Alkermes (ALKS) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Speaker0 and welcome to Alchemy's First Quarter twenty twenty five 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 Please note that this conference is being recorded. I will now turn the call over to Sandra Khoemps, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, you may now begin. Good morning. Welcome to ...

Alkermes (ALKS) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Company Participants Sandy Coombs - Senior Vice President, Corporate Affairs and Investor RelationsRichard Pops - Chairman & CEOTodd Nichols - SVP & CCOBlair Jackson - Executive VP & COOCraig Hopkinson - Executive VP of Research & Development and Chief Medical OfficerJames Condulis - Associate Vice President - Biotechnology Equity ResearchUmer Raffat - Senior Managing DirectorAmy Li - SVP Equity ResearchMarc Goodman - Senior MD - NeuroscienceJas ...

Exhibit 99.1 Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Katie Joyce +1 781 249 8927 Alkermes plc Reports First Quarter 2025 Financial Results — First Quarter Revenues of $306.5 Million — — GAAP Net Income of $22.5 Million and Diluted GAAP Earnings per Share of $0.13 — — Company Reiterates 2025 Financial Expectations — DUBLIN, May 1, 2025 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the first quarter of 2025. "Our first quarter financial performance provid ...

Core Insights - Alkermes plc reported a total revenue of $306.5 million for Q1 2025, a decrease from $350.4 million in Q1 2024, indicating a year-over-year decline of approximately 12.5% [3][9] - The company achieved a GAAP net income of $22.5 million for Q1 2025, down from $36.8 million in Q1 2024, reflecting a decrease of about 38.8% [4][9] - Alkermes reiterated its financial expectations for 2025, maintaining confidence in its strategic objectives and market position [2][13] Financial Performance - Total proprietary net sales for Q1 2025 were $244.5 million, compared to $233.5 million in Q1 2024, representing an increase of approximately 4.3% [3][23] - Key product revenues included VIVITROL® at $101.0 million, ARISTADA® at $73.5 million, and LYBALVI® at $70.0 million, with LYBALVI® showing a significant growth of 23% year-over-year [3][10][6] - The company reported an adjusted EBITDA of $45.6 million for Q1 2025, down from $81.8 million in Q1 2024, indicating a decline of about 44.3% [4][24] Research and Development - Alkermes completed enrollment in the Vibrance-1 phase 2 study for ALKS 2680, an oral orexin 2 receptor agonist for narcolepsy type 1, with topline results expected in early Q3 2025 [2] - The company is also progressing with the Vibrance-2 and Vibrance-3 phase 2 studies, targeting narcolepsy type 2 and idiopathic hypersomnia, respectively [2] Balance Sheet - As of March 31, 2025, Alkermes reported cash, cash equivalents, and total investments of $916.2 million, an increase from $824.8 million at the end of 2024 [12][25] - Total assets stood at $2.08 billion, with total shareholders' equity of $1.51 billion, reflecting a solid financial position [25]

Core Insights - The survey conducted by The Harris Poll on behalf of Alkermes, Inc. reveals that the diagnosis of alcohol use disorder (AUD) is often prompted by negative consequences of alcohol consumption, and treatment can lead to significant positive changes in the lives of individuals with AUD [1][2][4] Group 1: Diagnosis and Treatment Insights - 47% of respondents were diagnosed with AUD following a hospital or emergency room visit due to symptoms or alcohol-related incidents [2] - One-third of respondents indicated personal concern about alcohol use (36%), healthcare provider visits related to symptoms (35%), and encouragement from loved ones (32%) as factors leading to their diagnosis [2] - 79% of respondents reported negative feelings upon diagnosis, including fear (38%), shame (33%), and embarrassment (32%) [2][3] Group 2: Treatment Engagement and Impact - 70% of respondents reported currently being treated for AUD, while 28% had been treated in the past but were not currently receiving treatment [6] - Among those treated, 50% were using prescription medication, 46% were in behavioral therapy, and 43% were involved in support group therapy [6] - Over half of the respondents indicated that treatment positively impacted their physical health (61%), overall quality of life (60%), and relationships with children (60%) [6] Group 3: Role of Healthcare Providers - 33% of respondents were diagnosed by an addiction specialist, and 26% by a primary care physician [6] - 80% of respondents discussed prescription medication for AUD with their healthcare provider, with 50% choosing their medication based on provider recommendations [6] - Only 28% of respondents were diagnosed through routine screenings during standard healthcare visits, highlighting a gap in proactive diagnosis [6]

DUBLIN, April 17, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Thursday, May 1, 2025 to discuss the company's first quarter financial results.The webcast player and accompanying slides may be accessed on the Investors section of Alkermes' website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. A replay of the webcast w ...

Group 1 - Alkermes plc will participate in a webcast panel discussion on "Development of Orexin Receptor Agonist in Sleep-Wake Disorders" at the 24th Annual Needham Virtual Healthcare Conference on April 9, 2025 [1] - The live webcast will be accessible under the Investors tab on Alkermes' website and will be archived for 14 days [1] Group 2 - Alkermes plc is a global biopharmaceutical company focused on developing innovative medicines in neuroscience [2] - The company has a portfolio of proprietary commercial products for treating alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder [2] - Alkermes has a pipeline of clinical and preclinical candidates for neurological disorders, including narcolepsy and idiopathic hypersomnia [2] - The company is headquartered in Ireland, with additional offices in Massachusetts and a manufacturing facility in Ohio [2]

Core Viewpoint - Alkermes plc has initiated the phase II Vibrance-3 study for ALKS 2680, an oral orexin 2 receptor agonist, targeting idiopathic hypersomnia, a rare neurological sleep disorder [1][2]. Group 1: Study Details - The Vibrance-3 study is a double-blind, placebo-controlled trial assessing the safety and efficacy of ALKS 2680 in adults with idiopathic hypersomnia [2]. - The primary endpoint is to measure the reduction in sleepiness using the Epworth Sleepiness Scale score, comparing different dose levels of ALKS 2680 against placebo [2]. - Participants will receive one of three doses (10 mg, 14 mg, or 18 mg) or placebo daily for eight weeks, with secondary endpoints including changes in the Idiopathic Hypersomnia Severity Scale score and adverse event incidence [3]. Group 2: Market Performance - Year-to-date, Alkermes shares have increased by 13.1%, outperforming the industry average rise of 2.4% [4]. Group 3: Ongoing Research and Competition - ALKS 2680 is also being studied for narcolepsy type 1 and type 2 in the phase II Vibrance-1 and Vibrance-2 studies, respectively, with data expected in the second half of 2025 [5][6]. - Upon potential approval, ALKS 2680 may face competition from Axsome's Sunosi, which is already marketed for narcolepsy and has ongoing label expansion studies [7].

Core Insights - Alkermes plc has initiated the Vibrance-3 phase 2 clinical study to evaluate the safety and efficacy of ALKS 2680 in adults with idiopathic hypersomnia (IH) [1][2] - ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist aimed at treating chronic neurological disorders characterized by excessive daytime sleepiness [1][4] - The study aims to address the high unmet need for treatment options in the IH community, as over 90% of surveyed patients reported significant impacts on their lives due to IH symptoms [2][5] Company Overview - Alkermes plc is a global biopharmaceutical company focused on developing innovative medicines in neuroscience, with a portfolio that includes treatments for alcohol and opioid dependence, schizophrenia, and bipolar I disorder [6] - The company is headquartered in Ireland and has additional facilities in Massachusetts and Ohio [6] Clinical Study Details - The Vibrance-3 study is a randomized, double-blind, placebo-controlled trial involving approximately 96 patients across the U.S., Australia, and Europe [2][3] - Participants will receive one of three doses of ALKS 2680 (10 mg, 14 mg, or 18 mg) or a placebo once daily for eight weeks, with primary and secondary endpoints focused on sleepiness reduction and adverse events [2][3] Background on Idiopathic Hypersomnia - Idiopathic hypersomnia is a rare neurological disorder affecting an estimated 40,000 people in America, characterized by excessive daytime sleepiness despite normal sleep durations [5] - Common symptoms include severe sleep inertia, unrefreshing naps, fatigue, and cognitive dysfunction [5]

Core Insights - The survey highlights that medication adherence is a significant concern for healthcare providers when selecting treatments for patients with schizophrenia and bipolar I disorder (BDI) [1][4] - A strong consensus (98%) among respondents indicates that the quality of life for patients is equally important as symptom management in treatment considerations [1][4] Group 1: Survey Findings - The survey conducted by The Harris Poll on behalf of Alkermes involved over 250 healthcare providers treating BDI and schizophrenia patients [1][2] - 66% of healthcare providers reported that their BDI patients have good or excellent overall quality of life, while only 21% felt the same for their schizophrenia patients [2] - Medication switching is common, with BDI patients switching medications an average of seven times and schizophrenia patients eight times throughout their lifetime [4] Group 2: Treatment Concerns - The top concerns for BDI patients include long-term medication adherence (36%), frequency of manic symptoms (32%), and depressive symptoms (31%) [2] - For schizophrenia patients, the primary worries are the ability to take medication as prescribed (41%) and long-term adherence (41%) [2] - 82% of providers noted that patients often switch medications due to perceived ineffectiveness, while 81% cited intolerable side effects as a reason [4] Group 3: Treatment Selection Criteria - When selecting treatment options, healthcare providers prioritize whether patients can adhere to medication as prescribed (15%), the availability of extensive clinical trial research (15%), and experiences with other patients (13%) [4] - 68% of respondents indicated that inclusion in clinical guidelines would encourage them to explore new treatments, while 65% emphasized the importance of accessibility through insurance [4] Group 4: Importance of Quality of Life - Almost all surveyed healthcare providers (98%) agreed that managing quality of life is as crucial as symptom management in treatment efficacy [4] - Key outcomes for successful treatment include reduced symptom frequency (44%), independence in daily activities (38%), and long-term medication adherence (30%) [4]