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Alkermes(ALKS) - 2025 Q2 - Earnings Call Transcript
2025-07-29 13:00
Financial Data and Key Metrics Changes - The company reported total revenues of $390.7 million for Q2 2025, with proprietary product net sales of $307.2 million, reflecting a 14% year-over-year growth [12][14] - GAAP net income was $87.1 million, with EBITDA of $101.6 million and adjusted EBITDA of $126.5 million for the second quarter [14] - The company ended the quarter with $1.05 billion in cash and total investments, maintaining a strong financial position [14] Business Line Data and Key Metrics Changes - VIVITROL net sales were $121.7 million, driven by growth in the alcohol dependence indication market [17] - ARISTADA net sales reached $101.3 million, with encouraging leading indicators related to underlying demand [17] - LYBALBI net sales grew 18% year-over-year to $84.3 million, with underlying TRx growth of 22% [18] Market Data and Key Metrics Changes - The proprietary product portfolio's net sales exceeded expectations, driven by strong end market demand and favorable gross to net dynamics [17] - The company anticipates Q3 net sales from the proprietary product portfolio in the range of $280 million to $300 million [12] Company Strategy and Development Direction - The company is focused on accelerating future growth through development candidates in its pipeline, particularly in the orexin portfolio [6][34] - The successful results from the Vibrance one Phase II study of elixorextin are seen as a critical step in the development of the orexin portfolio [7][10] - The company plans to advance additional orexin candidates into clinical development later this year [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving record revenues from proprietary products in 2025, anticipating performance towards the higher end of previously issued financial expectations [14][34] - The management highlighted the importance of the positive Vibrance one data as a significant stride forward for the elixorexin development program [33] Other Important Information - The company has a remaining share repurchase authorization of $200 million and may opportunistically repurchase shares depending on market conditions [14] - The company is preparing for key regulatory interactions and plans to initiate a global Phase III program in narcolepsy following the top line data from the narcolepsy type two study [22][34] Q&A Session Summary Question: Focus on visual adverse events with the Orexin program - Management acknowledged the focus on visual AEs from Wall Street and emphasized the importance of the rigorous ophthalmic exams conducted during the study [39][40] Question: Efficacy of elixorextin compared to Takeda's program - Management expressed confidence in the competitive advantage of elixorextin's dosing range and efficacy, awaiting further data from ongoing studies [48] Question: Regulatory path and potential registrational trials - Management indicated that the NT2 study data will be crucial for discussions with the FDA regarding the Phase III design [51][52] Question: Dose response and statistical analysis - Management confirmed the use of negative binomial analysis for cataplexy data and expressed confidence in the clarity of the cataplexy signal [62][63] Question: Potency selectivity of elixorextin - Management confirmed that elixorextin is 5,000-fold more selective towards the orexin 2 receptor over the orexin 1 receptor [70] Question: Safety profile extrapolation to follow-on compounds - Management noted that while similarities are expected due to the same receptor targeting, different pharmacokinetic profiles may lead to variations in safety profiles [74][75] Question: Dosing flexibility in Phase III - Management stated that dosing decisions for Phase III will be informed by the comprehensive data from the Phase II studies [82][110]
Alkermes: Label Expansion Of LYBALVI With Ongoing Pediatric Trial Possible
Seeking Alpha· 2025-05-01 20:31
Group 1 - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and offers a model portfolio of small and mid-cap stocks [1][2] - The service includes over 600 biotech investing articles and live chat features to assist healthcare investors in making informed decisions [2] - A promotional offer is available for new subscribers, including a two-week free trial and a discounted annual subscription price [1] Group 2 - The author previously wrote about Alkermes, focusing on potential narcolepsy data that could influence the company's future [2] - The article emphasizes that the author has no financial positions in the companies mentioned, ensuring an unbiased perspective [3]
Here's What Key Metrics Tell Us About Alkermes (ALKS) Q1 Earnings
ZACKS· 2025-05-01 16:00
Core Insights - Alkermes reported a revenue of $306.51 million for the quarter ended March 2025, reflecting a 12.5% decrease year-over-year [1] - The earnings per share (EPS) was $0.13, down from $0.44 in the same quarter last year, indicating a significant decline [1] - The revenue fell short of the Zacks Consensus Estimate of $316.7 million, resulting in a surprise of -3.22% [1] - The company experienced an EPS surprise of -53.57%, with the consensus EPS estimate being $0.28 [1] Revenue Breakdown - Manufacturing and Royalty revenues were reported at $62.02 million, below the five-analyst average estimate of $65.33 million, marking a year-over-year decline of 46.9% [4] - Product sales, net, amounted to $244.49 million, slightly below the estimated $254.16 million, but showed a year-over-year increase of 4.7% [4] - Proprietary Sales for VIVITROL reached $101 million, exceeding the four-analyst average estimate of $98.71 million, with a year-over-year growth of 3.4% [4] - Proprietary Sales for ARISTADA were reported at $73.50 million, below the estimated $78.52 million, reflecting a year-over-year decrease of 6.8% [4] - Proprietary Sales for LYBALVI were $70 million, close to the estimated $70.91 million, showing a year-over-year increase of 22.8% [4] - Key Commercial Product Revenues for VUMERITY were $27.80 million, slightly below the three-analyst average estimate of $27.81 million, with a year-over-year decline of 11.1% [4] Stock Performance - Alkermes shares have returned -11.9% over the past month, contrasting with the Zacks S&P 500 composite's -0.7% change [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]