Harmony Biosciences Holdings, Inc. · NASDAQ:HRMY
Harmony Biosciences — Q1 2025 Earnings Presentation
16 slides from Harmony Biosciences's earnings presentation, May 6, 2025
Slide 1: Q1 2025 Financial Results & Business Update
Financial Results Q1 2025 & Business Update May 6, 2025 Copyright © 2025 Harmony Biosciences. All rights reserved.
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
4+ YEARS OF PROFITABILITY; $600M+ ON BALANCE SHEET SELF-FUNDING BIOTECH FOUR ONGOING PHASE 3 REGISTRATIONAL TRIALS; UNIQUE COMPANY PROFILE UP TO SIX BY YEAR-END U.S.-CENTRIC OPERATIONS Harmony Biosciences | May 2025 | All rights reserved.
Slide 4: WAKIX Net Revenue Performance
WAKIX® Net Revenue Performance Year-over-Year Revenue ($M) HIGHLIGHTS 20% • Q1 2025 Net Revenue of $184.7M $184.7 • Durable double-digit sales growth continued through year five on the market $154.6 o Strong patient interest o Highly differentiated product profile o Continue to add new prescribers a
Slide 5: Innovative Late-Stage Pipeline
Innovative Late-Stage Pipeline PRODUCT / INDICATION PRE-IND PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING MARKETED PRODUCT Sleep/Wake WAKIX® EDS in Narcolepsy (Adults) Cataplexy in Narcolepsy (Adults) EDS in Narcolepsy (Pediatric) Pitolisant Prader-Willi Syndrome (PWS) Myotonic Dystrophy (DM1) Pitolisan
Slide 6: Sleep/Wake, Neurobehavioral, Epilepsy Neuro Programs
NEURO SLEEP/WAKE EPILEPSY BEHAVIORAL Extending Our Next Major Most Advanced 5-HT2 Leadership Position Clinical Catalyst Development Program • BP1.15205: potential best-in-class • Recruitment completed in Phase 3 • EPX-100: Phase 3 registrational trials orexin-2 agonist data to be presented at regist
Slide 7: 2025 Anticipated Catalysts
2025 Anticipated Catalysts 2Q25 3Q25 4Q25 BP1.15205 ZYN002 Pitolisant HD (OX2R agonist) FXS Phase 3 Initiation of Phase 3 • Preclinical data Registrational Trial registrational trials in presentation at (RECONNECT Study) narcolepsy and idiopathic SLEEP 2025 topline data readout hypersomnia (IH) • IM
Slide 8: BP1.15205: Potential Best-in-Class Orexin Receptor (OX2R) Agonist
BP1.15205: Potential Best-in-Class Orexin 2 Receptor (OX2R) Agonist OREXIN CLASS Next wave of Sleep/Wake therapeutic innovation TEIJIN Tokyo-based Pharma; innovator of TPM-1116 (now BP1.15205) 2Q 25 PRECLINICAL DATA PRESENTATION AT SLEEP IN JUNE Preclinical safety and efficacy data presentation at S
Slide 9: ZYN002: Potential for First Approved Treatment in Fragile X Syndrome
ZYN002: Potential for First Approved Treatment in Fragile X Syndrome ZYN002: INNOVATIVE PRODUCT PROFILE Purely synthetic cannabidiol (CBD); devoid of THC; Permeation enhanced gel LEAD PROGRAM IN FRAGILE X SYNDROME (FXS) 3Q 25 Phase 3 RECONNECT Study designed to replicate the positive findings from t
Slide 10: Pivotal Phase 3 RECONNECT Trial
Pivotal Phase 3 RECONNECT Trial: Design Optimized from Phase 2/3 CONNECT-FX Trial Primary Analysis in patients with complete methylation Extended treatment period by 4 Successful completion of weeks Phase 3 pivotal trial expected to satisfy requirements for an NDA submission in the U.S. Increased do
Slide 11: Pitolisant HD: Phase 3 Registrational Trials in Narcolepsy and IH in Q4 2025
Pitolisant HD: Phase 3 Registrational Trials in Narcolepsy and IH in Q4 2025 OPTIMIZED PK PROFILE AND HIGHER DOSE Designed to address the need for greater efficacy in excessive daytime sleeping (EDS) and other symptoms in patients with central disorders of hypersomnolence 4Q 25 PROGRAMS TO PURSUE A
Slide 12: Financial Highlights Q1 2025
Financial Highlights Q1 2025 (In millions, USD) Three Months Ended March 31, 2025 20% UNIQUE COMPANY PROFILE $184.7 Net Product $154.6 ✓ 20% Revenue Growth: Year 6 on the market Net Product Revenue Revenue Q1 2024 Q1 2025 ✓ 2025 Full Year Revenue Guidance: $820-$860M 19% ✓ Strong Profitability: 4+ Y
Slide 13: Financial Summary Q1 2025
Financial Summary Q1 2025 (In millions, USD) Three Months Ended March 31, % Change Totals may not foot due to rounding 2025 2024 Net Product Revenue $184.7 $154.6 20% Cost of Product Sold 32.0 27.5 16% Total Operating Expenses $96.5 $75.1 29% R&D Expense 34.5 22.2 56% S&M Expense 30.7 27.2 13% G&A E
Slide 14: GAAP vs Non-GAAP Reconciliation Q1 2025
GAAP vs NON-GAAP Reconciliation Q1 2025 (In millions, USD) Three Months Ended March 31, Totals may not foot due to rounding 2025 2024 GAAP net income $45.6 $38.3 Non-cash interest expense(1) 0.2 0.2 Depreciation 0.0 0.2 Amortization(2) 6.0 6.0 Stock-based compensation expense 12.5 10.4 Income tax ef
Slide 15: Deliver On Promise To Patients
DELIVER ON DELIVER PROMISE STONG VALUE TO PATIENTS TO SHAREHOLDERS Commitment to patients Innovative Addressing unmet medical needs Catalyst-rich pipeline Delivering meaningful treatment options Profitable biotech company Helping patients thrive Meaningful investment opportunity 15 Harmony Bioscienc
Slide 16: company/harmonybiosciences/ @harmonybio harmony_biosciences
company/harmonybiosciences/ @harmonybio harmony_biosciences w w w. h a r m o n y b i o s c i e n c e s . c o m Copyright © 2025 Harmony Biosciences. All rights reserved.
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