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Alkermes (ALKS) Misses Q1 Earnings and Revenue Estimates
ZACKS· 2025-05-01 13:26
Core Insights - Alkermes reported quarterly earnings of $0.13 per share, missing the Zacks Consensus Estimate of $0.28 per share, and down from $0.44 per share a year ago, representing an earnings surprise of -53.57% [1] - The company posted revenues of $306.51 million for the quarter, missing the Zacks Consensus Estimate by 3.22%, and down from $350.37 million year-over-year [2] - Alkermes has surpassed consensus EPS estimates only once in the last four quarters, while it has topped revenue estimates two times in the same period [2] Earnings Outlook - The sustainability of Alkermes' stock price movement will depend on management's commentary during the earnings call and future earnings expectations [3] - The current consensus EPS estimate for the upcoming quarter is $0.46 on revenues of $346.92 million, and for the current fiscal year, it is $1.76 on revenues of $1.39 billion [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Alkermes belongs, is currently ranked in the top 32% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Alkermes' stock performance [5]
Alkermes(ALKS) - 2025 Q1 - Earnings Call Presentation
2025-05-01 12:08
Financial Performance - Q1 2025 - Total revenue decreased to $306.5 million from $350.4 million in Q1 2024 [7] - GAAP net income decreased to $22.5 million from $36.8 million in Q1 2024 [7] - GAAP earnings per share (diluted) decreased to $0.13 from $0.21 in Q1 2024 [7] - Adjusted EBITDA decreased to $45.6 million from $81.8 million in Q1 2024 [10] - The decrease in revenue and profitability reflects the expiration of royalty on U S net sales of INVEGA SUSTENNA® in August 2024 [8, 11] Revenue Breakdown - Q1 2025 - Total proprietary net sales increased to $244.5 million from $233.5 million in Q1 2024 [12] - VIVITROL® net sales were $101.0 million, compared to $97.7 million in Q1 2024 [12] - ARISTADA® net sales were $73.5 million, compared to $78.9 million in Q1 2024 [12] - LYBALVI® net sales were $70.0 million, reflecting a 23% growth compared to $57.0 million in Q1 2024 [12, 21] Financial Expectations - 2025 - Total revenues are expected to range from $1,340 million to $1,430 million [13] - GAAP net income is projected to be between $175 million and $205 million [13] - Adjusted EBITDA is projected to be between $310 million and $340 million [13] - VIVITROL® net sales are expected to range from $440 million to $460 million [17] - ARISTADA® net sales are expected to range from $335 million to $355 million [17] - LYBALVI® net sales are expected to range from $320 million to $340 million [17]
Alkermes(ALKS) - 2025 Q1 - Earnings Call Transcript
2025-05-01 12:00
Financial Data and Key Metrics Changes - The company reported total revenues of $306.5 million for Q1 2025, slightly above expectations, driven by a 5% year-over-year growth in proprietary product sales [17][18] - Net sales from proprietary products were $244.5 million, with a GAAP net income of $22.5 million and adjusted EBITDA of $45.6 million [13][19][20] - The company ended the quarter with $916.2 million in cash and investments, maintaining a strong financial position [20] Business Line Data and Key Metrics Changes - VIVITROL net sales were $101 million, primarily driven by alcohol dependence, which accounts for approximately 75% of its volume [13] - ARISTADA product family generated net sales of $73.5 million, with expectations for 2025 in the range of $335 million to $355 million [13] - LIVALVI saw a 23% year-over-year growth in net sales to $70 million, driven by a 22% increase in TRx growth [13][14] Market Data and Key Metrics Changes - The company noted that Medicaid coverage for its products is approximately 45% to 50% across VIVITROL, LYBOLVI, and ARISTADA [71] - The first quarter performance was slightly ahead of expectations, indicating a solid start to 2025 [15] Company Strategy and Development Direction - The company is focused on maximizing the potential of its commercial products while advancing its Orexin portfolio, particularly the ALKS 2680 Phase II program [8][9] - Strategic investments are being made to drive awareness and uptake of psychiatry franchise products, including an expanded sales force [14] - The company is preparing for key data readouts from the ALKS 2680 Phase II studies later this year, which are expected to provide substantial datasets [16][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the current macroeconomic conditions, highlighting the company's U.S.-based manufacturing and supply chain as advantageous [12][16] - The focus remains on advocating for policies that maintain access to care for patient populations and supporting regulatory work streams [32] - The company anticipates a pivotal year with transformative data expected in the second half of 2025 [11][31] Other Important Information - The company has a remaining share repurchase authorization of $200 million and may opportunistically repurchase shares depending on market conditions [20] - The Phase II studies for ALKS 2680 are advancing with strong momentum, with top-line results expected early in Q3 for the NT1 study [10][11] Q&A Session Summary Question: Update on NT2 study endpoints - The NT2 study has dual primary endpoints of mean wakefulness tests and Epworth Sleepiness Scale due to competitive landscape considerations [36] Question: Contribution of scripts from schizophrenia and bipolar for LIVALVI - The TRx split for LIVALVI is roughly 50/50 between schizophrenia and bipolar, with a trend towards 55% for bipolar in new patient starts [42][44] Question: Safety data from Orexin studies - An independent data safety monitoring board oversees safety across the study, with no modifications required at this time [50] Question: Contribution of volume versus price to sales - The majority of sales expectations are based on volume growth, with Medicaid coverage for products around 45% to 50% [70][71] Question: Future of VIVITROL with potential generic competition - The company believes VIVITROL will not follow a typical generic erosion curve due to its complex manufacturing and market dynamics [102]
Alkermes(ALKS) - 2025 Q1 - Earnings Call Transcript
2025-05-01 12:00
Financial Data and Key Metrics Changes - The company reported total revenues of $306.5 million for Q1 2025, slightly ahead of expectations, driven by a 5% year-over-year growth in proprietary product sales [20][21] - Net sales from proprietary products were $244.5 million, with expectations for Q2 net sales in the range of $260 million to $280 million [14][21] - GAAP net income for Q1 was $22.5 million, with adjusted EBITDA of $45.6 million [22][23] Business Line Data and Key Metrics Changes - VIVITROL net sales were $101 million, primarily driven by alcohol dependence, which accounts for approximately 75% of VIVITROL volume [14] - ARISTADA product family net sales were $73.5 million, with expectations for 2025 net sales in the range of $335 million to $355 million [14] - LIVALVI net sales grew 23% year-over-year to $70 million, with underlying TRx growth of 22% [14][15] Market Data and Key Metrics Changes - The company maintains a strong financial position with over $900 million in cash and investments [18] - Approximately 45% to 50% of VIVITROL, LIVALVI, and ARISTADA sales are covered by Medicaid [76] Company Strategy and Development Direction - The company is focused on maximizing the potential of its commercial products and driving growth and profitability [10] - The ALKS 2680 Phase II program is expected to generate substantial datasets for narcolepsy studies, with top-line results anticipated early in Q3 2025 [11][12] - The company is preparing for potential Phase III studies based on the outcomes of the ongoing Phase II studies [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the current macroeconomic conditions, emphasizing the importance of U.S.-based manufacturing and supply chain [19][36] - The company is focused on advocating for policies that maintain access to care for patient populations amid changing regulatory environments [37] Other Important Information - The company has a remaining share repurchase authorization of $200 million and may opportunistically repurchase shares depending on market conditions [23] - The company is advancing its research into new disease areas for orexin-two receptor agonists, with plans to start clinical work this year [26][34] Q&A Session Summary Question: Update on NT2 study endpoints - The NT2 study has dual primary endpoints of mean wakefulness tests and Epworth Sleepiness Scale due to competitive landscape considerations [41][43] Question: Contribution of LIVALVI from schizophrenia and bipolar - LIVALVI TRxs are roughly a 50/50 split between schizophrenia and bipolar, with a trend towards 55% for bipolar in new patient starts [47][48] Question: Safety data from orexin studies - Safety data is monitored by an independent data safety monitoring board, which has not reported any modifications to the study [56] Question: Efficacy definitions for upcoming readouts - Efficacy is assessed through both current market standards and the potential for normal wakefulness during daytime hours [62][63] Question: Future business development and M&A strategy - The company is open to acquiring additional assets that fit its strategy and can add value to its development program [70][71] Question: Impact of Medicaid cuts on VIVITROL - The company is not currently seeing changes in federal funding for VIVITROL, with less than 5% of demand based on government funding [84] Question: Visual disturbances in Vibrance studies - All patients in Phase II programs receive visual exams, and the data safety monitoring board oversees safety across the studies [94]
Alkermes(ALKS) - 2025 Q1 - Quarterly Results
2025-05-01 11:05
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 ...
Alkermes plc Reports First Quarter 2025 Financial Results
Prnewswire· 2025-05-01 11:00
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]
New Survey Provides Insights into Diagnosis and Treatment Journey for People Living With Alcohol Use Disorder (AUD)
Prnewswire· 2025-04-30 11:00
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]
Alkermes to Report First Quarter Financial Results on May 1, 2025
Prnewswire· 2025-04-17 20:00
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 ...
Alkermes to Participate in the 24th Annual Needham Virtual Healthcare Conference
Prnewswire· 2025-04-02 20:00
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]
Alkermes Begins Idiopathic Hypersomnia Study on ALKS 2680
ZACKS· 2025-04-02 14:35
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].