Harmony Biosciences Holdings, Inc. · NASDAQ:HRMY
Harmony Biosciences — Q3 2025 Earnings Presentation
17 slides from Harmony Biosciences's earnings presentation, Nov 4, 2025
Slide 1: Q3 2025 Financial Results & Business Update
Copyright © 2024 Harmony Biosciences. All rights reserved. Q3 2025 Financial Results & Business Update November 4 , 2025 Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080
Slide 2: Forward-Looking Statements
Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statement
Slide 3: Unique Company Profile
WAKIX® APPROACHING BLOCKBUSTER STATUS UP TO 5 PHASE 3 REGISTRATIONAL TRIALS BY YEAR-END PROFITABLE, SELF-FUNDING BIOTECH POISED TO ACCELERATE GROWTH STRATEGY UNIQUE COMPANY PROFILE Harmony Biosciences | Q3 2025 Financial Results & Business Update | All rights reserved. Docusign Envelope ID: 2D97A8FD
Slide 4: WAKIX: Q3 2025 Strong Revenue Growth
WAKIX®: Q3 2025 Strong Revenue Growth 4 Harmony Biosciences | Q3 2025 Financial Results & Business Update | All rights reserved. 29% $186.0 $239.5 Q3 2024 Q3 2025 Year-Over-Year Revenue ($M) DOUBLE-DIGIT REVENUE GROWTH in Year 6 on the Market RECENTLY RAISED 2025 FULL YEAR GUIDANCE TO $845M - $865M
Slide 5: Differentiated Product and Strong Execution Drives Growth
5 Harmony Biosciences | Q3 2025 Financial Results & Business Update | All rights reserved. Differentiated Product and Strong Execution Drives Growth Q3 2025 HIGHLIGHTS • ~500 average patient adds represents highest quarterly increase since launch • 8,100 average patients on WAKIX • Highly differenti
Slide 6: Innovative Late-Stage Pipeline
Innovative Late-Stage Pipeline 6 Harmony Biosciences | Q3 2025 Financial Results & Business Update | All rights reserved. PRODUCT / INDICATION DISCOVERY PHASE PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING MARKETED PRODUCT Sleep/Wake WAKIX® EDS in Narcolepsy (Adults) Cataplexy in Narcolepsy (
Slide 7: Extending Our Leadership Position
Extending Our Leadership Position • Pitolisant HD: IND submission completed; to initiate Phase 3 registrational trials in narcolepsy and IH Q4 2025; utility patents filed with potential protection until 2044 • Pitolisant GR: Pivotal BE study topline data readout Q4 2025; Dosing optimization study co
Slide 8: Pitolisant HD: Phase 3 Registrational Trials in Narcolepsy & IH – Q4 2025
Pitolisant HD: Phase 3 Registrational Trials in Narcolepsy & IH – Q4 2025 8 Harmony Biosciences | Q3 2025 Financial Results & Business Update | All rights reserved. Q4 2025 Initiation of Phase 3 Registrational Trials of Pitolisant HD • Narcolepsy • IH ENHANCED FORMULATION WITH OPTIMIZED PK PROFILE A
Slide 9: Pitolisant GR: Fast To Market Strategy
Pitolisant GR: Fast To Market Strategy Designed to Demonstrate Bioequivalence to WAKIX® Formulation 9 Q1 2027 Target PDUFA Date PIVOTAL BIOEQUIVALENCE STUDY COMPLETED Topline Data in Q4 2025 DOSING OPTIMIZATION STUDY COMPLETED 100% of the patients (46/46) able to initiate pitolisant GR at the therap
Slide 10: ZYN002: Pharmaceutically Manufactured Synthetic Cannabinoid Gel in FXS
ZYN002: Pharmaceutically Manufactured Synthetic Cannabinoid Gel in FXS 10 Harmony Biosciences | Q3 2025 Financial Results & Business Update | All rights reserved. ZYN002: INNOVATIVE PRODUCT PROFILE 100% synthetic, pharmaceutically manufactured cannabidiol (CBD), devoid of THC, in a patent-protected,
Slide 11: EPX-100: One of Most Advanced 5-HT2 (Serotonin) Agonist Programs in DEEs
EPX-100: One of Most Advanced 5-HT2 (Serotonin) Agonist Programs in DEEs 11 Harmony Biosciences | Q3 2025 Financial Results & Business Update | All rights reserved. 2026 Anticipate Topline Data from Ongoing Global Phase 3 Trials • DS • LGS ESTABLISHED 5-HT2 (SEROTONIN) AGONIST MECHANISM OF ACTION Mo
Slide 12: Catalyst-Rich Pipeline Driving Value Beyond 2025
Catalyst-Rich Pipeline Driving Value Beyond 2025 12 Harmony Biosciences | Q3 2025 Financial Results & Business Update | All rights reserved.. Pipeline Poised to Deliver Multiple New Product or Indication Launches Over the Next Several Years KEY TAKEAWAY Q4 2025 Pitolisant HD Initiation of Phase 3 re
Slide 13: Financial Highlights Q3 2025
Financial Highlights Q3 2025 13 1. Non-GAAP Adjusted Net Income= GAAP Net Income excluding non-cash interest expense, depreciation, amortization, stock-based compensation, and tax effect of these items. Three Months Ended September 30, 2025 (In millions, USD) $186.0 $239.5 Q3 2024 Q3 2025 Net Produc
Slide 14: Financial Summary Q3 2025
Financial Summary Q3 2025 14 Harmony Biosciences | Q3 2025 Financial Results & Business Update | All rights reserved. Totals may not foot due to rounding Three Months Ended September 30, % Change Nine Months Ended September 30, 2025 2024 2025 2024 % Change Net Product Revenue $239.5 $186.0 29% $624.
Slide 15: GAAP vs NON-GAAP Reconciliation Q3 2025
GAAP vs NON-GAAP Reconciliation Q3 2025 15 Harmony Biosciences | Q3 2025 Financial Results & Business Update | All rights reserved. (In millions, USD) Totals may not foot due to rounding Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP net income1 $50.9 $46.1
Slide 16: Commitment to patients; deliver strong value to shareholders
16 Harmony Biosciences | Q3 2025 Financial Results & Business Update | All rights reserved. Commitment to patients Addressing unmet medical needs Delivering meaningful treatment options Helping patients thrive DELIVER ON PROMISE TO PATIENTS Executional excellence Innovative, catalyst-rich pipeline P
Slide 17: Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080
Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080
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