ultimately over time drive a lot of depth, but but primarily job number one right now is continuing to drive prescriber breadth and we think we're still really early with that.

Speaker Change: And just as a quick follow up on that just how long does that take you know in terms of sort of accruing that experience to accrue.

Speaker Change: Feel confident in terms of for individual doctor to start writing more. Thank you yeah, yeah, well I think you've got to think about that in the context of the market that we compete.

Unknown Attendee: Well, I think you have to think about that in the context of the market that we compete in. Again, as I said earlier, this is, for schizophrenia and bipolar patients, this is a switch market. So it's a dynamic switch market. Patients in this category will switch therapies about five to eight times. So it's rather dynamic. It's more dynamic and bipolar than schizophrenia.

Speaker Change: Again as I said earlier this is for schizophrenia and bipolar patients. This is a switch market. So it's a dynamic switch market patients in this category, we will switch therapies about five to eight times. So it's rather dynamic it's more dynamic in bipolar and schizophrenia. So it really depends upon the origination of that patient.

Unknown Attendee: So it really depends upon the origination of the patient, the experience that they're having. But it would typically take a couple of months. So what we've seen is early on, once an HCP has a good experience with Lebovy, whether it's schizophrenia or bipolar, and they have a positive outcome from patients, they very quickly think about expanding utilization. So at large, I would say it's usually a couple of months, really based upon the issue with the patient, based upon the tolerability, and the efficacy they're receiving on the current medication.

Speaker Change: Experience that they're having but it would typically take a couple of months. So what we've seen is as early on once ACP has a good experience with evolving whether it's schizophrenia or bipolar and they have a positive outcome from patients theyre very quickly to think about expanding utilization. So so at large.

Speaker Change: I would say, it's usually a couple of months really based upon the issue with the patient based upon the tolerability of their efficacy they are receiving on the current medication.

Unknown Attendee: Okay, great, that's really it. Maria, I think we have time for one more question. Our last question then is from Chris Shibutani with Goldman Sachs. Please proceed with your question. Hi, this is Karishma on behalf of Chris.

Speaker Change: Okay, Great that's really helpful.

Speaker Change: I think we have time for one more question.

Speaker Change: Okay.

Speaker Change: Last question, then is from Chris Shaw with Tony with Goldman Sachs. Please proceed with your question.

Chris Shibutani: Thank you so much for taking our question. So, with the schizophrenia and bipolar markets, in particular with regard to long-acting injectables and the progress there, are your assets here, namely Libolvi and Aristotle, continuing to increase in terms of penetration in the US? Or is this kind of plateauing at this point in time?

Chris Shaw: Hi, This is Chris <unk> on for Chris. Thank you so much for taking our question.

Chris Shaw: So with the schizophrenia and bipolar markets.

Chris Shaw: Particularly with regard to long acting Injectables and the progress there are your assets here, namely labov in aerostar continuing to increase in terms of penetration in the U S or is this kind of plateauing at this point in time.

Speaker Change: And then I have a follow up as well.

Unknown Attendee: And then I have a follow-up as well. Yeah, absolutely. So we continue to see, you know, encouraging trends overall with both products, and they're not plateauing at all. Libavi's still in the initial phase, obviously, our view on launching.

Speaker Change: Yeah, absolutely. So we continue to see encouraging trends overall with both products and Theyre not plateauing at all the ball we still in the initial phase obviously, our view on launching it and I think that to support that as little Avi for Q1 and year over year continues to be the fastest growing branded product in the category.

Unknown Attendee: And I think that to support that, Libavi for Q1 and year over year continues to be the fastest growing branded product in the category, not only for TRXs but also for new patient starts. And that's a really important leading indicator right now. So it gives us a lot of confidence in the growth opportunity over the long term. And in terms of Aristata, you know, there is quite a bit of seasonality in the LAI category in Q1.

Speaker Change: Not only for <unk>, but also for new patient starts and that's a really important leading indicator right now so it gives us a lot of confidence in the growth opportunity long term and in terms of aerostar.

Speaker Change: <unk> thought it was quite a bit of seasonality in the <unk> category and.

Speaker Change: In Q1, but we've already seen encouraging trends going into Q2 and in fact, we see in Q2 already we're seeing encouraging new patient starts. So the lifeblood of the brand is new patient starts and we don't see that slowing down for aerostat as well.

Unknown Attendee: But we've already seen encouraging trends going into Q2. And in fact, we see in Q2 already that we're seeing encouraging new patient starts. So the lifeblood of the brand is new patient starts, and we don't see that slowing down for Aristata as well.

Unknown Attendee: Okay, great. Thank you. And then one follow-up question, if I could. What potential implications do you see for legacy products when potential new mechanisms such as muscarinic agonists are introduced? Should they be successfully developed?

Speaker Change: Okay, great. Thank you and then one follow up if I could.

Speaker Change: What potential implications do you see to the legacy products when potential new mechanisms such as muscarinic agonists or introduce should they be successfully develops.

Unknown Attendee: Yeah, absolutely. So, you know, we watch the competitive landscape category really, really closely. I think the key for us right now is the addressable market that we're focused on. We have a very clearly differentiated market that we're focused on for Lebalvi and also for Aristata. The value proposition for both brands resonates very well. For Lebalvi, it's about efficacy. Lebalvi is considered one of the most effective branded products in the category.

Speaker Change: Yeah, absolutely. So we watch the competitive landscape category really clearly I think the key for US right now is the addressable market that we're focused on we have a very clearly differentiated market that we're focused on for the <unk> and also for ARISTOTLE the value proposition for both brands.

Speaker Change: <unk> resonates very well for la ballsy, it's about efficacy the Bobby is considered one of the most efficacious branded products in the category and so that's a really really strong position to be in at this point and launch in.

Unknown Attendee: And so that's a really, really strong position to be in at this point in launch. In terms of Aristata, you don't typically see a lot of market growth with LAIs coming into the category. They typically trade within the molecule themselves. HCPs continue to report to us that Aristotle has a differentiated profile.

Speaker Change: In terms of ARISTOTLE, you don't typically see a lot of market growth with L. A is coming into the category. They typically trade within the molecule themselves.

Speaker Change: Hep's continue report to US that are started has a differentiated profile. It's the only <unk> that you were able to initiate on day one for up to two months in Hcp's tell us that differentiates the brand. So we feel really confident regardless of new market entrants on how these products can compete now and into the future.

Unknown Attendee: It's the only LAI that you were able to initiate on day one for up to two months, and HCPs tell us that that differentiates the brand, so we feel really confident, regardless of new market entrance, in how these products can compete now and into the future.

Speaker Change: Got it that makes sense. Thank you so much.

Speaker Change: Yeah.

Sandra Coombs: Thank you so much. We have reached the end of our Q&A session. I would now like to turn the floor back over to Sandy Combs for closing comments. Thanks, Maria, and thank you everyone for joining us on the call this morning. Please don't hesitate to reach out to us at the company if you have any follow-up questions.

Speaker Change: We have reached the end of our Q&A session I would now like to turn the floor back over to Sandy for closing comments.

Sandra Coombs: Have a good day. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Sandy: Thanks, Mariana and thank you everyone for joining us on the call. This morning, please don't hesitate to reach out to the company. If you have any follow up questions have a good day.

Speaker Change: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Sure.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: <unk>.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Thanks.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Sure.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Right.

unknown: Be like a sucker to it when you wanna come. Be like a sucker to it when you're on the go. Be like a sucker to it, love.

Speaker Change: Thank you.

Speaker Change: Yes.

Speaker Change: Right.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

unknown: When you wanna come. When you wanna come. When you wanna come. Come. [inaudible] My Island, give it to my son now Well, whoa, well, now Relax, don't do it when you wanna go to it Relax, don't do it when you wanna come But shootin' in the right direction Make makin' it, you're in town Live for the steam, steam, no steam Gotta catch me, catch me, catch me Hit me with those lazy beams Lazy beams One, two, relax Don't do it, relax When you wanna come, come I'm gonna, I'm gonna Relax, don't do it when you wanna go to it Relax, don't do it when you wanna come Relax, don't do it when you wanna go to it Relax, don't do it when you wanna come When you wanna come When you wanna come Come, [inaudible] Relax, don't see it. One time, one time, time. Ow, ow, ow.

Speaker Change: Thank you.

Speaker Change: Okay.

Speaker Change: Hi.

Speaker Change: Yes.

Speaker Change: Wayne.

Speaker Change: Yeah.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Right.

Speaker Change: Great.

Speaker Change: <unk>.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: <unk>.

Speaker Change: Sure.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Right.

Speaker Change: Uh huh.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Thanks.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Thanks.

Speaker Change: And they want it.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Thank you.

Speaker Change: Yes.

Speaker Change: Right.

Speaker Change: Thank you.

Speaker Change: Okay.

Speaker Change: Right.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Sure.

Speaker Change: Right.

Speaker Change: Got it.

Speaker Change: Great.

Speaker Change: Brian.

Speaker Change: Yes.

Speaker Change: Thanks, Brian.

Speaker Change: Sure.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: But.

Speaker Change: Sure.

Speaker Change: Okay.

Speaker Change: Thanks, Greg.

Speaker Change: Thanks.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Sure.

Speaker Change: Okay.

Speaker Change: Right.

Speaker Change: Brian.

Speaker Change: Yeah.

Speaker Change: Thanks.

Speaker Change: Okay.

Speaker Change: Carl.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Thanks.

Speaker Change: Thank you.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Thank you.

Speaker Change: Sure.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Thank you.

Speaker Change: Yes.

Speaker Change: When you are.

Speaker Change: Sure.

Speaker Change: Right.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Thank you.

Speaker Change: Okay.

Speaker Change: Right.

Speaker Change: Great.

Speaker Change: Okay.

Speaker Change: Thanks.

Speaker Change: Okay.

Speaker Change: Sure.

Speaker Change: Yes.

Speaker Change: Thank you.

Speaker Change: Sure.

Speaker Change: Okay.

Speaker Change: Alright.

Speaker Change: Okay.

Speaker Change: Sure.

Q1 2024 Alkermes PLC Earnings Call

Request a DemoDemo

ALKS

Alkermes

Earnings