Earnings summaries and quarterly performance for Alkermes.
Executive leadership at Alkermes.
Richard F. Pops
Chief Executive Officer
Blair C. Jackson
Executive Vice President, Chief Operating Officer and Chief Risk Officer
C. Todd Nichols
Senior Vice President, Chief Commercial Officer
Craig C. Hopkinson
Executive Vice President, Research and Development and Chief Medical Officer
David J. Gaffin
Executive Vice President, Chief Legal Officer and Chief Compliance Officer
Joshua Reed
Senior Vice President, Chief Financial Officer
Board of directors at Alkermes.
Research analysts who have asked questions during Alkermes earnings calls.
David Amsellem
Piper Sandler Companies
4 questions for ALKS
Douglas Tsao
H.C. Wainwright & Co.
4 questions for ALKS
Joseph Thome
TD Cowen
4 questions for ALKS
Marc Goodman
Leerink Partners
4 questions for ALKS
Paul Matteis
Stifel
4 questions for ALKS
Umer Raffat
Evercore ISI
4 questions for ALKS
Uy Ear
Mizuho Securities
4 questions for ALKS
Charles Duncan
Cantor Fitzgerald & Co.
3 questions for ALKS
Jason Gerberry
Bank of America Merrill Lynch
3 questions for ALKS
Jessica Fye
JPMorgan Chase & Co.
3 questions for ALKS
Joel Beatty
Baird
3 questions for ALKS
Leonid Timashev
RBC Capital Markets
3 questions for ALKS
Akash Tewari
Jefferies
2 questions for ALKS
Ami Fadia
Needham & Company, LLC
2 questions for ALKS
Ashwani Verma
UBS Group AG
2 questions for ALKS
David Hoang
Citigroup
2 questions for ALKS
Adam Ferrari
J.P. Morgan
1 question for ALKS
Anastasia Parafestas
Jefferies
1 question for ALKS
Andrea Newkirk
Goldman Sachs
1 question for ALKS
Ben Burnett
Stifel
1 question for ALKS
Chi Eze
Bank of America
1 question for ALKS
Chris Shibutani
Goldman Sachs Group, Inc.
1 question for ALKS
David Amsalem
Piper Sandler
1 question for ALKS
David Huang
Deutsche Bank
1 question for ALKS
Hoyanon
UBS
1 question for ALKS
Karishma Raghuram
Goldman Sachs
1 question for ALKS
Katherine Wang
Jefferies
1 question for ALKS
Lou Kerman
Baird
1 question for ALKS
Manoj Radder
Jefferies
1 question for ALKS
Mark Goodwin
Leerink Partners
1 question for ALKS
Omar Rafat
Evercore ISI
1 question for ALKS
Paul Matisse
Stifel Financial Corp.
1 question for ALKS
Troy Langford
TD Cowen
1 question for ALKS
Yuri
Mizuho
1 question for ALKS
Recent press releases and 8-K filings for ALKS.
- Alkermes' commercial business generated more than $1.4 billion in total revenues in 2025.
- The company plans to close the acquisition of Avidel and its commercial narcolepsy drug Lumryz in Q1 2026, which is expected to be accretive and accelerate its entry into the sleep medicine market. Lumryz generated approximately $250 million in sales over the last trailing 12-month period.
- ALKS 2680, an orexin compound, received FDA Breakthrough Therapy designation in narcolepsy type 1 (NT1) at the end of 2025 and is scheduled to initiate its registrational Phase 3 program for narcolepsy in Q1 2026. The market opportunity for orexins in narcolepsy and idiopathic hypersomnia (IH) is estimated to be in excess of $10 billion annually.
- ALKS 2680 demonstrated statistically significant and clinically meaningful improvements in Phase 2 studies for narcolepsy type 1 and type 2, with the idiopathic hypersomnia Phase 2 study expected to complete in Q4 2026.
- Alkermes' acquisition of Avadel Pharmaceuticals plc is expected to close in Q1 2026, accelerating its entry into the commercial sleep medicine market with LUMRYZ™ and is anticipated to be accretive and enhance profitability in 2026.
- The company plans to initiate the registrational phase 3 narcolepsy program for alixorexton in Q1 2026, a candidate that has received FDA Breakthrough Therapy designation for Narcolepsy Type 1 (NT1) and demonstrated positive phase 2 data.
- Alkermes' commercial business generated total revenues exceeding $1.45 billion in 2025, with pro forma key product revenues (including LUMRYZ™) growing from $715 million in FY 2021 to $1,563 million in the rolling 12 months ending Q3 2025.
- The company is also advancing other orexin 2 receptor agonist candidates, including ALKS 4510 for fatigue (Phase 2 initiation H2 2026) and ALKS 7290 for ADHD (Phase 1b data/Phase 2 initiation H2 2026).
- Alkermes' commercial business generated more than $1.4 billion in total revenues in 2025, demonstrating strong cash flow and profitability.
- The company's most advanced orexin compound, ALKS 2680, is entering Phase 3 in narcolepsy and was granted FDA Breakthrough Therapy designation in NT1. The market opportunity for narcolepsy and idiopathic hypersomnia (IH) alone is estimated to be in excess of $10 billion.
- Alkermes is acquiring Avidel, which includes its commercial narcolepsy drug Lumryz, an FDA-approved medicine that generated $390 million of cumulative sales since its launch two years ago and approximately $250 million in the last trailing 12-month period. This acquisition is expected to be accretive and enhance profitability in 2026.
- For 2026, Alkermes plans to initiate the ALKS 2680 registrational Phase 3 narcolepsy program in Q1 and complete its idiopathic hypersomnia Phase 2 study in Q4.
- Alkermes' commercial business generated more than $1.4 billion in total revenues in 2025, demonstrating strong cash flow and profitability.
- The planned acquisition of Avidel is expected to close this quarter, augmenting revenue growth, diversifying the commercial portfolio, and enhancing profitability in 2026. Avidel's narcolepsy drug, Lumryz, has generated $390 million of cumulative sales since launch and approximately $250 million in the last trailing 12-month period.
- ALKS 2680, an advanced orexin compound, is entering Phase 3 in narcolepsy in Q1 2026 and received FDA Breakthrough Therapy designation in NT1 at the end of 2025. The market opportunity for narcolepsy and idiopathic hypersomnia is estimated to be in excess of $10 billion annually.
- The company is also progressing other pipeline candidates, with 4510 initiating a multi-dose Phase 2A study for fatigue in MS and Parkinson's disease, and 7290 moving to Phase 2 in 2026.
- Alkermes' commercial business generated over $1.45 billion in total revenues in 2025, demonstrating strong cash flow and profitability.
- The company plans to close the acquisition of Avadel Pharmaceuticals plc in Q1 2026, which is expected to augment revenue growth, diversify the commercial portfolio, accelerate entry into the sleep medicine market, and be accretive and enhance profitability in 2026.
- Alixorexton, a development candidate with blockbuster potential, received FDA Breakthrough Therapy designation in Narcolepsy Type 1 (NT1) and is slated to enter Phase 3 in narcolepsy in Q1 2026.
- Topline data from the LUMRYZ™ (sodium oxybate) idiopathic hypersomnia Phase 3 study is anticipated in Q2 2026, with LUMRYZ™ holding patent protection until 2042.
- Alkermes plc announced on January 6, 2026, that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1 (NT1).
- Alixorexton is the company's novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist.
- This designation was based on positive phase 1 and phase 2 clinical data, including results from the Vibrance-1 study, which demonstrated statistically significant and dose-dependent improvements in wakefulness.
- Alkermes plans to initiate the global phase 3 development program for alixorexton in the first quarter of 2026.
- Alkermes plc received Breakthrough Therapy designation from the U.S. FDA for alixorexton, an investigational oral drug for the treatment of narcolepsy type 1 (NT1).
- This designation is supported by positive phase 1 and phase 2 clinical data, including the Vibrance-1 study, which demonstrated statistically significant and dose-dependent improvements in wakefulness for NT1 patients.
- Alkermes plans to initiate the global phase 3 program for alixorexton in the first quarter of 2026.
- Alkermes' CEO Richard Pops expressed high confidence in Elixirxton's approval for Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2), based on positive Vibrance-1 and Vibrance-2 clinical data.
- The Vibrance-2 study for NT2 demonstrated statistically and clinically significant changes, with 70% of patients at the 18mg dose achieving normalcy on the ESS score.
- Alkermes plans to leverage dosing flexibility for Elixirxton, including potential split dosing, given its favorable tolerability profile with no dose-limiting toxicity observed up to 18mg.
- Phase 3 study designs for NT1 and NT2 have been finalized, with the FDA expected to recommend 40-50 patients per arm and likely 3-4 active dosing arms for NT2.
- The company anticipates similar efficacy signals for Elixirxton in Idiopathic Hypersomnia (IH) from the Vibrance-3 study, with the Epworth Sleepiness Scale (ESS) as the primary endpoint.
- Alkermes' Elixirxton (ALKS 2680) is anticipated to have a high probability of approval for Narcolepsy Type 1 (NT1) and its labeling is expected to extend to Narcolepsy Type 2 (NT2), based on Vibrance-1 and Vibrance-2 study data.
- In the Vibrance-2 study for NT2, Elixirxton demonstrated statistically significant and clinically significant changes, with 70% of patients at the 18-milligram dose achieving normalcy on the Epworth Sleepiness Scale (ESS) score.
- The company has observed no dose-limiting toxicity in NT2 patients at tested doses, allowing for significant dosing flexibility in future development, including a potential anchor once-daily (QD) 18-milligram dose and split dosing options.
- Alkermes has finalized phase 3 dosing for both NT1 and NT2, with the end-of-phase-two meeting briefing book submitted this week, and the FDA is expected to recommend 40 to 50 patients per arm for these studies.
- Alkermes believes Elixirxton will show similar efficacy in Idiopathic Hypersomnia (IH) as observed in NT2, with ESS designated as the primary endpoint for the IH study.
- Alkermes has experienced a transformational year, marked by positive NT1 and NT2 data and the announced intention to acquire Avadel.
- The company plans to acquire Avadel, a profitable company with $275 million of sales this year, to aggressively move into the hypersomnia market and leverage its commercial infrastructure for the launch of ALKS 2680.
- Positive Phase 2 data for ALKS 2680 in narcolepsy (NT1 and NT2) showed significant effects on cognition and fatigue, with Phase 3 trials for narcolepsy expected to kick off in Q1 next year (2026).
- Alkermes intends to aggressively fund its orexin program for new indications while maintaining robust profitability.
Quarterly earnings call transcripts for Alkermes.
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