Nov 3, 2026 earnings call — Orexin pipeline and strong commercial quarter
Proprietary product net sales rose 31% year over year to $417.3 million in Q3.
Revenue $0.5B (est $0.5B) · EPS $0.09 (est $-0.08) · Next-quarter revenue outlook $0.4B–$0.4B
Key quotes
"I am pleased to report that we delivered strong performance across our commercial portfolio in the third quarter, reflecting contributions across addiction, psychiatry, and sleep medicine."
"Looking ahead, the next year will be a pivotal and data rich period for Alkermes. With 6 important studies expected to read out across our orexin portfolio."
"The REVITALIZE data will serve as the foundation for the sNDA submission for IH with the potential launch in March 2028, if approved."
Analyst Q&A 19
IH trial dosing and split dose
Q (Leonid Timashev): When will IH data come, how will you treat split dose vs once-daily, and what differences in response do you expect between populations?
A: Management said the IH dataset will give a lot of information, including once-daily dosing. They think IH is variable like NT2, but the long-sleeper subgroup is less known. They expect to see the split-dose data for the first time toward year-end.
"As you alluded to, first and foremost, we are going to be getting the once daily dosing for that program." — Blair C. Jackson (CEO)
Takeda pricing and your pricing flexibility
Q (Paul Matteis · Stifel): Where might Takeda price its product and can you adjust your pricing using different doses if they price low?
A: Management said Takeda will set pricing imminently in the next few weeks. They emphasized Alkermes has flexibility to adjust its pricing and will react after seeing Takeda's price.
"I think that you know, Takeda's going to be pricing imminently and we will see that in the next few weeks." — Blair C. Jackson (CEO)
Why try orexin in depression
Q (Mizuho): Why move into major depressive disorder and are there other psychiatric uses for an orexin agonist?
A: Management described preclinical work showing orexin agonism affects cognition, fatigue, mood and wakefulness, and translational signals in mood. They saw a synergistic serotonin increase when orexin agonists were combined with SSRIs/SNRIs and found depressive-like animal models responded similarly to ketamine or fluoxetine.
"we saw a really strong synergistic increase in serotonin in the prefrontal cortex when orexin agonism was given with SSRIs or SNRIs" — Blair C. Jackson (CEO)
ADHD trial design confidence
Q (Akash Tewari · Jefferies): Given existing stimulants' efficacy, why not change your ADHD trial to target a subtype and why do you think current design will show benefit?
A: Management said commercially attractive efficacy can vary and an orexin agonist may offer broader responses than stimulants. They believe Phase 1b supports their dose range and safety, so no study modification is needed and they will use the existing doses.
"And I think the early data that we saw in our Phase 1b program support all of those goals." — Blair C. Jackson (CEO)
How orexin agonist differs from antagonists
Q (Rudy Li · Wolfe): Why use an orexin agonist for MDD versus orexin antagonists like J&J used for insomnia?
A: Management said orexin agonism is a fundamentally different approach. They believe agonists directly impact mood centers and treat depressive symptoms, whereas antagonists targeted sleep hoping for downstream mood effects.
"We believe that we directly impact centers of mood within the brain and we are actually looking at treating the depressive symptoms directly." — Blair C. Jackson (CEO)
LUMRYZ outlook vs orexin launch
Q (David Amsellem · Piper Sandler): Will Takeda's daridorexant affect LUMRYZ new starts, and how will LUMRYZ uptake look in IH versus Xywav?
A: Management reported strong LUMRYZ performance and patient demand this year. They view orexin drugs and oxybates as complementary, expect initial switching but think LUMRYZ patients often remain on product, and see LUMRYZ competing both for new starts and switches in IH if approved.
"We think there is a long term durability in the oxybate market and a lot of excitement with orexins." — Christian Todd Nichols
ADHD physician feedback and placebo info
Q (Jessica Fye · JP Morgan): What feedback did physicians give on the ADHD dataset and how did placebo perform; when will more placebo details be available?
A: Management said physicians were excited about consistent responses across patient, physician, and objective measures. They reminded listeners the study was a safety study to explore therapeutic window and said a placebo comparison is not appropriate for that study, so they rely on objective and subjective measures already shared.
"Just as a reminder, the study itself was a safety study that was designed to look at the wide therapeutic potential that we could have and the therapeutic window we would have with an orexin agonist." — Blair C. Jackson (CEO)
Timing to Phase 3 after Vibrance-3
Q (David Hong · Deutsche Bank): After Vibrance-3 IH data, how quickly will you start Phase 3 and what might the Phase 3 design look like?
A: Management said they plan to move to Phase 3 as fast as possible but will meet the agency first, which may limit timing. They expect Phase 3 size to be similar to the NT2 study, but final size depends on the Phase 2 signal.
"What we would like to do though is meet with the agency first And so that actually will probably be our rate limiting step as making sure we get that meeting" — Blair C. Jackson (CEO)
Quarter dynamics for LUMRYZ
Q (Marc Goodman · Leerink Partners): What drove the quarter's LUMRYZ performance — new starts, discontinuations, pricing — any major changes?
A: Management said Q3 growth was driven by patient demand with patient counts rising to 4.1 thousand. They attributed growth to new enrollments, conversions, and persistency, and said net sales grew 16% year-over-year with no significant pricing pressure.
"the growth in LUMRYZ was really driven by patient demand." — Christian Todd Nichols
MDD study subgroup by sleepiness
Q (Joseph Thome · TD Cowen): Will the MDD study include a prespecified subgroup for excessive daytime sleepiness and will it be powered to compare groups or test mediation via ESS?
A: Management confirmed there is a prespecified subgroup with excessive daytime sleepiness. They will compare all-comers MDD versus that subgroup to see if the signal is enriched and use results to guide development.
"we do have a prespecified subgroup, which is a group that has excessive daytime sleepiness." — Blair C. Jackson (CEO)
Why Phase 1b ADHD was inpatient
Q (Truist): Why run Phase 1b ADHD in an inpatient setting and could that affect baseline or treatment response translation to outpatients?
A: Management said they ran Phase 1b inpatient to learn signals and dose range while using many tools; inpatient setting allowed controlled, staged assessments that would be hard outpatient. They do not think baseline characteristics changed and noted inpatient settings can amplify reported side effects, but overall safety profile was good and Phase 2 will determine clinical signal.
"So that is why we chose an inpatient setting." — Blair C. Jackson (CEO)
Split dosing and high doses in ADHD study
Q (Umer Raffat · Evercore): Could split dosing drive placebo and will you keep split dosing in ongoing outpatient ADHD and MDD trials? Also, what does the 90 mg upper dose say about potency versus narcolepsy drug?
A: Management said split dosing was used to standardize PK and to avoid confounding; ongoing Phase 2 uses both once-daily and split dosing and they may test other dosing forms later. They cautioned you cannot compare the 90 mg ADHD dose to narcolepsy because drugs, circuits and potency differ.
"So we use split dosing just because it was-- it is a more it just allowed us to standardize." — Blair C. Jackson (CEO)
IH baseline ESS and placebo similarity to NT2
Q (Ashwani Verma · UBS): Are IH baseline ESS scores and placebo response expected to resemble NT2, and what percent of IH are long-sleepers?
A: Management said entrance criteria are similar but actual enrollments depend on who shows up; they feel they are controlling placebo and usually wakefulness indications show smaller placebo responses than neuropsychiatric trials. They also said their study hasn't disclosed the long-sleeper percent, though in general IH long-sleepers are around 25%.
"I think as we as we look at this area overall, I think, you know, we feel pretty good that we are controlling placebo." — Blair C. Jackson (CEO)
Split dosing tradeoffs and learning who needs it
Q (Ami Fadia · Needham and Company): For IH readout, what guardrails on safety vs efficacy would stop pursuing split dosing, and will the study show which patients need split dosing?
A: Management said they have a wide therapeutic range and do not expect safety to be a gating factor for split dosing; they will compare split versus once-daily and assess if afternoon efficacy improves. They said the study may not give clear a priori predictors of who needs split dosing and doctors may have to empirically switch patients from once-daily to split as needed.
"split dosing, we do not see sort of a safety question as to what is going to determine whether we move to split dosing." — Blair C. Jackson (CEO)
What MADRS change is clinically meaningful
Q (Goldman Sachs): Given residual fatigue and anhedonia, what MADRS difference would be clinically meaningful for this novel mechanism?
A: Management said typical meaningful MADRS change versus placebo is about 2 to 5 points and cited Vraylar's roughly 3 to 3.5-point change as commercially meaningful due to unique characteristics and rapid onset. They aim to show statistical difference on MADRS and broader benefits in domains like cognition and fatigue as adjunctive therapy.
"I mean, I think, typically, people see a change versus placebo of somewhere between 2 and 5 as being a meaningful difference on MADRS" — Blair C. Jackson (CEO)
Vibrance-3 success criteria to advance
Q (Jason Gerberry · BofA): What do you need to see in Vibrance-3 to advance to Phase 3 — primary endpoint, magnitude on ESS/IHSS, and relation to Vibrance-2?
A: Management said Phase 2 is to understand signal and safety and help design Phase 3; they want statistical significance but would not stop the program if slightly short as long as a plausible trial design can overcome it. They hope to see similar once-daily effects as Vibrance-2 and added benefit from split dosing to inform Phase 3 planning.
"If we were to fall a little bit short, does that mean we would stop the program? No." — Blair C. Jackson (CEO)
Payer view if patients use both drugs
Q (Luke Herrmann · Baird): If some patients use both an orexin agonist and an oxybate, how do you expect payers to handle coverage and access?
A: Management said they are engaging payers and note oxybates have strong access north of 80%. They will consider Takeda's pricing and aim to set pricing and reimbursement so both products can have broad access.
"Our expectation is that we will put forward a profile in a pricing dynamic that will allow broad access to both products." — Christian Todd Nichols
MDD trial measures beyond MADRS
Q (Douglas Tsao · H. C. Wainwright): Will you assess individual MADRS domains or measures like SHAPS for anhedonia in the MDD trial?
A: Management said the primary endpoint is MADRS for the ongoing study, but they are looking at individual domains and will dive deeper into specific areas in later phases if signals emerge.
"for the ongoing study right now, our primary is really on the MADRS." — Blair C. Jackson (CEO)
Plans to test orexin plus oxybate together
Q (Benjamin Burnett · Wells Fargo): Do you plan studies of an orexin agonist combined with an oxybate and would you use LUMRYZ or valnoctamide as the comparator?
A: Management said they want to generate combination data to support safe and effective daytime orexin use with nighttime oxybates, but will wait until later in the registration program so core registrational work is not at risk. They said they will use LUMRYZ as the comparator.
"And, of course, we will use LUMRYZ as the comparator." — Blair C. Jackson (CEO)