Slides
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Develop and deliver transformative medicines for the hundreds of millions of people impacted by central nervous system conditions
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3 5 6 7 10 >$16B peak sales potential Robust intellectual property portfolio with patent protection through the 2040s >150M Patients impacted
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• • • •
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~ ൗ2 3
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FDA Breakthrough Therapy Designation FDA Orphan Drug Designation Major Depressive Disorder Alzheimer’s Disease Agitation Smoking Cessation Attention Deficit Hyperactivity Disorder Binge Eating Disorder Major Depressive Disorder with EDS Excessive Daytime Sleepiness in Narcolepsy or OSA Migraine Narcolepsy Fibromyalgia Shift Work Disorder AXS-05 (dextromethorphan-bupropion) Solriamfetol AXS-12 (reboxetine) AXS-14 (esreboxetine) Solriamfetol
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$0.5-$1B $0.5-$1B $1.5-$3B $1-$3B$0.5-$1B $0.3-$0.5B $0.5-$1B $1-$1.5B $0.3-$0.5B $1-$3B $0.5-$1B
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2025 & 2026 • • 2025 • • • • •
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Shaping the frontier of differentiated innovation in brain health
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$171.0 $104.8 63% $442.5 $266.9 66% $136.1 $80.4 69% $352.0 $198.8 77% $32.8 $24.4 35% $88.0 $68.1 29% $2.1 ̶ ̶ $2.5 ̶ ̶ $40.2 $45.4 -11% $134.5 $132.1 2% $150.2 $95.6 57% $401.3 $298.1 35%
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$325.3M $190M $6.7B 50.3M 9.3M Runway to reach cash flow positivity, based on the current operating plan
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~$5B combined peak sales potential • • • Migraine with or without auraMajor depressive disorder EDS in narcolepsy or OSA • • • • • •
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$5.2 $15.8 $27.6 $37.7 $49.0 $53.4 $65.0 $80.4 $92.6 $96.2 $119.6 $136.1 Millions 3Q 2025 net product sales of $136.1M 69% +69%
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$8.8 $16.8 $19.2 $13.1 $19.1 $20.1 $22.5 $21.6 $22.1 $24.4 $26.2 $25.2 $30.0 $32.8 Millions 3Q 2025 net product revenue of $32.8M represents 35% YoY growth +35%
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β
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7M 14M
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CMAI Total Score Week Weeks from Randomization Probability of Freedom from Relapse (%) Hazard Ratio (95% CI) p-value Supplemental New Drug Application (sNDA) submitted to the FDA
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• FOCUS Phase 3 (N PARADIGM Phase 3 (EDS subgroup n=51 ENGAGE Phase 3 (N SUSTAIN Phase 3 (N • • • • • ADHD MDD BED SWD
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LS mean change from baseline (SE) Initiation of Phase 3 pediatric trial anticipated in 4Q 2025
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• •
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• •
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Weekly cataplexy attacks (median) Change in weekly cataplexy attacks (median) Rate ratio* New Drug Application (NDA) submission on track for 4Q 2025
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Weekly mean pain score Week Weekly mean pain score Week Weekly mean pain score Week Initiation of new Phase 3 trial anticipated in 4Q 2025
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• • • • • • • • • • • • • • •
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Roger Jeffs, PhD Herriot Tabuteau, MD Nick Pizzie, CPA, MBA Mark Jacobson, MA Hunter Murdock, JD Ari Maizel Mark Saad Mark Coleman, MD Susan Mahony, PhD Herriot Tabuteau, MD
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Thank you