For 2026, Alkermes guided total revenues of $1.73 billion to $1.84 billion, including proprietary product net sales of $1.52 billion to $1.60 billion. It expects manufacturing and royalty revenues of $210 million to $240 million, reflecting scheduled expiration of certain XEPLION royalties that phase out on a country-by-country basis in the second half of 2026. The company also noted that its VUMERITY manufacturing obligations were completed in 2025, with future VUMERITY revenue expected to be solely royalt ...

Alkermes (NasdaqGS:ALKS) Q4 2025 Earnings call February 25, 2026 08:00 AM ET Company ParticipantsAmi Fadia - Managing DirectorAnya John - Research AssociateBlair Jackson - COODavid Huang - DirectorDouglas Tsao - Managing DirectorJason Gerberry - Managing DirectorJoon Lee - Managing DirectorJoseph Thome - Managing DirectorJoshua Reed - CFOJulian Pino - Biotechnology Equity ResearchRichard Pops - CEORudy Li - DirectorSandy Coombs - SVP of Investor Relations and Corporate AffairsTodd Nichols - Chief Commercial ...

Alkermes (NasdaqGS:ALKS) Q4 2025 Earnings call February 25, 2026 08:00 AM ET Company ParticipantsAmi Fadia - Managing DirectorAnya John - Research AssociateBlair Jackson - COODouglas Tsao - Managing DirectorIain Brown - CFOJoon Lee - Managing DirectorJoseph Thome - Managing DirectorJulian Pino - Biotechnology Equity ResearchRichard Pops - CEORudy Li - DirectorSandy Coombs - SVP of Investor Relations and Corporate AffairsTodd Nichols - Chief Commercial OfficerUmer Raffat - Senior Managing DirectorConference ...

Alkermes (NasdaqGS:ALKS) Q4 2025 Earnings call February 25, 2026 08:00 AM ET Speaker12Greetings, and welcome to the Alkermes' fourth quarter 2025 financial results conference call. My name is Melissa, and I will be your operator for today's call. All participant lines will be placed on mute to prevent background noise. If you should require operator assistance during the call, please press star 0 on your telephone keypad. Please note that this conference is being recorded. I will now turn the call over to S ...

Company Overview - Alkermes plc (NASDAQ:ALKS) is a biopharmaceutical company focused on developing and selling medicines for schizophrenia, bipolar I disorder, and addiction to alcohol or opioids [2]. Recent Developments - On January 6, Alkermes announced that the FDA granted Breakthrough Therapy designation to its alixorexton therapy for narcolepsy type 1, following positive results from phase 1 and phase 2 studies [2]. - The clinical trial involved 92 patients and demonstrated that the oral orexin 2 receptor agonist achieved its primary endpoint, showing statistically significant, dose-dependent improvements in wakefulness [2]. - Craig Hopkinson, M.D., emphasized that alixorexton could significantly improve treatment for narcolepsy type 1, addressing unmet medical needs in the community [2]. - The company plans to advance alixorexton into phase 3 development later this quarter [2]. Market Sentiment - Jim Cramer expressed skepticism about Alkermes, suggesting it is a hold, possibly a weak one, indicating a lack of strong recommendation for the stock [1].

Core Insights - Alkermes (ALKS) has received Breakthrough Therapy Designation from the FDA for alixorexton, an oral orexin 2 receptor agonist, aimed at treating narcolepsy type 1 (NT1) [1][7] - The Breakthrough Therapy designation is designed to expedite the development and review of therapies for serious diseases with unmet medical needs [1] Company Developments - Alixorexton's Breakthrough Therapy designation is based on positive data from the phase I and phase II Vibrance-1 study, which showed significant improvements in wakefulness compared to placebo [3] - The Vibrance-1 study met its primary endpoint, demonstrating dose-dependent improvements in wakefulness as measured by the Maintenance of Wakefulness Test [3][4] - Treatment with alixorexton also significantly reduced excessive daytime sleepiness at week six, as measured by the Epworth Sleepiness Scale [4] - Alkermes plans to initiate a global phase III program for alixorexton in Q1 2026 [7][10] Market Context - Over the past year, Alkermes' shares have increased by 1.3%, while the industry has seen a rise of 14.2% [2] - Alixorexton is also being studied for narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), with positive data from the phase II Vibrance-2 study for NT2 announced in November 2025 [8][10] - The Vibrance-2 study showed statistically significant improvements in wakefulness and reductions in excessive daytime sleepiness for NT2 patients [8]

Group 1 - Alkermes plc (NASDAQ:ALKS) is considered a promising mid-cap healthcare stock under $50, with a consensus of 11 Buy ratings and 4 Holds from 15 analysts, indicating a median 1-year price target of $46.17, representing a 62.3% upside potential [1] - The company plans to acquire Avadel, which has a topline of approximately $275 million, as part of its strategy to enter the hypersomnolence market and launch alixorexton, an oral drug for complex sleep disorders [2] - Analyst David Amsellem from Piper Sandler reaffirmed a Buy rating for Alkermes with a price target of $45, suggesting more than 58% upside potential for investors [3] Group 2 - Alkermes is a biopharmaceutical company focused on developing and commercializing innovative medicines for neurological disorders, utilizing proprietary technologies for formulations aimed at psychiatric conditions [4]

Core Viewpoint - Alkermes plc acknowledges the announcement by Avadel Pharmaceuticals plc regarding a potential acquisition offer from H. Lundbeck A/S for all issued and to be issued ordinary shares of Avadel [1][2]. Group 1: Transaction Agreement Details - The Transaction Agreement stipulates that Avadel cannot terminate the agreement to pursue a superior proposal unless the board determines that doing so is consistent with its fiduciary duties and that the Lundbeck offer qualifies as a superior proposal [3]. - Avadel must notify Alkermes in writing at least five business days prior to taking any action related to the Lundbeck offer and must engage in good faith discussions with Alkermes regarding any amendments to the Transaction Agreement [3]. Group 2: Future Announcements - Alkermes will make further announcements as appropriate regarding the situation and any developments related to the potential acquisition [4].

Summary of Alkermes Conference Call Company Overview - **Company**: Alkermes (NasdaqGS:ALKS) - **Event**: 2025 Conference on November 13, 2025 Key Industry Insights - **Focus Area**: Development of drugs for narcolepsy, specifically targeting narcolepsy type 1 (NT1) and type 2 (NT2) with the Rexin compound [2][8] - **Market Dynamics**: The company is addressing major unmet medical needs in the narcolepsy patient population, which has been historically under-researched [8][9] Core Findings from Recent Data Release - **Study Design**: The recent data release focused on NT2 patients, providing new insights into a previously under-studied population [9] - **Efficacy Signal**: The drug demonstrated a clear efficacy signal, particularly in the Maintenance of Wakefulness Test (MWT) at hour two and hour four, despite variability in patient responses [12][14] - **Tolerability**: Higher doses were well tolerated by NT2 patients, contradicting previous assumptions that higher doses would lead to increased adverse effects [10][17] - **Adverse Events**: Commonly reported adverse events included polyuria, urinary urgency, insomnia, and visual disturbances, but these did not significantly impact overall tolerability [17] Statistical Analysis and Drug Development - **Statistical Significance**: The study employed a phase three statistical plan in a phase two study, which complicated the interpretation of some lower doses [54][56] - **Dose Response**: There was a clear dose response observed in individual patient levels, although averaging across responders and non-responders obscured this [15][17] - **Future Studies**: Plans for phase three studies are underway, with a focus on both NT1 and NT2 populations, utilizing MWT and Epworth Sleepiness Scale (ESS) as primary endpoints [87][88] Competitive Landscape - **Market Position**: Alkermes is positioned as a pioneer in the NT2 space, with no direct competitors currently offering similar treatments [43][44] - **Comparison with Existing Treatments**: Current treatments like Provigil and Xyrem have not focused on pure NT2 cohorts, making Alkermes' data unique [46][50] Commercial Strategy and Financial Health - **Revenue Growth**: The company reported continuous growth driven by demand, with a billion-plus dollar top line generating significant profitability [94] - **Acquisition Strategy**: The acquisition of Avadel is being funded through cash generated from strong business performance, avoiding stock dilution [94] Regulatory Environment - **FDA Engagement**: Alkermes is preparing for a type B meeting with the FDA to discuss phase three study designs and endpoints, with expectations to initiate the program in early Q1 [87][88] - **PDUFA 8 Reauthorization**: The company is optimistic about the reauthorization of user fees that fund drug reviews, which is crucial for the drug development process [97][98] Future Directions - **Research Expansion**: Alkermes is exploring additional indications beyond narcolepsy and hypersomnolence, with plans to advance new rexins into clinical trials by 2026 [90] - **Focus on Cognition and Fatigue**: The company aims to incorporate measures of cognition and fatigue into future studies, addressing patient-reported outcomes that are critical for treatment satisfaction [88][89] This summary encapsulates the key points discussed during the conference call, highlighting Alkermes' strategic focus, recent findings, and future plans in the context of the narcolepsy treatment landscape.

Core Insights - Alkermes plc announced positive topline results from the Vibrance-2 phase 2 study for alixorexton in narcolepsy type 2, showing significant improvements in excessive daytime sleepiness and sleep latency compared to placebo [1][2][4] Group 1: Study Results - Alixorexton met dual primary endpoints, showing statistically significant improvements on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) at week eight [2] - The 14 mg and 18 mg doses of alixorexton achieved statistical significance in mean sleep latency improvements compared to placebo [3] - The 18 mg dose also showed statistically significant improvements in excessive daytime sleepiness on the ESS at week eight [4] Group 2: Safety and Tolerability - Alixorexton was generally well tolerated across all doses during the eight-week treatment period, with most treatment-emergent adverse events (TEAEs) being mild to moderate [4] Group 3: Future Plans - Results from Vibrance-2 and the previous Vibrance-1 study support the initiation of a global phase 3 program for alixorexton in patients with narcolepsy type 1 and type 2, planned to start in Q1 2026 [5] - Detailed results, including exploratory patient-reported outcomes related to cognition and fatigue, will be presented at a future scientific meeting [5] Group 4: Ongoing Studies - The Vibrance-3 phase 2 study evaluating alixorexton in adults with idiopathic hypersomnia is currently enrolling [6]