Slide 1: Daridorexant delivers outstanding results in a Phase 2 study in children with insomnia
Daridorexant delivers outstanding results in a Phase 2 study in children with insomnia Investor presentation | March 2026
Slide 2: Forward-looking statements
Forward-looking statements The information in this presentation contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as “intend”, "estimates", "believes", "expects", "may", "are expected to", "will",
Slide 3: Quote from Jean-Paul Clozel, Chairman of the Board
“These results once again highlight the exceptional profile of daridorexant and represent a tremendous opportunity for Idorsia.” Jean-Paul Clozel, MD, Chairman of the Board 3 Investor webcast | Pediatric insomnia | 31 Mar 2026
Slide 4: Quote from Martine Clozel on orexin system
“We are seeing new signals that the orexin system may play an even more important role in neurodevelopmental disorders than previously understood.” Martine Clozel, MD, Chief Scientific Officer & Head of Research 4 Investor webcast | Pediatric insomnia | 31 Mar 2026
Slide 5: QUVIVIQ works differently to treatments that sedate the brain
QUVIVIQ works differently to treatments that sedate the brain Orexin stimulates many orexin wake-promoting pathways Dopamine (VTA) Histamine (TMN) Acetylcholine (LDT, PPT) Serotonin QUVIVIQ is a dual (raphe) Norepinephrine (LC) orexin receptor antagonist that LHA / PH Orexin suppresses the wake LC O
Slide 6: Better by design
Better by design 1000 Plasma concentrations Night Day (ng/ml) > 600 Optimal sleep 600 drug profile Optimized pharmacokinetic profile 400 Night Day 200 Sub-optimal sleep drug profile 0 Somnolence 0 24 48 72 96 120 144 168 Excessive duration results in somnolence Night Day • Fast absorption • Optimal
Slide 7: Patients fall asleep faster, stay asleep longer, and QUVIVIQ works throughout the night
Patients fall asleep faster – stay asleep longer and QUVIVIQ works throughout the night 2 Change from baseline in WASO (min) 0 * • Daridorexant 50 mg significantly improved the objective sleep parameters LPS and WASO -2 vs placebo at months 1 and 3 -4 • Daridorexant 50 mg significantly improved -6 s
Slide 8: QUVIVIQ increases morning alertness at 50 mg
Morning sleepiness as measured by visual analog scale (VAS) is improved: QUVIVIQ increases morning alertness at 50 mg Rate the way you feel this morning by marking clearly and vertically across the line below: Very sleepy Not at all sleepy 37.2 Baseline 38.0 41.8 Placebo Month 1 48.1 Daridorexant 50
Slide 9: QUVIVIQ is the only therapy to demonstrate improvement in daytime functioning
QUVIVIQ is the only therapy to demonstrate improvement in daytime functioning IDSIQ© sleepiness domain IDSIQ© alert/cognition domain IDSIQ© mood domain 24 35 22 Placebo (n=310) Daridorexant 50 mg (n=310) Mean of observed values Mean of observed values Mean of observed values 20 22 (min) [± SEM] (min
Slide 10: Safety profile comparable with placebo
Safety profile comparable with placebo Reported Adverse Reactions in Overall Population (Study 1)1,2,a aRates of adverse reactions reported in ≥2% of QUVIVIQ 25 mg QUVIVIQ 50 mg Placebo QUVIVIQ-treated patients and greater than in placebo- treated patients (Study 1); (n = 310) (n = 308) (n = 309) bH
Slide 11: The burden of pediatric insomnia
The burden of pediatric insomnia Pediatric insomnia Significant unmet need • Difficulty initiating or maintaining sleep that is • Estimated prevalence of 10% to 30%* perceived as a problem by the child or • Higher prevalence in neurodevelopmental caregiver due to its severity, chronicity, conditions
Slide 12: Quote from Alberto Gimona on pediatric opportunity
“As the only DORA being investigated in children, daridorexant could become not only best-in-class for adults, but first-in-class for the pediatric population.” Alberto Gimona, MD, Head of Global Clinical Development & Medical Affairs Daridorexant for pediatric use is investigational and not approve
Slide 13: Phase 2 dose-finding study design
Phase 2 dose-finding study design Screening Treatment Period Safety Follow-up Multi-center, double-blind, randomized, placebo-controlled, Double-blind parallel group, polysomnography, dose finding Randomization study assessing the efficacy, safety, and pharmacokinetics of Day 1 EOT multiple-dose ora
Slide 14: Study objectives
Study objectives Primary objective • To characterize the dose-response relationship of daridorexant on objective TST in pediatric subjects with insomnia disorder. Exploratory objectives • To characterize the dose-response relationship of daridorexant on other objective sleep parameters in pediatric
Slide 15: Study population stratification
Study population stratification FDA EMA Group 1 Group 2 Group 3 Insomnia disorder Insomnia disorder Insomnia disorder (without associated NDD) associated with subthreshold associated with NDD ASD or ADHD traits 15 Investor webcast | Pediatric insomnia | 31 Mar 2026
Slide 16: Demographic characteristics
Demographic characteristics Placebo Daridorexant Daridorexant Daridorexant Total N=41 10 mg 25 mg 50 mg N=165 N=40 N=42 N=42 Age at screening (years) [n (%)] 10-11 6 (14.6) 16 (40.0) 3 (7.1) 9 (21.4) 34 (20.6) 12-17 35 (85.4) 24 (60.0) 39 (92.9) 33 (78.6) 131 (79.4) Sex [n (%)] Female 23 (56.1) 17 (
Slide 17: Baseline disease characteristics
Baseline disease characteristics Placebo Daridorexant Daridorexant Daridorexant Total N=41 10 mg 25 mg 50 mg N=165 N=40 N=42 N=42 Time since insomnia diagnosis at randomization (years) Mean (SD) 3.59 (3.07) 4.81 (3.70) 4.17 (3.55) 3.74 (3.32) 4.07 (3.42) Median (Min, Max) 2.4 (0.4, 12.1) 4.2 (0.3, 1
Slide 18: Daridorexant efficacy in pediatric population
Daridorexant efficacy in pediatric population • Analysis of the primary endpoint demonstrated a statistically significant (p=0.0185) dose-dependent improvement in TST from baseline on Day 1 • Phase 2 results show dose-dependent, clinically meaningful, and statistically significant improvements acros
Slide 19: Similar safety profile across treatment groups
Similar safety profile across treatment groups Placebo Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg N=41 N=40 N=42 N=42 n (%) n (%) n (%) n (%) Participants with at least one: AE 10 (24.4) 11 (27.5) 7 (16.7) 10 (23.8) SAE 1 (2.4) 0 0 0 AE leading to temporary study treatment interruption
Slide 20: Daridorexant well tolerated across all doses
Daridorexant well tolerated across all doses Placebo Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg N=41 N=40 N=42 N=42 Preferred Term n (%) n (%) n (%) n (%) Participants with at least one event 7 (17.1) 8 (20.0) 5 (11.9) 8 (19.0) Somnolence 1 (2.4) 2 (5.0) 1 (2.4) 3 (7.1) Headache 0 3 (7
Slide 21: Morning sleepiness as measured by visual analog scale is improved
Morning sleepiness as measured by visual analog scale (VAS) is improved Rate the way your child feels this morning by marking clearly and vertically across the line below: Very tired Very refreshed Baseline Placebo Daridorexant 50 mg Week 2 Daridorexant for pediatric use is investigational and not a
Slide 22: Next steps
Next steps Pediatric insomnia Beyond insomnia • Phase 2 dose-finding study is part of an approved • Detailed results will be shared at Pediatric Investigational Plan (PIP) with EMA and upcoming congresses and in peer- Initial Pediatric Study Plan (iPSP) with FDA reviewed publications • Engage with h
Slide 23: A turning point for Idorsia?
A turning point for Idorsia? What do these results mean? • Safety and tolerability profile in children as young as 10 will have a halo effect on adult population • The results in pediatric population should influence the de-scheduling process in the US • Significant medical need in pediatric insomni